A new granule formulation of Prograf (tacrolimus; Astellas) has been made available for the prophylaxis of organ rejection, in patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, in combination with other immunosuppressants. Prograf Granules is a new treatment option for patients who may have difficulty swallowing the capsule formulation.
The new formulation received approval from the Food and Drug Administration (FDA) in May 2018. The safety and efficacy of Prograf Granules were established in pediatric liver, kidney, and heart transplant patients. Its use among pediatric de novo transplant patients aged <16 years is supported by data from active, controlled studies (N=56), 2 pharmacokinetic and safety studies (N=151), and an uncontrolled trial of tacrolimus in living related donor liver transplantation (N=122).
Prograf Granules is supplied as 0.2mg and 1mg unit-dose packs. The granules should be mixed in room temperature drinking water and should not be sprinkled on food. When converting between Prograf capsules and granules, the total daily dose should remain the same. Dose adjustments should be made accordingly with therapeutic drug monitoring to ensure that systemic exposure is maintained.
Prograf, a calcineurin-inhibitor immunosuppressant, is also available in 0.5mg, 1mg, and 5mg capsules as well as 5mg/mL solution for IV infusion.
For more information call 800 727-7003 or visit Prograf.com.