Envarsus 0.75mg, 1mg & 4mg prolonged-release tablets
Chiesi Limited
contact details
Active ingredient
tacrolimus monohydrate
Legal Category
POM: Prescription only medicine
1. Name of the medicinal product
Envarsus 0.75 mg prolonged-release tablets
Envarsus 1 mg prolonged-release tablets
Envarsus 4 mg prolonged-release tablets
2. Qualitative and quantitative composition
Envarsus 0.75 mg prolonged-release tablets
Each prolonged-release tablet contains 0.75 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each tablet contains 41.7 mg lactose (as monohydrate).
Envarsus 1 mg prolonged-release tablets
Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each tablet contains 41.7 mg lactose (as monohydrate).
Envarsus 4 mg prolonged-release tablets
Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each tablet contains 104 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
0.75 mg:
Oval, white to off-white uncoated tablet, debossed with “0.75” on one side and “TCS” on the other side.
1 mg:
Oval, white to off-white uncoated tablet, debossed with “1” on one side and “TCS” on the other side.
4 mg:
Oval, white to off-white uncoated tablet, debossed with “4” on one side and “TCS” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
4.2 Posology and method of administration
Envarsus is a once-a-day oral formulation of tacrolimus. Envarsus therapy requires careful monitoring by adequately qualified and equipped personnel. This medicinal product should only be prescribed, and changes in immunosuppressive therapy be initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
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 adverse reactions, including under- or over immunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily 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). Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.
Posology
The recommended initial doses presented below are intended to act solely as a guideline. Envarsus 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.
Envarsus dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided