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These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF® (tacrolimus) capsules, USP PROGRAF® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994
Medication labelWhy this: Advisory · dailymed-prescription
Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that Prograf 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 Prograf [see Dosage and Administration (2.6)]. Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids [see Clinical Studies (14.2)]. Therapeutic drug monitoring is recommended for all patients receiving Prograf [see Dosage and Administration (2.6)]. Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that Prograf 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 Prograf [see Dosage and Administration (2.6)]. Prograf should not be used simultaneously with cyclosporine [see Dosage and Administration (2.5)]. Prograf injection should be reserved for patients unable to take Prograf capsules orally [see Dosage and Administration (2.1) and Warnings and Precautions (5.11)]. Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of Prograf with sirolimus has not been established in kidney transplant [see Warnings and Precautions (5.12)].
- generic_name
- tacrolimus
- product_names
- Tacrolimus
- ndc
- 43353-178, 0469-0617, 43353-178-53, 43353-178-60, 43353-178-80, 43353-178-09
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en