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Change from Prograf to Envarsus XR
Envarsus XR is an extended-release formulation of tacrolimus that suppresses the immune system by inhibiting calcineurin and T-cell activation to prevent organ transplant rejection.
Envarsus XR is an extended-release formulation of tacrolimus that suppresses the immune system by inhibiting calcineurin and T-cell activation to prevent organ transplant rejection. Used for Prevention of organ rejection in adult kidney transplant recipients, Prevention of organ rejection in adult heart transplant recipients, Prevention of organ rejection in adult liver transplant recipients.
At a glance
| Generic name | Change from Prograf to Envarsus XR |
|---|---|
| Also known as | Change from Tacrolimus to Envarsus XR |
| Sponsor | Vanderbilt University Medical Center |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus is a calcineurin inhibitor that binds to FKBP12 and blocks calcineurin phosphatase activity, preventing dephosphorylation of NFAT and subsequent T-cell cytokine production. Envarsus XR is a once-daily extended-release formulation designed to improve bioavailability and reduce dosing frequency compared to immediate-release Prograf (tacrolimus), while maintaining immunosuppressive efficacy in transplant recipients.
Approved indications
- Prevention of organ rejection in adult kidney transplant recipients
- Prevention of organ rejection in adult heart transplant recipients
- Prevention of organ rejection in adult liver transplant recipients
Common side effects
- Tremor
- Headache
- Hypertension
- Nephrotoxicity
- Hyperglycemia
- Infection
- Gastrointestinal disturbances
Key clinical trials
- Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients (PHASE4)
- Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants (PHASE4)
- Cognitive Outcomes in Stable Renal Transplant Patients Switched FromTacrolimus to Envarsus XR™ (PHASE4)
- Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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