Adult Dosing
Prophylaxis of rejection in kidney transplant patients
- Initial Phase
- 10 mg/kg IV on Day 1 (day of transplantation, prior to implantation), Day 5, and at the end of Week 2, 4, 8 and 12 after transplantation
- Maintenance Phase
- 5 mg/kg IV q4 wks; start at the end of Week 16 after transplantation
Note:
- The dose prescribed for the patient must be evenly divisible by 12.5 mg in order for the dose to be accurately prepared using the reconstituted solution and the silicone-free disposable syringe provided
- In clinical trials the median corticosteroid doses were tapered to approximately 15 mg/day (10-20 mg/day) by the first 6 weeks and remained at ~10 mg/day (5-10 mg/day) for the first 6 months post-transplant. Corticosteroid utilization should be consistent with the belatacept clinical trial experience
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Therapy may be associated with an increased risk of post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system [US Black Box Warning]
- Ascertain Epstein-Barr virus serology before starting belatacept therapy, as the risk of PTLD is higher in EBV seronegative patients compared to EBV seropositive patients. Hence, therapy is indicated in EBV seropositive patients only [US Black Box Warning]
- Cytomegalovirus (CMV) infection and T-cell-depleting therapy are reported to be other known risk factors for PTLD. CMV prophylaxis is recommended for at least 3 months after transplantation
- Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe belatacept; also, patients should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources [US Black Box Warning]
- Increased risk of developing malignancies, including the skin, has been reported. Exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor
- Progressive multifocal leukoencephalopathy (PML), rapidly progressive and fatal opportunistic infection of the CNS caused by the JC virus (human polyoma virus), has been reported in patients receiving belatacept at higher cumulative doses and more frequently than the recommended regimen. Consider dose reduction or withdrawal of immunosuppression if PML is diagnosed
- Immunosuppressant therapy, including belatacept, increase the risk of developing bacterial, viral (CMV and herpes), fungal, and protozoal infections, including opportunistic infections leading to serious or fatal outcomes
- Evaluate patients for tuberculosis and test for latent infection prior to initiating belatacept, as tuberculosis was more frequently observed in patients receiving belatacept. Start treatment of latent tuberculosis infection prior to belatacept use
- Polyoma virus-associated nephropathy (PVAN), associated with serious outcomes including deteriorating renal function and kidney graft loss, has been reported. Monitor patients at risk for PVAN and consider reductions in immunosuppression for patients who develop evidence of PVAN
- Belatacept is not recommended in liver transplant patients [US Black Box Warning]
- Avoid using live vaccines, including intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines, during belatacept treatment
- In post marketing studies corticosteroid minimization to 5 mg/day between Day 3 and Week 6 post-transplant was associated with an increased rate and grade of acute rejection, particularly Grade III rejection; these Grade III rejections occurred in patients with 4-6 HLA mismatches, graft loss was a consequence of Grade III rejection in some patients
Cautions: Use cautiously in
- CMV infection
- Immunosuppressed patients
- Latent tuberculosis
Supplemental Patient Information
- Instruct patients to promptly report any of the neurological, cognitive, or behavioral signs and symptoms including mood changes, confusion, loss of memory, problems thinking, changes in walking or talking, changes in vision, or weakness on one side of the body during or after belatacept therapy
- Instruct patients to look for any signs and symptoms of skin cancer including suspicious moles or lesions
- Inform patients to immediately report any signs and symptoms of infection during therapy; advise patients to adhere to antimicrobial prophylaxis regimens as prescribed
Pregnancy Category:C
Breastfeeding: Unknown if this drug is excreted in human milk; however, it is excreted in rat milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
