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Understanding side effects

You want a therapy that helps you stay healthy and feel your best. That's why it's important to understand the side effects associated with any drug you take.

The most common side effects with GAMUNEX in clinical trials were1

  • headache
  • cough
  • rash
  • fever
  • pharyngitis
  • chills
  • hypertension
  • injection site reaction
  • asthenia
  • back pain
  • vomiting
  • high blood pressure
  • nausea
  • urticaria

The most serious side effects with GAMUNEX in clinical trials were1

  • lung artery blockage (pulmonary embolism) in 1 patient with a history of this condition
  • exacerbation of a red blood cell disorder (autoimmune pure red cell aplasia) in 1 patient
  • heart inflammation (myocarditis) in 1 patient that occurred 50 days after infusion and was
    not considered drug related

IGIV products have been associated with kidney disease.1,2 Contact your doctor right away if you experience any of these symptoms, which could be symptoms of kidney disease1:

  • Decreased urine output
  • Sudden weight gain
  • Water retention
  • Swelling
  • Shortness of breath

If you have diabetes, kidney disease, or heart-related problems, you should know that some IGIV products contain sugar, salt, or other preservatives that may increase the risk of serious side effects.2

IGIVs containing sugar stabilizers have caused the greatest number of kidney-related side effects.1,2 GAMUNEX contains no sugar and no preservatives.1

In all IGIV products, including GAMUNEX, serious side effects include reports of fluid in the lungs that is not caused by heart disease (sometimes referred to as transfusion-related acute lung injury [TRALI]). There have also been rare cases of low red blood cell count, inflammation of the membranes that surround the brain (aseptic meningitis), blood clotting, and blood vessel blockage. High protein content in the blood (hyperproteinemia), thickening of the blood (increased serum viscosity), and low levels of sodium in the blood (hyponatremia) may occur in patients receiving IGIV therapy.1

If you are 65 years of age or older, have type 2 diabetes, kidney problems, hardening of the arteries, or heart disease, be sure to tell your doctor prior to starting any IGIV therapy.1

Ask your doctor if GAMUNEX is right for you.

Product production

GAMUNEX is made from donated human plasma that's collected by US plasma centers licensed by the FDA.1 These centers are strictly monitored by Talecris, the maker of GAMUNEX, and by the FDA. Every plasma donor is carefully screened, and every plasma donation is thoroughly tested to make sure that it is safe for use in the manufacture of our products.

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.

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

  2. Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6:592-599.