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Astellas Pharma US, Inc. Announces Availability of Mycamine(R) (Micafungin Sodium) 100 mg Vial

Mycamine (micafungin sodium) 100mg vial offers more convenient usage, less waste

Larger vial offers more convenient usage, less waste

DEERFIELD, IL -- January 12, 2007 -- Astellas Pharma US, Inc. announced today the availability of their antifungal agent Mycamine(R) (micafungin sodium) for injection in a 100mg vial format.

Approved in 2005 for the treatment of patients with esophageal candidiasis and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, Mycamine(R) was previously only available in a 50 mg vial. The addition of this vial size will increase the convenience of use when administering Mycamine while decreasing waste in the hospital setting.

"Astellas is committed to providing physicians with clinical options to make appropriate treatment decisions for their patients," said Richard White, Vice President, Critical Care at Astellas Pharma US, Inc. "The addition of the 100mg Mycamine vial provides physicians with a convenient option which may reduce waste in the clinical setting.

"From a pharmacist's perspective, the availability of Mycamine in a 100mg vial makes a big difference," stated Steven Gabardi, PharmD, BCPS, Organ Transplant Clinical Specialist, Brigham and Women's Hospital, Harvard Medical School. "Having this medication dosage format reduces storage space requirements and time spent on preparation. It is a little difference that will make a significant impact."

About Mycamine
Mycamine is a member of a new class of antifungal agents, the echinocandins. Mycamine inhibits an enzyme essential for fungal cell-wall synthesis and is fungicidal (lethal) for Candida. Mycamine can be used concomitantly with a variety of other drugs, including the HIV protease inhibitor ritonavir and the transplant medications cyclosporine and tacrolimus.

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).


SOURCE: Astellas Pharma US, Inc.

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