近日，美国FDA批准Fulphila（pegfilgrastim-jmdb）用于接受骨髓抑制性化疗的非骨髓癌症患者，以降低发热性中性粒细胞减少症（febrile neutropenia，FN）的发生率，这些患者具有临床显着的FN发生风险。FN是通常伴有其他感染迹象的发热，并且患者的白细胞数量异常低。Fulphila是Neulasta（pegfilgrastim，培非格司亭）的第一种生物类似药（Biosimilar），由Mylan和Biocon公司共同开发。
批准日期：2018年6月28日 公司：Mylan GmbH
FULPHILA（pegfilgrastim-jmdb）注射液，用于皮下使用
美国最初批准：2018年
FULPHILA（pegfilgrastim-jmdb）与NEULASTA（pegfilgrastim）具有生物相似性*。
作用机制
Pegfilgrastim产品是指通过与特定细胞表面受体结合而作用于造血细胞的集落刺激因子，从而刺激增殖，分化，定型和终细胞功能激活。
适应症和用法
Fulphila是一种白细胞生长因子
•降低感染的发生率，以中性粒细胞减少性发热表现为，患者的非骨髓恶性肿瘤接收与中性粒细胞减少性发热的临床显著发病率骨髓抑制抗癌药物。
使用限制
没有显示Fulphila用于动员外周血祖细胞进行造血干细胞移植。
剂量和用量
•接受骨髓抑制化疗的癌症患者
o每个化疗周期皮下注射6mg。
o在细胞毒性化学疗法给药前14天和24小时之间不要给药。
o对体重小于45 kg的儿科患者使用基于体重的剂量;参见表1。
剂量形式和强度
•注射：单剂量预充式注射器中的6 mg/0.6mL溶液，仅供手动使用。
禁忌症
对人粒细胞集落刺激因子如pegfilgrastim或非格司亭产品有严重过敏反应史的患者。
警告和注意事项
•致命性脾破裂：评估报告左上腹部或肩部疼痛，脾脏肿大或脾破裂的患者。
•急性呼吸窘迫综合征（ARDS）：评估发烧，肺部浸润或呼吸窘迫的患者。停用ARDS患者的Fulphila。
•严重的过敏反应，包括过敏反应：对患有严重过敏反应的患者永久性地停用Fulphila。
•致命的镰状细胞危象：已经发生过。
•肾小球肾炎：如果可能存在因果关系，评估并考虑Fulphila的剂量减少或中断。
不良反应
最常见的不良反应（与安慰剂相比，发病率差异≥5％）是骨痛和四肢疼痛。
* FDA批准的生物制品，称为参考产品，并且生物仿制药产品和参考产品之间没有临床意义上的差异。
全部使用中描述的强度，剂型，给药途径处方信息。
包装提供/存储和处理
Fulphila单剂量预充式注射器，供手动使用
Fulphila（培非司亭-jmdb）注射剂是在预填充单剂量注射器含6毫克培非司亭，jmdb手动使用，用29号供给供给的澄清，无色溶液，1/2英寸针头的超安全无源加™针后卫。
Fulphila以包含一个无菌6mg/0.6mL预装注射器的分配包装提供。
NDC 67457-833-06
Fulphila预充式注射器不承担刻度标记，并且仅意在提供用于直接施用递送注射器（6毫克/ 0.6毫升）的全部内容，不推荐的预充式注射器的使用直接给予儿科患者体重小于45公斤谁需要的剂量小于注射器的全部内容物。
在.如果冻结，解冻;存储在纸箱冷藏2°之间至8℃（36°-46°F）以避光不要摇动存储在室温下超过72小时丢弃的注射器避免冷冻给药前的冰箱。如果冷冻不止一次，请丢弃注射器。

完整资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ea915d7-2feb-4e75-91f7-913c965b7d8a
FULPHILA(pegfilgrastim-jmdb)injection,for subcutaneous
INDICATION
Fulphila™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
IMPORTANT SAFETY INFORMATION
Do not administer Fulphila to patients with a history of serious allergic reactions, including anaphylaxis, to pegfilgrastim or filgrastim. Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Fulphila.
Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Fulphila for ARDS. Discontinue Fulphila in patients with ARDS.
Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after discontinuation of initial anti-allergic treatment. Permanently discontinue Fulphila in patients with serious allergic reactions to any egfilgrastim or filgrastim products.
Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Glomerulonephritis has been reported in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Fulphila.
White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of CBCs during therapy with Fulphila is recommended.
Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
The G-CSF receptor, through which pegfilgrastim and filgrastim products act, has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.