FOR WHEN A STRIKES MIGRAINE

Pr CAMBIA® (diclofenac potassium) is indicated for the acute treatment of migraine attacks with or without aura in adults 18 years and older.

Completely dissolve one sachet of CAMBIA® in 30–60 mL of water only and drink immediately1* 30 mL = 2 Tbsp

Significantly measurable plasma levels were observed within 5 minutes of CAMBIA dosing, in fasted healthy individuals1†

Tmax was achieved1,2†:

• After ~15 minutes under fasting conditions‡

• After ~10 minutes under fed conditions§

Tmax: Time to reach maximum plasma levels.

*No other liquids should be used with CAMBIA.

† Clinical significance is unknown.

‡Range: 10–40 minutes.

§Range: 5 minutes–4 hours.

Please refer to the Product Monograph for complete administration information.

Indication and clinical use:

PrCAMBIA® (diclofenac potassium) is indicated for the acute treatment of migraine attacks with or without aura in adults 18 years and older. Efficacy and safety of CAMBIA beyond a single dose have not been studied.

CAMBIA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. Safety and efficacy have not been established for cluster headache which is present in an older, predominantly male population.

Geriatrics (> 65 years of age): Safety and efficacy of CAMBIA have not been studied in individuals over 65 years of age, and its use in this population is not recommended.

Pediatrics (< 18 years of age): Safety and efficacy of CAMBIA have not been in patients below the age of 18 years, and its use in this population is contraindicated.

Contraindications:

• Perioperative pain setting of coronary artery bypass graft surgery;

• Third trimester of pregnancy;

• Nursing women;

• Severe uncontrolled heart failure;

• History of asthma, urticarial, or allergic-type reactions after taking ASA or other NSAIDs;

• Active gastric/duodenal/peptic ulcer, active GI bleeding;

• Cerebrovascular, or other bleeding disorders;

• Inflammatory bowel disease;

• Severe liver impairment or active liver disease;

• Severe renal impairment or deteriorating renal disease;

• Known hyperkalemia;

• Children and adolescents less than 18 years of age

Most serious warnings and precautions:

Risk of CV adverse events: Diclofenac is associated with an increased risk of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) that is comparable to COX-2 inhibitors and which can be fatal. The risk may increase with duration of use. Metaanalysis of randomized clinical trials comparing several difference NSAIDs suggest that diclofenac, particularly at higher doses, is associated with an increased risk of cardiovascular adverse events that is comparable to COX-2 inhibitors. Large population-based observational studies conducted in the general population also support these findings. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. To minimize the potential risk for adverse CV event, CAMBIA should be used for the shortest possible duration.

Treatment with CAMBIA is not recommended in patients with preexisting cardiovascular disease (congestive heart failure NYHA II--IV, ischemic heart disease, peripheral arterial disease), cerebrovascular disease, uncontrolled hypertension, and caution should be exercised in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking). These patients should be treated with CAMBIA only after careful consideration. Use of NSAIDs, such as CAMBIA can promote sodium retention in a dose dependent manner, which can result in increased blood pressure and/or exacerbation of congestive heart failure.

Risk of GI adverse events: Use of NSAIDs such as CAMBIA is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and GI bleeding) which can be fatal. Elderly patients are at a greater risk.

Risk in pregnancy: Caution should be exercised in prescribing CAMBIA during the first and second trimesters of pregnancy. Use of NSAIDs at approximately 20 weeks of gestation or later may cause fetal renal dysfunction leading to oligohydramnios and neonatal renal impairment or failure. CAMBIA is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia.

Other relevant warnings and precautions

• CAMBIA cannot be replaced by any other diclofenac formulations, nor is it possible to convert dosing from any other formulation of diclofenac to CAMBIA;

• Not recommended in individuals over 65; increased risk of adverse events; safety and efficacy have not been studied;

• Special care in frail or debilitated patients;

• Caution in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function;

• Hepatic, renal and genitourinary impairment;

• Patients with a history of peptic/duodenal ulcer disease or gastrointestinal bleeding;

• Use in phenylketonurics patients;

• Use in women attempting to conceive, first and second trimesters of pregnancy;

• Caution in patients with Helicobacterpylori infection, prolonged use of NSAID therapy, excess alcohol intake, smoking, poor general health status;

• Observation for patients with hemophilia or platelet disorders;

• Monitor patients taking warfarin;

• Blood dyscrasias and antiplatelet effects;

• Use in patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa, chronic obstructive pulmonary diseases or chronic infections of the respiratory tract, Quicke’s edema or urticarial, and patients who are allergic to other substances;

• Serious skin reactions;

• May mask signs and symptoms of infectious disease;

• May cause photosensitivity and vision changes upon exposure to sunlight or UV light;

• Neurological adverse events including blurred or diminished vision, decreased alertness or depression;

• Concomitant use with: other NSAIDs, with the exception of low-dose ASA for cardiovascular prophylaxis; diclofenac sodium containing products; anti-coagulants; anti-platelet agents; oral corticosteroids; Selective Serotonin Reuptake Inhibitors; drugs that are known to be potentially hepatotoxic (e.g. acetaminophen, certain antibiotics, antiepileptics)

For more information:

Please consult the Product Monograph at: https://www.miravohealthcare. com/wp-content/uploads/2021/12/Cambia-PM-ENG-Dec2021.pdf for adverse reactions, interactions, dosing and conditions of clinical use. The Product Monograph is also available by calling Miravo Medical Information at 1-866-391-4503.

REFERENCES: 1. CAMBIA ® Product Monograph, Aralez Pharmaceuticals Canada Inc. December, 2021. 2. Diener HC, Montagna P, Gacs G, et al. Efficacy and tolerability of diclofenac potassium sachets in migraine: a randomized, double-blind, cross-over study in comparison with diclofenac potassium tablets and placebo. Cephalagia 2006:26:537–547.

Describe your place in the world of pharmacy.

Throughout my career as a pharmacist, I have followed a path that has naturally led me to become an advocate for the profession. I am so lucky to have found my perfect fit as RxA’s CEO. I’m a cheerleader, a strategist, a defender, a dreamer and a risktaker. I am the eternal advocate for the profession.

What’s your personal “mission statement”?

To be genuine and true to myself. Practise what I believe in, keep an open-mind, not automatically accept the status quo, stay progressive and keep moving forward.

What motivates you?

Talking to other pharmacists about pharmacy. There is no shortage of challenges or pressing issues to deal with. It’s motivating to find solutions to problems and to have a great team of colleagues to work with, from board members to staff. Their passion and commitment are contagious.

How do you define success for yourself?

Success for me is loving the work I do and knowing that it makes a difference. Working with policy makers, regulators, researchers, academics, administrators and pharmacists, then being able to see the profession make a difference in people’s lives is very rewarding.

What’s the best part of what you do in your career?

The people and the friendships that I’ve developed are the best.

The world of pharmacy continues to have emerging complex challenges and solutions won’t come easy. They will require commitment from many stakeholders, and I believe all these relationships matter. I have come to truly appreciate the professional relationships that I have developed throughout my career.

What’s your favourite thing to do when you’re not working?

In the summer, I love outdoor activities like walking the dogs and riding my KTM 790 Adventure motorcycle. During the winter, my two favourite pastimes are sewing and baking.

Favourite food?

I am very lucky to have a son who is a chef. He cooks many outstanding dishes. Though if I had to pick only one, I would go with his braised short ribs. Yum!

Any pets?

My husband and I have grown a fantastic pet family since COVID-19 began. First was Elsa, who we got as a kitten in July 2020. In July 2021 came Zoey, an Italian Mastiff. Then Buddy, a stray tomcat, in January 2022. And finally Tikka, a Black Russian Terrier, in April 2022. They bring us so much joy and often laughter every single day. What is really amazing is that they all get along so well. But now I am a little worried because my husband mentioned that he saw another stray cat hanging around the backyard…

What’s your secret to good mental and physical health?

My pets play a major role in helping me maintain both positive mental health and good physical health. I walk Zoey and Tikka daily. Both Zoey and Buddy practice yoga with me, but if I am honest, Zoey is mostly in the ‘couch potato’ position for the entire session.

What’s next for Margaret Wing?

One of the lessons I learned from COVID-19 is that you can’t see what is around the corner. In recent months, my husband and I have found ourselves in the role of caregivers to our parents. My Dad would have said, “Life is a beautiful ride. Keep your foot on the gas and don’t be scared to live it,” which I fully intend to do.