What is ITP?

"Idiopathic" refers to an unknown cause. "Thrombocytocytopenic" means there aren't enough circulating platelets in the bloodstream to prevent bleeding, and "purpura" (meaning purple in Greek) refers to bruising or a rash caused by bleeding into the skin. Since this term was adopted, we have discovered that Idiopathic Thrombocytopenic Purpura, or ITP, is actually an autoimmune disease, in which a patient's immune system mistakenly attacks and destroys platelets, which can result in bleeding. ITP is known commonly today as primary immune thrombocytopenia.1  

Who is affected by ITP? 

ITP can affect both children and adults. In children, ITP is usually a temporary condition that comes on fast, often following a viral infection. Most children with ITP recover without any treatment within 6 months.1,2

In adults, ITP tends to be chronic, and is more common in women than in men. Diagnosing ITP can be challenging, because many other conditions, like infections, can cause a low blood platelet count. Laboratory tests used to diagnose ITP include a complete blood count and bone marrow examination.1,2

What can be done?

The goal of treatment for ITP is to raise blood platelet counts to a normal range. Treatment may include IGIV, which has been shown to increase platelet counts in patients with ITP.1,2

In a clinical trial, GAMMAKED was proven to raise platelet counts within 7 days in patients with ITP.3

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


References: 1. Provan D, Sasis R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115:168-86. 2. Chapel H, Haeney SM and Snowden N. eds.  Non-Malignant Haematological Diseases In: Essentials in Clinical Immunology. 6th ed. John Wiley & Sons, Ltd., West Sussex, UK: John Wiley & Sons; 2014:305-308. 3. Bussell JB, Eldor A, Kelton JG, et al. IGIV-C, a novel intravenous immunoglobulin: evaluation of safety, efficacy, mechanisms of action and impact on quality of life. Thromb Haemost 2004;91:771–8. 
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Important Safety Information

APPROVED USES
GAMMAKED™ [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] is an immune globulin injection that is approved to treat Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older, Idiopathic Thrombocytopenic Purpura (ITP), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

GAMMAKED may cause: 

1. 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. 
2. 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.

  • 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.
  • 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) has been reported 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 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 disease 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.
  • In clinical studies, the most common side effects of GAMMAKED were:
                    - Headache, cough, injection site reaction, nausea, sore throat, and rash, when administered intravenously to patients with PI.

                    - Redness, swelling and itching at the injection site, headache, influenza, fatigue, pain (including pain in the back, joints, arms, legs) and fever, when administered subcutaneously to patients with PI.
                  - Headache, vomiting, fever, nausea, back pain, and rash in patients with ITP.
                  - Headache, fever, chills, high blood pressure, rash, nausea, 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 effects.
  • 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 GAMMAKED Full Prescribing Information.

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