Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 250 mg) |
| Drug Class | Selective T-cell costimulation blockers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids for prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- In hand transplants, 65.9% of patients experienced rejection, and 13.2% experienced graft loss; in face transplants, rejection occurred in 73% of patients, with a graft loss rate of 8.9%.
- Among hand transplant recipients, clinical cytomegalovirus (CMV) infection was observed in 6.6% of patients, while in face transplant recipients, the rate was 15.5%.
- For kidney transplants, no significant differences in efficacy and safety were noted between once-daily and twice-daily tacrolimus regimens; however, regimens involving calcineurin inhibitor avoidance and early steroid withdrawal were associated with increased rejection rates.
- In hand and face transplants, nephrotoxicity required modifications to standard triple maintenance therapy, with clinical CMV infection rates observed at 6.6% for hand transplants and 15.5% for face transplants.
- For kidney transplants, tacrolimus was associated with new-onset diabetes, nephrotoxicity, and electrolyte imbalances; belatacept showed a lower incidence of new-onset diabetes but carried a higher risk of infection, including EBV-related lymphoproliferative disorders, and had a reduced vaccine response.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nulojix (belatacept) Prescribing Information. | 2021 | Bristol-Myers Squibb, Princeton, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Immunosuppressive strategies in face and hand transplantation: a comprehensive systematic review of current therapy regimens and outcomes | 2024 | Frontiers in Transplantation |
| Comparative Safety and Efficacy of Immunosuppressive Regimens Post-kidney Transplant: A Systematic Review | 2023 | Cureus |
| Humoral and cellular response of COVID-19 vaccine among solid organ transplant recipients: A systematic review and meta-analysis | 2022 | Transplant Infectious Disease |
| Belatacept in Kidney Transplantation: What Are the True Benefits? A Systematic Review | 2022 | Frontiers in Medicine |
| Belatacept in renal transplantation in comparison to tacrolimus and molecular understanding of resistance pattern: Meta-analysis and systematic review | 2021 | World Journal of Transplantation |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Post-operative care in the kidney transplant recipient. | 2022 | The Renal Association |
| Egyptian clinical practice guideline for kidney transplantation. | 2021 | Arab Journal of Urology |
| KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation. | 2020 | Transplantation |