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Astellas Seeks Rigorous Testing and Safety-Related Labeling for Anti-Rejection Medications
Date:8/10/2009

sible care."

Post-transplant care is dedicated to maintaining the health of transplanted organs and a major obstacle to graft survival is rejection by the patient's immune system. Immunosuppressive drugs are the foundation of successful post-transplant care. A key to successful outcomes is patient adherence to a prescribed medication regimen. Small blood-level changes that result from changes in immunosuppressant therapy could tip the very delicate balance needed to maintain a healthy organ. Most often, the initial stages of organ rejection can be detected only by blood tests.

About Prograf(R) (tacrolimus)

Prograf(R) (tacrolimus capsules and injection) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis, Prograf injection should be reserved for patients unable to take Prograf capsules orally. In heart and kidney transplant recipients, it is recommended that Prograf be used in conjunction with azathioprine or mycophenolate mofetil. The safety and efficacy of the use of Prograf with sirolimus have not been established.

Important Safety Information

WARNING

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Prograf is contraindicated in patients with a hypersensitivity to tacrolimus. Prograf injection is contraindicated in patients with a hypersensitivity to castor oil. Patients receiving Prograf injection should be under continuous
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SOURCE Astellas Pharma US, Inc.
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