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New Data From Large Safety Analysis of MYCAMINE Shows Favorable Clinical Safety Profile
Date:9/18/2007

rse events showed an increase incidence with a longer duration of exposure to MYCAMINE. No trends were seen with analysis of adverse events. Shifts in hepatic and renal laboratory values during treatment with MYCAMINE were consistent with the underlying condition of patients.

About MYCAMINE

MYCAMINE is a member of a newer class of antifungal agents, the echinocandins. MYCAMINE inhibits an enzyme essential for fungal cell-wall synthesis and is fungicidal (lethal) for Candida.

Important Safety Information

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

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, worsening 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 mental confusion and possible histamine-mediated symptoms (including rash, pruritus, facial swelling, and vasodilatation).

About Astellas Pharma US, Inc.

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of immunology, urology, anti-infectives, cardiovascular and dermatology. For more information abou
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SOURCE Astellas Pharma US, Inc.
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