Prograf Prescribing Information
Warnings and Precautions 11/2022
Warnings and Precautions, Cannabidiol Drug Interactions 08/2023
PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants.
• Intravenous (IV) use recommended for patients who cannot tolerate oral formulations (capsules or suspension).• Administer capsules or suspension consistently with or without food.• Therapeutic drug monitoring is recommended.• Avoid eating grapefruit or drinking grapefruit juice.• See dosage adjustments for African-American patients , hepatic and renal impaired.• For complete dosing information, see Full Prescribing Information.
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 |
| Lung Transplant | ||
| With azathioprine or MMF | 0.075 mg/kg/dayPatients with cystic fibrosis may require higher doses due to lower bioavailability. capsules, divided in two doses, every 12 hours | Month 1-3: 10-15 ng/mL Month 4-12: 8-12 ng/mL |
PEDIATRIC | ||
| Patient Population | Initial Oral Dosage (formulation) | Whole Blood Trough Concentration Range |
| Kidney Transplant | ||
| 0.3 mg/kg/day capsules or oral suspension, divided in two doses, every 12 hours | Month 1-12: 5-20 ng/mL | |
| Liver Transplant | ||
| 0.15-0.2 mg/kg/day capsules or 0.2 mg/kg/day oral suspension, divided in two doses, every 12 hours | Month 1-12: 5-20 ng/mL | |
| Heart Transplant | ||
| 0.3 mg/kg/dayDose at 0.1 mg/kg/day if antibody induction treatment is administered. capsules or oral suspension, divided in two doses, every 12 hours | Month 1-12: 5-20 ng/mL | |
| Lung Transplant | ||
| 0.3 mg/kg/day, capsules or oral suspension, divided in two doses, every 12 hours | Weeks 1-2: 10-20 ng/mL Week 2 to Month 12: 10-15 ng/mL | |
| MMF= Mycophenolate mofetil | ||
PROGRAF is available in the following dosage forms and strengths:
Capsules | Oblong, hard capsule for oral administration contains anhydrous tacrolimus USP as follows: • 0.5 mg, light-yellow color, imprinted in red “0.5 mg” on the capsule cap and “ • 1 mg, white color, imprinted in red “1 mg” on the capsule cap and “ • 5 mg, grayish-red color, imprinted with white “5 mg” on the capsule cap and “ |
Injection | 1 mL ampule for intravenous infusion contains anhydrous tacrolimus USP, 5 mg/mL |
For Oral Suspension | Unit-dose packets with white granules for oral suspension contains anhydrous tacrolimus USP:
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