twice daily Prograf were converted to Envarsus at 1: 0.85 (mg:mg)
Gender
There is no evidence that male and female patients require different doses to achieve similar trough levels.
Elderly patients (> 65 years)
There is no evidence currently available to indicate that dose should be adjusted in elderly patients.
Paediatric population
The safety and efficacy of Envarsus in children below 18 years of age have not yet been established.
No data are available.
Method of administration
Envarsus is a once-a-day oral formulation of tacrolimus. It is recommended that the oral daily dose of Envarsus is administered once daily.
Patients should be advised not to swallow the desiccant. The tablets should be swallowed whole with fluid (preferably water) immediately following removal from the blister. Envarsus should generally be taken on an empty stomach to achieve maximal absorption (see section 5.2).
Envarsus is not interchangeable with other existing tacrolimus containing medicines (immediate release or prolonged release) on an equal dose by dose basis.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypersensitivity to other macrolides.
4.4 Special warnings and precautions for use
Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed with tacrolimus. This has led to serious adverse reactions, including graft rejection, or other adverse reactions which could be a consequence of either under- or over-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 4.2 and 4.8).
For treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients clinical studies are not yet available for the prolonged-release formulation Envarsus.
For prophylaxis of transplant rejection in adult heart, lung, pancreas, or intestine allograft recipients clinical data are not yet available for Envarsus.
During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations. If clinically relevant changes are seen, adjustments of the immunosuppressive regimen should be considered.
When substances with a potential for interaction (see section 4.5), particularly strong inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin, or clarithromycin) or inducers of CYP3A4 (such as rifampicin or rifabutin), are being combined with tacrolimus, tacrolimus blood levels should be monitored to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure.
Herbal preparations containing St. John's Wort (Hypericum perforatum) should be avoided when taking Envarsus due to the risk of interactions that lead to a decrease in both blood concentrations and the therapeutic effect of tacrolimus (see se |
