tacrolimus granules for suspension (Modigraf)

Following an abbreviated submission:  

tacrolimus granules for suspension (Modigraf): is accepted for restricted use in NHSScotland. Indication under review:
• Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.
• Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.

SMC restriction: for use in patients for whom tacrolimus is an appropriate choice of immunosuppressive therapy and where small changes (less than 0.5mg) in dosing increments are required (e.g. in paediatric patients) or seriously ill patients who are unable to swallow tacrolimus capsules.

Modigraf® granules for oral suspension offer 18% greater bioavailability than immediate release capsules and may have different bioavailability compared to other unlicensed tacrolimus suspensions in use in the past. Careful monitoring and possible dosage changes are needed when introducing treatment with Modigraf®.

Tacrolimus granules for oral suspension are significantly more expensive than the capsule formulation.