Gastro Health Magazine - Premier Issue

WOMEN’S CARE CENTER

GOT HEMORRHOIDS?

CANCER PREVENTION

INCREASE YOUR FIBER POCKET GUIDE INSIDE

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MAKE A DIFFERENCE FOR THE FUTURE PARTICIPATE IN CLINICAL RESEARCH ................................................................................................

Take Steps for

CROHN’S & COLITIS

PREMIERE EDITION

C onvenient &C ompassionate Galloway Endoscopy Center is an accredited surgical facility offering diagnostic and therapeutic gastrointestinal procedures in a comfortable and convenient outpatient setting.

Our compassionate, bilingual staff provides top-quality care while assisting our experienced and highly skilled doctors.

Best of all, because of advances in medical technology, endoscopic procedures can be safely performed outside the hospital, so you can return to the comfort of your home the same day as your procedure.

You have a choice in healthcare. Isn’t it time you got treated better?

A division of Baptist Surgery and Endoscopy Centers

7500 SW 87 Avenue, Suite 101 • Miami, FL 33173 • gallowayendoscopy.com • 305-595-9511 Committed to our faith-based charitable mission of medical excellence

Gastro Health Welcomes you The physicians and staff of Gastro Health are pleased to present the inaugural issue of Gastro Health Magazine. Inside you will find informative articles on various digestive diseases such as inflammatory bowel disease, irritable bowel syndrome, celiac disease, and fatty liver, among others. We hope you find the information useful and educational.

The physicians of Gastro Health are Board-Certified in Gastroenterology and are able to diagnose and treat digestive disorders and liver diseases like the ones discussed in the articles. Gastro Health’s physicians and clinical staff are dedicated to providing excellent medical care and customer service to their patients. This includes services such as a state-of-the-art imaging center with CT scanning and ultrasound, infusion services, pathology, nutritional consultation with our staff nutritionists, and our specialty care centers in Women’s Health and Inflammatory Bowel Disease.

At Gastro Health, we take great pride in performing endoscopic procedures in modern, cutting-edge ambulatory surgical centers. If you, a family member, or loved one needs consultation with a gastroenterologist, the physicians and staff at one of Gastro Health’s several locations would be privileged to assist you.

Lastly, educational opportunities such as Gastro Health Magazine would not be possible without the generous support of our sponsors and clinical partners. Together, we can all contribute to better health care for all our patients.

In this issue 5 6 8 9 10 12 13 16 17 22 23 24 28

Got Hemorrhoids?

The ABCs of IBD Nutrition Counseling for IBS The Fiber Guide Women’s Health Are You Gluten Sensitive?

Physicians Directory Clinical Staff New Approaches to Anemia Participate in Clinical Research What is Colorectal Cancer?

What is Fatty Liver?

Your Remicade Treatment

Eugene Hernandez, M.D. Managing Member, Gastro Health, PL

Designed and published by;

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9415 SW 72 ST, Suite 274

11900 Biscayne Blvd. Suite 630

Miami, FL 33173

Miami, FL 33181

T. 305.468.4180

T. 305.820.0690

www.gastrohealth.com

info@creativemindworks.com

GASTRO HEALTH MAGAZINE / JANUARY 2011

Got

Hemorrhoids?

We are excited to announce that our office is now offering a new hemorrhoid banding treatment. This new system allows the treatment of internal hemorrhoids in the office setting, without surgery or pain.

Our innovative technique is safe and effective. It does not require a preparation and, being virtually painless, can be done without anesthesia. It is done in three sessions, taking very few minutes each time. Patients are able to return to work immediately after the procedure.

Hemorrhoids affect more than 50% of the population over 30 years old. Many people with hemorrhoids suffer for years with symptoms that come and go, using creams, ointments and suppositories for partial and temporary relief.

They would avoid traditional hemorrhoid surgery because of the pain and discomfort.

Today, rubber band ligation is the most common procedure used to treat hemorrhoids with roughly 50 million performed worldwide each year. Rubber banding can treat approximately 90% of all hemorrhoid patients and is as effective as surgical removal of hemorrhoids , while being much less invasive and less painful.

Over the years, a number of other treatments have been used to treat serious cases of hemorrhoids, including infrared photocoagulation, cryotherapy, sclerotherapy, ultrasound activated scalpel and bicap electrocoagulation.

Compared to these techniques, rubber band ligation is more effective at elimination of hemorrhoid tissue and Gastro Health controlling symptoms. The technique is also faster and more comfortable than most of these methods.

Eduardo Ruan, MD Board Certified Gastroenterologist

At GastrHealth, we use the CRH-O’Regan® system, which cuts off the internal hemorrhoids’ blood supply with a tiny rubber band. It is faster, more accurate, more comfortable and less likely to result in post-procedure pain and bleeding. That’s because other hemorrhoid rubber band ligation methods use sharp, metal-toothed forceps to grab the tissue. This may puncture the muscle layer and result in post-procedure pain or other complications.

With the unique CRH-O’Regan® system we manually control all aspects of the procedure for a more gentle and accurate placement of the bands away from sensitive tissue. Because the device is also smaller than other systems, our method of treatment provides better comfort and faster healing for our patients.

To schedule an appointment for a consultation on the hemorrhoid banding treatment call 305.913.0666

GASTRO HEALTH MAGAZINE / JANUARY 2011

:: 05

The ABCs of IBD Inflammatory bowel disease (IBD)

The diagnosis of Crohn’s Disease involves taking the patient’s history

includes two painful conditions

and conducting a physical exam, laboratory tests, imaging studies and

– Crohn’s Disease (CD) and

endoscopic evaluation.

ulcerative colitis (UC) – that are

Jose P. Ferrer, Jr., MD Board Certified Gastroenterologist

associated with inflammation of

A variety of medical therapies are used to decrease inflammation in patients

the body’s digestive tissues. The

with Crohn’s Disease. But surgery may be needed to correct complications

inflammation is believed to be the

such as obstruction or blockage of the intestine. Signs of a blockage include

result of an abnormal response of

a swollen abdomen, pain and vomiting. Other complications of CD include

the body’s immune system that

fistulas, anal fissures and nutritional deficiencies. Smoking can worsen all

is influenced by our intestinal

of these conditions. Surgery can be highly effective in treating these types

flora, environment and certain

of complications. Our goal is always to preserve as much of the intestine as

genetic predispositions. In some

possible and improve the patient’s quality of life.

people, this response spirals out of control, leading to ulcerations

Ulcerative colitis is also characterized by chronic inflammation in the

and bowel pain. In addition, colorectal cancer has been linked to UC and to

gastrointestinal tract, but UC is limited to the colon or large intestine. The

CD, to a lesser extent.

inflammation usually begins in the rectum and extends continually into the colon.

Today, an estimated 1.4 million people in United States have IBD, a chronic

The first symptom of UC is usually diarrhea, which can be bloody. Abdominal

condition that can significantly reduce the quality of an individual’s daily life.

pain, weight loss and rectal urgency are also frequent symptoms. As with CD,

Approximately 20% of patients with UC have a close relative with IBD, indicating

there may be other symptoms outside the GI system, which may or may not

a possible genetic connection.

correlate with the colitis activity.

Therapies for IBD include anti-inflammatory medications that coat the colon

Complications of UC can include profuse bleeding and life-threatening

and those that regulate the immune system. The common anti-inflammatory

abdominal distention referred to as “mega colon.” Approximately 1/3 of

medications are aminosalicylates (5-ASA) and corticosteroids, while the “immune-

patients need surgery to remove the colon and reconnect the intestine.

modulators” include 6-Mercaptopurine and Azathioprine. There is also a class of

However, unlike CD, the surgery is “curative” as the inflammation is limited

medications referred to as “biologics,” which are antibodies directed toward tumor

to the colon.

necrosis factor (TNF), which can affect the degree of inflammation.

Besides a history and physical, the diagnosis may include labs, stool studies and Crohn’s Disease is characterized by chronic inflammation of any part of the GI

a flexible sigmoidoscopy to assess the rectal and colon tissues, and sometimes

tract, although it more commonly affects the ileum and colon. The most frequent

obtain biopsies. Medical therapies typically seek to decrease inflammation and

symptoms are diarrhea, abdominal pain, fever and GI bleeding. Decreased appetite

improve quality of life for our patients.

and weight loss also can occur, since the body is taking in fewer calories and has

06 ::

difficulty absorbing foods in the digestive tract. The symptoms of CD may also

Through research and advances seen in clinical trials, treatments for IBD, CD and

extend outside the GI tract to the skin, joints, eyes and the liver.

UC are moving forward rapidly and new medications are on the horizon.

GASTRO HEALTH MAGAZINE / JANUARY 2011

Load it. Chart it. SCore it. Show it.

Track your Crohn’s symptoms for your next doctor visit.

Let your iPhone * app tell your Crohn’s story. ®

Now it’s easy to share your symptoms with your doctor—and help determine the best treatment for you. Record symptoms as they happen and track them over time, along with your diet.

Get your Free Crohn’s diary app now at www.Cddiary.com *Indicated trademarks are registered trademarks of their respective owners. © Centocor Ortho Biotech Inc. 2010 8/10 25RGU10004

NUTRITION COUNSELING FOR IBS A new diet helps patients with

and if their symptoms will improve with this change in diet. We provide guidelines

irritable bowel syndrome (IBS) lose

for therapy to our patients and review their progress and symptoms.

weight and feel better.

If the patient’s symptoms do improve, we then go into a “challenge” phase, adding The FODMAPS Diet is a carbohydrate-

each FODMAPS group back into the diet one at a time. Along the way, our team of

restricted diet for patients diagnosed

nutritionists follows the patient’s progress on a regular basis. This phase lasts six

with

weeks, and allows us to determine which carbohydrate group is a trigger for the

IBS

and

other

digestive

conditions, like Crohn’s Disease or

digestive symptoms.

ulcerative colitis, for which traditional therapies have not been successful.

In general, our gastroenterologists work closely with our nutritionists to improve symptoms related to patients’ digestive disorders. One of the most common

Rebecca Karousatos, RD, LDN Registered Dietician and Licensed Nutritionist

The FODMAPS diet is carefully

topics involves losing weight. In fact, about 99% of patients want a nutritionist

structured to identify food substances

to provide weight loss instruction. Weight loss is also a vital aspect of a

that may be causing digestive problems.

treatment plan for other conditions like fatty liver, high cholesterol, hypertension

First, patients are given a Symptom

and diabetes.

Rating Checklist and asked to rate their symptoms for one week. Then, the patient starts the diet, beginning with the “elimination” of foods with lactose, fructose,

When patients are ready, we provide education and recommendations to make

fructans, polyols and galactans for two weeks..

a “healthy lifestyle change,” rather than “how to diet.” Of course, the ultimate success of this approach depends on the patient’s commitment to make the change

Within those two weeks, patients will be able to tell if they are FODMAPS sensitive

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GASTRO HEALTH MAGAZINE / JANUARY 2011

– but we are here to help them succeed in that goal.

THE FIBER GUIDE Fiber is probably one of the most misunderstood dietary components.

Many people, even physicians, are

Low Fiber:

High Fiber Alternative:

confused about the different types

Cheese crackers Corn flakes, rice cereals Croissants Dried fruit, nuts

Fresh or stewed fruit Fruit salad Nut butters Shredded or puffed wheat

of fiber, the benefits, and how much fiber should be consumed.

This article should help you better

Fruit juice

Vegetables

importance to your health.

Jam Pasta, white rice Pudding

Wheat crackers Whole grain pasta, brown rice Whole-grain bread

What is Fiber?

White bread

Whole-grain muffins

understand the role of fiber and its

Andrew Sable, MD Board Certified Gastroenterologist

Fiber is a polysaccharide, sugar-like substance that comes in hundreds

of forms. Dietary fiber is the indigestible portion of plant foods found mainly in its outer layers. Fiber passes through the human digestive tract virtually unchanged, without being broken down into nutrients. Most people know the importance of fiber, but few really understand how to best integrate fiber into a diet.

How much?

Over a hundred years ago, a change in the way wheat was processed substantially

Other High Fiber Foods Apples Beans (Legumes) Berries Bran Broccoli Brown rice Brussel sprouts Carrots Cauliflower Corn

Figs Multi-grain cereal Oatmeal Oranges Pears Peas Popcorn Prunes Whole-wheat bread

removed the dietary fiber in flour. Because of this, most of us only consume a small fraction of the amount of recommended daily fiber. In fact, the average American consumes only about 10% of the fiber that was part of a normal diet 100 years ago.

The human body is well designed to accommodate many of the different types of fiber found naturally in foods. In fact, the National Academy of Sciences Institute of Medicine recommends 30-38 grams of fiber for men and 21-25 grams of fiber for women, each day.

Understanding fiber: Dietary fibers are mostly soluble or insoluble. Fibers that dissolve in water (soluble) make a gel-like substance that may soften stools, hold cholesterol and fats, and lower blood sugar. Soluble fibers promote increased growth of essential bacteria in the colon thereby increasing bulk. Some examples are fruits, wheat, leafy vegetables, oats, beans and substances such as celluloses, pectin, psyllium and gums. Fibers that do not dissolve in water (insoluble), bind water in the colon.

Fiber Supplements: Although less ideal than natural food-based fibers, fiber supplements may be an important part of your daily fiber intake. Below are some examples of fiber products and their active ingredients that are commonly available. This is not intended to be a complete list.

Soluble:

Insoluble:

Benefiber

FiberCon (polycarbophil)

(before 2006 guar gum, now wheat dextran) Citrucel (methylcellulose) FiberSure (Inulin) Konsyl (Psyllium) Metamucil (psyllium)

This sponge-like effect bulks stools and binds materials such as bile and potential carcinogens. Examples of insoluble fibers include whole grains, cereals, vegetables corn, rice, and bran. Both soluble and insoluble fibers may help patients with irritable bowel syndrome, diverticular disease, heart disease, and obesity. They may

both soluble and insoluble, that’s healthier than fiber supplements as they contain

also potentially reduce the risk of colorectal cancer.

essential vitamins and minerals not found in supplements. However, some people may need supplements for certain medical problems if dietary changes do not

How to take fiber:

supply enough daily fiber.

High fiber foods are good for your health, but adding too much too quickly can

Food choices:

promote intestinal gas, bloating and cramps. Increase fiber in your diet gradually over a few weeks including plenty of fluids (6-8 glasses a day). This will allow

Many everyday low-fiber foods do have high-fiber alternatives, so make smart food

your digestive system the appropriate time to adjust. The best sources of fiber are

choices. Also, it’s important to know that freezing, drying, and normal cooking do

those found in foods. Eating a diet rich in fiber will incorporate varieties of fiber,

not significantly alter the fiber content of most foods.

GASTRO HEALTH MAGAZINE / JANUARY 2011

:: 09

Women’s Health Women and men share many of the same health concerns. However, there are many health issues that are more common in women, including constipation, irritable bowel syndrome, and non-ulcer dyspepsia. Women also have specific gastrointestinal issues, such as fecal incontinence and difficulty having a bowel movement usually caused by the trauma of childbirth.

Throughout the course of our lives, women have continuous hormonal changes that affect us in many ways, including our gastrointestinal system. Typically over time, women become more constipated, a problem that affects many postmenopausal women. Constipation may be a problem for pregnant women, as well.

Fortunately, constipation is easily treated and prescription medications are rarely needed. Most women can address this issue with lifestyle modifications and natural products. However, prescription medications are available for women who need them.

Stress is one of the health issues that affect women just as much as men. However, women tend to channel stress into their GI tracts. For women with irritable bowel syndrome (IBS), stress can worsen the situation, resulting in more abdominal discomfort or cramping, diarrhea, constipation or a combination of these symptoms. Symptoms of IBS may also include nausea and acid reflux.

There are many treatments available to women suffering with IBS, including medications. However, it is important to address the stressors in a woman’s life when medical treatment is initiated. This approach is important, because untreated IBS symptoms could lead to further problems, including peptic ulcer disease, Barrett’s esophagus or hemorrhoids.

Dr. Stefania Vernace Board Certified Gastroenterologist

In fact, many women suffer from hemorrhoids during pregnancy and childbirth or at some point after delivery. In many cases, hemorrhoids can be treated with over-the-counter and prescription medications.

If medications are not successful, the physicians at Gastro Health have a simple in-office procedure for treatment. This treatment, called the CRH-O’Reagan system, involves gently placing a rubber band around the tissue. It is performed by a physician in the office and takes only a few minutes. No preparation is needed and you can return to work immediately after the procedure.

As our society changes, women are called upon to do more and more each day. As a result, we are under increasing amounts of stress and external pressures. Most of the time, treating the gastrointestinal issues that women have requires a complete approach to her as an individual and not just treatment of the symptoms of a disease. Our doctors at Gastro Health understand this and have a complete team available to care for female patients and their specific gastrointestinal conditions.

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GASTRO HEALTH MAGAZINE / JANUARY 2011

PROMETHEUS® Crohn’s Prognostic Know their risk.

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Contact your Prometheus representative today or call 888-423-5227.

Prometheus provides important information to aid in the prognosis of CD and in the diagnosis and management of certain diseases and conditions. How this information is used to guide patient care is the responsibility of the physician.

PROMETHEUS, the Link Design, and For the person in every patient are trademarks or registered trademarks of Prometheus Laboratories Inc. ©2010 Prometheus Laboratories Inc. All rights reserved. CD10012 7/10 Prometheus products, services, and technology are covered by one or more US patents and patents pending. For more information, see www.prometheuslabs.com.

9410 Carroll Park Drive, San Diego, CA 92121 888-423-5227

www.prometheuslabs.com

are you gluten sensitive?

Celiac disease is a chronic intestinal disease that is caused by the body’s heightened sensitivity to gluten, a protein found in wheat, barley, and rye. Although the earliest known reports of celiac disease date back to the first century AD, celiac disease is now being diagnosed with increasing frequency due to improved testing and heightened public awareness.

Eugenio Hernandez, MD Board Certified Gastroenterologist

Although most people with Celiac disease do not have clear symptoms, they often suffer from gastrointestinal complaints, such as gas, bloating,

and flatulence. Other signs of Celiac disease are related to the body’s difficulty in absorbing food, resulting in diarrhea, abdominal pain, and weight loss.

Celiac disease may also create symptoms outside the gastrointestinal tract, such as rashes (dermatitis herpetiformis) and anemia due to deficiencies of iron, folic acid, B12, calcium, magnesium, zinc or other needed nutrients. In young children, Celiac can result in developmental problems.

Celiac disease is an inherited disease associated with certain chromosomal markers.

That means it’s important to review your family history to see if parents or siblings have suffered from these types of problems. In many cases, screening of the blood looking for certain antibodies may assist in making a diagnosis of Celiac disease.

Confirming this condition may require taking biopsies from the duodenum during an upper endoscopy.

The treatment of Celiac disease basically requires lifelong strict adherence to a gluten-restricted diet. This can be difficult due to the widespread use of gluten in many food products. However, an increasing number of grocery stores, bakeries and restaurants are now aware of Celiac disease and offer patrons gluten-free foods.

Consultation with a registered nutritionist is also often recommended and usually proves quite helpful in the successful treatment of this condition.

In rare instances, specific nutritional therapies and corticosteroids may be necessary to manage Celiac disease. In any case, regular follow-up care with a gastroenterologist is advised to manage potential complications, including malignancies of the GI tract and other associated conditions.

If you suspect that you or a loved one may have signs and symptoms of celiac disease, the physicians and nutrition staff at Gastro Health can assist in the diagnosis and management of the condition.

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GASTRO HEALTH MAGAZINE / JANUARY 2011

PHYSICIANS DIRECTORY

GASTRO HEALTH MAGAZINE / JANUARY 2011

:: 13

PHYSICIANS DIRECTORY

Francisco J. Baigorri, MD *

Simon Behar, MD *

Marc S. Carp, MD

John P. Christie, MD

Jose P. Ferrer, Sr., MD *

Moises E. Hernandez, MD *

Daniel Gelrud, MD *

Richard E. Hernandez, MD *

Barry E. Brand, MD

Lewis R. Felder, MD

Harris I. Goldberg, MD

Robert C. Lanoff, MD *

Gustavo Calleja, MD *

Jose P. Ferrer, Jr., MD *

Eugenio J. Hernandez, MD *

Jose A. Lavergne, MD *

* Habla Espa単ol

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GASTRO HEALTH MAGAZINE / JANUARY 2011

James S. Leavitt, MD

Alfredo Rabassa, MD *

S. Lawrence Rothman, MD

Arie Slomianski, MD *

Marc Lederhandler, MD

Brett R. Neustater, MD

Ricardo J. Roman, MD *

Seth D. Rosen, MD

Eduardo Ruan, MD *

Andrew I. Sable, MD

David A. Sommer, MD

Javier L. Parra, MD *

Neil E. Rosenkranz, MD

Howard I. Schwartz, MD

Stefania L. Vernace, MD

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GASTRO HEALTH MAGAZINE / JANUARY 2011

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CLINICAL STAFF

Diana P. Bell, MS, RD, LDN *

Darlene Boytell-Perez, ARNP *

Sabrina Kaplan, PA *

Rebecca Karousatos, MS, RD, LDN

Ellen Matas-Sosa, PA

Raisa Miller, PA *

Hernando Mispireta, ARNP *

Rachael Robinson, RN

Hengameh Shahidpoor, ARNP

Kayce Tugg, MSN, RN

LOCATIONS

INSURANCES

Aventura 21110 Biscayne Boulevard, Suite 206 Aventura, FL 33180 Phone: 305-770-0062

AARP Medicare Complete Aetna American Heritage Life Insurance American Medical Security AvMed Baptist Executive Health Beechstreet Blue Cross Blue Shield Cigna Coventry Health Care Dimensions Health First Health Network Humana Humana Champus Tricare Mail Handlers Benefit Plans Medica Health Plan Medicare Part B MultiPlan Neighborhood Health Plan OneSource Preferred Care Partners United Healthcare VISTA Health Plans

North Miami Beach 1400 NE Miami Gardens Drive, Suite 221 North Miami Beach, FL 33179 Phone: 305-949-2020 16855 NE 2nd Avenue, Suite 202 North Miami Beach, FL 33162 Phone: 305-770-0062 Miami Lakes 5803 NW 151 Street, Suite 105 Miami Lakes, FL 33014 Phone: 305-770-0062 South Miami 6141 Sunset Drive, Suite 301 Miami, FL 33143 Phone: 305-913-0666 6140 SW 70th Street, 2nd Floor Miami, FL 33143 Phone: 305-665-7523 Galloway 7500 SW 87th Avenue, Suite 200 Miami, FL 33173 305-913-0666 7765 SW 87th Avenue, Suite 105 Miami, FL 33173 Phone: 305-274-0808 Kendall 8950 N. Kendall Drive, Suite 306-W Miami, FL 33176 Phone: 305-596-9966

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GASTRO HEALTH MAGAZINE / JANUARY 2011

New approaches to anemia and occult blood To treat bleeding that occurs in

One of these techniques is capsule endoscopy, which involves using a camera with

the patient’s gastrointestinal tract

two batteries and a radio transmitter inside an 11x26mm pill. After the patient

historically has been a difficult

swallows the device in an outpatient center, it transmits up to 50,000 images to

challenge. Today, the physicians at

antennae worn on the patient’s abdomen, which in turn are stored on a hard drive.

Gastro Health have advanced tools

After an eight-hour period, the patient comes to the office, drops off the device and

and techniques to identify the site

the 50,000 images are converted into a video that is read by the gastroenterologist.

of a lesion and treat this potentially

This technique has revolutionized small bowel endoscopy, which used to be

dangerous condition.

considered a “black box” where the lack of a very long endoscope meant that no diagnosis or therapy could be done.

The typical signs of a bleeding problem

iron

Since the advent of capsule endoscopy, another instrument was developed in

deficiency and blood in the stool,

Japan to treat lesions found in the bowel. This was the start of double-balloon,

which is called occult blood. When

and then single-balloon enteroscopes, which use a sleeve-like device that has

the patient’s bleeding site cannot

a balloon on its tip (the double-balloon scope, also has a balloon on the tip of

be found by upper endoscopy or colonoscopy, the condition is called occult

the scope). The balloon serves as an anchoring device that opens up the small

gastrointestinal bleeding (OGIB). OGIB occurs in approximately 5% of patients with

bowel, so the scope is able to advance deeper and through a small channel.

gastrointestinal bleeding.

This allows gastroenterologists to find and treat bleeding lesions or remove

Javier Parra, MD Board Certified Gastroenterologist

include

anemia,

polyps or tumors in the small bowel. It can also leave a tattoo, so if the patient Symptoms of OGIB include a change in the color of stools to black-tarry or even

requires surgery, the surgeon can easily find the area of the lesion is in order to

maroon, a drop in red blood cells (anemia) and low blood pressure, on occasion.

remove it.

Patients with OGIB may be admitted to the hospital several times for blood transfusions. But if nothing is found by an upper endoscopy or colonoscopy and

Even more recently, a new kind of sleeve-like device has been developed by a

the bleeding has stopped, the patient is sent home, only to have the condition recur.

Boston company. This device has a corkscrew-like shape on its tip. Instead of

Several earlier research studies indicated the average time to diagnosis and treat

pushing and pulling to open the bowel, it uses the rotational ability of a corkscrew-

OGIB was 2.7 years, and an average of 30 units of blood needed to be transfused.

like tip to achieve the same objective. The spiral will eventually be incorporated onto an endoscope and coupled to a motor, so the entire small bowel can be

In the early 20th century, patients used to have to swallow a rope with a heavy

evaluated with a single procedure.

tip to propel it through the intestine into the small and large bowels. The rope was then tied to a camera, which was pulled through the GI tract to evaluate the

With balloon and spiral-assisted enteroscopy, cauterization of small bowel lesions

bowels. Needless to say, this required general anesthesia, as did a later technique

can be easily achieved. When no other abnormalities are found – such as those

that involved navigating a small scope through the patient’s body.

that need surgical intervention – the patient’s iron and transfusion requirements drop dramatically. This substantially decreases the risk of repeated transfusions

Today, new techniques have been developed and deployed into practice that are

and the cost to the healthcare system. All of these advanced techniques are

safer, more comfortable and much more effective in locating and treating OGIB.

available at Gastro Health.

GASTRO HEALTH MAGAZINE / JANUARY 2011

:: 17

Maintain remission in the comfort of home...

…wherever home may be at the moment.

• In a maintenance trial, of the patients who achieved clinical response at week 4, greater proportions of HUMIRA-treated patients, compared to placebo patients, were in clinical remission at week 26 (40% vs 17%, P<0.001) and week 56 (36% vs 12%, P<0.001)1 • HUMIRA can be self-injected at home or almost anywhere, after a physician determines that it is appropriate and after proper training in injection technique. Instruct patients to refer to storage instructions found in the Medication Guide1

Indications1

HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.

HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Safety Considerations1

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Patients treated with HUMIRA also may be at risk for other serious adverse reactions including malignancies, anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome.

IMPORTANT SAFETY INFORMATION1 WARNINGS SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

HUMIRA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before HUMIRA use and during therapy. Treatment for latent infection should be initiated prior to HUMIRA use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with HUMIRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.

Serious Infections Do not start HUMIRA in patients with an active infection, including localized infections. Exercise caution in patients with chronic or recurrent infection or with underlying conditions which may predispose them to infection, patients who have been exposed to TB, or patients who have resided or traveled in regions where TB or mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, are endemic.

Treatment of latent TB infection prior to therapy with TNF-blocking agents has been shown to reduce the risk of TB reactivation during therapy.

When TB skin testing is performed, an induration size of 5 mm or greater should be considered positive, even if vaccinated previously with Bacille Calmette-Guerin (BCG). HUMIRA should be discontinued if a patient develops a serious infection or sepsis. Patients who develop a new infection should undergo a prompt and complete diagnostic workup, and appropriate antimicrobial therapy should be initiated.

Malignancies More cases of malignancies were observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. In the controlled and open-label portions of HUMIRA clinical trials, there was an approximately 3-fold higher rate of lymphoma than expected in the general population. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use.

Postmarketing cases of malignancies, some fatal, were reported among children, adolescents, and young adults receiving TNF blockers, of which HUMIRA is a member. Approximately half of these were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most patients were receiving concomitant immunosuppressants.

The potential role of TNF-blocking therapy in the development of malignancies is not known.

Hypersensitivity Anaphylaxis and angioneurotic edema have been reported rarely following HUMIRA administration.

Hepatitis B Reactivation Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers.

Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF blocker therapy. For patients identified as carriers of HBV, exercise caution when prescribing HUMIRA, with careful evaluation and monitoring prior to and during treatment. HUMIRA should be stopped and antiviral therapy should be initiated in patients who develop hepatitis B reactivation.

Neurologic Reactions TNF-blocking agents, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system demyelinating disease, including multiple sclerosis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution when considering HUMIRA for patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

Hematologic Reactions Rare reports of pancytopenia including aplastic anemia have been reported with TNF-blocking agents. Medically significant cytopenia (e.g. thrombocytopenia, leukopenia) has been infrequently reported with HUMIRA. The causal relationship of these reports to HUMIRA remains unclear.

Congestive Heart Failure Worsening congestive heart failure (CHF) has been observed with TNF-blocking agents, including HUMIRA, and new-onset CHF has been reported with TNF-blocking agents.

Autoimmunity Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

Immunizations Patients on HUMIRA should not receive live vaccines. It is recommended that juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating HUMIRA therapy.

Drug Interactions Serious infections were seen in studies with concurrent use of anakinra and another TNF-blocking agent; therefore, the combination of HUMIRA and anakinra is not recommended.

Adverse Reactions In the placebo-controlled clinical studies of adult patients with rheumatoid arthritis, the most frequent adverse reactions vs placebo were injection site reactions (20% vs 14%), upper respiratory infection (17% vs 13%), injection site pain (12% vs 12%), headache (12% vs 8%), rash (12% vs 6%), and sinusitis (11% vs 9%). Discontinuations due to adverse events were 7% for HUMIRA vs 4% for placebo.

In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, and plaque psoriasis, the safety profile for patients treated with HUMIRA was similar to the safety profile seen in patients with rheumatoid arthritis. In the placebo-controlled clinical trials in plaque psoriasis, the incidence of arthralgia was 3% in HUMIRA-treated patients versus 1% in controls.

In general, the adverse reactions in juvenile idiopathic arthritis (JIA) patients were similar in frequency and type to those seen in adult patients. Severe adverse reactions reported in the clinical trial in JIA included neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, and appendicitis. Serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment with HUMIRA and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster. The safety of HUMIRA in pediatric patients for uses other than JIA has not been established.

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.

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HUMIRA® (adalimumab) WARNINGS SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

HUMIRA should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include: • Active tuberculosis, including reactivation of latent tuberculosis.

Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before HUMIRA use and during therapy.

Treatment for latent infection should be initiated prior to HUMIRA use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benets of treatment with HUMIRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. [See Warnings and Precautions and Adverse Reactions] MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.

INDICATIONS AND USAGE Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. HUMIRA can be used alone or in combination with methotrexate.

Psoriatic Arthritis HUMIRA is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with DMARDs. Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Crohn’s Disease HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to iniximab.

Plaque Psoriasis HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed WARNINGS and Warnings and Precautions].

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Serious Infections (see also Boxed Warning) Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving TNFblocking agents. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most commonly reported. Patients have frequently presented with disseminated rather than localized disease, and are often taking concomitant immunosuppressants such as methotrexate or corticosteroids with HUMIRA. Treatment with HUMIRA should not be initiated in patients with an active infection, including localized infections. The risks and benets of treatment should be considered prior to initiating therapy in patients: • with chronic or recurrent infection; • who have been exposed to tuberculosis; • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or • with underlying conditions that may predispose them to infection.

Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving HUMIRA, including patients who have previously received treatment for latent or active tuberculosis. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating HUMIRA and periodically during therapy.

Treatment of latent tuberculosis infection prior to therapy with TNF blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy.

Anti-tuberculosis therapy should also be considered prior to initiation of HUMIRA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be conrmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.

Tuberculosis should be strongly considered in patients who develop a new infection during HUMIRA treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or

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PROFESSIONAL BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION who have had close contact with a person with active tuberculosis.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Tests for latent tuberculosis infection may also be falsely negative while on therapy with HUMIRA. HUMIRA should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with HUMIRA should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.

For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy.

Malignancies In the controlled portions of clinical trials of some TNFblocking agents, including HUMIRA, more cases of malignancies have been observed among patients receiving those TNF blockers compared to control patients. During the controlled portions of HUMIRA trials in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and plaque psoriasis, malignancies, other than lymphoma and non-melanoma (basal cell and squamous cell) skin cancer, were observed at a rate (95% condence interval) of 0.6 (0.3, 1.0)/100 patient-years among 3853 HUMIRA-treated patients versus a rate of 0.4 (0.2, 1.0)/100 patient-years among 2183 control patients (median duration of treatment of 5.5 months for HUMIRA-treated patients and 3.9 months for control-treated patients). The size of the control group and limited duration of the controlled portions of studies precludes the ability to draw rm conclusions. In the controlled and uncontrolled open-label portions of the clinical trials of HUMIRA, the more frequently observed malignancies, other than lymphoma and non-melanoma skin cancer, were breast, colon, prostate, lung, and melanoma. These malignancies in HUMIRA-treated and control-treated patients were similar in type and number to what would be expected in the general population. During the controlled portions of HUMIRA rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and plaque psoriasis trials, the rate (95% condence interval) of non-melanoma (basal cell and squamous cell) skin cancers was 0.9 (0.57, 1.35)/100 patientyears among HUMIRA-treated patients and 0.3 (0.08, 0.80)/100 patient-years among control patients. The potential role of TNF blocking therapy in the development of malignancies is not known.

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which HUMIRA is a member. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents.

The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported post-marketing and are derived from a variety of sources including registries and spontaneous postmarketing reports.

In the controlled portions of clinical trials of all the TNF-blocking agents, more cases of lymphoma have been observed among patients receiving TNF blockers compared to control patients. In controlled trials in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and plaque psoriasis, 2 lymphomas were observed among 3853 HUMIRA-treated patients versus 1 among 2183 control patients. In combining the controlled and uncontrolled open-label portions of these clinical trials with a median duration of approximately 2 years, including 6539 patients and over 16,000 patientyears of therapy, the observed rate of lymphomas is approximately 0.11/100 patient-years. This is approximately 3-fold higher than expected in the general population. Rates in clinical trials for HUMIRA cannot be compared to rates of clinical trials of other TNF blockers and may not predict the rates observed in a broader patient population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk for the development of lymphoma.

Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis and other indications.

Even in the absence of TNF-blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.

Hypersensitivity Reactions In postmarketing experience, anaphylaxis and angioneurotic edema have been reported rarely following HUMIRA administration. If an anaphylactic or other serious allergic reaction occurs, administration of HUMIRA should be discontinued immediately and appropriate therapy instituted. In clinical trials of HUMIRA in adults, allergic reactions overall (e.g., allergic rash, anaphylactoid reaction, xed drug reaction, non-specied drug reaction, urticaria) have been observed in approximately 1% of patients.

Hepatitis B Virus Reactivation Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF blocker therapy.

Prescribers should exercise caution in prescribing TNF blockers for patients identied as carriers of HBV. Adequate data are not available on the safety or efcacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV reactivation. In patients who develop HBV reactivation, HUMIRA should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known.

Neurologic Reactions Use of TNF blocking agents, including HUMIRA, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Prescribers should exercise caution in considering the use of HUMIRA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

Hematological Reactions Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically signicant cytopenia (e.g., thrombocytopenia, leukopenia) have been infrequently reported with HUMIRA [see Adverse Reactions]. The causal relationship of these reports to HUMIRA remains unclear. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on HUMIRA. Discontinuation of HUMIRA therapy should be considered in patients with conrmed signicant hematologic abnormalities.

Use with Anakinra Serious infections were seen in clinical studies with concurrent use of anakinra (an interleukin-1 antagonist) and another TNF-blocking agent, etanercept, with no added benet compared to etanercept alone. Therefore, the combination of HUMIRA and anakinra is not recommended [see Drug Interactions].

Heart Failure Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with HUMIRA. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully.

Autoimmunity Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with HUMIRA, treatment should be discontinued [see Adverse Reactions].

Immunizations In a placebo-controlled clinical trial of patients with rheumatoid arthritis, no difference was detected in anti-pneumococcal antibody response between HUMIRA and placebo treatment groups when the pneumococcal polysaccharide vaccine and inuenza vaccine were administered concurrently with HUMIRA. Patients on HUMIRA may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving HUMIRA. It is recommended that juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating HUMIRA therapy. Patients on HUMIRA may receive concurrent vaccinations, except for live vaccines.

Immunosuppression The possibility exists for TNF blocking agents, including HUMIRA, to affect host defenses against infections and malignancies since TNF mediates inammation and modulates cellular immune responses. The safety and efcacy of HUMIRA in patients with immunosuppression have not been evaluated.

ADVERSE REACTIONS Clinical Studies Experience The most serious adverse reactions were [see Warnings and Precautions]: • Serious Infections • Neurologic Reactions • Malignancies The most common adverse reaction with HUMIRA was injection site reactions.

In placebo-controlled trials, 20% of patients treated with HUMIRA developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of patients receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.

The proportion of patients who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of Studies RA-I, RA-II, RA-III and RA-IV was 7% for patients taking HUMIRA and 4% for placebo-treated patients. The most common adverse reactions leading to discontinuation of HUMIRA were clinical are reaction (0.7%), rash (0.3%) and pneumonia (0.3%).

Infections In placebo-controlled rheumatoid arthritis trials, the rate of infection was 1 per patient-year in the HUMIRA-treated patients and 0.9 per patient-year in the placebo-treated patients. The infections consisted primarily of upper respiratory tract infections, bronchitis and urinary tract infections. Most patients continued on HUMIRA after the infection resolved.

The incidence of serious infections was 0.04 per patient-year in HUMIRA treated patients and 0.02 per patient-year in placebo-treated patients.

Serious infections observed included pneumonia, septic arthritis, prosthetic and post-surgical infections, erysipelas, cellulitis, diverticulitis, and pyelonephritis [see Warnings and Precautions].

Tuberculosis and Opportunistic Infections In completed and ongoing global clinical studies that include over 13,000 patients, the overall rate of tuberculosis is approximately 0.26 per 100 patient-years. In over 4500 patients in the US and Canada, the rate is approximately 0.07 per 100 patient-years. These studies include reports of miliary, lymphatic, peritoneal, as well as pulmonary. Most of the cases of tuberculosis occurred within the rst eight months after initiation of therapy and may reect recrudescence of latent disease. Cases of opportunistic infections have also been reported in these clinical trials at an overall rate of approximately 0.075/100 patientyears. Some cases of opportunistic infections and tuberculosis have been fatal [see Warnings and Precautions].

Malignancies More cases of malignancy have been observed in HUMIRAtreated patients compared to control-treated patients in clinical trials [see Warnings and Precautions].

Autoantibodies In the rheumatoid arthritis controlled trials, 12% of patients treated with HUMIRA and 7% of placebo-treated patients that had negative baseline ANA titers developed positive titers at week 24. Two patients out of 3046 treated with HUMIRA developed clinical signs suggestive of new-onset lupus-like syndrome. The patients improved following discontinuation of therapy. No patients developed lupus nephritis or central nervous system symptoms. The impact of long-term treatment with HUMIRA on the development of autoimmune diseases is unknown.

Immunogenicity Patients in Studies RA-I, RA-II, and RA-III were tested at multiple time points for antibodies to adalimumab during the 6- to 12-month period. Approximately 5% (58 of 1062) of adult rheumatoid arthritis patients receiving HUMIRA developed low-titer antibodies to adalimumab at least once during treatment, which were neutralizing in vitro. Patients treated with concomitant methotrexate had a lower rate of antibody development than patients on HUMIRA monotherapy (1% versus 12%). No apparent correlation of antibody development to adverse reactions was observed.

With monotherapy, patients receiving every other week dosing may develop antibodies more frequently than those receiving weekly dosing.

In patients receiving the recommended dosage of 40 mg every other week as monotherapy, the ACR 20 response was lower among antibody-

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positive patients than among antibody-negative patients. The long-term immunogenicity of HUMIRA is unknown.

In patients with juvenile idiopathic arthritis, adalimumab antibodies were identied in 16% of HUMIRA-treated patients. In patients receiving concomitant methotrexate, the incidence was 6% compared to 26% with HUMIRA monotherapy.

In patients with ankylosing spondylitis, the rate of development of antibodies to adalimumab in HUMIRA-treated patients was comparable to patients with rheumatoid arthritis. In patients with psoriatic arthritis, the rate of antibody development in patients receiving HUMIRA monotherapy was comparable to patients with rheumatoid arthritis; however, in patients receiving concomitant methotrexate the rate was 7% compared to 1% in rheumatoid arthritis. In patients with Crohn’s disease, the rate of antibody development was 2.6%.

The immunogenicity rate was 8% for plaque psoriasis patients who were treated with HUMIRA monotherapy.

Other Adverse Reactions The data described below reect exposure to HUMIRA in 2468 patients, including 2073 exposed for 6 months, 1497 exposed for greater than one year and 1380 in adequate and well-controlled studies (Studies RA-I, RA-II, RA-III, and RA-IV). HUMIRA was studied primarily in placebo-controlled trials and in long-term follow up studies for up to 36 months duration. The population had a mean age of 54 years, 77% were female, 91% were Caucasian and had moderately to severely active rheumatoid arthritis. Most patients received 40 mg HUMIRA every other week.

Table 1 summarizes reactions reported at a rate of at least 5% in patients treated with HUMIRA 40 mg every other week compared to placebo and with an incidence higher than placebo. Adverse reaction rates in patients treated with HUMIRA 40 mg weekly were similar to rates in patients treated with HUMIRA 40 mg every other week. In Study RA-III, the types and frequencies of adverse reactions in the second year open-label extension were similar to those observed in the one-year double-blind portion.

Table 1. Adverse Reactions Reported by ≥5% of Patients Treated with HUMIRA During Placebo-Controlled Period of Rheumatoid Arthritis Studies HUMIRA Placebo 40 mg subcutaneous Every Other Week (N=705) (N=690) Adverse Reaction (Preferred Term) Percentage Percentage Respiratory Upper respiratory infection 17 13 Sinusitis 11 9 Flu syndrome 7 6 Gastrointestinal Nausea 9 8 Abdominal pain 7 4 Laboratory Tests* Laboratory test abnormal 8 7 Hypercholesterolemia 6 4 Hyperlipidemia 7 5 Hematuria 5 4 Alkaline phosphatase increased 5 3 Other Injection site pain 12 12 Headache 12 8 Rash 12 6 Accidental injury 10 8 Injection site reaction ** 8 1 Back pain 6 4 Urinary tract infection 8 5 Hypertension 5 3 * Laboratory test abnormalities were reported as adverse reactions in European trials ** Does not include erythema and/or itching, hemorrhage, pain or swelling Juvenile Idiopathic Arthritis Clinical Studies In general, the adverse reactions in pediatric patients were similar in frequency and type to those seen in adult patients [see Warnings and Precautions and other sections under Adverse Reactions]. Important ndings and differences from adults are discussed in the following paragraphs.

HUMIRA has been studied in 171 pediatric patients, 4 to 17 years of age, with polyarticular juvenile idiopathic arthritis. Severe adverse reactions reported in the study included neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, appendicitis.

Serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment with HUMIRA and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster.

A total of 45% of children experienced an infection while receiving HUMIRA with or without concomitant MTX in the rst 16 weeks of treatment. The types of infections reported in juvenile idiopathic arthritis patients were generally

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similar to those commonly seen in outpatient JIA populations. Upon initiation of treatment, the most common adverse reactions occurring in the pediatric population treated with HUMIRA were injection site pain and injection site reaction (19% and 16%, respectively). A less commonly reported adverse event in children receiving HUMIRA was granuloma annulare which did not lead to discontinuation of HUMIRA treatment.

In the rst 48 weeks of treatment, non-serious hypersensitivity reactions were seen in approximately 6% of children and included primarily localized allergic hypersensitivity reactions and allergic rash.

Isolated mild to moderate elevations of liver aminotransferases (ALT more common than AST) were observed in children with juvenile idiopathic arthritis exposed to HUMIRA alone; liver function tests (LFT) elevations were more frequent among those treated with the combination of HUMIRA and MTX. In general, these elevations did not lead to discontinuation of HUMIRA treatment.

In the juvenile idiopathic arthritis trial, 10% of patients treated with HUMIRA who had negative baseline anti-dsDNA antibodies developed positive titers after 48 weeks of treatment. No patient developed clinical signs of autoimmunity during the clinical trial.

Approximately 15% of children treated with HUMIRA developed mild-tomoderate elevations of creatine phosphokinase (CPK). Elevations exceeding 5 times the upper limit of normal were observed in several patients. CPK levels decreased or returned to normal in all patients. Most patients were able to continue HUMIRA without interruption.

Psoriatic Arthritis and Ankylosing Spondylitis Clinical Studies HUMIRA has been studied in 395 patients with psoriatic arthritis in two placebo-controlled trials and in an open label study and in 393 patients with ankylosing spondylitis in two placebo-controlled studies. The safety prole for patients with psoriatic arthritis and ankylosing spondylitis treated with HUMIRA 40 mg every other week was similar to the safety prole seen in patients with rheumatoid arthritis, HUMIRA Studies RA-I through IV. In the clinical trials of patients with psoriatic arthritis and ankylosing spondylitis, elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving HUMIRA than in controls, both when HUMIRA was given as monotherapy and when it was used in combination with other immunosuppressive agents. Most elevations of ALT and AST observed were in the range of 1.5 to 3 times the upper limit of normal. In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of HUMIRA, or modication of concomitant medications.

Crohn’s Disease Clinical Studies HUMIRA has been studied in 1478 patients with Crohn’s disease in four placebo-controlled and two open-label extension studies. The safety prole for patients with Crohn’s disease treated with HUMIRA was similar to the safety prole seen in patients with rheumatoid arthritis.

Plaque Psoriasis Clinical Studies HUMIRA has been studied in 1696 patients with plaque psoriasis in placebo-controlled and open-label extension studies.

The safety prole for patients with plaque psoriasis treated with HUMIRA was similar to the safety prole seen in patients with rheumatoid arthritis with the following exceptions. In the placebo-controlled portions of the clinical trials in plaque psoriasis patients, HUMIRA-treated patients had a higher incidence of arthralgia when compared to controls (3% vs. 1%).

Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving HUMIRA than in controls.

Most elevations of ALT and AST observed were in the range of 1.5 to 3 times the upper limit of normal. In general, patients who developed ALT and AST elevations were asymptomatic, and most of the abnormalities decreased or resolved with either continuation or discontinuation of HUMIRA. Postmarketing Experience Adverse reactions have been reported during post-approval use of HUMIRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to HUMIRA exposure.

Hematologic reactions: Thrombocytopenia [see Warnings and Precautions] Hypersensitivity reactions: Anaphylaxis, angioneurotic edema [see Warnings and Precautions] Respiratory disorders: Interstitial lung disease, including pulmonary brosis Skin reactions: Cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar) DRUG INTERACTIONS Anakinra Concurrent administration of anakinra (an interleukin-1 antagonist) and another TNF-blocking agent has been associated with an increased risk of serious infections, an increased risk of neutropenia and no additional benet compared to these medicinal products alone. Therefore, the combination of anakinra with other TNF-blocking agents, including HUMIRA, may also result in similar toxicities [see Warnings and Precautions].

Live Vaccines Live vaccines should not be given concurrently with HUMIRA [see Warnings and Precautions].

Methotrexate Although methotrexate reduces the apparent adalimumab clearance, the data do not suggest the need for dose adjustment of either HUMIRA or methotrexate.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B - There are, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction and developmental studies are not always predictive of human response, HUMIRA should be used during pregnancy only if clearly needed.

Pregnancy Registry: To monitor outcomes of pregnant women exposed to HUMIRA, a pregnancy registry has been established. Physicians are encouraged to register patients by calling 1-877-311-8972.

Nursing Mothers It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from HUMIRA, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use Safety and efcacy of HUMIRA in pediatric patients for uses other than juvenile idiopathic arthritis have not been established.

Juvenile Idiopathic Arthritis In the juvenile idiopathic arthritis study, HUMIRA was shown to reduce signs and symptoms of active polyarticular juvenile idiopathic arthritis in patients 4 to 17 years of age. HUMIRA has not been studied in children less than 4 years of age, and there are limited data on HUMIRA treatment in children with weight <15 kg.

Safety of HUMIRA in pediatric patients was generally similar to that observed in adults with certain exceptions [see Adverse Reactions].

Geriatric Use A total of 519 rheumatoid arthritis patients 65 years of age and older, including 107 patients 75 years of age and older, received HUMIRA in clinical studies RA-I through IV. No overall difference in effectiveness was observed between these subjects and younger subjects. The frequency of serious infection and malignancy among HUMIRA treated subjects over 65 years of age was higher than for those under 65 years of age. Because there is a higher incidence of infections and malignancies in the elderly population in general, caution should be used when treating the elderly.

OVERDOSAGE Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies of HUMIRA have not been conducted to evaluate the carcinogenic potential or its effect on fertility. No clastogenic or mutagenic effects of HUMIRA were observed in the in vivo mouse micronucleus test or the Salmonella-Escherichia coli (Ames) assay, respectively.

PATIENT COUNSELING INFORMATION Patient Counseling Patients should be advised of the potential benets and risks of HUMIRA. Physicians should instruct their patients to read the Medication Guide before starting HUMIRA therapy and to reread each time the prescription is renewed.

• Immunosuppression Inform patients that HUMIRA may lower the ability of their immune system to ght infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis and reactivation of hepatitis B virus infections.

Patients should be counseled about the risk of lymphoma and other malignancies while receiving HUMIRA. • Allergic Reactions Patients should be advised to seek immediate medical attention if they experience any symptoms of severe allergic reactions. Advise latex-sensitive patients that the needle cap of the prelled syringe contains latex.

• Other Medical Conditions Advise patients to report any signs of new or worsening medical conditions such as heart disease, neurological disease, or autoimmune disorders. Advise patients to report any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever.

Rev. July, 2010 Ref: 03-A329-R21 U.S. Govt. Lic. No. 0043 Abbott Laboratories North Chicago, IL 60064, U.S.A. 64C-419218 MASTER

64E-450902

9/29/10 5:30 PM

Participate in Clinical Research and Help Make a Difference for the Future

Gastro Health offers our patients

Phase 4 >>

an opportunity to participate in

medication after it has been approved to go on the market.

These studies generally are used to evaluate the safety of a

clinical trials for new medications.

By

participate,

Our physicians work closely with Miami Research Associates, which conducts

our patients can help others by

volunteering

to

Phase 1 to 4 clinical trials on vaccines as well as drugs for nutrition, GI disorders,

contributing to medical research.

diabetes, psychiatry, neurology, sleep disorders, women’s health issues, and rheumatology. MRA has national reputation as a research center with the highest

Our physicians are associated with

caliber of ACRP Certified Research Coordinators and board certified physicians.

Miami Research Associates (MRA),

Howard Schwartz, MD, AGAF Board Certified Gastroenterologist

a national research center, and

Before participating in a clinical trial, you will be asked to sign an informed consent

have participated in the development

approved by an Independent Review Board (IRB) that approves the conduct of the

of many important products for

study and makes sure it conforms to the principles of the Declaration of Helsinki

the treatment

and FDA guidelines. For further details you can visit www.fda.gov.

of gastrointestinal

conditions. For example, our team has

been involved in the clinical trials for Nexium, Protonix, Prevacid, Remicade, Humira, Amitiza, Lialda, Asacol, Osmoprep, Interferon, and Ribaviron.

Today, all new drugs or medical devices need to go through extensive testing prior to being approved for use by patients. In order to come to the market, a medication or device needs to go through preclinical trials, which are used to evaluate the safety and potential effectiveness in experimental models. If the drug or device seems promising, it then goes into clinical testing, which consists of the following four phases.

Phase 1 >> These studies determine the safety and dosing schedule in healthy volunteers. These involve healthy individuals who generally have no medical issues that are paid to take the drug in order to evaluate its safety.

Phase 2 >>

These studies involve between 150-400 subjects to determine if a

drug works for a specific condition and to gather additional safety data.

Phase 3 >>

An informed consent is required to provide you with the following information: The purpose of the study • How long the study will last and the number and frequency of visits required.

• Procedures and tests that may be required by participating in study • The potential risks and benefits of study medication • Other treatment options that maybe available.

• If there is a chance that subjects participating in a study receive a placebo • Who will have access to your medical records • Who will pay for medical care if you are injured in study • As a research volunteer you can stop your participation at anytime without bias.

Active research is underway on conditions like hepatitis C, constipation, Crohn’s Disease, ulcerative colitis, osteoarthritis, rheumatoid arthritis, insomnia, depression, ADHD for children and adults, restless leg syndrome, vaccine for smoking cessation, prevention of

These studies are considered pivotal in the approval process. They

involve from 500-3000 subjects and are what is generally used by the FDA and other government agencies to see if a drug works for a specific disease and if it is safe to use.

22 ::

GASTRO HEALTH MAGAZINE / JANUARY 2011

common cold, new prep for colonoscopy and new anesthesia for colonoscopy, If you are interested in participating or finding out the latest treatment being tested, tell your Gastro Health physician that you want to make a difference for the future.

What is colorectal cancer?

Colon cancer is a malignant growth in the colon. The most common type of colon cancer starts out as a simple polyp. According to multiple sources, it takes a minimum of 5-10 years for that polyp to become malignant. If it is discovered and removed prior to that transformation, your chances of dying of colon cancer drop dramatically. Unfortunately, polyps have very few symptoms. For that matter, neither do malignancies of the colon. That is why approximately 50,000 Americans will die from colon cancer this year.

What is a colonoscopy?

This is considered the “gold standard” of screening and diagnostic tests for colorectal cancer. The entire colon is visualized with even the smallest polyps found and removed before they have a chance to become malignant.

Preparing for a colonoscopy?

How often should one undergo a screening?

The colon needs to be thoroughly emptied of all fecal matter in order to visualize the colon and find polyps. It is very important that a good prep is followed and your physician will explain which one is best for you.

PATIENT DESCRIPTION

EVALUATION INDICATED

LOW RISK Sedation during the colonoscopy?

In order to limit or eliminate the discomfort during the procedure you may be offered sedation during the colonoscopy. Sedation allows the best possible visualization and smoothest possible maneuvering of the scope during the procedure. New studies suggest it leads to higher polyp detection rates.

Colonoscopy beginning at age 50 (For African Americans beginning at the age of 45)

AGE 50 No Risk Factors

HIGH RISK Family history of colon cancer or polyps

Colonoscopy beginning 10 years younger than the age the relative was diagnosed

Blood in stool or iron deficiency anemia, rectal bleeding, or a change in bowel habit

Colonoscopy now

Ulcerative Colitis or Crohn’s Disease

Yearly colonoscopy, after 10 years of disease

Personal history of colon cancer or polyps

Regular screening colonoscopy as determined by your physician

OTHER INDIVIDUALIZED APPROACH Other gastrointestinal symptoms which may include; abdominal pain, narrow stools, constipation diarrhea, "gas" or bloating, family history of breast, gynecological, abdominal, colon or other gastrointestinal cancers.

GASTRO HEALTH MAGAZINE / JANUARY 2011

:: 23

what is fatty liver ?

Non-alcoholic fatty liver disease

the USA over the past 10 years, rising from 0.1% in 1966 to 4.7% in 2007.

(NAFLD) is a disease resembling

Jose Porfirio Ferrer, MD, FACP Board Certified Gastroenterologist Fellow of the American College of Physicians

the damage seen in the liver

Conditions frequently associated with NASH include overweight/obesity, type 2

when there is alcohol abuse,

diabetes mellitus and hyperlipidemia (high blood triglycerides and/or cholesterol).

but occurring in patients with

NASH is also closely associated with the “metabolic syndrome”, which is a risk

little or no alcohol consumption.

factor for cardiovascular disease. Therefore, it is not surprising that cardiovascular

NAFLD is the most common liver

disease is a leading cause of death in subjects with NAFLD.

disorder in the Western world.

It is a serious public health

Most people with NASH have no symptoms and it is often discovered during

problem in the USA, where an

routine laboratory testing when liver enzymes (AST/ALT) are found to be elevated.

estimated 90 million Americans

Imaging studies like ultrasound and CT scan can assist to evaluate the presence

are affected.

of NASH. Usually a liver biopsy is required to confirm the diagnosis as well as to determine the severity of the disease. This procedure is safely done, under local

The spectrum of NAFLD includes

anesthesia, by an expert radiologist. While guided by an ultrasound machine, the

fatty

radiologist introduces a slender needle in the liver to obtain a sample that is then

liver

and

non-alcoholic

steatohepatitis (NASH). Fatty liver

examined under a microscope.

represents the build-up or accumulation of fat (triglycerides) in the liver cells. In

NASH, steato refers to fat and hepatitis means inflammation and damage to the

Other causes of chronic liver disease (e.g. viral hepatitis B & C, medications, etc.)

liver. Patients with fatty liver, have a relatively benign condition. By contrast, NASH,

should also be excluded during the evaluation of these patients.

due to the ongoing inflammation, can cause scarring and hardening of the liver, and

when it becomes extensive is called cirrhosis.

Treatment is focused on weight loss through exercise and decreased caloric intake; a consultation with a nutritionist can help achieve this goal. Also

24 ::

This condition (cirrhosis) may develop in up to 25% of patientsand can lead to

good control of blood sugar in diabetic patients, as well as decreasing blood

complications such as liver cancer, liver failure and liver-related death or the requirement for

triglyceride and cholesterol levels when elevated, will help in the treatment of

liver transplantation. In fact, rates of transplantation performed for NASH have increased in

this condition.

GASTRO HEALTH MAGAZINE / JANUARY 2011

Over 17

years experience and nearly 7 million prescriptions1 PENTASA 500 mg delivers

4

grams of mesalamine

with 50% fewer capsules than PENTASA 250 mg

PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis Proven results, fewer capsules*

= PENTASA 500 mg

(tablets not actual size)

PENTASA 250 mg

*Represents PENTASA 250 mg dosed at 4 pills, 4 times daily, and PENTASA 500 mg dosed at 2 pills, 4 times daily. Both equal 4 grams of mesalamine.

Important Safety Information

• As with other mesalamine products, serious adverse

therapy have been described in the foreign literature. events may occur. PENTASA is contraindicated in There have been rare reports of interstitial nephritis in patients with a hypersensitivity to mesalamine, any patients receiving PENTASA. Patients with preexisting other components in this medication, or salicylates. renal disease, increased BUN or serum creatinine, or proteinuria should be carefully monitored, especially Mesalamine has been associated with an acute • during the initial phase of treatment. intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult • PENTASA is generally well tolerated. The most to distinguish from a flare of inflammatory bowel common adverse events in US clinical trials disease. Symptoms include cramping, acute (N=451) were diarrhea (3.5%), headache (2.2%), abdominal pain and bloody diarrhea, sometimes fever, nausea (3.1%), abdominal pain (1.1%), rash (1.3%), headache, and rash. If acute intolerance syndrome is anorexia (1.1%), and nausea and vomiting (1.1%). suspected, prompt withdrawal is required.

In combined domestic and foreign trials (N>2100), most common adverse events were diarrhea • Caution should be exercised if PENTASA is the (3.4%), headache (2.0%), nausea (1.8%), abdominal administered to patients with impaired hepatic or renal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), function. Single reports of nephrotic syndrome and and rash (1.0%). interstitial nephritis associated with mesalamine

Please see Brief Summary of Full Prescribing Information on adjacent page.

Reference: 1. IMS Health, NPA™, July 1993-January 2010.

PENTASA® is a registered trademark of Ferring A/S.

Committed to being your GI support company ©2010 Shire US Inc., Wayne, PA 19087

PEN-00294

06/10

BRIEF SUMMARY: Consult the Full Prescribing Information for complete product information.

PENTASA® (mesalamine) Rx only Controlled-Release Capsules 250 mg and 500 mg INDICATIONS AND USAGE PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.

CONTRAINDICATIONS PENTASA is contraindicated in patients who have demonstrated hypersensitivity to mesalamine, any other components of this medication, or salicylates.

PRECAUTIONS General Caution should be exercised if PENTASA is administered to patients with impaired hepatic function.

Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence cannot be ascertained, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required. If a rechallenge is performed later in order to validate the hypersensitivity, it should be carried out under close medical supervision at reduced dose and only if clearly needed.

Renal Caution should be exercised if PENTASA is administered to patients with impaired renal function. Single reports of nephrotic syndrome and interstitial nephritis associated with mesalamine therapy have been described in the foreign literature. There have been rare reports of interstitial nephritis in patients receiving PENTASA. In animal studies, a 13-week oral toxicity study in mice and 13-week and 52-week oral toxicity studies in rats and cynomolgus monkeys have shown the kidney to be the major target organ of mesalamine toxicity. Oral daily doses of 2400 mg/kg in mice and 1150 mg/kg in rats produced renal lesions including granular and hyaline casts, tubular degeneration, tubular dilation, renal infarct, papillary necrosis, tubular necrosis, and interstitial nephritis. In cynomolgus monkeys, oral daily doses of 250 mg/kg or higher produced nephrosis, papillary edema, and interstitial fibrosis. Patients with preexisting renal disease, increased BUN or serum creatinine, or proteinuria should be carefully monitored, especially during the initial phase of treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.

Drug Interactions There are no data on interactions between PENTASA and other drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week dietary carcinogenicity study of mesalamine, CD-1 mice were treated with doses up to 2500 mg/kg/day and it was not tumorigenic. For a 50 kg person of average height (1.46 m2 body surface area), this represents 2.5 times the recommended human dose on a body surface area basis (2960 mg/m2/day). In a 104-week dietary carcinogenicity study in Wistar rats, mesalamine up to a dose of 800 mg/kg/day was not tumorigenic. This dose represents 1.5 times the recommended human dose on a body surface area basis.

No evidence of mutagenicity was observed in an in vitro Ames test and an in vivo mouse micronucleus test.

No effects on fertility or reproductive performance were observed in male or female rats at oral doses of mesalamine up to 400 mg/kg/day (0.8 times the recommended human dose based on body surface area).

Semen abnormalities and infertility in men, which have been reported in association with sulfasalazine, have not been seen with PENTASA capsules during controlled clinical trials.

Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 1000 mg/kg/day (5900 mg/M2) and rabbits at doses of 800 mg/kg/day (6856 mg/M2) and have revealed no evidence of teratogenic effects or harm to the fetus due to mesalamine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, PENTASA should be used during pregnancy only if clearly needed.

Mesalamine is known to cross the placental barrier.

Nursing Mothers Minute quantities of mesalamine were distributed to breast milk and amniotic fluid of pregnant women following sulfasalazine therapy. When treated with sulfasalazine at a dose equivalent to 1.25 g/day of mesalamine, 0.02 μg/mL to 0.08 μg/mL and trace amounts of mesalamine were measured in amniotic fluid and breast milk, respectively.

N-acetylmesalamine, in quantities of 0.07 μg/mL to 0.77 μg/mL and 1.13 μg/mL to 3.44 μg/mL, was identified in the same fluids, respectively.

Caution should be exercised when PENTASA is administered to a nursing woman.

No controlled studies with PENTASA during breast-feeding have been carried out.

Hypersensitivity reactions like diarrhea in the infant cannot be excluded.

Pediatric Use Safety and efficacy of PENTASA in pediatric patients have not been established.

ADVERSE REACTIONS In combined domestic and foreign clinical trials, more than 2100 patients with ulcerative colitis or Crohn's disease received PENTASA therapy. Generally, PENTASA therapy was well tolerated. The most common events (ie, greater than or equal to 1%) were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%).

In two domestic placebo-controlled trials involving over 600 ulcerative colitis patients, adverse events were fewer in PENTASA-treated patients than in the placebo group (PENTASA 14% vs placebo 18%) and were not dose-related. Events occurring at 1% or more are shown in the table below. Of these, only nausea and vomiting were more frequent in the PENTASA group. Withdrawal from therapy due to adverse events was more common on placebo than PENTASA (7% vs 4%).

Table 1. Adverse Events Occurring in More Than 1% of Either Placebo or PENTASA Patients in Domestic Placebo-controlled Ulcerative Colitis Trials. (PENTASA Comparison to Placebo) PENTASA Placebo Event n=451 n=173 Diarrhea 16 (3.5%) 13 (7.5%) Headache 10 (2.2%) 6 (3.5%) Nausea 14 (3.1%) --Abdominal Pain 5 (1.1%) 7 (4.0%) Melena (Bloody Diarrhea) 4 (0.9%) 6 (3.5%) Rash 6 (1.3%) 2 (1.2%) Anorexia 5 (1.1%) 2 (1.2%) Fever 4 (0.9%) 2 (1.2%) Rectal Urgency 1 (0.2%) 4 (2.3%) Nausea and Vomiting 5 (1.1%) --Worsening of Ulcerative Colitis 2 (0.4%) 2 (1.2%) Acne 1 (0.2%) 2 (1.2%)

Clinical laboratory measurements showed no significant abnormal trends for any test, including measurement of hematological, liver, and kidney function.

The following adverse events, presented by body system, were reported infrequently (ie, less than 1%) during domestic ulcerative colitis and Crohn's disease trials. In many cases, the relationship to PENTASA has not been established.

Gastrointestinal: abdominal distention, anorexia, constipation, duodenal ulcer, dysphagia, eructation, esophageal ulcer, fecal incontinence, GGTP increase, GI bleeding, increased alkaline phosphatase, LDH increase, mouth ulcer, oral moniliases, pancreatitis, rectal bleeding, SGOT increase, SGPT increase, stool abnormalities (color or texture change), thirst Dermatological: acne, alopecia, dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, pruritus, sweating, urticaria Nervous System: depression, dizziness, insomnia, somnolence, paresthesia Cardiovascular: palpitations, pericarditis, vasodilation Other: albuminuria, amenorrhea, amylase increase, arthralgia, asthenia, breast pain, conjunctivitis, ecchymosis, edema, fever, hematuria, hypomenorrhea, Kawasaki-like syndrome, leg cramps, lichen planus, lipase increase, malaise, menorrhagia, metrorrhagia, myalgia, pulmonary infiltrates, thrombocythemia, thrombocytopenia, urinary frequency One week after completion of an 8-week ulcerative colitis study, a 72-year-old male, with no previous history of pulmonary problems, developed dyspnea. The patient was subsequently diagnosed with interstitial pulmonary fibrosis without eosinophilia by one physician and bronchiolitis obliterans with organizing pneumonitis by a second physician. A causal relationship between this event and mesalamine therapy has not been established.

Published case reports and/or spontaneous postmarketing surveillance have described infrequent instances of pericarditis, fatal myocarditis, chest pain and T-wave abnormalities, hypersensitivity pneumonitis, pancreatitis, nephrotic syndrome, interstitial nephritis, hepatitis, aplastic anemia, pancytopenia, leukopenia, agranulocytosis, or anemia while receiving mesalamine therapy. Anemia can be a part of the clinical presentation of inflammatory bowel disease. Allergic reactions, which could involve eosinophilia, can be seen in connection with PENTASA therapy.

Postmarketing Reports The following events have been identified during post-approval use of the PENTASA brand of mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine: Gastrointestinal: Reports of hepatotoxicity, including elevated liver enzymes (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), hepatitis, jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome which included hepatic function changes was also reported.

Other: Postmarketing reports of pneumonitis, granulocytopenia, systemic lupus erythematosis, acute renal failure, chronic renal failure and angioedema have been received in patients taking PENTASA. OVERDOSAGE Single oral doses of mesalamine up to 5 g/kg in pigs or a single intravenous dose of mesalamine at 920 mg/kg in rats were not lethal.

There is no clinical experience with PENTASA overdosage. PENTASA is an aminosalicylate, and symptoms of salicylate toxicity may be possible, such as: tinnitus, vertigo, headache, confusion, drowsiness, sweating, hyperventilation, vomiting, and diarrhea.

Severe intoxication with salicylates can lead to disruption of electrolyte balance and blood-pH, hyperthermia, and dehydration.

Treatment of Overdosage. Since PENTASA is an aminosalicylate, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. This includes prevention of further gastrointestinal tract absorption by emesis and, if necessary, by gastric lavage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate intravenous therapy. Adequate renal function should be maintained.

DOSAGE AND ADMINISTRATION The recommended dosage for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis is 1g (4 PENTASA 250 mg capsules or 2 PENTASA 500 mg capsules) 4 times a day for a total daily dosage of 4g. Treatment duration in controlled trials was up to 8 weeks.

Store at 25˚C (77˚F) excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature].

Manufactured for Shire US Inc. 725 Chesterbrook Blvd., Wayne, PA 19087, USA Licensed U.S. Patent Nos. B1 4,496,553 and 4,980,173 189 0107 009 Licensed from Ferring A/S, Denmark © 2008 Shire US Inc. Rev. 06/2008 PEN-00299

Gastro Health and the Crohn’s and colitis community in Florida are committed to continue awareness and fundraising efforts because we need to find better therapies and ultimately a cure for our patients, friends and neighbors who struggle daily with the disease. Therefore, all Gastro Health physicians are members of the CCFA; Marc Lederhandler, MD and Jose Ferrer, Sr., MD are co-chairs of the Chapter Medical Advisory Committee; Hengi Shahidpoor, ARNP is co-facilitator of the Chapter’s Miami Support Group which is held every first Thursday of the month a the Galloway office; and Alejandro Fernandez, MBA, CMPE, Administrator for Gastro Health is the co-chair of the Miami Take Steps Walk to be held this year at Tropical Park on Saturday, May 21.

Take Steps is just around the corner, so please consider participating this year! Now is the time to register – www.cctakesteps.org . Don’t forget to get all of your team members registered. Once you get your teammates on board, encourage them to fundraise with Facebook, set up their own online fundraising page and upload a photo or a video message. It is very easy to hit your team goal when you get all of your teammates to raise money with you. If you aren’t a part of a team, see if you can get your friends, family and co-workers to walk with you and be sure to spread awareness about Take Steps and IBD along the way! Take Steps for Crohn’s & Colitis is CCFA’s national evening walk and celebration of the nation’s largest event dedicated to finding cures for Crohn’s disease and ulcerative colitis.

Over 1.4 million American adults and children are affected by digestive diseases -- one in every 200 Americans! While many suffer in silence, Take Steps brings together this community and encourages them to make noise and be heard. The money you raise through Take Steps helps support patient programs, education efforts, and furthers crucial research. In the past two years alone, we have been able to bring together over 75,000 people and raise over $13 million to help further our mission.

A little bit goes such a long way. The Crohn’s & Colitis Foundation uses approximately 79 cents of every dollar you raise in Take Steps to support research and local programs. Your funds are also used to bring support services and information to families in need when they or a loved one is chronically ill. Your support and generosity gives hope to the many children and adults who are living with Crohn’s Disease and ulcerative colitis (known as inflammatory bowel disease or IBD).

CCFA research programs are creating tomorrow’s treatments and perhaps laying the groundwork for cures. Last year, the Information Resource Center at CCFA connected with more than 17,500 patients, caregivers and healthcare professionals. CCFA offers educational and patient services through its 41 chapters nationwide that include teleconferences, support groups, the latest clinical trials information and much more. Any amount you can give makes a difference.

Please join the physicians and staff of Gastro Health at the TAKE STEPS on May 21 in Miami. Register today at www.cctakesteps.org For more information about the Crohn’s and Colitis Foundation of America, please call the local office at 561-218-2929.

FUND RESEARCH RAISE AWARENESS CHANGE LIVES

Walk With Us This Spring!

Fort Lauderdale: April 16, 2011 Miami: May 21, 2011

Take Steps for Crohn’s & Colitis is CCFA’s national evening walk and the nation’s largest event dedicated to nding cures for digestive diseases. Over 1.4 million Americans suffer from Crohn’s disease and ulcerative colitis, two life-changing digestive diseases. You can make a difference. When you walk, you’ll help raise funds for a cure! For more information: 561.218.2929 • jbaker@ccfa.org

Register Today! www.cctakesteps.org

florida2011.indd 1

12/16/2010 2:51:20 PM

GASTRO HEALTH MAGAZINE / JANUARY 2011

:: 27

Your Remicade Treatment

At Gastro Health, our mission is to deliver quality medical and preventative care in the field of gastroenterology. We take pride in improving our patients’ quality of life and ensuring an excellent healthcare experience. In order to fulfill our mission and assist patients who are diagnosed with chronic diseases we offer in-office IV infusion treatment center for the following: • Crohn’s and Ulcerative Colitis • Rheumatoid Arthritis • Dermatology Our care coordinators provide a seamless approach to working with pharmaceutical and insurance companies in order to facilitate the process and lessen the financial burden to patients.

PREPARATION

To minimize complications with the infusion, you need to have the following done before beginning REMICADE treatments: • Physical exam • Chest x-ray • Test for Tuberculosis (TB) • Test for Hepatitis B Virus (HBV) In preparation for your treatment, please drink plenty of water the night before and on the day of the treatment. Also, take Claritin 10 mg (an over the counter, non-drowsy, antihistamine) and 2 extra strength Tylenol at least 1 hour prior to the infusion.

This will help to prevent possible reactions to the REMICADE. You may also be prescribed Prednisone. Please take as ordered.

If you have a cold, flu-like symptoms, fever, or cough, please cancel your appointment and reschedule once you are well.

SCHEDULING

REMICADE appointments are available Monday through Friday. If you need to cancel your appointment for any reason, please do so at least 72 hours before your scheduled time, so that another patient may be accommodated. Please arrive 15 minutes before your appointment time in order to fill out paperwork necessary to process your visit.

The usual schedule for REMICADE infusions is as follows: • 1st treatment • 2nd treatment (2 weeks after 1st) • 3rd treatment (4 weeks after 2nd) • 4th treatment (8 weeks after 3rd) All other treatments are every 8 weeks per your physician. Your doctor can change this schedule if necessary.

After the infusion has taken place, a report will be sent back to your physician so your progress can be monitored. Gastro Health does not replace your physician and it is important that a follow-up appointment be scheduled with your physician every 3 to 6 months.

You can schedule an appointment by calling (305) 913-0690.

Colon cancer is the second-deadliest form of cancer in the U.S., yet it doesn’t have to be. Did you know that it’s 90 percent preventable? Screening is the key.

Colon cancer stops with you This simple procedure – called a colonoscopy – can actively prevent colon cancer. Do it for you and your loved ones. If you are at-risk, get screened, and get on with your life!

We are pleased to announce the Spring opening of the Galloway Surgery Center, a new state of the art facility created for your digestive health needs.

Who should get screened?

Galloway Surgery Center 7600 SW 87th Ave. Suite 100 Miami, FL 33173 Phone: 786-235-3750 www.gallowaysurgerycenter.com

Anyone 50 and older People who have a family history of polyps or colon or rectal cancer

Simon Behar, M.D. Jose P. Ferrer, Sr., M.D. Jose P. Ferrer, Jr., M.D. Nelson Garcia, M.D. Alfredo Hernandez, M.D. Eugenio J. Hernandez, M.D. Moises E. Hernandez, M.D. Andrew Sable, M.D.

African-Americans who are 45 and older Other minority groups where the disease is more prevalent

To schedule your colon cancer screening, please call 786-235-3750

StopColonCancerNow.com

17976a_04-06778 R1 Lialda Q1 JA Asz 12/13/10 12:05 PM Page 3

Continued from previous page.

TRANSFORMING THE LIVES OF PEOPLE LIVING SEVERE DISEASES www.ucb.com

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GASTRO HEALTH MAGAZINE / JANUARY 2011

Nursing Mothers Low concentrations of mesalamine and higher concentrations of its N-acetyl metabolite have been detected in human breast milk. The clinical significance of this has not been determined and there is limited experience of nursing women using mesalamine. Caution should be exercised if LIALDA is administered to a nursing woman.

Pediatric Use Safety and effectiveness of LIALDA tablets in pediatric patients have not been established.

Geriatric Use Clinical trials of LIALDA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic exposures are increased in elderly subjects. [see Clinical Pharmacology in the Prescribing Information] In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy.

Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias, i.e., neutropenia and pancytopenia in patients who were 65 years or older who were taking mesalamine-containing products such as LIALDA. Caution should be taken to closely monitor blood cell counts during mesalamine therapy. [see Warnings and Precautions] OVERDOSAGE LIALDA is an aminosalicylate, and symptoms of salicylate toxicity may include tinnitus, vertigo, headache, confusion, drowsiness, sweating, seizures, hyperventilation, dyspnea, vomiting, and diarrhea. Severe intoxication may lead to disruption of electrolyte balance and blood-pH, hyperthermia, dehydration, and end organ damage.

There is no specific known antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate intravenous therapy. Adequate renal function should be maintained.

Manufactured for Shire US Inc., 725 Chesterbrook Blvd., Wayne, PA 19087, USA Š 2010 Shire US Inc. U.S. Patent No. 6,773,720 by license of Giuliani S.p.A., Milan, Italy Rev. 9/10 LIA-02128

BRIEF SUMMARY: Consult the Full Prescribing Information for complete product information.

LIALDA速 (mesalamine) Delayed Release Tablets

Rx only

INDICATIONS AND USAGE LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond 8 weeks has not been established.

CONTRAINDICATIONS LIALDA is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of LIALDA. [see Description in the Prescribing Information] WARNINGS AND PRECAUTIONS Renal Impairment Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as LIALDA that contain mesalamine or are converted to mesalamine.

It is recommended that patients have an evaluation of renal function prior to initiation of LIALDA therapy and periodically while on therapy. Exercise caution when using LIALDA in patients with known renal dysfunction or a history of renal disease.

In animal studies, the kidney was the principal organ for toxicity. [See Drug Interactions and Nonclinical Toxicology in the Prescribing Information] Mesalamine-Induced Acute Intolerance Syndrome Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with LIALDA. Hypersensitivity Reactions Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to LIALDA tablets or to other compounds that contain or are converted to mesalamine.

Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported with LIALDA and other mesalamine medications. Caution should be taken in prescribing this medicine to patients with conditions predisposing them to the development of myocarditis or pericarditis.

Hepatic Impairment There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering LIALDA to patients with liver disease.

Upper GI Tract Obstruction Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of LIALDA which would delay mesalamine release in the colon.

ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

LIALDA tablets have been evaluated in 655 ulcerative colitis patients in controlled and open-label trials.

In two 8-week placebo-controlled clinical trials involving 535 ulcerative colitis patients, 356 received 2.4 g/day or 4.8 g/day LIALDA tablets and 179 received placebo. More treatment emergent adverse events occurred in the placebo group (119) than in each of the LIALDA treatment groups (109 in 2.4 g/day, 92 in 4.8 g/day). A lower percentage of LIALDA patients discontinued therapy due to adverse events compared to placebo (2.2% vs. 7.3%). The most frequent adverse event leading to discontinuation from LIALDA therapy was exacerbation of ulcerative colitis (0.8%).

The majority of adverse events in the double blind, placebo-controlled trials were mild or moderate in severity. The percentage of patients with severe adverse events was higher in the placebo group (6.1% in placebo; 1.1% in 2.4 g/day; 2.2% in 4.8 g/day). The most common severe adverse events were gastrointestinal disorders which were mainly symptoms associated with ulcerative colitis. Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with LIALDA in patients experiencing this event.

Overall, the percentage of patients who experienced any adverse event was similar across treatment groups. Treatment related adverse events occurring in LIALDA or placebo groups at a frequency of at least 1% in two Phase 3, 8-week, double blind, placebo-controlled trials are listed in Table 1. The most common treatment related adverse events with LIALDA 2.4 g/day and 4.8 g/day were headache (5.6% and 3.4%, respectively) and flatulence (4% and 2.8%, respectively).

Table 1: Treatment-Emergent Related Adverse Events in Two Phase 3 Trials Experienced by at Least 1% of the LIALDA Group and at a Rate Greater than Placeboa,b Event Headache Flatulence Increased alanine aminotransferase Alopecia Pruritus

LIALDA 2.4g/day (n = 177) 10 (5.6%) 7 (4%)

LIALDA 4.8g/day (n = 179) 6 (3.4%) 5 (2.8%)

(n = 179) 1 (0.6%) 5 (2.8%)

1 (0.6%) 0 1 (0.6%)

2 (1.1%) 2 (1.1%) 2 (1.1%)

0 0 2 (1.1%)

Placebo

a: Treatment-emergent related adverse events for which the placebo rate equalled or exceeded the rate for at least one of the LIALDA treatment groups were abdominal pain, dizziness, dyspepsia, and nausea. b: Percentages in this table are based on the treatment-emergent adverse event incidences.

The following treatment-emergent related adverse events, presented by body system, were reported infrequently (less than 1%) by LIALDA-treated ulcerative colitis patients in the two Phase 3 controlled trials.

Cardiac Disorder: tachycardia Vascular Disorders: hypertension, hypotension Skin and Subcutaneous Tissue Disorders: acne, prurigo, rash, urticaria Gastrointestinal Disorders: abdominal distention, colitis, diarrhea, pancreatitis, rectal polyp, vomiting Investigations: decreased platelet count, elevated total bilirubin Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain Nervous System Disorders: somnolence, tremor Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain General Disorders and Administrative Site Disorders: asthenia, face edema, fatigue, pyrexia Ear and Labyrinth Disorders: ear pain Postmarketing Experience In addition to the adverse reactions reported above in clinical trials involving LIALDA, the adverse events listed below have been identified during postapproval use of LIALDA and in controlled clinical trials, open label studies, literature reports, or foreign and domestic marketing experience with other products that contain or are metabolized to mesalamine. Because many of these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: lupus-like syndrome, drug fever Cardiac Disorders: pericarditis, pericardial effusion, myocarditis Gastrointestinal: pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes Hematologic: agranulocytosis, aplastic anemia Neurological/Psychiatric: peripheral neuropathy, Guillain-Barre syndrome, transverse myelitis Renal Disorders: interstitial nephritis Respiratory, Thoracic and Mediastinal Disorders: hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis) Skin: psoriasis, pyoderma gangrenosum, erythema nodosum Urogenital: reversible oligospermia DRUG INTERACTIONS No investigations of interaction between LIALDA and other drugs have been performed. However, the following are reports of interactions between mesalamine medications and other drugs.

Nephrotoxic agents, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of renal reactions.

Azathioprine or 6-mercaptopurine The concurrent use of mesalamine can increase the potential for blood disorders.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B. Reproduction studies with mesalamine have been performed in rats at doses up to 1000 mg/kg/day (1.8 times the maximum recommended human dose based on a body surface area comparison) and rabbits at doses up to 800 mg/kg/day (2.9 times the maximum recommended human dose based on a body surface area comparison) and have revealed no evidence of impaired fertility or harm to the fetus due to mesalamine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Mesalamine is known to cross the placental barrier.

Brief Summary continued on next page.

For active, mild to moderate ulcerative colitis (UC)

Lialda is approved to induce remission with once-daily dosing* ®

Lialda tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of Lialda have been established for up to 8 weeks.

Important Safety Information

• Lialda is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of Lialda.

• Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported with products such as Lialda that contain mesalamine or are converted to mesalamine. It is recommended that patients have an evaluation of renal function prior to initiating use of Lialda and periodically while on therapy. Exercise caution when using Lialda in patients with known renal dysfunction or a history of renal disease.

• Mesalamine has been associated with an acute intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from an exacerbation of ulcerative colitis. Symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance is suspected, promptly discontinue treatment with Lialda.

• Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Lialda or compounds that contain or are converted to mesalamine. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported with Lialda and other mesalamine-containing medications. Caution should be taken when prescribing Lialda to patients with conditions predisposing them to the development of myocarditis or pericarditis.

• There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering Lialda to patients with liver disease.

• Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of Lialda, which would delay mesalamine release in the colon.

• The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate in severity. The most common treatmentemergent related adverse events (incidence ≥1%) are headache, flatulence, increased alanine aminotransferase, alopecia, and pruritus.

Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with Lialda.

• The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of renal reactions. In patients receiving azathioprine or 6-mercaptopurine, concurrent use of mesalamine can increase the potential for blood disorders. *Remission was calculated using a modified UC-DAI score ≤1 with a score of 0 for rectal bleeding and stool frequency, and a combined Physician’s

Global Assessment (PGA) and a sigmoidoscopy score ≤1 with a sigmoidoscopy score reduction of 1 point or more from baseline and no friability.1,2

Please see Brief Summary of Full Prescribing Information on adjacent page.

Visit hcp.Lialda.com to learn more.

References: 1. Lichtenstein GR, Kamm MA, Boddu P, et al. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007;5:95-102.

2. Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis.

Gastroenterology. 2007;132:66-75.

Lialda® is a registered trademark of Shire LLC. MMX® is a registered trademark owned by Cosmo Technologies Ltd, Ireland, a wholly owned subsidiary of Cosmo Pharmaceuticals SpA.

©2010 Shire US Inc., Wayne, PA 19087 LIA-02136 12/10

1200 mg of mesalamine per tablet