新型肾移植药Nulojix（belatacept）注射剂获美国食品和药物管理局（FDA）批准用于肾移植成人患者以预防急性排斥反应 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（贝拉西普 诺其 belatacept）用于注射，供静脉内使用 美国首次批准：2011 警告： 移植后淋巴增殖性疾病，其他恶性肿瘤，严肃INFECTIONSSee完整处方资料完整的黑框警告。 •风险增加显影移植后淋巴增殖性疾病（PTLD），主要是涉及中枢神经系统（CNS）。收件人没有免疫力Epstein-Barr病毒（EBV）是在一个特别的风险增加;因此，在使用仅EB病毒阳性患者。不要在移植受者谁是EBV阴性或未知的血清状况使用NULOJIX。 •只有医生经历了免疫抑制治疗，肾移植患者的管理应该开NULOJIX。 •增加对感染的易感性和恶性肿瘤的可能发展可能导致免疫抑制。 •使用在肝移植患者，不推荐由于接枝损失和死亡的风险增加。 适应症和用法 •NULOJIX是器官排斥反应的成人患者接受预防肾移植表明选择性T细胞共刺激阻断剂。 •使用结合巴利昔单抗诱导，霉酚酸酯和糖皮质激素。 使用限制： •只有在病人谁是EB病毒血清阳性使用。 •使用尚未建立用于器官排斥在移植器官比肾脏以外的预防。 用法用量 •使用比推荐的或更频繁的给药更高不会由于严重的感染和恶性肿瘤的风险增加推荐。 •有关完整的剂量说明，请参阅完整的处方信息。 NULOJIX的剂量对肾移植受者剂量的初始阶段 剂量 1日（移植当天，植入前）和第5天（后第1天剂量的约96小时）  每公斤10毫克 第2周和第4周结束移植后   每公斤10毫克 第8周和第12周移植后结束  每公斤10毫克 配料为维护阶段 剂量 第16周的移植后端和每4周（加或减3天）之后 5毫克每千克 •静脉滴注只;管理在30分钟内。 •仅使用随附的硅免费提供一次性注射器的管理做准备。 剂型和规格 •冻干粉针剂：每瓶250毫克 禁忌 •谁是病人EBV阴性或未知的EB病毒血清状况。 警告和注意事项 •移植后淋巴障碍（PTLD）：增加的风险，主要是涉及中枢神经系统;监视新的或恶化的神经，认知，行为或症状和体征。（黑框警告） •其他恶性肿瘤：风险与所有免疫抑制剂增加;似乎与强度和使用时间。避免长时间暴露在紫外线和阳光。 •进行性多灶性白质脑病（PML）的风险增加;考虑患者报告新的或恶化的神经，认知，或行为症状和体征诊断。推荐剂量的免疫抑制剂不应该被超过。 •其他严重感染：细菌，病毒，真菌的风险增加，和原虫感染，包括机会性感染和肺结核。有些感染是致命的。多瘤病毒相关性肾病可导致肾移植失败;考虑减少免疫抑制。评估结核病，并开始治疗潜伏感染NULOJIX使用前。巨细胞病毒和肺预防被移植术后建议。 •肝移植：不推荐使用。 •急性排斥反应和移植物失用皮质类固醇最小化：糖皮质激素的利用应与NULOJIX临床试验的经验相一致。 •预防接种：治疗期间避免使用活疫苗。 不良反应 最常见的不良反应（上NULOJIX处理≥20％）是贫血，腹泻，尿路感染，血管神经性水肿，便秘，高血压，发热，移植肾功能异常，咳嗽，恶心，呕吐，头痛，低钾血症，高钾血症，和白细胞减少。 特殊人群中使用 •妊娠：根据动物实验数据，可能会对胎儿造成伤害;妊娠登记使用。 •哺乳母亲：请停止药物或哺乳，考虑到药物对母亲考虑的重要性。 包装规格 美国包装 NULOJIX KIT FOR INJ 250MG SDV 1/EA  BELATACEPT     00003-0371-13  NULOJIX VIAL 250MG+SYR 1  BELATACEPT     00003-0371-13 欧洲包装 250mgx1套 NULOJIX® (belatacept) is approved for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. Use NULOJIX only in patients who are Epstein-Barr virus (EBV) seropositive. Use of NULOJIX for prophylaxis of organ rejection in transplanted organs other than kidney has not been established. Selected Important Safety Information: NULOJIX is associated with increased risk for post-transplant lymphoproliferative disorder (PTLD), predominantly in the central nervous system (CNS). NULOJIX is contraindicated in patients who are EBV seronegative or with unknown serostatus because the risk of PTLD is particularly increased in patients who are EBV seronegative. NULOJIX is to be used only in patients who are EBV seropositive. Patients should be monitored for new or worsening neurological, cognitive, or behavioral signs and symptoms. Higher than recommended doses or more frequent dosing of NULOJIX and concomitant immunosuppressives is not recommended. Immunosuppression may result in increased susceptibility to infection and development of malignancies. NULOJIX should be prescribed only by physicians experienced in immunosuppressive therapy and management of kidney transplant patients. Use in liver transplant patients is not recommended due to an increased risk of graft loss and death. Continue to read Important Safety Information >> Dosage Formulation and Strength: 250 mg lyophilized powder for injection, for intravenous use. IMPORTANT SAFETY INFORMATION Post-Transplant Lymphoproliferative Disorder (PTLD) NULOJIX patients are at increased risk for developing PTLD, predominantly involving the central nervous system (CNS) Recipients without immunity to EBV (ie, seronegative) are at particularly increased risk; therefore, NULOJIX is contraindicated in transplant recipients who are EBV seronegative or unknown serostatus Monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms As the total burden of immunosuppression is a risk factor for PTLD, higher than recommended doses or more frequent dosing of NULOJIX or concomitant immunosuppressive agents are not recommended Other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell-depleting therapy CMV prophylaxis is recommended for at least 3 months after transplantation Use T-cell-depleting therapy to treat acute rejection cautiously Patients who are EBV seropositive and CMV seronegative may be at increased risk of PTLD Since CMV seronegative patients are at increased risk for CMV disease (a known risk factor for PTLD), the clinical significance of CMV serology for PTLD remains to be determined; however, these findings should be considered when prescribing NULOJIX Management of Immunosuppression Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX Patients should be managed in facilities with adequate laboratory and supportive medical resources  The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient Progressive Multifocal Leukoencephalopathy (PML) NULOJIX® (belatacept) patients are at increased risk for PML, often a rapidly progressive and fatal opportunistic infection In clinical trials, two cases were reported in patients receiving NULOJIX at higher cumulative doses and more frequently than the recommended regimen, along with MMF and corticosteroids; one occurred in a kidney transplant recipient and one occurred in a liver transplant recipient As PML has been associated with high levels of immunosuppression, higher than recommended doses or more frequent dosing of NULOJIX and concomitant immunosuppressive agents, including MMF, are not recommended Monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms PML is usually diagnosed by brain imaging, cerebrospinal fluid testing for JC viral DNA by polymerase chain reaction, and/or brain biopsy Consultation with a specialist should be considered If PML is diagnosed, consider reduction or withdrawal of immunosuppression, weighing risk to the graft Other Malignancies and Serious Infections Increased susceptibility to infection and possible development of malignancies may result from immunosuppression Patients should avoid prolonged exposure to ultraviolet light and sunlight Patients receiving immunosuppressants, including NULOJIX, are at increased risk for bacterial, viral, fungal, and protozoal infections, including opportunistic infections and tuberculosis.  Some infections were fatal Polyoma virus-associated nephropathy can lead to deteriorating renal function and graft loss; consider reduction in immunosuppression, weighing risk to the graft Tuberculosis was more frequently observed in patients receiving NULOJIX. Evaluate for tuberculosis and initiate treatment for latent infection prior to NULOJIX use CMV and Pneumocystis jiroveci prophylaxis is recommended after transplantation Liver Transplant: use in liver transplant patients is not recommended due to increased risk of graft loss and death in a clinical trial with more frequent administration of NULOJIX than studied in kidney transplant, along with MMF and corticosteroids Immunizations: avoid use of live vaccines during NULOJIX treatment Pregnancy Category C: based on animal data, NULOJIX may cause fetal harm. NULOJIX should not be used in pregnancy unless potential benefit to the mother outweighs potential risk to the fetus. To monitor maternal-fetal outcomes of pregnant women who have received NULOJIX, or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the National Transplant Pregnancy Registry (NTPR) by calling 1-877-955-6877 Nursing Mothers: discontinue NULOJIX® (belatacept) or nursing, considering importance of NULOJIX to the mother Most Common Adverse Reactions (≥20%): anemia (45%), diarrhea (39%), urinary tract infection (37%), peripheral edema (34%), constipation (33%), hypertension (32%), pyrexia (28%), graft dysfunction (25%), cough (24%), nausea (24%), vomiting (22%), headache (21%), hypokalemia (21%), hyperkalemia (20%), and leukopenia (20%) http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c16ac648-d5d2-9f7d-8637-e2328572754e