A Question & Answer Guide to Help Patients & Caregivers Have Productive Conversations With Their Healthcare Providers
Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of dermatomyositis (DM) in adults. Octagam 10% is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to control or prevent bleeding in adults.
Important Safety Information
Contraindications
Octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam 10% contains trace amounts of IgA (average 106 μg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Please see accompanying full Prescribing Information for additional important information.
Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam 10%.
Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IGIV products, including Octagam 10%. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV product containing sucrose. Octagam 10% does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Octagam 10% at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
TREATING DERMATOMYOSITIS (DM) WITH OCTAGAM 10%
Questions for your healthcare team
Before every office visit, it’s helpful to make a list of questions about your condition and Octagam 10% treatment to discuss with your healthcare team. Below are some of the common questions patients and caregivers often ask.
QUESTIONS ABOUT DM
What are the most common symptoms of DM? Does Octagam 10% work against the common DM symptoms?
How do DM symptoms develop? Can DM symptoms change over time? Can DM be cured?
QUESTIONS ABOUT OCTAGAM 10%
What is Octagam 10%? How is Octagam 10% made?
How does Octagam 10% work in DM? How is Octagam 10% different from other DM treatments?
How effective is Octagam 10% against the symptoms of DM? Can I expect major improvement of my symptoms?
How is improvement measured with Octagam 10%? What does Total Improvement Score mean?
What is the ProDERM study?
How quickly does Octagam 10% work against DM symptoms? How long do I have to take Octagam 10%?
QUESTIONS ABOUT SUPPORT
Is Octagam 10% covered by insurance? Does Octapharma offer copay assistance with Octagam 10%?
Can Octapharma provide assistance getting approval for Octagam 10% from my health insurance company?
Indications and Usage
Octagam® 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of dermatomyositis in adults. Octagam 10% is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to control or prevent bleeding in adults.
What are the goals of therapy in DM?
What types of medical (drug) treatments are available for DM?
How soon after treatment starts do patients feel better or see results?
Can Octagam 10% be used in children with DM?
Can I take other treatments for DM while taking Octagam 10%?
How do I take Octagam 10%? Where are Octagam 10% infusions given? How long does an infusion take?
Can I take my infusions at home?
What should I do before an infusion? Is premedication required with Octagam 10% infusions?
What are the most common side effects of Octagam 10%? What is the most important thing I need to know about Octagam 10%? Are there any serious side effects?
Where can I get more information about DM and Octagam 10%? What professional and patient organizations (websites, social media) can I go to for more information and support?
QUESTIONS ABOUT DM
What are the most common symptoms of DM? Does Octagam 10% work against the common DM symptoms? 1,2
What types of medical (drug) treatments are available for DM? 1,6,7
In DM, the inflammation of the blood vessels under the skin and in the muscles typically leads to rash, skin changes, and muscle weakness. DM is more likelty to occur in adults between ages 40 to 70 years. While both men and women can develop DM, it is twice as common in females.
• Rash and skin changes. Rash is often the first sign of DM, and can occur on the eyelids, chest, and upper back. It can be itchy and painful, or may cause no discomfort. Patients may also experience red or violet bumps on their fingers, elbows, knees, and ankles, as well as discoloration on their fingers, cuticles, and thighs. Some patients may develop hair thinning.
• Muscle weakness. Patients typically experience gradual muscle weakness over weeks or months. Some patients may also have muscle pain and painful joints. The muscles most often affected include the neck, hip, back, and shoulders. Some people have trouble swallowing (dysphagia) and hoarse voice (dysphonia). In some cases, joints feel stiff and painful and turn pale when exposed to cold temperatures—and feel better when warmed (a condition known as Raynaud’s phenomenon).
Octagam 10% is proven to significantly improve rash and skin changes and muscle weakness in adults with DM (see Questions about Octagam 10%) 3,4
How do DM symptoms develop? Can DM symptoms change over time? Can DM be cured? 5,6
The signs and symptoms of DM can appear either gradually or suddenly—and in different areas of the body. This can vary from person to person. Sometimes, DM symptoms disappear for a while, only to later return. That’s why it is important to get diagnosed and start treatment as early as possible. While there is no cure for DM, symptoms can be managed and improved with long-term (sometimes life-long) medications and physical therapy that can help improve rashes and muscle strength.
What are the goals of therapy in DM? 1,7
The goal of treatment is to reduce inflammation—thereby improving skin and muscle symptoms—leading to improved function, less disability, and better quality of life. To achieve this goal, it is better to start treatment early in the disease process. Managing DM often requires a team approach with patients, their caregivers, and multiple healthcare providers (eg, rheumatologists, dermatologists, physical therapists, nurses, family physicians). Patient education is very important in achieving treatment goals.
Important Safety Information Contraindications
Octagam® 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
While there is no cure for DM, the symptoms can be treated and managed. There are several types of medications typically used in the treatment of DM:
• Corticosteroids, such as prednisone (given orally or intravenously), are used initially to reduce inflammation. In many patients, prednisone may be needed for life. While corticosteroids are effective, they may come with severe side effects, including osteoporosis (brittle bones), eye cataracts and glaucoma, stomach upset, weight gain, mood swings, diabetes, and a condition known as Cushing’s syndrome (rounded face, a fatty lump between the shoulders, abdominal weight gain, acne). It is important to be aware of “steroid myopathy,” which may actually “mimic” a worsening of DM symptoms. Doctors monitor patients closely for these side effects.
• Immunosuppressive or cytotoxic agents such as methotrexate (given by injection), may be used in patients who do not respond well to steroids. These medications do have a number of side effects, including stomatitis (sore or inflammation inside the mouth), fibrosis and cirrhosis (scarring of the liver), nausea, abdominal pain, neutropenia (low neutrophils/white blood cells leading to increased risk of infection), pruritus (itchiness), fever, pneumonitis (lung inflammation), and other gastrointestinal symptoms.
• Intravenous immune globulin, such as Octagam 10%, is a blood product derived from large pools of donated human plasma that contains the part of the blood that carries antibodies—which can boost your body’s immune system.
• Other drug therapies that have been used to treat DM include: monoclonal antibodies, such as rituximab (given by injection); calcium channel blockers, such as diltiazem (given orally); and antimalarial drugs such as hydroxychloroquine (given orally).
How soon after treatment starts do patients feel better?
1,3,4
It can take a several months for symptoms to improve after beginning treatment. With Octagam 10%, adult DM patients had significant symptom improvement at 4 months. For most people living with DM, they feel better as they regain muscle strength. How long it takes depends on the treatments needed/ given and the type and severity of symptoms. Ask your healthcare provider about what to expect and when you should notice your symptoms getting better.
Important Safety Information Adverse Reactions
The most common adverse reactions observed in >5% of clinical study subjects with DM were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusion site reactions.
QUESTIONS ABOUT OCTAGAM 10%
What is Octagam 10%? How is Octagam 10% made? 3
Octagam 10% is an intravenous immune globulin (IVIg)—made from donated, pooled healthy human plasma, which comes from blood. IVIg therapies like Octagam 10% are made under strict Food & Drug Administration (FDA) guidelines to ensure they’re safe to use. These include:
How effective is Octagam 10% against the symptoms of DM? Can I expect major improvement of my symptoms? 3,4
• Getting human plasma from FDA-approved donation centers
• Checking plasma donors for prior exposure to certain viruses and other diseases
• Testing the collected plasma to help ensure that it is virus- and disease-free
• Virus inactivation and removal steps in the manufacturing process
How does Octagam 10% work in DM? How is Octagam 10% different from other DM treatments? 3,8
There are a number of theories why IVIg treatment, like Octagam 10%, are effective in DM. IVIg provides extra antibodies to the blood. It is believed that IVIg acts as an immune system “booster,” reducing the inflammation of the blood vessels under the skin and in the muscle. What is different about IVIg is that is a biologic treatment, made from purified human plasma, and not a drug like prednisone (a steroid) or methotrexate (a cytotoxic agent).
What is the ProDERM study? 3,4
ProDERM stands for the Progress in DERMatomyositis study. The ProDERM study is the successful pivotal study that evaluated Octagam 10% in the treatment of DM. Octagam 10% is the first IVIg therapy with a successful phase 3 study resulting in FDA approval for dermatomyositis in adults. Octagam 10% is currently still the only FDA-approved IVIg treatment for dermatomyositis in adults.
How is symptom improvement measured with Octagam 10%? What does Total Improvement Score mean? 3,4
In the ProDERM study, 95 adults with DM were given an infusion of Octagam 10% or placebo (saline). Patients in both treatment groups could continue taking their other medications while they were part of the study. The main study objective was improvement in the Total Improvement Score (or TIS). The TIS is measured on a scale of 0 to 100, and uses different tools that measure muscle strength, amount of visible rash, activity level, protein levels in muscle, and quality of life. With the TIS, a higher score indicates better improvement of DM signs and symptoms.
Important Safety Information Contraindications
Octagam® 10% contains maltose, a disaccharide which is derived from corn. Patients known to have corn allergies should avoid using Octagam 10%. Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to Octagam 10% treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia. Aseptic meningitis syndrome may occur in patients receiving Octagam 10%, especially with high doses or rapid infusion.
In the ProDERM study, TIS (Total Improvement Score) was measured on a scale of 0 to 100. A higher score indicates better improvement of DM. Investigators evaluated improvement in TIS as minimal (20 or higher), moderate (40 or higher), and major (60 or higher) with Octagam 10% or placebo after 16 weeks. For all 3 categories (minimal, moderate, major), adults with DM treated with Octagam 10% achieved substantially higher improvements in TIS, with 79% of patients treated with Octagam 10% achieving at least minor improvement and almost one-third of patients experiencing major improvement.
Improvement in TIS Octagam 10% Placebo
Minor (20 or higher) 79% 44%
Moderate (40 or higher) 68% 23% Major (60 or higher)
Investigators also measured changes in the severity of skin disease in DM with a test called Cutaneous Dermatomyositis Disease Area and Severity Index (or CDASI). The CDASI looks at over 15 areas, including: scalp, face, neck, upper back and shoulders, buttocks, arms, abdomen, hands, thigh, legs, and feet. CDASI is measured on a scale of 0-100. Lower scores indicate lower disease severity. After 16 weeks, patients treated with Octagam 10% achieved an average decrease of 9.4 points in CDASI compared with only 1.2 points with placebo.
How fast does Octagam 10% work to improve DM symptoms? How long does improvement last? How long do I have to take Octagam 10%? 3,4
In the ProDERM study the mean TIS with Octagam 10% was more than double that of placebo at week 16 (48.4 vs 21.6). As early as week 4, patients treated with Octagam 10% had notable symptom improvement, with a TIS score of 24.4 (compared to 10.7 for placebo). At week 40, improvements in TIS score were maintained with Octagam 10%, with a TIS score of 55.4. It’s important to note that after week 16, patients in the placebo group were able to start Octagam 10%, and also achieved a TIS score of 51.1 at week 40.
As with most treatments for DM, continued treatment is generally required to maintain symptom control.
Can Octagam 10% be used in children with DM? 3
Octagam 10% is only approved for adults with DM. If you have a child with DM, talk to your provider about treatment options.
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QUESTIONS ABOUT OCTAGAM 10%
(continued)
Can I take other treatments for DM while taking Octagam 10%? 3,4
Yes. Patients with DM may continue taking their other prescribed medications, such as corticosteroids, immunosuppressants, as well as anti-inflammatory and antirheumatic products. In the ProDERM study, most of the patients continued on their stable prior DM medications. Your physician will work with you to determine if additional or previous treatment are needed while taking Octagam 10%.
How do I take Octagam 10%? Where are infusions given? How long does an infusion take? Can I take my infusions at home? 3
Octagam 10% is given intravenously, through a needle inserted in a vein, usually by a nurse or healthcare professional. For the treatment of adults with DM, Octagam 10% is given every 4 weeks over 2 to 5 days. Each infusion may last several hours. The total time depends on your dose and rate of infusion. Some people may have a quicker infusion, while others may need more time. It may take a few infusions to find what works for you.
Your infusion may be given either at a hospital, infusion center, or in your own home (with a home infusion nurse). For many patients, there may be benefits to receiving IVIg therapy outside of a hospital: it’s a more relaxed and comfortable place for infusions, and offers the convenience of not travelling to a hospital or clinic. Talk to your healthcare team about your infusion options.
What should I do before an infusion? Is premedication required with Octagam 10% infusions? 3,4
• Getting ready for your infusion. The day before and the day of your infusion, make sure you drink plenty of water, avoiding caffeine or alcohol. Your infusion time will vary and could take several hours. Have an activity available to help pass the time (eg, reading a book).
• During and after your infusion. All patients are monitored carefully throughout the infusion, including blood pressure and temperature. Certain adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly. Once the symptoms subside, the infusion may then be resumed at a lower rate. Some people may require premedication before an infusion to minimize side effects. In the ProDERM study around 11% of patients receiving Octagam 10% received premedication with analgesics, and 8.5% received an antihistamine. After the infusion, you can continue with the regular activities of your day, as tolerated.
Indications and Usage
Octagam® 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of dermatomyositis in adults. Octagam 10% is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to control or prevent bleeding in adults.
What are the most common side effects of Octagam 10%? Are there any serious side effects? 3,4
Treatment of adults with DM with Octagam 10% is generally well tolerated. In the ProDERM study, the majority of adverse events were mild. The most common side effects reported with Octagam 10% were: headache, fever, nausea, vomiting, increased blood pressure, chills, muscle pain, and increased heart rate.
Patients should be informed of the signs and symptoms of hypersensitivity reactions including urticaria, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, and to contact their physicians immediately if allergic symptoms occur.
As with any IVIg therapy, severe side effects may occur, but are generally uncommon. In the ProDERM study, 9 serious treatment-related adverse events occurred among 7 patients—which were managed. No deaths and no hemolytic transfusion reactions were reported.
Patients should immediately report the signs and symptoms of the following conditions to their physician:
• Renal (kidney) failure, such as decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath
• Aseptic meningitis, such as headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting
• Hemolysis, such as fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine
• Transfusion-related acute lung injury (TRALI ), such as troubled breathing, chest pain, blue lips or extremities, and fever. TRALI typically occurs within 1 to 6 hours following transfusion
Thrombosis and Thomboembolic Events (TEEs)
Thrombosis (blood clots) and TEEs may occur following treatment with immune globulin products, including Octagam 10%.
In addition, patients with DM are at increased risk for TEEs. Therefore, patients with DM require careful monitoring during treatment with Octagam 10% for signs and symptoms of thrombosis — and the infusion rate should not exceed 0.04 ml/kg/min.
Important Safety Information
Contraindications
Octagam® 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
QUESTIONS ABOUT SUPPORT
Is Octagam 10% covered by insurance? Is Octagam 10% covered by Medicare? Does Octapharma offer copay assistance with Octagam 10%? Can Octapharma provide assistance getting approval for Octagam 10% from my health insurance company?
Yes. IVIg treatments (including Octagam 10%) are covered by most commercial (private) health insurance. To cover IVIg treatment, most insurance companies require prior authorization. Prior authorization refers to the decision from an insurer that deems a drug to be medically necessary.
For patients on Medicare with inflammatory myopathies such as DM, IVIg is covered when the following criteria have been met:9
1. Patient has a diagnosis of dermatomyositis AND
2. Impaired function by assessment and/or objective findings on physical exam at the time of initial therapy AND
3. Refractory to corticosteroids given in therapeutic doses over at least 4 months, OR is intolerant of/has a contraindication to corticosteroids
Octapharma offers a co-pay program for patients treated with their immunoglobulin therapies, including Octagam 10%
Eligible patients with commercial insurance who are currently using Octagam 10%, or who have a prescription to begin therapy, can receive up to $2,500 on out-of-pocket costs per calendar year or the cost of patient’s co-pay in a 12-month period (whichever is less) for claims received by the program. Terms and conditions apply.
• This can be applied to co-payments, deductibles, and co-insurance subject to plan requirements related to the cost of Octagam 10%
• Patients must have commercial insurance to be eligible
• Patients enrolled in a state or federally funded insurance program are not eligible
Octapharma also provides free assistance with reimbursement, including:
• Individual insurance claims processing reviews
• Assistance in appeals
• Insurance benefits investigations into product coverage
• Understanding requirements for prior authorizations
Call the Octapharma Support Center at 1-800-554-4440 for more information on co-pay assistance and reimbursement
Important Safety Information
The following serious adverse reactions were observed in the DM study: muscle spasms and dyspnea in one subject, loss of consciousness in one subject, and thromboembolic events (TEEs) in five subjects, including deep vein thrombosis and pulmonary embolism in one subject, cerebrovascular accident in one subject, cerebral infarction in one subject, hypoesthesia in one subject and pulmonary embolism in one subject.
Where can I get more information about DM and Octagam 10%?
Your local Octapharma patient representative can provide you with answers to questions about our products, programs, and services. Call the Octapharma Support Center at 1-800-554-4440 for more information.
What professional and patient organizations (websites, social media) can I go to for more information and support?
There are several DM organizations that offer comprehensive education, advocacy, and support for people living with DM.
• The Myositis Foundation (myositis.org) | Dedicated to improving the lives of persons affected by myositis, fund innovative research, and increase myositis awareness and advocacy
• Myositis Support and Understanding Association (understandingmyositis.org) | Patientcentered, all-volunteer, nonprofit organization empowering the myositis community through education, support, awareness, advocacy, access to research, and need-based financial assistance
• National Organization for Rare Disorders (rarediseases.org) | Patient advocacy organization dedicated to individuals with rare diseases, such as DM, and the organizations that serve them. NORD, along with its more than 300 patient organization members, is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services.
• Patients Like Me (patientslikeme.com) | Patient organization dedicated to improving the lives of patients managing complex health conditions. Their unique digital platform empowers patients to navigate their health journeys together through peer support, personalized health insights, tailored digital health services, and patient-friendly clinical education.
• American Association of Neuromuscular & Electrodiagnostic Medicine (aanem.org) | Professional organization dedicated to the advancement of neuromuscular disease (including DM)
• Autoimmune Association (autoimmune.org) | World’s leading nonprofit organization dedicated to autoimmune awareness, advocacy, education, and research
• National Institute of Neurological Disorders and Stroke (ninds.nih.gov) | Part of the National Institutes of Health (NIH). Comprehensive information on research and fundings, as well as disease fact sheets
Facebook Groups
• Myositis Support Group
• Dermatomyositis Awareness
• Living with Polymyositis/Dermatomyositis
Important Safety Information
Octagam® 10% contains maltose, a disaccharide which is derived from corn. Patients known to have corn allergies should avoid using Octagam 10%. Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to Octagam 10% treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.
For all inquiries relating to drug safety, or to report adverse events, please contact our local Drug Safety Officer: Tel: 201-604-1137 | Cell: 201-772-4546 | Fax: 201-604-1141 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
References: 1. Cleveland Clinic. Dermatomyositis: symptoms, causes & treatments. May 2022. https://my.clevelandclinic.org/health/diseases/ 15701-dermatomyositis 2. Johns Hopkins. Dermatomyositis. https://www.hopkinsmedicine.org/health/conditions-and-diseases/dermatomyositis 3. Octagam 10% Full Prescribing Information. Paramus, NJ: Octapharma; rev March 2022. 4. Aggarwal R, et al. N Engl J Med. 2022;387:1264-1278. 5. Sparrow Health System. Dermatomyositis. June 2022. https://www.sparrow.org/departments-conditions/conditions/dermatomyositis#:~:text= The%20cause%20of%20dermatomyositis%20is,also%20might%20play%20a%20role 6. The Myositis Foundation. Myositis 101: your guide to understanding myositis. 2012. Accessed September 13, 2022. https://www.myositis.org/wp-content/uploads/2018/01/Myositis101.pdf 7. Koler RA, et al. Am Fam Physician. 2001;64:1565-1572. 8. Patwardhan A. Cureus. 2020;12(2): e7049. DOI 10.7759/cureus.7049. 9. BlueCross BlueShield of West Virginia. Pharmacy Policy Bulletin. May 21, 2008. https://www.highmarkbcbswv.com/PDFFiles/pharmacy/ivig-policy.pdf
