belatacept

Contraindicated in:

Epstein-Barr virus (EBV) seronegativity or unknown EBV serostatus;
Liver transplantation;
Lactation: Lactation.

Use Cautiously in:

Cytomegalovirus (CMV) infection/T-cell depleting therapy (↑ risk of post-transplant lymphoproliferative disorder [PTLD]), CMV prophylaxis recommended for 3 mo following transplant;
Change in body weight >10% (dose adjustment recommended);
Unknown tuberculosis status (latent infection should be treated prior to use);
Evidence of polyoma virus-associated nephropathy, ↓ immunosuppression may be necessary;
Patients being converted from a calcineurin inhibitor based maintenance regimen (↑ risk of rejection) (conversion is only recommended if patient is intolerant to calcineurin inhibitor);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, peripheral edema

Endo: diabetes mellitus

F and E: hyperkalemia, hypokalemia

GI: constipation, diarrhea, nausea, vomiting

GU: proteinuria

Hemat: anemia, leukopenia

Neuro: headache, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Resp: cough

Misc: fever, graft dysfunction, INFECTION, infusion reactions, MALIGNANCY, PTLD

Interactions ⬆ ⬇

Drug-drug:

May ↓ antibody response to and ↑ risk of adverse reactions from live virus vaccines; avoid use during treatment.
May ↑ levels and risk of toxicity of mycophenolate mofetil; ↓ dose of mycophenolate mofetil.
Concurrent use with antithymocyte globulin may ↑ risk of venous thrombosis of renal allograft; separate administration by 12 hr.

Availability ⬆ ⬇

Lyophilized powder for injection: 250 mg/vial

Route/Dosage ⬆ ⬇

Prescribed dose must be evenly divisible by 12.5 to ensure accurate preparation
IV (Adults ): Initial phase: 10 mg/kg on day of transplant/prior to implantation, day 5 (96 hr after day 1 dose), and at end of wk 2, 4, 8, and 12 following transplantation; Maintenance phase: 10 mg/kg at end of wk 16 and then every 4 wk (±3 days).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to CD80 and CD86 sites, thereby blocking T-cell costimulation; result is inhibition of T-lymphocyte proliferation and cytokine production.

Therapeutic effects:

Prolonged graft survival with decreased production of antidonor antibodies following kidney transplantation.

Classifications ⬆ ⬇

Therapeutic Classification: Immunosuppressant agents

Pharmacologic Classification: fusion proteins

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Not widely distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 9.8 days.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IV	unknown	end of infusion	up to 4 wk

Patient/Family Teaching ⬆ ⬇

Explain purpose of belatacept to patient.
Reinforce the need for lifelong therapy to prevent transplant rejection. Review symptoms of rejection for the transplanted organ, and stress need to notify health care professional immediately if signs of rejection or infection occur.
Advise patient to avoid contact with persons with contagious diseases.
Inform patient of the increased risk of skin cancer and other malignancies. Advise patient to use sunscreen with a high protection factor and wear protective clothing to decrease risk of skin cancer.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to notify health care professional immediately if signs or symptoms of infection, PTLD, or PML occur.
Advise patients to avoid live vaccines during therapy.
Rep: Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Encourage patients who become pregnant or whose partners have received belatacept to register with the Transplant Pregnancy Registry International by calling 1-877-955-6877.
Emphasize the importance of routine follow-up laboratory tests.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0003- E.R. Squibb and Sons, L.L.C.
- 0003-0371- NULOJIX
  - 0003-0371-13- 1 VIAL, SINGLE-USE in 1 CARTON (0003-0371-13) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

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Indications ⬇

Contraind./Precautions ⬆ ⬇