MARKHAM, ON, Oct. 17 /CNW/ - Astellas Pharma Canada, Inc., is pleased to
announce that Mycamine(R) (micafungin sodium for injection) is now
commercially available in Canada. Mycamine was approved by Health Canada in
May 2007, for the treatment of esophageal candidiasis and prophylaxis of
Candida infections in patients undergoing hematopoietic stem cell
transplantation. This is the first echinocandin to be approved for the
prophylaxis of Candida infections.
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. Based on the results of 32
international clinical studies, Mycamine has demonstrated effectiveness and
safety in the treatment of Candida fungal infections in patients with
hematologic malignancies, bone marrow transplant recipients or those who are
HIV positive(1). Mycamine can be used concomitantly with a variety of other
drugs, including the HIV protease inhibitor ritonavir and the transplant
medications cyclosporine and tacrolimus.
"Fungal infections can be a serious complication for patients with a
compromised immune system," says Barbara Reynolds, Director of Marketing,
Astellas Pharma Canada, Inc. "We are pleased to provide health professionals
with an effective clinical option to manage these infections and help improve
patient quality of life."
Mycamine is now approved in eight countries for the treatment of
esophageal candidiasis and prophylaxis of Candida infections in patients
undergoing hematopoietic stem cell transplantation. Mycamine is also approved
and indicated for the treatment of candidemia and invasive candidiasis in
Japan, Jordan, USA, China, Taiwan, Korea, Syria and Canada.
The novel mechanism of action of echinocandins specifically targets the
wall of fungal cells to treat or prevent infections. Mycamine is
contraindicated in patients with hypersensitivity to any component of the
product. Patients receiving Mycamine have reported isolated cases of serious
hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock),
significant hemolysis and hemolytic anemia. The most common side effects
experienced in clinical trials included changes in liver and renal function.
Possible histamine-mediated symptoms have been reported with Mycamine,
including rash, pruritus, facial swelling, and vasodilatation. Injection site
reactions, including phlebitis and thrombophlebitis, have been reported at
Mycamine doses of 50-150 mg/day.(1)
About Astellas Pharma Canada, Inc.
Astellas Pharma Canada, Inc., is highly focused on customers and their
needs and is committed to making a difference in the treatment of infectious
diseases. Astellas Pharma Canada, Inc., is dedicated to improving the health
of people around the world through the provision of innovative and reliable
pharmaceutical products. Astellas Pharma Canada, Inc., is one of the Astellas
Group of companies in North America and an affiliate of Astellas Pharma Inc.,
located in Tokyo. The organization is committed to becoming a global
pharmaceutical leader by combining outstanding R&D and marketing capabilities.
Additional corporate information is available at www.astellas.com/ca.
Mycamine (R) is a registered trade-mark of Astellas Pharma Inc.
(1) Mycamine Product Monograph, Astellas Pharma Canada, Inc.
April 9, 2007.
For further information:
For further information: Communications MECA, Lindsay Peterson,