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Envarsus XR is a once-daily, extended-release formulation of Tacrolimus, a calcineurin inhibitor immunosuppressant. It is FDA-approved for the prevention of organ rejection in kidney transplant patients — both in new (de novo) transplant recipients and in patients converting from twice-daily immediate-release Tacrolimus (Prograf). Envarsus XR uses a proprietary MeltDose technology that improves Tacrolimus bioavailability, allowing for once-daily dosing with more consistent blood levels throughout the day.
Tacrolimus, the active ingredient in Envarsus XR, works by inhibiting calcineurin, a key enzyme in the immune system. Calcineurin normally activates T cells by triggering the production of interleukin-2 (IL-2). By blocking this pathway, Tacrolimus suppresses T-cell activation and proliferation, preventing the immune system from attacking and rejecting the transplanted kidney. The extended-release formulation provides steady drug levels over 24 hours with once-daily dosing.
Envarsus XR is taken once daily on an empty stomach, preferably in the morning. Tablets must be swallowed whole — do not split, crush, or chew.
Envarsus XR scores a 60 out of 100 on our findability scale. As a single-source brand-name product manufactured exclusively by Veloxis Pharmaceuticals, it has no generic equivalent and is more vulnerable to supply disruptions than widely available generics. While it is not currently listed on the FDA Drug Shortage database as of February 2026, transplant patients have reported intermittent difficulty locating it at retail pharmacies due to its specialty status. Most pharmacies do not stock it routinely and may need to special-order it. Specialty pharmacies affiliated with transplant centers are typically the most reliable source.
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Envarsus XR is prescribed almost exclusively by transplant specialists, including:
Due to the critical nature of transplant immunosuppression and the need for regular blood-level monitoring, this medication is not typically prescribed by primary care physicians.
No, Envarsus XR is not a controlled substance. It does not have a DEA schedule and is not subject to the prescribing restrictions that apply to controlled medications. However, it does carry an FDA boxed warning about increased risk of serious infections and malignancies, and it requires careful therapeutic drug monitoring through regular blood tests.
Serious side effects include increased risk of infections, lymphoma and other cancers, kidney damage (nephrotoxicity), neurotoxicity, and QT prolongation. Contact your transplant team immediately if you experience fever, unusual bruising, confusion, vision changes, or signs of infection.
Important: Never switch between Tacrolimus formulations without your transplant team's guidance — they are not interchangeable and dose adjustments are required.
Always inform your transplant team about all medications, supplements, and herbal products you take.
Envarsus XR is a critical medication for kidney transplant recipients, offering the convenience of once-daily dosing with more stable Tacrolimus blood levels compared to twice-daily formulations. As a single-source brand-name product with no generic equivalent, it can be expensive and occasionally difficult to locate at retail pharmacies. Transplant patients should work closely with their transplant center's specialty pharmacy and explore Veloxis's patient assistance programs if cost is a concern. Never switch between Tacrolimus formulations on your own — even small changes in blood levels can affect transplant outcomes. If you're having trouble finding Envarsus XR in stock, Medfinder can help you locate pharmacies with availability near you.