The PROOF is in our ITP indication

What is ITP?

Let's break "idiopathic thrombocytopenic purpura" down. "Idiopathic" means that the cause is unknown. "Thrombocytopenic" means the blood doesn't have enough platelets. "Purpura" means excessive bruising.1 Platelets are the cells found in the blood that your body needs to control bleeding. They seal minor cuts and wounds and form blood clots.1

If you have ITP, your immune system makes antibodies that destroy platelets.2 Having too few platelets can cause you to bruise easily and to bleed for a long time if you are injured. If the platelet count is very low, nose bleeding can occur as well as bleeding in the intestines.2

Who does ITP affect?

ITP can affect children and adults. In children, it is usually an acute, temporary condition that comes on fast, usually following an infection.2

In adults, ITP tends to be chronic, and is more common in women than in men.3

In children and in adults, diagnosing ITP can be difficult, involving a complete blood count including platelets and bone marrow examination.2

ITP can be managed

Treatment for most people with ITP includes corticosteroids and immune globulin intravenous (IGIV).4 IGIV therapy, such as GAMUNEX, can quickly raise dangerously low platelet counts to control bleeding.5

Ask your doctor if GAMUNEX is right for you.

Important Safety Information for GAMUNEX

Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.

Gamunex is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV.

Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Gamunex is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

In clinical studies, the most common adverse reactions with Gamunex were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP). The most serious adverse reactions were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Please see accompanying GAMUNEX full Prescribing Information for complete prescribing details.

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.

References:

  1. Dorland's Illustrated Medical Dictionary, 27th ed. Philadelphia, PA: W.B. Saunders; 1988.

  2. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York, NY: McGraw-Hill; 2008.

  3. Sandler SG, Bhanji R. Immune thrombocytopenic purpura. May 2006. eMedicine article. http://www.emedicine.com/med/topic1151.htm. Accessed May 20, 2009.

  4. Bussel JB, Eldor A, Kelton JG, et al, and the IGIV-C in ITP Study Group. IGIV-C, a novel intravenous immunoglobulin: evaluation of safety, efficacy, mechanisms of action, and impact on quality of life. Thromb Haemost. 2004;91:771-778.

  5. GAMUNEX [package insert]. Research Triangle Park, NC: Talecris Biotherapeutics; 2008.