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FDA Approves Additional Indication for Astellas' MYCAMINE(R)
Date:1/23/2008

(lethal) for Candida.

MYCAMINE is approved for the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses; for the treatment of patients with Esophageal Candidiasis and the prophylaxis of Candida Infections in patients undergoing Hematopoietic Stem Cell Transplantation. The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established. MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections.

MYCAMINE can be used concomitantly with a number of other drugs, including the HIV protease inhibitor ritonavir and the transplant medications cyclosporine and tacrolimus with no alteration in the pharmacokinetics of MYCAMINE. Patients should be monitored for sirolimus, nifedipine or itraconazole toxicity if receiving these drugs in combination with MYCAMINE and their dosage reduced, if necessary.

MYCAMINE is available in two sizes, 50mg vial and 100mg vial, offering clinicians convenience of use in the administration of the drug, while reducing waste in the hospital setting.

Important Safety Information

MYCAMINE is contraindicated in patients with hypersensitivity to any component of this product or other echinocandins.

Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE.

Isolated cases of clinically significant hepatic dysfunction, hepatitis, hepatic failure, renal dysfunction, acute renal failure, hemolysis, or hemolytic anemia have occurred in some patients who have received MYCAMINE. Patients who develop these conditions, or abnormal liver or renal function tests, should be monitored for worsening function and evaluated for risk/benefit of continuing MYCAMINE therapy.

Adverse events with MYCAMINE included histamine-mediated symptoms (including rash, pruritus, fac
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SOURCE Astellas Pharma Inc.
Copyright©2008 PR Newswire.
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