In clinical studies, the most common adverse reactions with Gamunex-C were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PI) and infusion site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).
The most serious adverse reactions in clinical studies 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).
Due to a potential risk of hematoma formation, Gamunex-C should not be administered subcutaneously in patients with ITP. Subcutaneous administration of Gamunex-C in patients with ITP has not been studied.
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.
For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information. The package insert is currently being revised to incorporate information regarding subcutaneous administration for treatment of primary immunodeficiency.
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This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are no
|SOURCE Talecris Biotherapeutics, Inc.|
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