Tacrolimus Prescribing Information
Warnings and Precautions (5.5, 5.10, 5.16) 11/2022
Warnings and Precautions, Cannabidiol Drug Interactions (5.17) 08/2023
Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart transplants, and pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. (1.1)
- Intravenous (IV) use recommended for patients who cannot tolerate oral formulations (capsules). (2.1, 2.2)
- Administer capsules consistently with or without food. (2.1)
- Therapeutic drug monitoring is recommended. (2.1, 2.6)
- Avoid eating grapefruit or drinking grapefruit juice. (2.1)
- See dosage adjustments for African-American patients (2.2), hepatic and renal impaired. (2.4, 2.5)
- For complete dosing information, see Full Prescribing Information.
MMF = Mycophenolate mofetil | ||
1. Patients with cystic fibrosis may require higher doses due to lower bioavailability. | ||
2. Dose at 0.1 mg/kg/day if antibody induction treatment is administered. | ||
ADULT | ||
| Patient Population | Initial Oral Dosage (formulation) | Whole Blood Trough Concentration Range |
| Kidney Transplant | ||
| With azathioprine | 0.2 mg/kg/day capsules, divided in two doses, every 12 hours | Month 1-3: 7-20 ng/mL Month 4-12: 5-15 ng/mL |
| With MMF/IL-2 receptor antagonist | 0.1 mg/kg/day capsules, divided in two doses, every 12 hours | Month 1-12: 4-11 ng/mL |
| Liver Transplant | ||
| With corticosteroids only | 0.1-0.15 mg/kg/day capsules, divided in two doses, every 12 hours | Month 1-12: 5-20 ng/mL |
| Heart Transplant | ||
| With azathioprine or MMF | 0.075 mg/kg/day capsules, divided in two doses, every 12 hours | Month 1-3: 10-20 ng/mL Month ≥ 4: 5-15 ng/mL |
PEDIATRIC | ||
| Patient Population | Initial Oral Dosage (formulation) | Whole Blood Trough Concentration Range |
| Liver Transplant | ||
| 0.15-0.2 mg/kg/day capsules divided in two doses, every 12 hours | Month 1-12: 5-20 ng/mL | |
- Capsules: 0.5 mg, 1 mg and 5 mg ()
3 DOSAGE FORMS AND STRENGTHS- Capsules: 0.5 mg, 1 mg and 5 mg
- Oblong, hard capsule for oral administration contains anhydrous tacrolimus as follows:
- 0.5 mg -opaque red, imprinted "SAL" on the cap and "720" on the body
- 1 mg- opaque green, imprinted "SAL" on the cap and "721" on the body
- 5 mg- opaque teal, imprinted "SAL" on the cap and "722" on the body
Pregnancy: Can cause fetal harm. Advise pregnant women of the potential risk to the fetus. (8.1, 8.3)
Additional pediatric use information is approved for Astellas Pharma US, Inc.'s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.