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1 Indications And Usage Tacrolimus Is A Calcineurin-Inhibitor Immunosuppressant Indicated For Prophylaxis Of Organ Rejection In Patients Receiving Allogeneic Liver, Kidney Or Heart Transplants ( 1.1 , 1.2 , 1.3 ) Use Concomitantly With Adrenal Corticosteroids; In Kidney And Heart Transplant, Use In Conjunction With Azathioprine Or Mycophenolate Mofetil (Mmf) ( 1.1 , 1.2 , 1.3 ) Limitations Of Use ( 1.4 ): Do Not Use Simultaneously With Cyclosporine Intravenous Use Reserved For Patients Who Can Not Tolerate Capsules Orally Use With Sirolimus Is Not Recommended In Liver And Heart Transplant; Use With Sirolimus In Kidney Transplant Has Not Been Established 1.1 Prophylaxis Of Organ Rejection In Kidney Transplant Tacrolimus Capsules Is Indicated For The Prophylaxis Of Organ Rejection In Patients Receiving Allogeneic Kidney Transplants. It Is Recommended That Tacrolimus Be Used Concomitantly With Azathioprine Or Mycophenolate Mofetil (Mmf) And Adrenal Corticosteroids [See Clinical Studies ( 14.1) ] . Therapeutic Drug Monitoring Is Recommended For All Patients Receiving Tacrolimus [See Dosage And Administration ( 2.6) ]. 1.2 Prophylaxis Of Organ Rejection In Liver Transplant Tacrolimus Capsules Is Indicated For The Prophylaxis Of Organ Rejection In Patients Receiving Allogeneic Liver Transplants. It Is Recommended That Tacrolimus Be Used Concomitantly With Adrenal Corticosteroids [See Clinical Studies ( 14.2 )] . Therapeutic Drug Monitoring Is Recommended For All Patients Receiving Tacrolimus [See Dosage And Administration ( 2.6 )]. 1.3 Prophylaxis Of Organ Rejection In Heart Transplant Tacrolimus Capsules Is Indicated For The Prophylaxis Of Organ Rejection In Patients Receiving Allogeneic Heart Transplants. It Is Recommended That Tacrolimus Capsules Be Used Concomitantly With Azathioprine Or Mycophenolate Mofetil (Mmf) And Adrenal Corticosteroids [See Clinical Studies ( 14.3 )] . Therapeutic Drug Monitoring Is Recommended For All Patients Receiving Tacrolimus Capsules [See Dosage And Administration ( 2.6 )]. 1.4 Limitations Of Use Tacrolimus Capsules Should Not Be Used Simultaneously With Cyclosporine [See Dosage And Administration ( 2.5 )]. Use With Sirolimus Is Not Recommended In Liver And Heart Transplant. The Safety And Efficacy Of Tacrolimus With Sirolimus Has Not Been Established In Kidney Transplant [See Warnings And Precautions ( 5.12 )]. Intravenous Use Reserved For Patients Who Cannot Tolerate Capsules Orally.
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