Last reviewed · How we verify
Tacrolimus with rapid steroid withdrawal
Tacrolimus suppresses T-cell activation by inhibiting calcineurin, while rapid steroid withdrawal minimizes long-term corticosteroid exposure and associated toxicity in transplant recipients.
Tacrolimus suppresses T-cell activation by inhibiting calcineurin, while rapid steroid withdrawal minimizes long-term corticosteroid exposure and associated toxicity in transplant recipients. Used for Organ transplant rejection prevention (kidney, heart, liver transplants) with rapid corticosteroid withdrawal protocol.
At a glance
| Generic name | Tacrolimus with rapid steroid withdrawal |
|---|---|
| Also known as | Simulect; Dacortin; Prograf/Advagraf; Cellcept/Myfortic. |
| Sponsor | Armando Torres Ramírez |
| 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 prevents T-cell proliferation and cytokine production, providing immunosuppression for transplant rejection prevention. The rapid steroid withdrawal protocol aims to reduce cumulative steroid-related adverse effects (hyperglycemia, hypertension, osteoporosis, infection risk) by transitioning patients off corticosteroids quickly while maintaining tacrolimus-based immunosuppression as the primary agent.
Approved indications
- Organ transplant rejection prevention (kidney, heart, liver transplants) with rapid corticosteroid withdrawal protocol
Common side effects
- Nephrotoxicity / renal dysfunction
- Neurotoxicity (tremor, headache, seizures)
- Hyperglycemia / new-onset diabetes
- Hypertension
- Infections
- Hyperkalemia
Key clinical trials
- Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation (PHASE4)
- Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant (PHASE4)
- Pharmacokinetic Profile of Myfortic in Combination With Tacrolimus in Fed Versus Fasting State (PHASE4)
- Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (PHASE4)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape: