英文药名：Granix(Tbo-filgrastim Injection, for Subcutaneous) 中文药名：TBO-粒细胞集落刺激因子预充注射器 生产厂家：Cephalon公司 药品简介 GRANIXTM（TBO-粒细胞集落刺激因子）注射，皮下和静脉内使用 美国首次批准时间：2012年  生产厂家Cephalon公司： 适应症及用法 GRANIX（TBO-粒细胞集落刺激因子）是一个非髓性恶性肿瘤的患者接受骨髓抑制伴有发热性中性粒细胞减少症的发病率的临床意义抗癌药物的严重中性粒细胞减少的持续时间表示白细胞生长因子。 剂量与用法 推荐剂量：每天5微克/公斤皮下注射给药。 管理首次剂量不早超过24小时后骨髓抑制性化疗。前24小时内不要给予化疗。 剂型和规格 300 mcg/0.5毫升在单使用预充式注射器 480 mcg/0.8毫升一次性使用的预充式注射器。 禁忌 没有。 警告和注意事项 如果怀疑脾破裂：停止GRANIX 急性呼吸窘迫综合征（ ARDS ） ：监视，立即和管理。停止GRANIX如果怀疑。 过敏性反应（血管神经性水肿，过敏性皮炎，药物过敏，过敏，皮疹，瘙痒性皮疹和荨麻疹） 镰状细胞危象：严重的，有时甚至是致命的镰状细胞危机可能发生。停止GRANIX如果怀疑。 不良反应 最常见的不良反应到GRANIX是骨痛。 Granix(Tbo-filgrastim Injection, for Subcutaneous Use) Granix Injection gets FDA approval for self-administration U.S. Food and Drug Administration (FDA) has approved GRANIX (tbo-filgrastim) Injection for self-administration by patients and caregivers. GRANIX, a leukocyte growth factor, is indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. GRANIX has been commercially available in the U.S. since November 2013. The currently marketed GRANIX syringe is indicated only for administration by a healthcare professional. Teva plans to launch a new GRANIX syringe, for self-administration by patients and caregivers, in early 2015. "In partnership with their physician, patients will be able to decide whether administering GRANIX via self-injection at home or by a healthcare professional is the right course for them," said Lee S. Schwartzberg, MD, FACP, Division Chief of Hematology Oncology at the University of Tennessee Health Science Center. "Selecting a course of self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers." "This new administration option demonstrates Teva's continued commitment to enhancing the patient experience by providing patients, in partnership with their physician, with flexibility in their treatment regimen," said Paul Rittman, Vice President and General Manager, Teva Oncology. "We are proud to be adding to the value of this important product." About Granix® GRANIX® is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. The safety of GRANIX was evaluated in three Phase 3 clinical trials in patients receiving myelosuppressive chemotherapy for breast cancer, lung cancer, and non-Hodgkin lymphoma (NHL). The most common treatment-emergent adverse reaction (at least 1% or greater and two times more frequent than in the placebo group) that occurred in patients treated with GRANIX was bone pain. In a Phase 3 clinical study, GRANIX demonstrated a 71 percent reduction in the duration of severe neutropenia when compared to placebo. GRANIX significantly reduced the duration of severe neutropenia when compared to placebo (1.1 days vs. 3.8 days). The efficacy of GRANIX was evaluated in a multinational, multicenter, randomized, controlled Phase 3 study of chemotherapy-naïve patients with high-risk stage II, stage III, or stage IV breast cancer receiving a myelosuppressive regimen of doxorubicin (60 mg/m2 IV bolus) and docetaxel (75 mg/m2). Comparisons with placebo occurred in the first cycle. GRANIX Rx  Generic Name and Formulations: Tbo-filgrastim 300mcg/0.5mL, 480mcg/0.8mL; soln for SC inj; preservative-free. Company: Teva Pharmaceuticals Indications for GRANIX: To reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Adult Dose for GRANIX: Administer the 1st dose no earlier than 24hrs following myelosuppressive chemotherapy. Do not administer within 24hrs prior to chemotherapy. Inject 5mcg/kg SC once daily until expected neutrophil nadir is passed and neutrophil count has recovered to normal range. Monitor CBC prior to chemotherapy and twice per week until recovery. Recommended inj sites: the abdomen (except for the 2-inch area around navel), the front of the middle thighs, the upper outer area of the buttocks, or the upper back portion of the upper arms; rotate inj site daily. Avoid injecting into an area that is tender, red, bruised or hard, or that has scars or stretch marks. Children's Dose for GRANIX: <18yrs: not established. Pharmacological Class: Granulocyte colony stimulating factor. Warnings/Precautions: Risk of splenic rupture; discontinue and evaluate if symptoms of enlarged spleen or rupture occur. Evaluate for acute respiratory distress syndrome if fever and lung infiltrates or respiratory distress develop after treatment; discontinue if acute respiratory distress syndrome is diagnosed. Permanently discontinue if serious allergic reactions occur. Sickle cell disease: consider potential risks and benefits prior to treatment and discontinue if sickle cell crisis develops. Hepatic or moderate-to-severe renal impairment. Pregnancy (Cat. C). Nursing mothers. Interactions: Caution with drugs that may potentiate release of neutrophils (eg, lithium). May cause transient positive changes in bone-imaging test results. Adverse Reactions: Bone pain; splenic rupture (may be fatal), acute respiratory distress syndrome, serious allergic reactions, sickle cell crisis, potential for tumor growth stimulatory effects on malignant cells. How Supplied: Single-use prefilled syringe (0.5mL, 0.8mL)—1, 10 (w. safety needle guard) https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df918ec2-0907-443f-a52a-b72866959644