TacrolimusPronunciation.
Dosage Form: capsule
BOX WARNING – MALIGNANCIES AND SERIOUS INFECTIONS

•Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.2)].
•Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions (5.3, 5.4, 5.5) ].
•Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Tacrolimus. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.1)].

Indications and Usage for Tacrolimus
 
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Tacrolimus capsules 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)].

1.2 Prophylaxis of Organ Rejection in Liver Transplant
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)].

Prophylaxis of Organ Rejection in Heart Transplant
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)].

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 capsules with sirolimus has not been established in kidney transplant [see Warnings and Precautions (5.12)].

Tacrolimus Dosage and Administration

2.1 Dosage in Adult Kidney, Liver. or Heart Transplant Patients
The initial oral dosage recommendations for adult patients with kidney, liver, or heart transplants along with recommendations for whole blood trough concentrations are shown in Table 1. The initial dose of Tacrolimus capsules should be administered no sooner than 6 hours after transplantation in the liver and heart transplant patients. In kidney transplant patients, the initial dose of Tacrolimus capsules may be administered within 24 hours of transplantation, but should be delayed until renal function has recovered. For blood concentration monitoring details see Dosage and Administration (2.6).