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Belatacept: Drug information

Belatacept: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Belatacept: Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Posttransplant lymphoproliferative disorder, other malignancies, and serious infections:

Increased risk for developing posttransplant lymphoproliferative disorder, predominantly involving the CNS. Recipients without immunity to Epstein-Barr virus are at a particularly increased risk; therefore, use in Epstein-Barr virus–seropositive patients only. Do not use belatacept in transplant recipients who are Epstein-Barr virus seronegative or with unknown Epstein-Barr virus serostatus.

Only health care providers experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe belatacept. Manage patients receiving the drug in facilities equipped and staffed with adequate laboratory and supportive medical resources. The health care provider 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.

Use in liver transplant patients is not recommended because of an increased risk of graft loss and death.

Brand Names: US
  • Nulojix
Pharmacologic Category
  • Selective T-Cell Costimulation Blocker
Dosing: Adult

Note: Dosing is based on actual body weight at the time of transplantation; do not modify weight-based dosing during course of therapy unless the change in body weight is >10%. The prescribed dose must be evenly divisible by 12.5 mg to allow accurate preparation of the reconstituted solution using the provided required disposable syringe for preparation. For example, the calculated dose for a 64 kg patient: 64 kg × 10 mg per kg = 640 mg. The nearest doses to 640 mg that are evenly divisible by 12.5 mg would be 637.5 mg or 650 mg; the closest dose to the calculated dose is 637.5 mg, therefore, 637.5 should be the actual prescribed dose for the patient.

Heart transplant, prophylaxis of organ rejection

Heart transplant, prophylaxis of organ rejection (alternative agent) (off label): Note: Calcineurin inhibitor sparing (eg, minimization or withdrawal) regimens should include maintenance corticosteroids ± mycophenolate mofetil ± everolimus or other adjunctive therapy based on patient-specific risk factors (Ref).

Initial phase: IV: 10 mg/kg on days 1, 5, 14, and 28, followed by 10 mg/kg at the end of weeks 8 and 12 (Ref).

Maintenance phase: IV: 5 mg/kg every 4 weeks starting at the end of week 16 (Ref).

Kidney transplant, prophylaxis of organ rejection

Kidney transplant, prophylaxis of organ rejection: Note: Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. Use of belatacept-based regimens with early corticosteroid withdrawal may not provide adequate protection against rejection (Ref).

De novo use:

Initial phase: IV: 10 mg/kg on day 1 (day of transplant, prior to implantation) and on day 5 (~96 hours after day 1 dose), followed by 10 mg/kg at the end of week 2, week 4, week 8, and week 12 following transplantation.

Maintenance phase: IV: 5 mg/kg every 4 weeks (±3 days) beginning at the end of week 16 following transplantation.

Conversion from calcineurin inhibitor (off-label dosing): Note: Taper calcineurin inhibitor dose slowly over 1 month (100% of calcineurin inhibitor dose on day 1, 40% to 60% calcineurin inhibitor dose on day 15, 20% to 30% calcineurin inhibitor dose on day 22; discontinue on day 29 and beyond) (Ref).

Initial phase: IV: 5 mg/kg on transition days 1, 15, 29, 43, and 57 (Ref).

Maintenance phase: IV: 5 mg/kg every 4 weeks beginning 4 weeks after completion of the initial phase (Ref).

Lung transplant, prophylaxis of organ rejection

Lung transplant, prophylaxis of organ rejection (off-label use): Note: Basiliximab may be administered prior to initiation of belatacept (Ref), and initial phase may be truncated based on risk of overimmunosuppression (Ref).

1-month initial phase: IV: 10 mg/kg on days 0, 4, 14, and 28; followed by 10 mg/kg monthly (Ref).

2-month initial phase: IV: 10 mg/kg on days 1, 5, 15, 29, 45, and 59; followed by 5 mg/kg monthly (Ref).

3-month initial phase: IV: 5 mg/kg every 2 weeks for 6 doses, followed by 5 mg/kg monthly thereafter (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; however, renal function did not affect clearance in pharmacokinetic studies of kidney transplant recipients.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; however, hepatic function did not affect clearance in pharmacokinetic studies of kidney transplant recipients.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences reported as part of a combination therapy regimen in adults.

>10%:

Cardiovascular: Hypertension (32%), hypotension (18%), peripheral edema (34%)

Endocrine & metabolic: Dyslipidemia (19%), hypercholesterolemia (11%), hyperglycemia (16%), hyperkalemia (20%), hypocalcemia (13%), hypokalemia (21%), hypophosphatemia (19%)

Gastrointestinal: Abdominal pain (19%; upper abdominal pain [9%]), constipation (33%), diarrhea (39%), nausea (24%), vomiting (22%)

Genitourinary: Dysuria (11%), hematuria (16%), proteinuria (16% to 33%), urinary tract infection (37%)

Hematologic & oncologic: Anemia (45%), leukopenia (20%)

Infection: Infection (72% to 82%; including cytomegalovirus disease [11% to 13%], fungal infection [18%], herpes virus infection [7% to 14%], influenza [11%], polyomavirus infection [3% to 4%], serious infection [24% to 36%])

Nervous system: Headache (21%), insomnia (15%)

Neuromuscular & skeletal: Arthralgia (17%), back pain (13%)

Renal: Increased serum creatinine (15%)

Respiratory: Cough (24%), dyspnea (12%), nasopharyngitis (13%), upper respiratory tract infection (15%)

Miscellaneous: Fever (28%)

1% to 10%:

Cardiovascular: Arteriovenous fistula site complication (thrombosis: <10%), atrial fibrillation (<10%)

Dermatologic: Acne vulgaris (8%), alopecia (<10%), hyperhidrosis (<10%)

Endocrine & metabolic: Diabetes mellitus (new onset: 5% to 8%), hyperuricemia (5%), hypomagnesemia (7%)

Gastrointestinal: Stomatitis (<10%; including aphthous stomatitis)

Genitourinary: Urinary incontinence (<10%)

Hematologic & oncologic: Hematoma (<10%), lymphocele (<10%), malignant neoplasm (4%), malignant neoplasm of skin (nonmelanoma: 2%), neutropenia (<10%)

Hypersensitivity: Infusion-related reaction (5%)

Immunologic: Antibody development (2%)

Nervous system: Anxiety (10%), dizziness (9%), Guillain-Barré syndrome (<10%), tremor (8%)

Neuromuscular & skeletal: Musculoskeletal pain (<10%)

Renal: Kidney disease (polyomavirus-associated nephropathy: 1%), kidney impairment (<10%; including acute kidney injury, hydronephrosis, renal artery stenosis), renal tubular necrosis (9%)

Respiratory: Bronchitis (10%), tuberculosis (1% to 2%)

Frequency not defined: Hematologic & oncologic: Lymphoproliferative disorder (post-transplant)

Postmarketing:

Dermatologic: Psoriasis (Ville 2018)

Gastrointestinal: Colitis (Bozon 2017)

Hypersensitivity: Anaphylaxis

Infection: Toxoplasmosis (ocular) (Lanfranco 2016)

Nervous system: Meningitis (cryptococcal), progressive multifocal leukoencephalopathy (higher dosing regimen)

Neuromuscular & skeletal: Lupus erythematosus (chilblain) (Kinariwalla 2022)

Ophthalmic: Cytomegalovirus retinitis (Deliège 2020)

Contraindications

Transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus due to increased risk for posttransplant lymphoproliferative disorder (PTLD).

Warnings/Precautions

Concerns related to adverse effects:

• Infections: [US Boxed Warning]: Risk for infection is increased. Immunosuppressive therapy may lead to bacterial, viral (cytomegalovirus [CMV] and herpes), fungal, and protozoal infections, including opportunistic infections (may be fatal). Tuberculosis (TB) is increased; test patients for TB infection (latent TB) prior to initiation, and treat TB infection prior to use. Prophylaxis for cytomegalovirus (CMV) is recommended for at least 3 months after transplantation; prophylaxis for Pneumocystis jirovecii is recommended after transplantation.

• Latent viral infections: Patients receiving immunosuppressive therapy are at an increased risk of activation of latent viral infections, including John Cunningham virus (JCV) and BK virus infection. Activation of JCV may result in progressive multifocal leukoencephalopathy (PML), a rare and potentially-fatal condition affecting the CNS. Symptoms of PML include apathy, ataxia, cognitive deficiencies, confusion, and hemiparesis. Polyoma virus-associated nephropathy (PVAN), primarily from activation of BK virus, may also occur and lead to the deterioration of renal function and/or renal graft loss. Risk factors for the development of PML and PVAN include immunosuppression and treatment with immunosuppressant therapy. The onset of PML or PVAN may warrant a reduction in immunosuppressive therapy; however, in transplant recipients, the risk of reduced immunosuppression and graft rejection should be considered.

• Lymphoproliferative disorders: [US Boxed Warning]: Risk of post-transplant lymphoproliferative disorder (PTLD) is increased, primarily involving the CNS, in patients receiving belatacept compared to patients receiving cyclosporine-based regimens. Degree of immunosuppression is a risk factor for PTLD developing; do not exceed recommended dosing. Patients who are Epstein-Barr virus (EBV) seronegative are at an even higher risk; use is contraindicated in patients without evidence of immunity to EBV. Cytomegalovirus (CMV) infection and T-cell depleting therapy also increases the risk for PTLD; T-cell depleting therapies to treat acute rejection should be used with caution. CMV prophylaxis is recommended for a minimum of 3 months following transplantation. Although CMV disease is a risk for PTLD and CMV seronegative patients are at an increased risk for CMV disease, the clinical role, if any, of determining CMV serology to determine risk of PTLD development has not been determined.

• Malignancy: [US Boxed Warning]: Risk for malignancy is increased. Malignancy, including skin malignancy and PTLD, is associated with the use of belatacept; patients should be advised to limit their exposure to sunlight/UV light.

Concurrent drug therapy issues:

• Coadministration with anti-thymocyte globulin: In postmarketing reports, venous thrombosis of the renal allograft has occurred in de novo kidney transplant recipients, some with other predisposing venous thrombosis risk factors, when the initial anti-thymocyte globulin dose was coadministered (at the same or nearly the same time) with belatacept; if administering anti-thymocyte globulin or any other cell-depleting induction therapy concomitantly with belatacept, separate the dosing by 12 hours. Use with caution in these patients as concurrent administration may increase renal allograft venous thrombosis risk.

• Conversion from calcineurin inhibitor therapy: Risk of acute rejection is increased, especially during the first year, post conversion from a calcineurin inhibitor maintenance regimen to a belatacept maintenance regimen. Conversion is recommended only in calcineurin inhibitor–intolerant patients.

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: Belatacept is not recommended in liver transplant recipients due to increased risk of graft loss and death.

• Corticosteroid minimization: Increased rate and grade of acute rejection, particularly grade 3 rejection, and graft loss has been observed with belatacept when corticosteroids were minimized to 5 mg daily between day 3 and week 6 post-transplant; corticosteroid dosing should be consistent with clinical trial experience (ie, tapered to ~15 mg [10 to 20 mg] daily by the first 6 weeks post-transplant and remain at ~10 mg [5 to 10 mg] daily for the first 6 months post-transplant).

• EBV serostatus: Therapy is only appropriate in patients who are EBV seropositive via evidence of acquired immunity, such as presence of IgG antibodies to viral capsid antigen [VCA] and EBV nuclear antigen [EBNA].

• Experienced physician: [US Boxed Warning]: Should be administered under the supervision of a physician experienced in immunosuppressive therapy.

• Immunizations: Immunization with live vaccines should be avoided during treatment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Nulojix: 250 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Nulojix Intravenous)

250 mg (per each): $1,163.86

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Prescribing and Access Restrictions

Patients (new and existing) must be registered in the Nulojix Distribution Program. Additional information is available by calling (855) 511-6180 or at http://www.nulojixhcp.bmscustomerconnect.com/index.

Administration: Adult

IV: Administer as an IV infusion over 30 minutes using an infusion set with a 0.2 to 1.2 micron low protein-binding filter. The infusion must be completed within 24 hours of reconstitution of the lyophilized powder. Infuse in a separate line from other infused agents.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf#page=49, must be dispensed with this medication.

Use: Labeled Indications

Kidney transplant (de novo use): Prophylaxis of organ rejection concomitantly with basiliximab induction, mycophenolate, and corticosteroids in adult Epstein-Barr virus (EBV) seropositive kidney transplant recipients

Limitations of use: Use only in EBV seropositive patients; use for prophylaxis of organ rejection in transplanted organs other than the kidney has not been established.

Use: Off-Label: Adult

Heart transplant, prophylaxis of organ rejection; Kidney transplant, prophylaxis of organ rejection, conversion from calcineurin inhibitor; Lung transplant, prophylaxis of organ rejection

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (immunosuppressant agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care and Long-Term Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Androgens: Hypertension-Associated Agents may enhance the hypertensive effect of Androgens. Risk C: Monitor therapy

Antithymocyte Globulin (Equine): May enhance the adverse/toxic effect of Belatacept. Specifically, the risk for venous thrombosis of the renal allograft may be increased. Belatacept may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Management: A 12-hour interval between administration of these 2 agents is suggested if used concomitantly. Monitor for venous thrombosis of the renal allograft, infections, and if the belatacept dose is reduced, monitor for unmasking of antithymocyte reactions. Risk D: Consider therapy modification

Antithymocyte Globulin (Rabbit): May enhance the adverse/toxic effect of Belatacept. Specifically, the risk for venous thrombosis of the renal allograft may be increased. Management: A 12-hour interval between administration of these 2 agents is suggested if these agents are to be used concomitantly. Monitor for venous thrombosis of the renal allograft. Risk D: Consider therapy modification

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Risk C: Monitor therapy

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Pregnancy Considerations

Information related to belatacept use in pregnancy is limited (Combs 2018; Klintmalm 2020).

Data collection to monitor pregnancy and infant outcomes following exposure to belatacept is ongoing. The Transplant Pregnancy Registry International (TPR) is a registry that follows pregnancies that occur in maternal transplant recipients or those fathered by male transplant recipients. The TPR encourages reporting of pregnancies following solid organ transplant by contacting them at 1-877-955-6877 or www.transplantpregnancyregistry.org.

Breastfeeding Considerations

It is not known if belatacept is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Monitor for new-onset or worsening neurological, cognitive, or behavioral signs/symptoms; signs/symptoms of infection or malignancy; GI side effects (eg, nausea, vomiting, diarrhea); TB screening prior to therapy initiation; EBV serostatus verification prior to therapy initiation (only use belatacept in seropositive patients); potassium, magnesium; signs/symptoms of solid organ transplant rejection.

Mechanism of Action

Fusion protein which acts as a selective T-cell (lymphocyte) costimulation blocker by binding to CD80 and CD86 receptors on antigen presenting cells (APC), blocking the required CD28 mediated interaction between APCs and T cells needed to activate T lymphocytes. T-cell stimulation results in cytokine production and proliferation, mediators in immunologic rejection associated with kidney transplantation.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vss: 0.11 L/kg (kidney transplant recipients)

Half-life elimination: ~10 days (healthy patients and kidney transplant recipients)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body weight: Higher clearance of belatacept may be seen with increasing body weight.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Nulojix;
  • (AT) Austria: Nulojix;
  • (CH) Switzerland: Nulojix;
  • (CO) Colombia: Nulojix;
  • (CZ) Czech Republic: Nulojix;
  • (DE) Germany: Nulojix;
  • (ES) Spain: Nulojix;
  • (FI) Finland: Nulojix;
  • (FR) France: Nulojix;
  • (GB) United Kingdom: Nulojix;
  • (GR) Greece: Nulojix;
  • (HU) Hungary: Nulojix;
  • (IE) Ireland: Nulojix;
  • (IT) Italy: Nulojix;
  • (LV) Latvia: Nulojix;
  • (MX) Mexico: Nulohjix;
  • (NL) Netherlands: Nulojix;
  • (NO) Norway: Nulojix;
  • (PL) Poland: Nulojix;
  • (PR) Puerto Rico: Nulojix;
  • (PT) Portugal: Nulojix;
  • (RO) Romania: Nulojix;
  • (RU) Russian Federation: Nulojix;
  • (SA) Saudi Arabia: Nulojix;
  • (SE) Sweden: Nulojix;
  • (SI) Slovenia: Nulojix
  1. Bozon A, Jeantet G, Rivière B, et al. Stricturing Crohn's disease-like colitis in a patient treated with belatacept. World J Gastroenterol. 2017;23(48):8660-8665. doi:10.3748/wjg.v23.i48.8660 [PubMed 29358873]
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  9. Iasella CJ, Winstead RJ, Moore CA, et al. Maintenance belatacept-based immunosuppression in lung transplantation recipients who failed calcineurin inhibitors. Transplantation. 2018;102(1):171-177. doi:10.1097/TP.0000000000001873 [PubMed 28691954]
  10. Kaufman DB, Woodle ES, Shields AR, et al; BEST Study Group. Belatacept for simultaneous calcineurin inhibitor and chronic corticosteroid immunosuppression avoidance: two-year results of a prospective, randomized multicenter trial. Clin J Am Soc Nephrol. 2021;16(9):1387-1397. doi:10.2215/CJN.13100820 [PubMed 34233921]
  11. Kinariwalla N, Tarazi M, Lewin JM, Husain S, Husain SA, Gallitano SM. A case of belatacept-induced chilblain lupus. JAAD Case Rep. 2022;21:112-115. doi:10.1016/j.jdcr.2022.01.007 [PubMed 35198715]
  12. Klintmalm GB, Gunby RT Jr. Successful pregnancy in a liver transplant recipient on belatacept. Liver Transpl. 2020;26(9):1193-1194. doi:10.1002/lt.25785 [PubMed 32337853]
  13. Lanfranco L, Olle Delahaye P, Dorr G, Del Bello A, Kamar N. Late isolated ocular toxoplasmosis in a belatacept-treated kidney transplant patient. Transpl Int. 2016;29(12):1352-1353. doi:10.1111/tri.12853 [PubMed 27614031]
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  16. Nulojix (belatacept) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; July 2021.
  17. Rostaing L, Massari P, Garcia VD, et al. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011;6(2):430-439. doi:10.2215/CJN.05840710 [PubMed 21051752]
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  20. Ville S, Cantarovich D. Belatacept and autoimmune adverse events. Transplantation. 2018;102(7):e355-e356. doi:10.1097/TP.0000000000002247 [PubMed 29672443]
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  22. Woodle ES, Kaufman DB, Shields AR, et al; BEST Study Group. Belatacept-based immunosuppression with simultaneous calcineurin inhibitor avoidance and early corticosteroid withdrawal: a prospective, randomized multicenter trial. Am J Transplant. 2020;20(4):1039-1055. doi:10.1111/ajt.15688 [PubMed 31680394]
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