belatacept (Rx)

Brand and Other Names:Nulojix
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Dosing & Uses

AdultPediatricGeriatric

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

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Interactions

Interaction Checker

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            Contraindicated (0)

              Serious - Use Alternative (4)

              • 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.

              • 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.

              • tofacitinib

                belatacept, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (119)

              • 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.

              • 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)

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                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

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                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 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
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                Pregnancy & Lactation

                Pregnancy

                To monitor maternal-fetal outcomes of pregnant women who have received 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.

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                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])

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                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

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Nulojix intravenous
                -
                250 mg vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                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 persist or worsen, 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 worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. 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: Laboratory and/or medical tests (such as kidney tests, complete blood count) should be performed periodically to monitor your progress or check for side effects. 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 September 2021. Copyright(c) 2021 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.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.