FDA药品评价和研究中的抗微生物产品室主任Edward Cox, M.D., M.P.H,说“Nulojix为肾移植患者提供一种新选择，”“这个新药与其它免疫抑制剂联用有助于在接受肾移植患者中控制免疫系统和预防器官排斥.”
批准日期：2011年6月15日：公司：百时美施贵宝[Bristol-Myers Squibb]公司
NULOJIX(belatacept)为静脉注射使用
NULOJIX Rx
Generic Name and Formulations:
Belatacept 250mg/vial; lyophilized pwd for IV infusion after reconstitution.
Company:
Bristol-Myers Squibb
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. Use has not been established for prophylaxis of organ rejection in transplanted organs other than kidney.
Adult Dose for NULOJIX:
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 30 mins. Initial phase (Day 1 [day of transplantation, prior to implantation]; Day 5 [approx. 96 hours 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's Dose for NULOJIX:
<18yrs: not established.
Pharmacological Class:
Selective T-cell costimulation blocker.
Rems:
YES
Contraindications:
Transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus.
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 malignancies (including the 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). Pregnancy (Cat.C). Nursing mothers.
Interactions:
Concomitant live vaccines: not recommended. Potentially can alter CYP450 substrates. Concomitant mycophenolate mofetil: may possibly affect mycophenolic acid exposure after crossover to/from cyclosporine.
Adverse Reactions:
Anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia, leukopenia; PTLD (predominately CNS), PML, PVAN, other malignancies.
How Supplied:
Single-use vial—1