"The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of factor VIII-containing products to evaluate the risk of neutralizing antifactor VIII alloantibodies (inhibitors) developing in patients"...
AMICAR (aminocaproic acid) is generally well tolerated. The following adverse experiences have been reported:
Allergic and anaphylactoid reactions, anaphylaxis.
Tinnitus, vision decreased, watery eyes.
BUN increased, renal failure. There have been some reports of dry ejaculation during the period of AMICAR (aminocaproic acid) treatment. These have been reported to date only in hemophilia patients who received the drug after undergoing dental surgical procedures. However, this symptom resolved in all patients within 24 to 48 hours of completion of therapy.
Read the Amicar (aminocaproic acid) Side Effects Center for a complete guide to possible side effects
Drug Laboratory Test Interactions
Prolongation of the template bleeding time has been reported during continuous intravenous infusion of AMICAR (aminocaproic acid) at dosages exceeding 24 g/day. Platelet function studies in these patients have not demonstrated any significant platelet dysfunction. However, in vitro studies have shown that at high concentrations (7.4 mMol/L or 0.97 mg/mL and greater) aminocaproic acid inhibits ADP and collagen-induced platelet aggregation, the release of ATP and serotonin, and the binding of fibrinogen to the platelets in a concentration-response manner. Following a 10 g bolus of AMICAR (aminocaproic acid) , transient peak plasma concentrations of 4.6 mMol/L or 0.60 mg/mL have been obtained. The concentration of AMICAR (aminocaproic acid) necessary to maintain inhibition of fibrinolysis is 0.99 mMol/L or 0.13 mg/mL. Administration of a 5 g bolus followed by 1 to 1.25 g/hr should achieve and sustain plasma levels of 0.13 mg/mL. Thus, concentrations which have been obtained in vivo clinically in patients with normal renal function are considerably lower than the in vitro concentrations found to induce abnormalities in platelet function tests. However, higher plasma concentrations of AMICAR (aminocaproic acid) may occur in patients with severe renal failure.
Read the Amicar Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/11/2009
Additional Amicar Information
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