美国FDA批准(tbo-filgrastim)注射剂对严重中性粒细胞减少在某些癌症患者治疗 为治疗：伴化疗中性粒细胞减少 2012年8月29日美国食品药品监督管理局(FDA)批准Sicor Biotech公司的tbo-filgrastim减少有些患者接受癌症化疗经受严重中性粒细胞减少，与感染斗争的白细胞被称为嗜中性粒细胞减低的时间。 Tbo-filgrastim是意向为成年有癌症，除血液或骨髓癌症(非骨髓恶性病)和正在使用化疗药物引起骨髓中嗜中性粒细胞生成实质上减低。这种嗜中性减低可导致感染和发热(发热性中性粒细胞减少)。 Tbo-filgrastim刺激骨髓生成嗜中性粒细胞。在化疗治疗开始后24小时注射。 FDA的药物评价和研究中心血液学和肿瘤室主任Richard Pazdur，M.D说：“支持性医疗产品，例如tbo-filgrastim，减低或允许从癌症治疗副作用更迅速回复”。 在一项348例成年晚期乳癌患者接受抗癌药物阿霉素和多西他奇治疗临床研究中评价Tbo-filgrastim。患者被随机赋予接受tbo-filgrastim，一种安慰剂，或非美国批准的非格司亭[filgrastim]产品，一种药物也刺激骨髓生成嗜中性粒细胞。The effectiveness of tbo-filgrastim的有效性是根据研究结果确定证明接受 tbo-filgrastim患者从严重中性粒细胞减少恢复比接受安慰剂3.8天减少1.1天。 在三项临床研究包括680例乳癌，肺癌，或非何杰金氏淋巴瘤成年接受高剂量化疗减低骨髓细胞(清骨髓化疗)中评价Tbo-filgrastim的安全性。接受tbo-filgrastim患者最常观察到副作用是骨痛。 批准日期： 2012年8月29日；公司：Sicor Biotech tbo-filgrastim注射剂为皮下使用 美国初次批准：2012 适应证和用途 Tbo-filgrastim是一种白细胞生长因子适用于在非-骨髓恶性病患者接受骨髓抑制抗癌药伴有临床意义发热性中性粒细胞减少的发生率，减少严重中性粒细胞减少时间。(1) 剂量和给药方法 1）剂量 推荐剂量的tbo-filgrastim是5 μg/kg每天皮下注射给药。给予首次剂量tbo-filgrastim不早于骨髓抑制化疗后24小时。化疗前24小时内不要给予tbo-filgrastim[见警告和注意事项(5)]。 每天给于tbo-filgrastim应继续直至预期的中性粒细胞最低点已过去和嗜中性计数已回复至正常范围。化疗前和每周2次监视完全血细胞计数(CBC)直至恢复。 2）为给药的一般考虑 应由医疗专业人员给予Tbo-filgrastim。 给药前肉眼观察非肠道药物产品有无科罗物质和变色。如观察到变色或颗粒物不要给予tbo-filgrastim。 预装注射器只为单次使用。遗弃未使用部分。 为皮下tbo-filgrastim注射推荐部位包括腹部(除脐周围2英寸)，大腿中前部，臀部上外区，或上臂上背部。应每天变换注射部位。Tbo-filgrastim不应注入容易疼痛，红，瘀伤，或应或瘢痕或妊娠纹区域。 3 ）为使用安全性针防护装置的指导 从装置的开口侧抓住注射器组装和取下针屏蔽。 推注射器活塞针芯至顶端注射全部药物。注射整个预装注射器需要激活针头保护装置。 剂型和规格 （1）300 μg/0.5 mL在单次使用预装注射器 （2）480 μg/0.8 mL在单次使用预装注射器(3) 禁忌证 无。 警告和注意事项 （1）脾破裂：如怀疑终止tbo-filgrastim (5.1) （2）急性呼吸窘迫综合征(ARDS)监视和立即处理。如怀疑终止tbo-filgrastim (5.2) • （3）过敏反应(血管神经性水肿，过敏性皮炎，药物超敏性，超敏性，皮疹，瘙痒皮疹和荨麻疹) (5. 3) • （4）镰状细胞危象：可能发生严重和有时致命性危象。如怀疑终止tbo-filgrastim。(5.4) 不良反应 （1）对tbo-filgrastim最常见不良反应是骨痛。(6) 为报告怀疑不良反应，连续TEVA电话1-866-832-8537或FDA电话1-800-FDA-1088或www.fda.gov/medwatch. 特殊人群中使用 （1） 在妊娠期间只有如果潜在获益升高对胎儿潜在风险，才应使用Tbo-filgrastim (8.1) • （2）不知道tbo-filgrastim是否排泄在人乳汁中。(8.3) • （3）尚未在18岁以下患者中确定tbo-filgrastim 的安全性和有效性。(8.4) Tbo-filgrastim Side Effects Serious Tbo-filgrastim side effects, including: •Spleen rupture, which can cause death. Call your doctor right away if you have pain in your left upper stomach area or left shoulder area while taking tbo-filgrastim. This pain could mean your spleen is enlarged or ruptured. •A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Get medical help right away if you have any of these symptoms of Acute Respiratory Distress Syndrome (ARDS): •fever •shortness of breath •trouble breathing •Serious Allergic Reactions. If you have a serious allergic reaction during a tbo-filgrastim injection, your doctor will treat your allergic reaction and stop giving you the injections. Tell your doctor right away if you have any of these symptoms during or after your injection: •a rash over the whole body •shortness of breath •trouble breathing (wheezing) •dizziness •swelling around the mouth or eyes •fast heart rate •sweating •Severe Sickle Cell Crisis in people with a sickle cell disease. If you have sickle cell disease, talk to your doctor about the risks of taking tbo-filgrastim. Tbo-filgrastim Directions: Tbo-filgrastim is a prescription medicine: •used in people with certain types of cancer (non-myeloid malignancies), who are receiving chemotherapy that affects the bone marrow •given to help decrease the length of time that the number of certain white blood cells (neutrophils) are very low (severe neutropenia). Neutrophils are white blood cells that are important in fighting bacterial infections It is not known if tbo-filgrastim is safe and effective in children under 18 years of age. ------------------------------------------------------ The U.S. Food and Drug and Administration has approved tbo-filgrastim for the treatment of chemotherapy induced neutropenia in cancer patients. Neutrophils. are the white blood cells of the body that play important role in immunity. The reduce level of neutrophils is termed as neutropenia. Different types of infections and fevercan results due to reduced level of neutrophils such as ebrile neutropenia. Tbo-filgrastim normalize the level of neutrophils be increasing their production from bone marrow.  Its injection is usually given to those patients undergoing chemotherapy within 24 hours. “Supportive care products, such as tbo-filgrastim, reduce or allow for more rapid recovery from side effects of cancer treatments,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. The safety and efficacy of Tbo-filgrastim was determined by conducting trials in 348 adult patients suffering from advance type of breast cancer taking undergoing chemotherapy with doxorubicin and docetaxel. Patients were given either drug or placebo (non- US approved drug product that can also increase the level of neutrophils) randomly.  Those patients who receive Tbo-filgrastim recover from neutropenia within 1.1 days whereas those patients who tool placebo recover within 3.8 days. Tbo-filgrastim is manufactured by Sicor Biotech UAB, a member of Teva Corporation. the most common side effect of this drug is bone pain.