Names and pronunciation
(bel-a-ta′sept) Nulojix
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Drug reference
(bel-a-ta′sept) Nulojix
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Func. class.: Immunosuppressant
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Chem. class.: Fusion protein
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ACTION: Activated T-lymphocytes are the mediators of immunologic rejection. This product is a selective T-cell costimu- lation blocker; blocks the CD28 medi- ated costimulation of T lymphocytes by binding to CD80 and CD86 on antigen- presenting cells; inhibits T-lymphocyte proliferation and the production of the cytokines
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USES: Kidney transplant rejection prophylaxis given with basiliximab induc tion, mycophenolate mofetil, corticosteroids
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CONTRAINDICATIONS: Hyper- sensitivity, Epstein-Barr virus (EBV) sero- negative, EBV status unknown Precautions: Breastfeeding, child/infant/ neonate, pregnancy, diabetes mellitus, progressive multifocal leukoencephalopa- thy, immunosuppression, sunlight expo- sure, TB
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Black Box Warning: Infection, organ transplant, requires an experienced clinician and specialized care setting, secondary malignancy, posttransplant lymphoproliferation disorder (PLD), im- munosuppression Black Box Warning: Only providers skilled in the use of immunosuppressants and the management of transplants should use these products IV route • Visually inspect for particulate matter, discoloration; discard if present • Calculate the number of vials re- quired • Reconstitute each vial/10.5 mL of either sterile water for injection, 0.9% sodium chloride, D5W, using the silicone-free dis- posable syringe provided and an 18-21G needle; for additional silicone-free disposable syringes, call 888-685-6549; discard any solution prepared using siliconized syringes • Inject diluent into the vial and direct the stream to the glass wall; rotate and invert with gentle swirling; do not shake, when reconstituted (25 mg/mL), product 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 re- constituted 25 mg/mL solution required; further dilute with a volume of infusion fluid equal to the volume of the reconsti- tuted drug solution required; use either NS or D5W if drug was reconstituted with SWFI; use NS if drug was reconstituted with NS; use D5W if drug was reconstituted with D5W; with the same silicone-free disposable syringe; final concentrations 2-10 mg/mL; but total infusion volumes ranging from 50 to 250 mL may be used; discard any unused solution; after recon- stitution, immediately transfer the recon- stituted solution to the infusion bag or bottle; complete within 24 hr • 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 • Store refrigerated, protected from light ≤24 hr; max 4 hr of the total 24 hr can be at room temperature and room light Black Box Warning: Transplant rejec- tion: flulike 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; immunosuppression occurs Black Box Warning: Posttransplant lym- phoproliferation disorder: may lead to sec- ondary malignancy (lymphoma) or infectious mononucleosis–like lesions (mood change, confusion, memory loss, change in gait, talk- ing); treat with antivirals or immunosuppres- sant; product may need to be discontinued • PML: apathy, confusion, ataxia • Pregnancy/breastfeeding: use only if benefits outweigh risk to the fetus; preg- nant females should enroll in the National Transplant Pregnancy Registry by calling 877-955-6877; use adequate contraception during treatment and for 4 mo after last dose; discontinue breastfeeding or product; excretion in breast milk is unknown
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SIDE EFFECTS CV: Hypo/hypertension CNS: Progressive multifocal leukoen- cephalopathy (PML), headache, fever GI: Abdominal pain, constipation, diar- rhea, nausea, vomiting GU: Proteinuria HEMA: Anemia, neutropenia, leukopenia INTEG: Infusion reaction META: Hyperglycemia, hyper/hypokalemia SYST: Secondary malignancy, posttrans- plant lymphoproliferation disorder, wound dehiscence
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INTERACTIONS • Increase: effect, toxicity—mycophenolic acid B • Do not use 30 days before or with this product: live virus vaccines
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DOSAGE AND ROUTES • Adult: IV 10 mg/kg give over 30 min the day of transplantation (day 1) but before transplantation, on day 5 96 hr after the day 1 dose, 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 5 mg/kg rounded to the nearest 12.5- mg increment; give over 30 min at the end of wk 16 and q4wk ± 3 days there- after
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Available forms: Powder for injection 250 mg
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Administer:
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Assess:
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Evaluate: • Therapeutic response: absence of re- nal transplant rejection
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Reason for product and expected re- sult; use REMS guidelines • To avoid exposure to sunlight, tanning beds; risk of secondary malignancy, in- cluding skin cancer • To avoid crowds, persons with known infections • That repeated lab test will be needed • To avoid with vaccines; to inform pro- viders of all OTC, prescription medica- tions, herbs, supplements • That immunosuppressants will be needed for life to prevent rejection; to call provider immediately if symptoms of rejection/infection arise
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PHARMACOKINETICS Half-life, 6.1-15.1 days steady state by wk 8 after transplantation and by mo 6 during maintenance phase, peak infusion end
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• Adult: IV 10 mg/kg give over 30 min the day of transplantation (day 1) but before transplantation, on day 5 96 hr after the day 1 dose, 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 5 mg/kg rounded to the nearest 12.5- mg increment; give over 30 min at the end of wk 16 and q4wk ± 3 days there- after
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