DEERFIELD, Ill., Aug. 10 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas") announced today that the U.S. Food and Drug Administration (FDA) has substantially denied the company's Citizen Petition to ensure the safe and effective use of immunosuppressants (also called anti-rejection medications) used to prevent rejection in organ transplant patients. In their petition, Astellas requested that the FDA take additional measures to protect transplant recipients, a unique and vulnerable patient population, from substitute critical dose immunosuppressant drugs that have not demonstrated bioequivalence in rigorous clinical trials in transplant patients.
Additionally, the FDA denied Astellas' request for labeling changes that require physicians to be notified whenever a substituted oral formulation is about to be provided to a transplant patient so that the physician can determine whether additional drug blood concentration testing should be done to ensure the health and safety of the patient. Astellas is also challenging this part of the FDA's decision.
About Organ Transplantation
There are nearly 100,000 patients on the waiting list for an organ transplant and 4,000 patients are added to the list each month. Each day, on average, seventeen patients on the list die waiting for a life-saving organ transplant.
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.
Important Safety Information
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 observation for at least the first 30 minutes following the start of infusion and at frequent intervals thereafter. If signs or symptoms of anaphylaxis occur, the infusion should be stopped.
Prograf has been associated with nephrotoxicity, particularly when used in high doses. In particular, to avoid excess nephrotoxicity, Prograf should not be used simultaneously with cyclosporine. Prograf or cyclosporine should be discontinued at least 24 hours prior to initiating the other. In the presence of elevated Prograf or cyclosporine concentrations, dosing with the other drug usually should be further delayed.
Mild to severe hyperkalemia was reported in 31% of kidney transplant recipients, in 45% and 13% of liver transplant recipients in the US and European randomized trials, respectively, and in 8% of heart transplant recipients in a European randomized trial, and may require treatment. Serum potassium levels should be monitored and potassium-sparing diuretics should not be used during Prograf therapy (see PRECAUTIONS).
In post marketing experience, patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES). If PRES is suspected or diagnosed, immediate reduction of immunosuppression is advised. Activation of latent viral infections, including BK virus-associated nephropathy and JC virus-associated progressive multifocal leukoencephalopathy (PML), has also been reported. These viral infections may lead to serious, including fatal, outcomes.
For full prescribing information please visit www.prograf.com or call Astellas at 1-800-727-7003.
SOURCE Astellas Pharma US, Inc.
CONTACT: Maribeth Landwehr, +1-847-317-8988,
Maribeth.Landwehr@us.astellas.com, or Jenny Keeney, +1-847-317-5405,
Jenny.Keeney@us.astellas.com, both of Astellas Pharma US, Inc.
Web site: http://www.us.astellas.com/
