Post Transplant Lymphoproliferative Disorder, Other Malignancies, And Serious Infections
- Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system.
- Recipients wthout immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only.
- Do not use this drug in transplant recipients who are EBV seronegative or with unknow EBV serostatus [See Contraindications and Warnings and Precautions]
- Increased suseptibility to infection and the possible development of malignancies may result rom immunosuppression. [See Warnings and Precautions]
- Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe belatacept. The physician responsible fpr maintenance therapy should have complete information requisite for the follow-up of the patient.
- Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and suportive medical resources.
- Use in liver transplant patients is not recommended due to increased risk of graft loss and death. [See Warnings and Precautions]
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information
Updated January 2018