What is CIDP?

Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP, is a neurological disorder that causes weakness, tingling, or numbness in the arms and legs. The symptoms of CIDP are caused by damage to the myelin sheath, which is a protective covering wrapped around the nerves of the arms and legs (peripheral nerves).¹

We don't know the exact reason for its clinical symptoms, but CIDP is thought to be an autoimmune disorder, in which a patient's immune system mistakenly attacks the myelin sheath. This results in defects in the ability of nerves to conduct electrical impulses, resulting in the weakness, tingling and numbness characteristic of CIDP.¹

Diagnosing CIDP

Diagnosing CIDP can be challenging, because patients can have a wide range of clinical symptoms, and responses to treatment can vary.¹ Early diagnosis is important, because patients are more likely to respond to treatment when it is begun early in the course of the disease.²

Diagnosis is usually made by a combination of symptoms and the results of nerve conduction studies, which measure the ability of nerves to conduct electrical signals. These tests can provide evidence of myelin damage.¹

What can be done?

GAMMAKED is an IG therapy proven effective in reducing the neuromuscular disability of patients with CIDP and in preventing relapse.^3,4

This information is not intended to be a substitute for professional medical care. You should consult your healthcare professional for specific information on the diagnosis, treatment, and clinical care for patients with CIDP.

References: 1. Mathey EK, Park SB, Hughes RAC, et al. Chronic inflammatory demyelinating polyradiculoneuropathy: from pathology to phenotype. J Neurol Neurosurg Psychiatry. 2015;86:973-85. 2. Steinberg JS, Koski CL. Guillain-Barré syndrome, CIDP and variants. An overview for the layperson. 10th ed. http://30g7el1b4b1n28kgpr414nuu.wpengine.netdna-cdn.com/wp-content/uploads/2012/01/OverviewENG.pdf. Accessed July 27, 2021. 3. Hughes RAC, Donofrio P, Bril V, et al. 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;7:136-44. 4. GAMMAKED [prescribing information]. Ft. Lee, NJ: Kedrion Biopharma; 2018.

Important Safety Information

What is GAMMAKED?

GAMMAKED™ [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] is an immune globulin injection that is used to treat primary humoral immunodeficiency (PI) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

What is the most important information I should know about GAMMAKED?

GAMMAKED should be infused under your skin (in the subcutaneous tissue). DO NOT inject GAMMAKED into a blood vessel or directly into a muscle.

GAMMAKED May Cause

Blood Clots (Thrombosis). Blood clots may occur in patients taking immune globulin intravenous (IGIV) products, including GAMMAKED. You may be at greater risk for blood clots if you are of advanced age, sit or lie for long periods, have a clotting condition or a history of blood clots, take estrogen hormones, have a central catheter, have thick blood, and/or if you have other conditions that put you at risk for cardiovascular disease. Blood clots may occur even if you do not have any of these known risk factors.

Impaired kidney function or kidney failure. IGIV products, particularly those that contain sugar (sucrose), have been reported to be associated with kidney dysfunction and damage, kidney failure, and death. Kidney damage and kidney failure happen more often in patients receiving IGIV products containing sucrose. GAMMAKED does not contain sucrose. You may be at greater risk for kidney failure if you have kidney disease, diabetes, are over age 65, are seriously dehydrated, have a blood infection (sepsis), have a blood condition called paraproteinemia, or take drugs that can damage your kidneys.

CONTRAINDICATIONS

Do not use GAMMAKED if:

You have a history of severe allergic reactions to human immune globulin. Tell your healthcare provider if you have had a serious reaction to other medicines that contain human immune globulin. Ask if you are not sure.
You have an immunoglobulin A (IgA) deficiency and have antibodies to IgA and have a history of allergic reactions. Tell your healthcare provider if you have an IgA deficiency or ask if you are not sure.

WARNINGS AND PRECAUTIONS

Severe allergic reactions may occur with IGIV products, including GAMMAKED. IgA deficient patients who have antibodies against IgA are at greater risk of developing severe allergic reactions. Your healthcare provider should have medications, such as epinephrine, to immediately treat any sudden severe allergic reactions.

If you are receiving GAMMAKED, you could experience higher than normal levels of protein in your blood, thick blood, or low sodium (salt) in your blood. This may prevent your blood from flowing easily and possibly lead to blood clots.

Brain inflammation or brain swelling called Aseptic Meningitis Syndrome (AMS) may occur infrequently with IGIV products, including GAMMAKED, especially if you receive a high dose or a rapid infusion.

Blood damage called hemolysis and hemolytic anemia can develop after treatment with GAMMAKED. Your healthcare provider will closely monitor you for signs and symptoms of hemolysis and hemolytic anemia.

Swelling of the lungs may occur in patients following IGIV treatment, including GAMMAKED. Your healthcare provider will monitor you for signs of lung damage (also known as transfusion-related acute lung injury [TRALI]).

GAMMAKED is made from human blood and, therefore, carries a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.

Be sure to tell your healthcare provider about your recent history of vaccinations. Live vaccines for diseases like measles, mumps, rubella and varicella may not work as well for you while you are receiving GAMMAKED. Tell your healthcare provider that you are taking GAMMAKED before you receive any vaccination.

ADVERSE REACTIONS

In clinical studies, the most common side effects of GAMMAKED were:

Increased cough, stuffy nose, sore throat, headache, asthma, nausea, fever, diarrhea, and sinus infection, when administered intravenously to patients with PI.
Swelling and itching at the injection site, fatigue, headache, upper respiratory infection, joint pain, diarrhea, nausea, sinus infection, bronchitis, depression, allergic skin reactions, redness of the skin, migraine, muscle pain, viral infection, and fever, when administered subcutaneously to patients with PI.
Headache, bruising, vomiting, fever, nausea, rash, abdominal pain, back pain, and indigestion in patients with ITP.
Headache, fever, increased blood pressure, chills, rash, nausea, joint pain, and weakness in patients with CIDP.

During treatment with GAMMAKED, be sure to tell your healthcare provider about any unusual symptoms you experience as they may indicate a possible side effect.

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.

Please click here for the Full Prescribing Information, for more information including the Boxed Warning, a description of who should not take GAMMAKED, and dosing and administration information.