belatacept (Rx)
Generic: Belatacept
Brand: Nulojix
(bel- a- ta'sept)
Pharmacological Action
Activated T lymphocytes are the mediators of immunologic rejection, and this product is a selective T- cell costimulation blocker; blocks the CD28 mediated costimulation of T lymphocytes by binding to CD80 and CD86 on antigen- presenting cells; inhibits T lymphocyte proliferation and the production of the cytokines interleukin- 2, interferon- gamma, interleukin- 4, and TNF- alpha.
Therapeutic outcome: Absence of kidney transplant rejection
Uses
Kidney transplant rejection prophylaxis given with basiliximab induction, mycophenolate mofetil, corticosteroids
Contraindications
Hypersensitivity
BLACK BOX WARNING: Infection, organ transplant, requires an experienced clinician, secondary malignancy, post- transplant lymphoproliferation disorder (PTLD)
Precautions: Breastfeeding, child/infant/neonate, pregnancy C, diabetes mellitus, progressive multifocal leukoencephalopathy, immunosuppression, sunlight exposure, TB
Dosage & Routes
Adult: IV 10 mg/kg rounded to nearest 12.5 mg increment give over 30 min the day of transplantation (day 1) but before transplantation, on day 5 approximately 96 hours after the day 1 dose 1, at the end of wk 2, at the end of wk 4, at the end of wk 8, and at the end of wk 12; maintenance dosage is 5 mg/kg rounded to nearest 12.5 mg increment given over 30 min at the end of wk 16 and q4 wk ± 3 days thereafter; doses should be calculated on actual body weight on the transplantation day unless the patient's weight varies by >10%
Available forms: Powder for inj 250 mg
Implementation
BLACK BOX WARNING: Only providers skilled in the use of immunosuppressant and management of transplant should use these products
IV route: Visually inspect products for particulate matter, discoloration whenever solution/container permit, discard if present Calculate the number of drug vials required to provide total infusion dose Reconstitute each vial/10.5 ml of sterile water for injection, 0.9% sodium chloride, D5 W using the silicone- free disposable syringe provided with each vial and an 18 G to 21 G needle. If silicone- free disposable syringe is dropped or becomes contaminated, use a new silicone- free disposable syringe from inventory. If you need additional silicone- free disposable syringes, call 1- 888- 685- 6549. If the powder is accidentally reconstituted using a different syringe than the one provided, the solution may develop a few translucent particles. Discard any solutions prepared using siliconized syringes. Using aseptic technique, inject the diluent into the vial and direct the stream of diluent to the glass wall of the vial. To minimize foaming, rotate the vial and invert with gentle swirling until the contents are dissolved. Do not shake when reconstituted (25 mg/ml), should be clear to slightly opalescent and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present. Calculate the total volume of the reconstituted 25 mg/ml sol required to provide the total inf dose. Further dilute this volume with a volume of inf fluid equal to the volume of the reconstituted drug sol required to provide the prescribed dose. Use either NS or D5 W if drug was reconstituted with SWFI; use NS if drug was reconstituted with NS; use D5 W if drug was reconstituted with D5 W. With the same silicone- free disposable syringe used for reconstitution, withdraw the required amount of belatacept sol from the vial, inject it into the inf container, gently rotate the inf container to ensure mixing; final concentration in inf container should range (2 - 10 mg/ml). Volume of 100 ml will be appropriate for most patients and doses, but total inf volumes ranging from 50- 250 ml may be used. Discard any unused drug solution remaining in the vials; after reconstitution, immediately transfer the reconstituted sol from the vial to the inf bag or bottle; complete within 24 hr. IV INF route: Give over 30 min, use an infusion set and a sterile, nonpyrogenic low- protein- binding filter (0.2- 1.2 mm), use a separate line
Storage: refrigerate, protect from light ≤ 24 hr; max 4 hr of the total 24 hr can be at room temp and room light
Adverse Effects
CNS: Guillain- Barré syndrome, anxiety, dizziness, fever, insomnia, tremor
EENT: Pharyngitis, stomatitis
GI: Abdominal pain, constipation, diarrhea, nausea, vomiting
GU: Renal tubular necrosis, renal failure, proteinuria, urinary incontinence
HEMA: Anemia, neutropenia, leukopenia, leukoencephalopathy
INTEG: Acne, alopecia
META: Hypercholesterolemia, hyperglycemia, hyper/hypokalemia, hypocalcemia, hypophosphatemia, hypomagnesemia
MS: Arthralgia
SYST: Secondary malignancy, post- transplant lymphoproliferation disorder (PTLD), wound dehiscence, BK- virus associated neuropathy
Pharmacokinetics
Absorption: Unknown
Distribution: Steady-state by week 8 after transplantation and by month 6 during the maintenance phase
Metabolism: Unknown
Excretion: Unknown
Half-life: Half life range 6.1-15.1 days during receipt of 10 mg/kg IV doses; 3.1-11.9 days during receipt of 5 mg/kg IV doses
Pharmacodynamics
Unknown
Interactions
Individual drugs Basiliximab induction, mycophenolate mofetil: increased effect
Drug classifications
Corticosteroids: increased belatacept effect
Vaccines: avoid concurrent use
Immunosuppressives: avoid increased dose
Nursing Considerations
Assessment
BLACK BOX WARNING: Transplant rejection: flu- like symptoms, decreasing urinary output, malaise; some may experience pain in area (rare; monitor BUN/Creatinine)
BLACK BOX WARNING:
Infection: Monitor for fever, chills, increased WBC, wound dehiscences
BLACK BOX WARNING: Post- transplant lymphoproliferation disorder (PTLD): May lead to secondary malignancy (lymphoma) or infectious mononucleosis- like lesions; may be treated with antivirals or immunosuppressant may need to be discontinued
Hyperlipidemia: Monitor cholesterol, triglycerides; an antidiplemic may be needed Store refrigerated, protected from light ≤ 24 hr; max 4 hr of the total 24 hr can be at room temperature and room light
Evaluation
Positive therapeutic outcome: Absence of renal transplant rejection
Patient/family education - Teach reason for product and expected result - Teach to avoid exposure to sunlight, tanning beds, risk of secondary malignancy - Teach to avoid crowds, persons with known infections - Advise that repeated lab test will be needed - Advise to avoid with vaccines - Advise that immunosuppressants will be needed for life to prevent rejection; teach symptoms of rejection and to call provider immediately
Reference
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