Organ rejection prophylaxis:
Indications for: NULOJIX
Organ rejection prophylaxis in patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
Limitations of Use:
Use only in patients who are EBV seropositive. Not established for prophylaxis of organ rejection in transplanted organs other than kidney.
Adult Dosage:
See full labeling. Administering higher than the recommended doses or more frequent dosing: not recommended. Base total infusion dose on patient's body wt. at the time of transplantation. The prescribed dose must be evenly divisible by 12.5mg for accurate reconstitution. Give as IV infusion over 30mins. Initial phase (Day 1 [day of transplantation, prior to implantation]; Day 5 [approx. 96hrs after Day 1 dose]; end of Weeks 2, 4, 8, 12 after transplantation): 10mg/kg. Maintenance phase (end of Week 16 after transplantation and every 4 weeks±3 days) thereafter: 5mg/kg.
Children Dosage:
<18yrs: not established.
NULOJIX Contraindications:
Transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus.
Boxed Warning:
Post-transplant lymphoproliferative disorder. Other malignancies. Serious infections.
NULOJIX Warnings/Precautions:
Liver transplant patients: not recommended. Increased risk of post-transplant lymphoproliferative disorder (PTLD) or progressive multifocal leukoencephalopathy (PML); monitor for new or worsening neurological, cognitive, or behavioral signs/symptoms. Increased risk of other malignancies (eg, skin); limit sun and UV exposure. Increased risk of bacterial, viral (eg, CMV, herpes), fungal, protozoal, and opportunistic infections. Evaluate and treat latent TB infection prior to initiating therapy. Prophylaxis for CMV or pneumocystis after transplantation. Monitor for polyoma virus nephropathy (PVAN). Acute rejection and graft loss with corticosteroid minimization: utilization should be consistent with clinical trial experience (see full labeling). Increased risk of rejection with conversion from a CNI based maintenance regimen. Conversion to belatacept maintenance is not recommended unless CNI intolerant. Pregnancy. Nursing mothers.
NULOJIX Classification:
Selective T-cell costimulation blocker.
NULOJIX Interactions:
Concomitant live vaccines: not recommended. Concomitant mycophenolate mofetil: may possibly affect mycophenolic acid exposure after crossover to/from cyclosporine. Concomitant anti-thymocyte globulin (at the same or nearly the same time): risk for venous thrombosis of the renal allograft; separate doses by a 12hr interval.
Adverse Reactions:
Anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia, leukopenia.
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1
