Tacrolimus Extended Release
Tacrolimus extended-release is an immunosuppressant known as a calcineurin inhibitor. It works by lowering your body's immune system to help prevent it from rejecting a newly transplanted organ. Unlike immediate-release tacrolimus which is taken twice daily, extended-release formulations are designed for once-daily dosing to provide stable blood concentrations over 24 hours.
Dosage by Body Weight
Must be taken consistently once daily in the morning, either consistently with food or consistently on an empty stomach. Dosage must be highly individualized based on the type of organ transplant, patient weight, clinical response, and target whole blood trough concentrations. Extended-release formulations are not interchangeable with immediate-release formulations on a milligram-for-milligram basis.
- Body Weight
- Below 5 kg
- Dose
- Not routinely recommended
- Frequency
- Use only if specifically prescribed by a transplant specialist
- Tracking Notes
- Safety and efficacy of extended-release formulations are not well-established in infants. Immediate-release formulations or liquid suspensions are typically preferred for very small pediatric patients.
- Body Weight
- 5-7 kg
- Dose
- 0.1 to 0.15 mg/kg/day as a starting dose
- Frequency
- Once daily in the morning
- Tracking Notes
- Dose must be rounded to the nearest available strength (e.g., 0.5 mg, 1 mg). Frequent therapeutic drug monitoring of whole blood trough levels is mandatory to adjust the dose.
- Body Weight
- 8-10 kg
- Dose
- 0.1 to 0.15 mg/kg/day as a starting dose (approx. 0.8 mg to 1.5 mg)
- Frequency
- Once daily in the morning
- Tracking Notes
- Adjustments are made based on clinical response, tolerability, and blood trough concentration levels.
- Body Weight
- 11-15 kg
- Dose
- 0.1 to 0.15 mg/kg/day as a starting dose (approx. 1.1 mg to 2.25 mg)
- Frequency
- Once daily in the morning
- Tracking Notes
- Regular monitoring of renal function, blood pressure, and blood glucose is required during therapy.
- Body Weight
- 16-20 kg
- Dose
- 0.1 to 0.15 mg/kg/day as a starting dose (approx. 1.6 mg to 3 mg)
- Frequency
- Once daily in the morning
- Tracking Notes
- Ensure patient does not swallow capsules or tablets damaged, wet, or opened, as this alters the extended-release mechanism.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not routinely recommended | Use only if specifically prescribed by a transplant specialist | Safety and efficacy of extended-release formulations are not well-established in infants. Immediate-release formulations or liquid suspensions are typically preferred for very small pediatric patients. |
| 5-7 kg | 0.1 to 0.15 mg/kg/day as a starting dose | Once daily in the morning | Dose must be rounded to the nearest available strength (e.g., 0.5 mg, 1 mg). Frequent therapeutic drug monitoring of whole blood trough levels is mandatory to adjust the dose. |
| 8-10 kg | 0.1 to 0.15 mg/kg/day as a starting dose (approx. 0.8 mg to 1.5 mg) | Once daily in the morning | Adjustments are made based on clinical response, tolerability, and blood trough concentration levels. |
| 11-15 kg | 0.1 to 0.15 mg/kg/day as a starting dose (approx. 1.1 mg to 2.25 mg) | Once daily in the morning | Regular monitoring of renal function, blood pressure, and blood glucose is required during therapy. |
| 16-20 kg | 0.1 to 0.15 mg/kg/day as a starting dose (approx. 1.6 mg to 3 mg) | Once daily in the morning | Ensure patient does not swallow capsules or tablets damaged, wet, or opened, as this alters the extended-release mechanism. |
Formulation
Purpose
Used to prevent organ rejection in patients who have received a kidney, liver, or heart transplant, typically in combination with other immunosuppressive medications.
Generic Name
Tacrolimus Extended-ReleaseBranded Drug Names
Tacrolimus Extended Release is listed as a generic drug name. Common branded medicines that may contain the same active ingredient include:
Scheduled Drug
No. This medicine is generally not treated as a scheduled/prescription-only drug in common consumer references, but local rules may vary.