Astagraf XL
Astagraf XL is a prescription-only, once-daily extended-release formulation of tacrolimus. It is a calcineurin-inhibitor immunosuppressant indicated for the prevention of organ rejection in kidney transplant recipients, typically used in combination with other immunosuppressive drugs.
Dosage by Body Weight
Must be taken consistently once daily in the morning, either consistently with food or consistently on an empty stomach (at least 1 hour before or 2 hours after a meal). Swallow capsules whole; do not chew, divide, or crush. Dosages must be highly individualized and adjusted based on clinical evidence of rejection, tolerability, and whole blood trough concentration monitoring.
- Body Weight
- Below 5 kg
- Dose
- Highly individualized
- Frequency
- Once daily in the morning
- Tracking Notes
- Safety and efficacy in pediatric patients weighing this low or under 4 years of age have not been established. Requires direct specialist titration.
- Body Weight
- 5-7 kg
- Dose
- 0.10 - 0.15 mg/kg/day starting dose
- Frequency
- Once daily in the morning
- Tracking Notes
- Patient must be at least 4 years of age and able to swallow intact capsules. Dose must be adjusted based on blood trough levels.
- Body Weight
- 8-10 kg
- Dose
- 0.10 - 0.15 mg/kg/day starting dose
- Frequency
- Once daily in the morning
- Tracking Notes
- Monitor tacrolimus whole blood trough concentrations regularly to titrate to target therapeutic ranges.
- Body Weight
- 11-15 kg
- Dose
- 0.10 - 0.15 mg/kg/day starting dose
- Frequency
- Once daily in the morning
- Tracking Notes
- Adjust dose to maintain therapeutic blood levels. Do not interchange daily dose with immediate-release formulations on a mg-to-mg basis.
- Body Weight
- 16-20 kg
- Dose
- 0.10 - 0.15 mg/kg/day starting dose
- Frequency
- Once daily in the morning
- Tracking Notes
- Titrate carefully based on blood concentration monitoring, renal function, and adverse reactions.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Highly individualized | Once daily in the morning | Safety and efficacy in pediatric patients weighing this low or under 4 years of age have not been established. Requires direct specialist titration. |
| 5-7 kg | 0.10 - 0.15 mg/kg/day starting dose | Once daily in the morning | Patient must be at least 4 years of age and able to swallow intact capsules. Dose must be adjusted based on blood trough levels. |
| 8-10 kg | 0.10 - 0.15 mg/kg/day starting dose | Once daily in the morning | Monitor tacrolimus whole blood trough concentrations regularly to titrate to target therapeutic ranges. |
| 11-15 kg | 0.10 - 0.15 mg/kg/day starting dose | Once daily in the morning | Adjust dose to maintain therapeutic blood levels. Do not interchange daily dose with immediate-release formulations on a mg-to-mg basis. |
| 16-20 kg | 0.10 - 0.15 mg/kg/day starting dose | Once daily in the morning | Titrate carefully based on blood concentration monitoring, renal function, and adverse reactions. |
Formulation
Purpose
Prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants.
Generic Name
Tacrolimus extended-releaseScheduled Drug
No. This medicine is generally not treated as a scheduled/prescription-only drug in common consumer references, but local rules may vary.