Modigraf 0.2mg & 1mg granules for oral suspension
Astellas Pharma Ltd
Active ingredient
tacrolimus monohydrate
Legal Category
POM: Prescription only medicine
1. Name of the medicinal product
Modigraf 0.2 mg granules for oral suspension
Modigraf 1 mg granules for oral suspension
2. Qualitative and quantitative composition
Modigraf 0.2 mg granules for oral suspension
Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each sachet contains 94.7 mg lactose (as monohydrate).
Modigraf 1 mg granules for oral suspension
Each sachet contains 1 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each sachet contains 473 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Granules for oral suspension.
White granules.
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. Modigraf is a granular formulation of tacrolimus, for twice-a-day administration. Modigraf therapy requires careful monitoring by adequately qualified and equipped personnel.
Posoloy
The recommended initial doses presented below are intended to act solely as a guideline. Modigraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period. The dose may vary depending upon the immunosuppressive regimen chosen. Modigraf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under “Therapeutic drug monitoring”). If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.
Careful and frequent monitoring of tacrolimus trough levels is recommended in the first 2 weeks post-transplant to ensure adequate exposure to the active substance in the immediate post-transplant period. As tacrolimus is a substance with low clearance, it may take several days after adjustments to the Modigraf dose regimen before steady state is achieved (see below under “Therapeutic drug monitoring” and section 5.2).
Modigraf should not be switched with the prolonged-release capsules (Advagraf) as a clinically relevant difference in bioavailability between the two formulations cannot be excluded. In general, inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe. This can lead to graft rejection or increased incidence of undesirable effects, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8). Followin