近日，美国食品和药物管理局（FDA）已批准Nyvepria（pegfilgrastim-apgf，培非格司亭）上市，用于降低发热性中性粒细胞减少症的发生率，这是许多类型的化疗最严重的副作用之一，可降低癌症患者抵抗感染的能力。
中性粒细胞减少症是化疗最严重的副作用之一。有研究表明，在美国，每年有4000名癌症患者死于发热性中性粒细胞减少症，6万人因中性粒细胞减少症住院治疗。 
批准日期：2020年6月11日 公司：辉瑞
NYVEPRIA（培非格司亭[pegfilgrastim-apgf]）注射剂，用于皮下使用
美国初次批准：2020年
NYVEPRIA（pegfilgrastim-apgf）与NEULASTA（pegfilgrastim）具有生物相似性*
作用机理
Pegfilgrastim产品是集落刺激因子，通过与特定的细胞表面受体结合而作用于造血细胞，从而刺激增殖，分化，定型和终末细胞功能激活。
适应症和用途
NYVEPRIA是一种白细胞生长因子，在患有骨髓抑制性抗癌药物并伴有发热性中性粒细胞减少症临床上显着发病率的非骨髓性恶性肿瘤患者中，可降低感染的发生，如发热性中性粒细胞减少症所显示。
使用限制NYVEPRIA并未用于动员外周血祖细胞进行造血干细胞移植。
剂量和给药
癌症患者接受骨髓抑制化疗6mg，每个化疗周期皮下注射一次。
在施用细胞毒性化疗之前和之后的14天之间不要施用。
对于体重不足45千克的儿科患者，请使用基于体重的剂量；请参阅表。
剂量形式和强度
注射：在单剂量预装注射器中的6mg/0.6mL溶液仅供手动使用。
禁忌症
有对人类粒细胞集落刺激因子（如Pegfilgrastim产品或filgrastimproducts）严重过敏反应史的患者。
警告和注意事项
致命性脾破裂：评估报告左上腹或肩部疼痛导致脾脏或脾破裂扩大的患者。
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。在ARDS患者中停用NYVEPRIA。
严重的过敏反应，包括过敏反应：患有严重过敏反应的患者永久中止NYVEPRIA。
致命的镰状细胞危机：已经发生。
肾小球肾炎：评估和考虑是否可能因果关系减少剂量或中断NYVEPRIA。
不良反应
最常见的不良反应（与安慰剂相比，发生率差异≥5％）是骨痛和四肢疼痛。
要报告可疑的不良反应，请致电1-800-438-1985与Pfizer Inc.或致电1-800-FDA-1088与FDA联系，或访问www.fda.gov/medwatch。
包装供应/存储和处理方式
NYVEPRIA（pegfilgrastim-apgf）注射剂是透明无色溶液，装在手动预装的单剂量注射器中，含6mg pegfilgrastim-apgf，配有27英寸1/2英寸针头和BDUltraSafe Plus™被动式针头保护器。
NYVEPRIA注射器柱塞塞和针头盖不是用天然橡胶乳胶制成的。
NYVEPRIA提供在一个分配包装中，该分配包装包含一个无菌的6mg/0.6mL预装注射器（NDC 0069-0324-01）。
NYVEPRIA预装的注射器不带有刻度，仅用于输送注射器的全部内容物（6mg/0.6mL）以直接给药。不建议将预充式注射器直接用于体重小于45kg且需要剂量小于全部剂量的儿科患者
注射器的内容物。
将冷藏后的温度在36°F至46°F（2°C至8°C）之间的纸箱中存放，以防光照。不要摇晃。丢弃在室温下存放超过15天的注射器。避免冻结；如果冻结，则在使用前在冰箱中解冻。如果多次冷冻，请丢弃注射器。
*生物仿制药是指该生物制品是基于数据的认可的，这表明该生物制品与FDA批准的生物制品（称为参考产品）高度相似，并且该生物仿制品与参考产品之间没有临床意义上的区别。
NYVEPRIA的使用条件（例如适应症，给药方案，剂量，剂量，剂型和给药途径）已证明其生物相似性 信息。
完整说明资料附件：
http://labeling.pfizer.com/ShowLabeling.aspx?id=13622
FDA APPROVES PFIZER’S ONCOLOGY SUPPORTIVE CARE BIOSIMILAR, NYVEPRIA™ (PEGFILGRASTIM-APGF)
U.S.Food and Drug Administration(FDA)has approved NYVEPRIA(pegfilgrastim-apgf), a biosimilar to Neulasta(pegfilgrastim).NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
“The FDA approval of NYVEPRIA is a positive step that could both enable cost savings and increase access to an important treatment option,” said Andy Schmeltz, Global President, Pfizer Oncology. “We are proud to add this new, long-acting supportive care option to our robust portfolio, now with six FDA-approved oncology biosimilars including three specifically approved for supportive care for patients with cancer. We look forward to making NYVEPRIA available to U.S. patients and physicians later this year.”
About NYVEPRIA (pegfilgrastim-apgf)
NYVEPRIA, a biosimilar to Neulasta, is approved by the FDA to help reduce the chance of infection due to a low white blood cell count in people with non-myeloid cancer who receive anti-cancer medicines, like chemotherapy, that can cause fever and low white blood cell count.2 This condition, known as febrile neutropenia, is a common side effect of many types of chemotherapy and lowers the body’s ability to defend itself against infections.
NYVEPRIA INDICATION AND IMPORTANT SAFETY INFORMATION
Indication
NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Limitations of Use
NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Important Safety Information
Contraindication
NYVEPRIA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
Reactions have included anaphylaxis
Splenic Rupture
Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products
eva luate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving NYVEPRIA
Acute Respiratory Distress Syndrome(ARDS)
Can occur in patients receiving pegfilgrastim products
eva luate patients who develop fever and lung infiltrates or respiratory distress after receiving NYVEPRIA
Discontinue NYVEPRIA in patients with ARDS
Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products
The majority of reported events occurred upon initial exposure
Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti‐allergic treatment
Permanently discontinue NYVEPRIA in patients with serious allergic reactions
Do not administer NYVEPRIA to patients with history of serious allergic reactions to pegfilgrastim products or filgrastim products
Use in Patients with Sickle Cell Disorders
Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products
Discontinue NYVEPRIA if sickle cell crisis occurs
Glomerulonephritis
Glomerulonephritis has occurred in patients receiving pegfilgrastim products
The diagnoses were based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy
Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products
If suspected, eva luate for cause, and if causality is likely consider dose-reduction or interruption ofNYVEPRIA
Leukocytosis
White blood cell counts of 100x109/L or higher have been observed in patients receiving pegfilgrastim products
Monitoring of complete blood count(CBC)during NYVEPRIA therapy is recommended
Capillary Leak Syndrome (CLS)
CLS has been reported after granulocyte-colony stimulating factor (G‐CSF) administration, including pegfilgrastim products
Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
Episodes vary in frequency and severity and may be life‐threatening if treatment is delayed
Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
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
Aortitis
Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy
Manifestations may include generalized signs and symptoms, such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c‑reactive protein and white blood cell count)
Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NYVEPRIA if aortitis is suspected
Nuclear Imaging
Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results
Most Common Adverse Reactions
Bone pain
Pain in extremity