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Astellas Receives FDA Approval for Use of Prograf(R) (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients
Date:5/28/2009

ated Prograf or cyclosporine concentrations, dosing with the other drug usually should be further delayed.

Use of Prograf with sirolimus in heart transplant patients in a US study was associated with increased risk of wound healing complications, renal function impairment, and insulin-dependent post-transplant diabetes, and is not recommended.

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).

Neurotoxicity, including tremor, headache, and other changes in motor function, mental status, and sensory function, was reported in approximately 55% of liver transplant recipients in the two randomized studies. Tremor occurred more often in Prograf-treated kidney transplant (54%) and heart transplant patients (15%) compared with cyclosporine-treated patients. Seizures have occurred in adult and pediatric patients receiving Prograf. Coma and delirium also have been associated with high plasma concentrations of tacrolimus.

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.

The principal adverse reactions of Prograf include tremor, headache, hypertension, gastrointestinal disturbance, abnormal ren
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