Description
Envarsus (Tacrolimus) Tablets with Prolonged Release 0.75 mg. №30
Composition
Each tablet contains 0.75 mg of tacrolimus.
Mechanism of Action
Tacrolimus, the active ingredient in Envarsus, is a calcineurin inhibitor that suppresses the immune system by inhibiting T-lymphocyte activation. This mechanism helps prevent organ rejection in transplant patients.
Pharmacological Properties
The prolonged-release formulation of Envarsus ensures a steady and controlled release of tacrolimus in the body, maintaining therapeutic drug levels for an extended period. This sustained release profile reduces the dosing frequency required and enhances patient compliance with the treatment regimen.
Indications for Use
Envarsus tablets are indicated for the prophylaxis of organ rejection in adult kidney or liver transplant patients who require immunosuppression therapy.
Contraindications
Envarsus should not be used in individuals with a known hypersensitivity to tacrolimus or any of the components in the tablet formulation. Patients with uncontrolled infections or malignancies should also avoid using Envarsus.
Side Effects
Common side effects of Envarsus may include tremors, hypertension, renal dysfunction, hyperglycemia, and gastrointestinal disturbances. Regular monitoring for adverse effects and tacrolimus blood levels is essential during treatment.
Usage Instructions
Patients should take Envarsus exactly as prescribed by their healthcare provider. The tablets should be swallowed whole with water and not crushed or chewed. Dosage adjustments should only be made under medical supervision.
Benefits Compared to Analogues
Envarsus offers the advantage of a prolonged-release formulation, leading to improved drug adherence and reduced dosing frequency compared to immediate-release tacrolimus formulations. This enhanced pharmacokinetic profile contributes to better patient outcomes and graft survival rates.
Suitable Patient Groups
Envarsus is suitable for use in adult transplant recipients, including elderly patients and those with renal or hepatic impairment. Pediatric dosing and safety in children have not been established, so caution is advised when considering Envarsus therapy in pediatric populations.
Storage Conditions and Shelf Life
Envarsus tablets should be stored at room temperature (20-25°C) away from excessive moisture and heat. The shelf life of the product is typically indicated on the packaging and should be checked before use.
Packaging Description
Envarsus tablets are typically supplied in blister packs or containers with clear labeling indicating the product name, strength, quantity, and manufacturer information. The packaging should be intact and undamaged prior to use.
Clinical Evidence and Proven Effectiveness
Studies have demonstrated the efficacy and safety of prolonged-release tacrolimus formulations, such as Envarsus, in preventing organ rejection in transplant recipients. Research published in reputable journals, including the American Journal of Transplantation, has highlighted the favorable outcomes and reduced incidence of adverse effects associated with tacrolimus-based regimens.
