Helpful Websites

For more information on CIDP, PI and ITP click on the links below.

CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY:

GBS/CIDP Foundation International
Providing support and assistance to GBS/CIDP patients and their families and committed to increasing knowledge and awareness in both the public and professional communities, the Foundation provides print information and educational opportunities, sponsors worldwide meetings, lectures, and support groups, hosts the biannual GBS/CIDP International Symposium, and encourages new findings by awarding research grants for further study and experimentation. Learn more»

National Institute of Neurological Disorders and Stroke
The mission of NINDS is to reduce the burden of neurological disease—a burden borne by every age group, and every segment of society. NINDS is the leading supporter of biomedical research on disorders of the brain and nervous system. Learn more»

MedlinePlus
MedlinePlus is a website hosted by the US National Library of Medicine that brings together resources from the National Institutes of Health (NIH) and other government agencies and health-related organizations. MedlinePlus also has extensive information about drugs, an illustrated medical encyclopedia, interactive patient tutorials, and the latest health news. Learn more»

PRIMARY IMMUNODEFICIENCY:

Immune Deficiency Foundation (IDF)
The IDF is a nonprofit organization dedicated to improving the diagnosis and treatment of PI through research and education. The goal of IDF is to help patients with PI and their families to live healthy and productive lives. It also strives for a broader understanding of PI through education and outreach efforts to patients and the medical community. Learn more»

The Jeffrey Modell Foundation, National Resource Center for Primary Immune Deficiency
The Jeffrey Modell Foundation is a nonprofit research foundation devoted to Pl. It sponsors symposia and workshops, supports research and training, and provides diagnostic, clinical, and educational services. Learn more»

International Patient Organization for Primary Immunodeficiencies (IPOPI)
IPOPI is the association of national patient organizations dedicated to improving awareness, access to early diagnosis, and optimal treatments for PI patients worldwide. Established in 1992, IPOPI works as the global advocate for the PI patient community in cooperation with its National Member Organizations (NMOs) and key PI stakeholders. Learn more»

IDIOPATHIC THROMBOCYTOPENIC PURPURA:

Idiopathic Thrombocytopenic Purpura (ITP) Support Association
ITP patient and family education and support resource. Learn more »

Platelet Disorder Support Association
Patient support website with information about ITP and other platelet disorders. Learn more»

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.

For treating PI: GAMMAKED can be given intravenously (IV, into a vein) or subcutaneously (SC, under the skin into the tissue) for PI. If you are infusing GAMMAKED subcutaneously for PI, DO NOT inject GAMMAKED into a blood vessel or directly into a muscle.

For treating CIDP or ITP: GAMMAKED should be given intravenously only (IV, into a vein) for CIDP or ITP. DO NOT infuse GAMMAKED subcutaneously (SC, under the skin into the tissue) for CIDP or ITP.

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.