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As with other immunosuppressive therapies, the risk of malignancies in Prograf recipients may be higher than in the normal, healthy population.
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However, the safety and efficacy of substitution with generic tacrolimus in transplant patients have not been evaluated.
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One-year patient survival and graft survival in the Prograf-based treatment groups were equivalent to those in the CBIR treatment groups in both studies.
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The aim of this review is to critically analyse the published data on the clinical pharmacokinetics of once-daily tacrolimus in solid-organ transplant patients.
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The company says the FDA's review of Prograf for use in heart transplant patients was based on two open-label, randomized, comparative clinical studies - one US-based study, and one European-based study.
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Some medications that decrease the immune system include azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), prednisone (Deltasone, Orasone), corticosteroids (glucocorticoids), and others.
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