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These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, USP for oral useInitial U.S. Approval: 1994
Medication labelWhy this: Advisory · dailymed-prescription
Tacrolimus capsules, USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that tacrolimus capsules 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 capsules [see Dosage and Administration (2.6)]. Tacrolimus capsules are indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that tacrolimus capsules be used concomitantly with adrenal corticosteroids [see Clinical Studies (14.2)]. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules [see Dosage and Administration (2.6)]. Tacrolimus capsules are 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)]. Tacrolimus capsules should not be used simultaneously with cyclosporine [see Dosage and Administration (2.5)]. Tacrolimus injection should be reserved for patients unable to take tacrolimus capsules orally [see Warnings and Precautions (5.11)]. Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of tacrolimus capsules with sirolimus has not been established in kidney transplant [see Warnings and Precautions (5.12)].
- generic_name
- tacrolimus
- product_names
- Tacrolimus
- ndc
- 43353-317, 60429-378, 43353-317-09
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en