Last reviewed · How we verify
Envarsus
At a glance
| Generic name | Envarsus |
|---|---|
| Also known as | ENVARSUS XR 0.75Mg Extended-Release Tablet, ENVARSUS XR 1Mg Extended-Release Tablet, ENVARSUS XR 4Mg Extended-Release Tablet, extended release tacrolimus, Tacrolimus |
| Sponsor | Barts & The London NHS Trust |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions (5.1 , 5.2 )]. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or deat
Common side effects
- Tremor
- Headache
- Diarrhea
- Hypertension
- Nausea
- Abdominal pain
- Insomnia
- Constipation
Serious adverse events
- Esophagitis
- Polyomavirus-associated nephropathy
- Graft dysfunction
- Complications of transplanted kidney
- Diabetes mellitus
- New Onset Diabetes After Transplantation (NODAT)
- Serious infections
Key clinical trials
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
- Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
- Tocilizumab in Lung Transplantation (PHASE2)
- Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients With Delayed Graft Function
- A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (PHASE2, PHASE3)
- Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases (PHASE1, PHASE2)
- MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases (PHASE2)
- Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile (PHASE2, PHASE3)
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 |