Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 250mg/vial
Kidney Transplant Rejection Prophylaxis
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
Dose calculation and schedule
- Total infusion dose based on actual body weight of patient at time of transplantation; modify dose if weight changes by >10%
- Prescribed dose must be divisible by 12.5 mg in order to accurately prepare dose from the reconstituted solution
- Initial phase: 10 mg/kg IV on day of transplant (prior to implantation); repeat this dose on Day 5 and at end of Weeks 2, 4, 8, and 12 after transplantation
- Maintenance phase: 5 mg/kg IV at end of Week 16 after transplantation and then q4Weeks (within +/- 3 days) thereafter
Dosage Modifications
Renal impairment
- Dose adjustments may not be necessary per pharmacokinetic studies showing clearance of belatacept not affected in kidney transplant patients; not described in manufacturer's label
Hepatic impairment
- Dose adjustments may not be necessary per pharmacokinetic studies showing clearance of belatacept not affected in kidney transplant patients; not described in manufacturer's label
Dosing Considerations
Corticosteroid utilization
- In clinical trials the median corticosteroid doses were tapered to ~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 clinical trial experience
Limitations of use
- Use only in patients who are EBV seropositive
- Use for the prophylaxis of organ rejection in transplanted organs other than kidney not been established
<18 years: Safety and efficacy not established
Because T cell development continues into the teenage years, the potential concern for autoimmunity in neonates applies to pediatric use as well
Of 401 patients treated with belatacept, 15% were 65 years of age and older, while 3% were 75 and older
No overall differences in safety or effectiveness were observed between these recipients and younger recipients, but cannot rule out greater sensitivity or less efficacy in older individuals
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- upadacitinib
belatacept, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious - Use Alternative (10)
- axicabtagene ciloleucel
belatacept, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
belatacept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
belatacept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
belatacept, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, adjuvanted
belatacept decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
belatacept decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- lisocabtagene maraleucel
belatacept, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sipuleucel-T
belatacept and sipuleucel-T both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant use of sipuleucel-T and immunosuppressives should be avoided.
- tisagenlecleucel
belatacept, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
belatacept, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (120)
- abatacept
belatacept and abatacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- adalimumab
belatacept and adalimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- adenovirus types 4 and 7 live, oral
belatacept decreases effects of adenovirus types 4 and 7 live, oral by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- alefacept
belatacept and alefacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- alemtuzumab
belatacept and alemtuzumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- anakinra
belatacept and anakinra both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- anthrax vaccine
belatacept decreases effects of anthrax vaccine by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- antithymocyte globulin equine
belatacept and antithymocyte globulin equine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
belatacept, antithymocyte globulin equine. Either decreases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Venous thrombosis of the renal allograft when belatacept and antithymocyte coadministered at the same or nearly the same time. - antithymocyte globulin rabbit
belatacept and antithymocyte globulin rabbit both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- azacitidine
belatacept and azacitidine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- azathioprine
belatacept and azathioprine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- basiliximab
belatacept and basiliximab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- BCG vaccine live
belatacept decreases effects of BCG vaccine live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- belimumab
belatacept and belimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- betamethasone
belatacept and betamethasone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- busulfan
belatacept and busulfan both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cabazitaxel
belatacept and cabazitaxel both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- canakinumab
belatacept and canakinumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- capecitabine
belatacept and capecitabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- carboplatin
belatacept and carboplatin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- carmustine
belatacept and carmustine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- certolizumab pegol
belatacept and certolizumab pegol both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- chlorambucil
belatacept and chlorambucil both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cholera vaccine
belatacept decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- cisplatin
belatacept and cisplatin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cladribine
belatacept and cladribine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cortisone
belatacept and cortisone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cyclophosphamide
belatacept and cyclophosphamide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cyclosporine
cyclosporine will decrease the level or effect of belatacept by decreasing metabolism. Modify Therapy/Monitor Closely. Monitor for a need to adjust concomitant mycophenolate mofetil (MMF) dosage when patient?s therapy is switched between cyclosporine and belatacept,
- cytarabine
belatacept and cytarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- dacarbazine
belatacept and dacarbazine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- dactinomycin
belatacept and dactinomycin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- daunorubicin
belatacept and daunorubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- dengue vaccine
belatacept decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
belatacept and denosumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- dexamethasone
belatacept and dexamethasone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- dichlorphenamide
dichlorphenamide and belatacept both decrease serum potassium. Use Caution/Monitor.
- diphtheria & tetanus toxoids
belatacept decreases effects of diphtheria & tetanus toxoids by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- diphtheria & tetanus toxoids/ acellular pertussis vaccine
belatacept decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- docetaxel
belatacept and docetaxel both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- doxorubicin
belatacept and doxorubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- doxorubicin liposomal
belatacept and doxorubicin liposomal both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- epirubicin
belatacept and epirubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- etoposide
belatacept and etoposide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- everolimus
belatacept and everolimus both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- fingolimod
belatacept and fingolimod both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- floxuridine
belatacept and floxuridine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- fludarabine
belatacept and fludarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- fluorouracil
belatacept and fluorouracil both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- gemcitabine
belatacept and gemcitabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- golimumab
belatacept and golimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- hydrocortisone
belatacept and hydrocortisone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- hydroxyurea
belatacept and hydroxyurea both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ibritumomab tiuxetan
belatacept and ibritumomab tiuxetan both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- idarubicin
belatacept and idarubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ifosfamide
belatacept and ifosfamide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- imatinib
belatacept and imatinib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- infliximab
belatacept and infliximab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- influenza A (H5N1) vaccine
belatacept decreases effects of influenza A (H5N1) vaccine by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- influenza virus vaccine (H5N1), adjuvanted
belatacept decreases effects of influenza virus vaccine (H5N1), adjuvanted by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- influenza virus vaccine quadrivalent, intranasal
belatacept decreases effects of influenza virus vaccine quadrivalent, intranasal by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- isavuconazonium sulfate
belatacept and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- leflunomide
belatacept and leflunomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
belatacept and lomustine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- measles mumps and rubella vaccine, live
belatacept decreases effects of measles mumps and rubella vaccine, live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- melphalan
belatacept and melphalan both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- meningococcal A C Y and W-135 polysaccharide vaccine combined
belatacept decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- meningococcal group B vaccine
belatacept decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- mercaptopurine
belatacept and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- methotrexate
belatacept and methotrexate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- methylprednisolone
belatacept and methylprednisolone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- mitoxantrone
belatacept and mitoxantrone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- muromonab CD3
belatacept and muromonab CD3 both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- mycophenolate
belatacept increases levels of mycophenolate by Other (see comment). Use Caution/Monitor. Comment: Potential change of mycophenolic acid (MPA) exposure after crossover from cyclosporine to belatacept or from belatacept to cyclosporine in patients concomitantly receiving MMF.
belatacept and mycophenolate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. - natalizumab
belatacept and natalizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- nelarabine
belatacept and nelarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ocrelizumab
belatacept and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- ofatumumab
belatacept and ofatumumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ofatumumab SC
ofatumumab SC, belatacept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
belatacept and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- ozanimod
ozanimod, belatacept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.
- paclitaxel
belatacept and paclitaxel both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- paclitaxel protein bound
belatacept and paclitaxel protein bound both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- pentostatin
belatacept and pentostatin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ponesimod
ponesimod and belatacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- pralatrexate
belatacept and pralatrexate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- prednisolone
belatacept and prednisolone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- prednisone
belatacept and prednisone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- procarbazine
belatacept and procarbazine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- rilonacept
belatacept and rilonacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- rituximab
belatacept and rituximab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- rituximab-hyaluronidase
belatacept and rituximab-hyaluronidase both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- rotavirus oral vaccine, live
belatacept decreases effects of rotavirus oral vaccine, live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- siponimod
siponimod and belatacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
belatacept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- sirolimus
belatacept and sirolimus both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- smallpox (vaccinia) vaccine, live
belatacept decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- tacrolimus
belatacept and tacrolimus both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- temozolomide
belatacept and temozolomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- temsirolimus
belatacept and temsirolimus both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- teniposide
belatacept and teniposide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- thioguanine
belatacept and thioguanine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- thiotepa
belatacept and thiotepa both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- tocilizumab
belatacept and tocilizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- topotecan
belatacept and topotecan both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- tositumomab
belatacept and tositumomab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- trastuzumab
trastuzumab, belatacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, belatacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- triamcinolone acetonide injectable suspension
belatacept and triamcinolone acetonide injectable suspension both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- typhoid vaccine live
belatacept decreases effects of typhoid vaccine live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- ublituximab
ublituximab and belatacept both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- ustekinumab
belatacept and ustekinumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- varicella virus vaccine live
belatacept decreases effects of varicella virus vaccine live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- vinblastine
belatacept and vinblastine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- vincristine
belatacept and vincristine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- vincristine liposomal
belatacept and vincristine liposomal both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- vinorelbine
belatacept and vinorelbine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- yellow fever vaccine
belatacept decreases effects of yellow fever vaccine by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- zoster vaccine live
belatacept decreases effects of zoster vaccine live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- zoster vaccine recombinant
belatacept decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (0)
Adverse Effects
≥ 10%
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%)
1-10%
Anxiety (10%)
Bronchitis (10%)
Renal tubular necrosis (9%)
New onset diabetes (8%)
Acne (8%)
Hypomagnesemia (7%)
Hyperuricemia (5%)
Postmarketing Reports
Venous thrombosis of the renal allograft when belatacept and antithymocyte coadministered at the same or nearly the same time
Anaphylaxis
Warnings
Black Box Warnings
Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS)
Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only
Contraindicated in transplant recipients who are EBV seronegative or with unknown EBV serostatus
Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe
Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources
The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient
Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression
Not recommended for use in liver transplant patients because of increased risk of graft loss and death
Contraindications
Hypersensitivity
Patients who are EBV seronegative or with unknown EBV serostatus (see Black Box Warnings)
Cautions
See Black Box 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 immunologics#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
Post-transplant lymphoproliferative disorder
- Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the CNS, compared to patients on a cyclosporine-based regimen
- As the total burden of immunosuppression is a risk factor for PTLD, higher than the recommended doses or more frequent dosing of belatacept and higher than recommended doses of concomitant immunosuppressive agents are not recommended
- Consider PTLD in patients reporting new or worsening neurological, cognitive, or behavioral signs or symptoms
- Risk of PTLD was higher in EBV seronegative patients compared to EBV seropositive patients
- EBV seropositive patients are defined as having evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA)
- Epstein-Barr virus serology should be ascertained before starting administration of belatacept, and only patients who are EBV seropositive should receive belatacept
- Transplant recipients who are EBV seronegative, or with unknown serostatus, should not receive belatacept (see Black Box Warnings and Contraindications)
- Other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell depleting therapy
Progressive multifocal leukoencephalopathy (PML)
- PML is a rare occurrence but is a rapidly progressive and fatal opportunistic infection of the CNS that is caused by the JC virus, a human polyoma virus
- In clinical trials, 2 cases of PML were reported in patients receiving belatacept at higher cumulative doses and administered more frequently than the recommended regimen
Drug interaction overview
- Avoid use of live vaccines during treatment with belatacept, including but not limited to the following: intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines
- In postmarketing experience in de novo kidney transplant recipients, venous thrombosis of the renal allograft reported when the initial dose of antithymocyte globulin (ATG), as immunosuppressive induction, was coadministered (at the same or nearly the same time) with the first dose of belatacept; coadministration of ATG and belatacept may pose a risk for venous thrombosis of the renal allograft; if ATG (or any other cell-depleting induction treatment) and belatacept will be administered concomitantly, consider a 12-hr interval between the 2 administrations
- Monitor mycophenolate mofetil (MMF) dosage when a patient’s therapy is switched between cyclosporine and belatacept; cyclosporine decreases mycophenolic acid (MPA) exposure by preventing enterohepatic recirculation of MPA while belatacept does not
Pregnancy & Lactation
Pregnancy
To monitor maternal-fetal outcomes of pregnant women who have received immunologics#immunosuppressants, healthcare providers are strongly encouraged to register pregnant patients in the Transplant Pregnancy Registry International (TPR) by calling 1-877-955-687
There is insufficient data with belatacept use in pregnant women to inform on drug-associated risk
Animal data
- Belatacept is known to cross the placenta of animals
- Administration of belatacept to pregnant rats and rabbits during the period of organogenesis was not teratogenic at exposures approximately 16 and 19 times greater than that observed at the maximum recommended human dose (MRHD) of 10 mg/kg body weight administered over the first month of treatment, based on area under the concentration-time curve (AUC)
- In a pre- and postnatal development study in rats, treatment-related infections in dams were associated with increased pup mortality, presumably secondary to deteriorating maternal health, at exposures 3 times higher than that observed at MRHD
Lactation
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
Belatacept is excreted in rat milk after IV administration, and it is possible that the drug will be present in human milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Monoclonal antibody; inhibits T-cell CD28 activation and proliferation by binding costimulatory ligands (CD80, CD86) of antigen presenting cells
Inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-alpha, interleukin-4, and TNF-alpha
Activated T lymphocytes are the predominant mediators of immunologic rejection
Absorption
Peak plasma concentration: 300 mcg/mL (healthy subjects [after 10mg/kg single dose); 247 mcg/mL (kidney transplant pts [after 10 mg/kg multiple doses]); 139 mcg/mL (kidney transplant pts [after 5 mg/kg multiple doses])
AUC: 26,398 mcg•hr/mL (healthy subjects [after 10mg/kg single dose); 22,252 mcg•hr/mL(kidney transplant pts [after 10 mg/kg multiple doses]); 14,090 mcg•hr/mL (kidney transplant pts [after 5 mg/kg multiple doses])
Distribution
Vd: 0.09 L/kg (healthy subjects [after 10mg/kg single dose); 0.11 L/kg (kidney transplant pts [after 10 mg/kg multiple doses]); 0.12 L/kg (kidney transplant pts [after 5 mg/kg multiple doses])
Excretion
Half-life: 9.8 days (healthy subjects [after 10mg/kg single dose); 9.8 days (kidney transplant pts [after 10 mg/kg multiple doses]); 8.2 days (kidney transplant pts [after 5 mg/kg multiple doses])
Clearance: 0.39 mL/hr/kg (healthy subjects [after 10mg/kg single dose); 0.49 mL/hr/kg (kidney transplant pts [after 10 mg/kg multiple doses]); 0.51 mL/hr/kg (kidney transplant pts [after 5 mg/kg multiple doses])
Administration
IV Compatibilities
D5W or NS
IV Preparation
Reconstitution
- Reconstitute each vial with 10.5 mL of diluent (ie, sterile water for injection [SWFI], 0.9% NaCl, D5W)
- Use a silicone-free syringe only during preparation; if siliconized syringe is used, solution may develop a few translucent particles and therefore should be discarded
- Direct the stream of diluent to the wall of vial to minimize foam formation
- To minimize foam formation, rotate vial and invert with gentle swirling until the contents are completely dissolved
- DO NOT SHAKE vial and avoid prolonged or vigorous agitation
- Reconstituted solution contains concentration of 25 mg/mL and should be clear to slightly opalescent and colorless to pale yellow; do not use if opaque particles, discoloration, or other foreign particles are present
Dilution
- Transfer reconstituted vials to an infusion bag or bottle immediately
- Calculate total volume required (refer to prescribing information) for injection
- Using the same silicone-free disposable syringe used for reconstitution, withdraw required amount of belatacept solution from the vial
Infusion bag
- Reconstituted with SWFI: Further dilute with either 0.9% NaCl or D5W
- Reconstituted with 0.9% NaCl or D5W: Further dilute with the same diluent used to reconstitute the vial with
- Inject reconstituted drug into appropriate infusion container, and gently rotate infusion container to ensure mixing (final concentration: 2-10 mg/mL)
- Discard any unused solution remaining in the vials
IV Administration
Visually inspect for particulate matter and discoloration prior to administration
Discard the infusion if any particulate matter or discoloration is observed
Administer over 30 minutes and must be administered with an infusion set and a sterile, nonpyrogenic, low-protein-binding filter (with a pore size of 0.2-1.2 microns)
Infuse in a separate IV line from other concomitantly infused agents and should not be infused concomitantly in the same intravenous line with other agents
Storage
Unused vials: Refrigerate at 2-8ºC (36-46ºF) and protected from light
Reconstituted vials: Refrigerate at 2-8ºC (36-46ºF) and protected from light for up to 24 hr
Infusion must be completed within 24 hr of reconstitution of the lyophilized powder
Reconstituted solutions: Refrigerate at 2-8ºC (36-46ºF) and protected from light for up to 24 hr or may be stored at room temperature (20-25ºC [68-77ºF]) and room light for up to 4 hr of the total 24 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Nulojix intravenous - | 250 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
belatacept intravenous
BELATACEPT - INJECTION
(bel-AT-a-sept)
COMMON BRAND NAME(S): Nulojix
WARNING: This medication may increase the risk for developing serious (even fatal) infections or certain cancers after receiving a kidney transplant. Belatacept may also increase the risk for developing a certain medical condition, post-transplant lymphoproliferative disorder (PTLD), which can become a type of cancer. The risk is greater in people who have not previously been exposed to a certain virus (Epstein-Barr virus) that causes a common mild infection, usually before adulthood. Before starting treatment with this medication, your doctor should test you to check if you have had previous exposure to Epstein-Barr virus. (See also the Medication Guide.)This medication is not recommended for use to help prevent organ rejection after a liver transplant.
USES: Belatacept is used to help prevent organ rejection in people who have received a kidney transplant. It is used along with other medications (such as mycophenolate, corticosteroids) to allow your new organ to function normally. Belatacept belongs to a class of drugs known as immunosuppressants. It works by weakening your body's natural defense (immune system) to prevent your body from rejecting the new kidney.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using belatacept and each time you get a refill. Your doctor may direct you to enroll in a special program from the manufacturer (ENLIST Registry) before using this medication. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein as directed by your doctor, usually over 30 minutes. After the first dose, this medication is given on a regular schedule as directed by your doctor. The dosage is based on your weight.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and the risk of serious side effects may increase.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.This medication can increase your risk for serious (even fatal) infections, such as cytomegalovirus or pneumocystis. To help prevent these serious infections, your doctor may direct you to also take other medications along with belatacept. Ask your doctor for details. (See also Precautions section.)You should receive this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.
SIDE EFFECTS: See also Warning section.Headache, nausea, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine).Because belatacept works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor promptly if you develop any signs of an infection such as cough, sore throat, fever, or chills.This drug increases the risk of a rare and possibly fatal brain infection (progressive multifocal leukoencephalopathy-PML). Tell your doctor right away if you develop symptoms such as: clumsiness, difficulty speaking, problems with balance, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), vision changes, weakness of the arms and legs that gets worse.The immune system is also important in preventing and controlling cancer. Very rarely, patients using belatacept have developed cancers (such as lymphoma, skin cancer). Tell your doctor right away if you develop symptoms such as: new skin lesion or bump, or change in size or color of a mole, night sweats, swollen glands, unexplained weight loss, unusual tiredness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using belatacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent/returning infection (such as tuberculosis, hepatitis, cytomegalovirus-CMV infection), cancer, immune system disorder (such as HIV infection, bone marrow disorder).Belatacept can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using belatacept before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Since this medication may increase your risk of developing skin cancer, limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as kidney function, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Consult the product instructions and your pharmacist for storage details. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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