belatacept

(redirected from Nulojix)

belatacept

(be-lat-a-sept) ,

Nulojix

(trade name)

Classification

Therapeutic: immunosuppressants
Pharmacologic: fusion proteins
Pregnancy Category: C

Indications

Prevention of organ rejection following kidney transplant in adult patients; in combination with basiliximab induction, mycophenolate and corticosteroids.

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 anti-donor antibodies following kidney transplantation.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 9.8 days.

Time/action profile

ROUTEONSETPEAKDURATION
IVunknownend of infusionup to 4 wk

Contraindications/Precautions

Contraindicated in: Ebstein-Barr virus (EBV) seronegativity or unknown EBV serostatus;Liver transplantation; Lactation: Avoid breast feeding.
Use Cautiously in: Cytomegalovirus (CMV) infection/T-cell depleting therapy (↑ risk of post-transplant lymphoproliferative disorder [PTLD]), CMV prophylaxis recommended for 3 mos 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 (PVAN), ↓ immunosuppression may be necessary; Obstetric: Use only if potential benefit to mother outweighs potential risk to fetus; Pediatric: Safety and effectiveness not established.

Adverse Reactions/Side Effects

Central nervous system

  • Progressive multifocal leukoencephalopathy (PML) (life-threatening)
  • headache (most frequent)

Respiratory

  • cough (most frequent)

Cardiovascular

  • hypertension (most frequent)
  • peripheral edema (most frequent)

Gastrointestinal

  • constipation (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)

Genitourinary

  • proteinuria

Endocrinologic

  • new-onset diabetes mellitus

Fluid and Electrolyte

  • hyperkalemia (most frequent)
  • hypokalemia (most frequent)

Hematologic

  • anemia (most frequent)
  • leukopenia (most frequent)

Miscellaneous

  • post-transplant lymphoproliferative disorder (PTLD) (life-threatening)
  • ↑ risk of malignancy (life-threatening)
  • serious infections (life-threatening)
  • fever (most frequent)
  • graft dysfunction (most frequent)

Interactions

Drug-Drug interaction

May potentially alter the effects of drugs metabolized by the CYP 450 enzyme system.May ↓ antibody response to and ↑ risk of adverse reactions from live virus vaccines; avoid use during treatment.May ↑ blood levels, effects and toxicity of mycophenolic acid.

Route/Dosage

Prescribed dose must be evenly divisible by 12.5 to ensure accurate preparation
Intravenous (Adults) Initial phase—10 mg/kg on day of transplant/prior to implantation, day 5 (96 hr after day 1 dose), end of week 2, 4, 8 and 12 post transplantation; maintenance phase—10 mg/kg end of week 16 and every four weeks (±3 days) thereafter.

Availability

Lyophilized powder for injection (requires reconstitution): 250 mg/vial

Nursing implications

Nursing assessment

  • Assess for symptoms of organ rejection throughout therapy.
  • Assess for signs of progressive multifocal leukoencephalopathy (hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia) periodically during therapy.
  • Monitor for signs and symptoms of infection (fever, dyspnea) periodically during therapy.
  • Assess for signs and symptoms of post-transplant lymphoproliferative disorder (changes in mood or usual behavior, confusion, problems thinking, loss of memory, changes in walking or talking, decreased strength or weakness on one side of the body, changes in vision) during and for at least 36 mo post-transplant.
  • Monitor for infusion reactions (hypotension, hypertension) during therapy.
  • Lab Test Considerations: May cause hyperkalemia, hypokalemia, hypophosphatemia, hyperglycemia, hypocalcemia, hypercholesterolemia, hypomagnesemia, and hyperuricemia.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)

Implementation

  • Pre-medication is not required.
  • Cortisone doses should be consistent with clinical trials experience. Cortisone doses were tapered to between 10–20 mg/day by first 6 wks after transplant, then remained at 10 mg (5–10 mg) per day for first 6 months after transplant.
  • Treat patient for latent tuberculosis prior to therapy.
  • Prophylaxis for Pneumocystis jiroveci is recommended after transplant.
  • Intermittent Infusion: Calculate number if vials required for total infusion dose. Reconstitute contents of each vial with 10.5 mL of 0.9% NaCl or D5W using the silicone-free disposable syringe provided and an 18–21 gauge needle for a concentration of 25 mg/mL. Direct stream of diluent to wall of vial. Rotate and invert vial gently; do not shake to avoid foaming. Solution is clear to slightly opalescent and colorless to pale yellow; do not use of opaque particles, discoloration, or other particles are present. Calculate total volume needed for infusion dose. Diluent: Dilute further with 0.9% NaCl or D5W if reconstituted with sterile water for injection, 0.9% NaCl if reconstituted with 0.9% NaCl, or with D5W if reconstituted with D5W.Concentration: 2 mg/mL. Withdraw amount of diluent from infusion container equal to volume of infusion dose. Using same silicone-free disposable syringe used for reconstitution, withdraw required amount of belatacept solution from vial, inject into infusion container, and rotate gently to mix. Typical infusion volume is 100 mL, but may range from 50–250 mL. Transfer from vial to infusion container immediately; infusion must be completed within 24 hr of reconstitution. May be refrigerated and protected from light for 24 hr. Do not administer solutions that are discolored or contain particulate matter. Discard unused solution in vials.
  • Rate: Infuse over 30 min using a non-pyrogenic, low-protein-binding filter with 0.2–1.2 micron pore size.
  • Y-Site Incompatibility: Do not mix or infuse in same line with other agents.

Patient/Family Teaching

  • 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, post-transplant lymphoproliferative disorder or progressive multifocal leukoencephalopathy occur.
  • Advise patients to avoid live vaccines during therapy.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding. Encourage patients who become pregnant or whose partners have received belatacept to register with the National Transplant Pregnancy Registry (NTPR) by calling 1-877-955-6877.
  • Emphasize the importance of routine follow-up laboratory tests.

Evaluation/Desired Outcomes

  • Prevention of rejection of transplanted kidneys.
References in periodicals archive ?
There she led late-stage clinical development and supported regulatory filings for Orencia and Nulojix.
In last year's report, we mentioned the approval of melanoma treatment Yervoy and pending applications for Nulojix.
Bristol-Myers Squibb Company (NYSE:BMY) announced yesterday that the US Food and Drug Administration (FDA) has approved NULOJIX in combination with basiliximab induction, mycophenolate mofetil (MMF) and corticosteroids.
The company said that NuLOJIX is the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Bristol-Myers Squibb, Princeton, NJ, announced it has received approval from the US Food and Drug Administration (FDA) for Nulojix (belatacept) for preventing rejection in adult patients who have had a kidney transplant.
Nulojix is a type of drug called a selective T-cell costimulation blocker.
BMS is hoping to hear soon from the FDA regarding the Nulojix, a
compounds--Yervoy, Eliquis, Nulojix, dapagliflozin (diabetes treatment,
Bristol-Myers Squibb Company (NYSE:BMY) reported on Wednesday the receipt of approval from the US Food & Drug Administration (FDA) for NULOJIX (belatacept) for the prevention of graft rejection after kidney transplants.
In June, at the annual meeting of the American Transplant Congress in Boston, the Company presented new four-year results from the long-term extensions of the BENEFIT and BENEFIT-EXT trials for Nulojix which showed a consistent safety profile through year four compared with year three, and renal function benefit versus cyclosporine that was maintained through four years in patients enrolled in the long-term extension from both trials.
In September, at the European Society for Organ Transplantation (ESOT) meeting in Glasgow, Scotland, the Company presented new data on NULOJIX([R]) , including donor sub-type analysis of three-year outcomes from a Phase III study of NULOJIX in recipients with extended criteria donor kidneys (BENEFIT-EXT Trial), and three-year outcomes in kidney transplant recipients with pre-transplant diabetes from two Phase III studies.
received a positive advisory opinion from European regulatory authorities for both ELIQUIS and NULOJIX, and presented promising data on our investigational hepatitis C portfolio at the annual meeting of the European Association for the Study of the Liver," Andreotti said.