Classes
DEA Class; Rx
Common Brand Names; Nulojix
- Immunosuppressants;
- Selective T-Cell Costimulation Blockers
Description
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
Indications
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
Contraindications
Hypersensitivity
Patients who are EBV seronegative or with unknown EBV serostatus
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
10 mg/kg/dose IV for first 6 doses then 5 mg/kg/dose IV.
10 mg/kg/dose IV for first 6 doses then 5 mg/kg/dose IV.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Belatacept
injection, lyophilized powder for reconstitution
- 250mg/vial
