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Belatacept

    Brands

    DEA Class; Rx

    Common Brand Names; Nulojix

    • Immunosuppressants; 
    • Selective T-Cell Costimulation Blockers

    Selective T-cell costimulation blocker
    For rejection prophylaxis in adults receiving a kidney transplant
    May increase risk for developing post-transplant lymphoproliferative disorder; ONLY use in Epstein-Barr virus seropositive patients

    Indicated for use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids to prevent kidney transplant rejection

    Due to an increased risk of post-transplant lymphoproliferative disorder predominantly involving the central nervous system, progressive multifocal leukoencephalopathy, and serious CNS infections, administration of higher than the recommended doses or more frequent dosing is NOT recommended

    Hypersensitivity

    Patients who are EBV seronegative or with unknown EBV serostatus 

    • Anemia (45%)
    • Diarrhea (39%)
    • Urinary tract infection (37%)
    • Peripheral edema (34%)
    • Constipation (33%)
    • Hypertension (32%)
    • Pyrexia (28%)
    • Graft dysfunction (25%)
    • Cough (24%)
    • Nausea (24%)
    • Vomiting (22%)
    • Headache (21%)
    • Hypokalemia (21%)
    • Hyperkalemia (20%)
    • Leukopenia (20%)
    • Dyslipidemia (19%)
    • Abdominal pain (19%)
    • Hypophosphatemia (19%)
    • Hypotension (18%)
    • Arthralgia (17%)
    • Hyperglycemia (16%)
    • Hematuria (16%)
    • Proteinuria (16%)
    • Blood creatinine increased (15%)
    • Insomnia (15%)
    • Upper respiratory infection (15%)
    • Nasopharyngitis (13%)
    • Back pain (13%)
    • Hypocalcemia (13%)
    • CMV infection (12%)
    • Dyspnea (12%)
    • Influenza (11%)
    • Dysuria (11%)
    • Hypercholesterolemia (11%)

    In postmarketing experience, use in conjunction with basiliximab induction, MMF, and 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 to 6 HLA mismatches; graft loss was a consequence of Grade III rejection in some patients.

    Serious infection may occur including bacterial, viral (cytomegalovirus [CMV], herpes, polyoma virus nephropathy), fungal, and protozoal infections, including opportunistic infections (eg, tuberculosis); these infections may lead to serious, including fatal, outcomes

    Tuberculosis was more frequently observed

    Cases of polyoma virus-associated nephropathy (PVAN), mostly due to BK virus infection, reported

    Patients receiving immunosuppressants, including belatacept, are in increased risk for developing malignancies; advised added precautions including limiting UV exposure and wearing sunscreen

    Risk of rejection with conversion from a calcineurin inhibitor (CNI) based maintenance regimen reported; conversion of stable kidney transplant recipients from a CNI based maintenance therapy to a belatacept based maintenance therapy not recommended unless the patient is CNI intolerant

    There is insufficient data with belatacept use in pregnant women to inform on drug-associated risk

    There are no data on the presence of belatacept in human milk or the effects of belatacept on breastfed infants or human milk production to inform risk of belatacept to an infant during lactation

    Adults

    10 mg/kg/dose IV for first 6 doses then 5 mg/kg/dose IV.

    Geriatric

    10 mg/kg/dose IV for first 6 doses then 5 mg/kg/dose IV.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Belatacept 

    injection, lyophilized powder for reconstitution

    • 250mg/vial