Is CIDP treatable?
While there is no cure for chronic inflammatory demyelinating polyneuropathy (CIDP), it can be treated with intravenous immune globulin (IVIG). Immunoglobulin is another name for antibodies that come from donated human plasma.1,2 The antibodies in IVIG help to block the immune and inflammatory processes that attack and destroy the nerve protective coating in adults with CIDP.
What happens if CIDP is not treated?
If CIDP is left untreated, symptoms may get worse over time. These can range from worsening sensory symptoms, such as tingling and numbness, to weakness and loss of balance.
What is GAMUNEX-C?
GAMUNEX-C is an intravenous immune globulin (IVIG) treatment approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. If you have CIDP, you may only take GAMUNEX-C intravenously.
Who is GAMUNEX-C for?
GAMUNEX-C may meet the needs of a variety of CIDP patient types who may also have other conditions like diabetes, cardiovascular disease, and kidney dysfunction.
Immune globulin (IG) therapies that contain sugar stabilizers are more likely to cause kidney-related side effects. GAMUNEX-C may be suitable for patients with kidney dysfunction because it contains no sugar and no preservatives.3
Increased sodium content may cause cardiovascular side effects. GAMUNEX-C may be suitable for patients with cardiovascular disease because it contains only trace amounts of sodium.3
How is GAMUNEX-C made?
GAMUNEX-C is made from donated plasma, using a unique process that preserves the biologic activity of antibodies. This results in a product with maximum purity.
Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
How is GAMUNEX-C administered for CIDP?
If you have CIDP, GAMUNEX-C will be administered intravenously (IV), through a vein, typically in your arm. GAMUNEX-C can be administered in the home, a hospital, or an infusion clinic by a healthcare professional.
See how GAMUNEX-C is administered here.
How long does it take to receive an infusion of GAMUNEX-C?
Intravenous immunoglobulin (IVIG) infusions usually last 2 to 4 hours from start to finish. Consider having a game, book, or tablet to occupy your time during the infusion. Your doctor or infusion nurse may ask you to keep track of how you're feeling so that he/she can determine the treatment schedule that is right for you.
Your first infusion of GAMUNEX-C may be given over several days. Your healthcare professional will monitor your initial infusion closely and help with any questions you may have.
What kind of improvements are seen in patients with CIDP who respond to GAMUNEX-C?
Patients who responded to GAMUNEX-C experienced:
- Significant improvement in disability scores through week 24 (primary endpoint)4
- Improved grip strength in both hands4
- Improvements in physical and social functioning at 48 weeks5
Not all patients responded to GAMUNEX-C. Learn more about how GAMUNEX-C works.
What side effects should I be aware of with GAMUNEX-C?
The most common side effects for CIDP patients taking GAMUNEX-C were:
- Pain in the region of the head or neck
- Raised body temperature or fever
- Abnormally high blood pressure
- Feelings of coldness accompanied by shivering
- Noticeable change in the texture or color of the skin such as the skin becoming scaly, bumpy, itchy, or otherwise irritated
- Sensation of unease and discomfort in the upper stomach
- Joint pain
- Abnormal physical weakness or lack of energy
The most serious side effect for CIDP patients taking GAMUNEX-C was:
- Blood clot in the lung (pulmonary embolism) in 1 patient with a history of this condition
If you take GAMUNEX-C or a similar immune globulin product, you could experience a serious and life-threatening blood clot (thromboembolism), which may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness, or weakness on one side of the body.
Immune globulin therapies given intravenously, including GAMUNEX-C, have been associated with kidney disease. Talk to your doctor right away if you experience any of these symptoms:
- Decreased urination
- Sudden weight gain
- Swelling in your legs (edema)
- Shortness of breath
What do I need to know about long-term management for CIDP?
Managing your CIDP over the long term is very important to your treatment success. Since there is no known cure for CIDP, it can relapse, in which symptoms come back slowly or all of a sudden. Finding the right treatment regimen is critical to best manage your symptoms. Watch for any changes and talk with your doctor right away if symptoms return or get worse.
When patients were given GAMUNEX-C every 3 weeks, more than 87% of people who responded to treatment were relapse-free through 48 weeks of treatment, compared with 57% of people who received placebo.4
Watch Julie discuss CIDP, long-term treatment, relapse, and having a good support system here.
What resources are available to help support me with CIDP?
There are tools and resources available to support you throughout treatment, including the CIDP Symptom Questionnaire, educational videos and brochures, and support organizations for those living with CIDP. Learn more about the support tools and resources that are available to you.
What is Gamunex Connexions®?
Gamunex Connexions is a patient support program dedicated to providing information and financial support. Learn more about Gamunex Connexions. For any questions, call Gamunex Connexions for all of your support and financial needs at 1-888-MYGAMUNEX (1-888-694-2686) Monday through Friday from 8 am to 8 pm ET.
What financial support is available to me through Gamunex Connexions?
GAMUNEX-C offers the Copay Assistance Program to eligible patients* through Gamunex Connexions. The program offers assistance up to $10,000 per calendar year and is available to help with deductibles, copayment, and coinsurance.
If you have CIDP or PIDD, you may be qualified to receive GAMUNEX-C at no cost in the event of loss of insurance or underinsurance. Learn more about financial support with Gamunex Connexions.
*Subject to terms and conditions.
What other support does Gamunex Connexions offer?
Besides financial support, Gamunex Connexions can provide you with educational information about CIDP to help support your needs, answer any questions about GAMUNEX-C, and help connect you to support organizations and other resources to help you manage your condition. For more information about these resources, you can call 1-888-MYGAMUNEX (1-888-694-2686) Monday through Friday from 8 am to 8 pm ET.
Important Safety Information
GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is approved to treat primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older. If you have PIDD, you may take GAMUNEX-C under the skin (subcutaneously) or in a vein (intravenously). GAMUNEX-C is also approved to treat idiopathic thrombocytopenic purpura (ITP) in adults and children and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. If you have ITP or CIDP, you may only take GAMUNEX-C intravenously.
If you take GAMUNEX-C or a similar immune globulin product, you could experience a serious and life-threatening blood clot (thromboembolism), which may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness, or weakness on one side of the body. You are more likely to develop a blood clot if you have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart). You may also be more likely to get a blood clot if you are elderly, if you have a blood clotting disorder, if you are inactive for long periods of time (such as long bed rest), if you use estrogens, or if you have thickening of your blood. For patients at risk, GAMUNEX-C should be administered at the lowest dose and slowest infusion rate that is practical. However, blood clots may occur in the absence of any of the known risk factors. Patients should be well hydrated by drinking enough water before GAMUNEX-C is administered. Tell your doctor immediately if your medical history is similar to what is described here, and especially if you start having any of these symptoms while taking GAMUNEX-C.
If you take GAMUNEX-C or a similar immune globulin product intravenously, you could experience serious kidney disease and death. You may have symptoms of decreased urination, sudden weight gain, swelling in your legs (edema), or shortness of breath. You are more likely to develop serious kidney disease if you already have a kidney problem, have Type II diabetes mellitus, or are older than 65. You are more likely to develop serious kidney disease if you are dehydrated, have a blood infection (sepsis), have high protein content in your blood, or if you are receiving other medicines that are harmful to your kidneys. Tell your doctor immediately if your medical history is similar to what is described here, and especially if you start having any of these symptoms while taking GAMUNEX-C.
You are more likely to develop serious kidney disease if you take an intravenous immune globulin product that contains sugar (sucrose). GAMUNEX-C does not contain sugar. If your situation makes you more likely to experience serious kidney disease, you should take GAMUNEX-C at the lowest concentration available and the slowest infusion rate that is practical.
Do not take GAMUNEX-C if you have an allergy to immune globulin. Tell your doctor if you have had a serious reaction to other medicines that contain human immune globulin. Also tell your doctor if you have immunoglobulin A (IgA) deficiency. If you have a serious reaction while taking GAMUNEX-C, stop taking it immediately and tell your doctor.
Periodic monitoring of kidney function and urine output is particularly important in patients more likely to experience severe kidney disease.
You could experience other serious and life-threatening problems due to immune globulin. You could get aseptic meningitis (a type of brain inflammation with symptoms of severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea, and vomiting), a blood problem called hemolytic anemia (common symptoms include increased heart rate, fatigue, yellow skin or eyes, and dark-colored urine), and/or a lung problem called transfusion-related acute lung injury (commonly referred to as TRALI). TRALI is a condition where you build up fluid in the lungs (called pulmonary edema) that is not the result of heart failure.
If you have higher than normal body fluid volumes or if you have a condition where increasing body fluid volume may be a concern, a higher dose, such as 1g/kg for 1-2 days, is not recommended.
Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
You may not take GAMUNEX-C subcutaneously if you have ITP. If you have ITP and take GAMUNEX-C subcutaneously, you could experience a very serious and life-threatening black and blue wound (hematoma, which is a pocket of blood within a tissue).
After you take GAMUNEX-C, your blood antibody levels may rise, which could cause some blood antibody tests to give false results.
The most common side effects in a clinical study with PIDD patients who got subcutaneous injections of GAMUNEX-C were infusion-site reactions such as redness, swelling, and itching; extreme tiredness; pain in the region of the head or neck; a runny nose, nasal congestion, sneezing, cough, and sputum production; joint pain; loose stools; a sensation of unease and discomfort in the upper stomach; swelling of the tissue lining the sinuses; inflammation of the airways that carry air to your lungs; a feeling of unhappiness, sadness, melancholy, gloom, hopelessness, or low spirits; red rash or bumps, itchy, swollen, and tender skin with or without blisters or a burning feeling; a severe throbbing pain or a pulsing sensation, usually on just one side of the head; muscle pain; familiar infectious diseases such as the common cold or flu; and raised body temperature or fever. In clinical studies with PIDD patients who got GAMUNEX-C intravenously, the most common side effects were cough; irritation and inflammation of the mucous membrane inside the nose; sore throat caused by inflammation of the back of the throat; pain in the region of the head or neck; a condition in which your airways narrow and swell and produce extra mucus; a sensation of unease and discomfort in the upper stomach; raised body temperature or fever; loose stools; and swelling of the tissue lining the sinuses. In a clinical study with CIDP patients who got GAMUNEX-C intravenously, the most common side effects were pain in the region of the head or neck; raised body temperature or fever; abnormally high blood pressure; feelings of coldness accompanied by shivering; a noticeable change in the texture or color of your skin such as your skin becoming scaly, bumpy, itchy, or otherwise irritated; a sensation of unease and discomfort in the upper stomach; joint pain; and abnormal physical weakness or lack of energy. In clinical trials with ITP patients who got GAMUNEX-C intravenously, the most common side effects were pain in the region of the head or neck; a discoloration of the skin resulting from bleeding underneath, typically caused by bruising; vomiting, fever, nausea, rash, abdominal pain, back pain, and a pain or an uncomfortable feeling in the upper middle part of your stomach.
The most serious side effects in clinical studies were a blood clot to the lung (pulmonary embolism) in 1 patient with a history of this condition (in CIDP), a flare-up of an existing type of anemia (autoimmune pure red cell aplasia) in 1 patient (in PIDD), and heart inflammation (myocarditis) in 1 patient (in ITP).
Please see accompanying full Prescribing Information for GAMUNEX-C.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Terms to know
CIDP, chronic inflammatory demyelinating polyneuropathy; IG, immune globulin; ITP, idiopathic thrombocytopenic purpura; IV, intravenous; PIDD, primary immunodeficiency disease; SCIG/sub Q, subcutaneous immunoglobulin.
References
- Koski CL. CIDP: Chronic Inflammatory Demyelinating Polyneuropathy. Narberth, PA: GBS/CIDP Foundation International; 2012.
- Chronic inflammatory demyelinating polyradiculoneuropathy. University of Rochester Medical Center website. https://www.urmc.rochester.edu/encyclopedia/ content.aspx?ContentTypeID=134&ContentID=210. Accessed August 2, 2023.
- Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006:6(4):592-599.
- Hughes RAC, Donofrio P, Bril V, et al; on behalf of the ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008;7(2)136-144.
- Merkies IS, Bril V, Dalakas MC, et al. Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: the ICE Study. Neurology. 2009;72(15):1337-1344.