设为首页 加入收藏

TOP

Nivestym 300mcg/0.5ml(filgrastim-aafi,非格司亭预装注射器)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 300微克/0.5毫升/支 10支/盒 
包装规格 300微克/0.5毫升/支 10支/盒 
计价单位: 盒 
生产厂家中文参考译名:
辉瑞公司
生产厂家英文名:
Pfizer Inc
该药品相关信息网址1:
https://www.nivestym.com/
该药品相关信息网址2:
https://www.drugs.com/history/nivestym.html
该药品相关信息网址3:
原产地英文商品名:
Nivestym 300mcg/0.5ml/syringe 10syringe/box
原产地英文药品名:
filgrastim-aafi
中文参考商品译名:
Nivestym预装注射器 300微克/0.5毫升/支 10支/盒
中文参考药品译名:
非格司亭
曾用名:
简介:

 

近日,美国食品药品监督管理局(FDA)批准了旗下仿制药Nivestym(filgrastim-aafi,非格司亭生物相似性)静脉注射剂,用于治疗所有适应症。
试验证明:Nivestym与其参考产品相比具有高度相似性。Nivestym在美国可用于于5种情况的中性粒细胞减少症,包括:接受骨髓抑制剂进行化疗的癌症患者、接受诱导化疗或巩固化疗的急性髓性白血病(AML)患者、经历骨髓移植的癌症患者、经历自体外周血干细胞采集和治疗患者、以及严重慢性嗜中性粒细胞减少症患者。
批准日期:2018年7月24日 公司:辉瑞公司
NIVESTYM(非格司亭[filgrastim-aafi])注射剂,用于皮下或静脉内使用
美国初次批准:2018年
NIVESTYM(非格司亭-aafi)与NEUPOGEN(非格司亭)具有生物相似性*。
作用机理
集落刺激因子是糖蛋白,通过与特定的细胞表面受体结合并刺激增殖,分化作用和某些终末细胞功能激活而作用于造血细胞。
内源性G-CSF是由单核细胞,成纤维细胞和内皮细胞产生的谱系特异性菌落刺激因子。G-CSF调节骨髓内嗜中性粒细胞的产生,并影响嗜中性粒细胞祖细胞的增殖,分化和选定的终末细胞功能(包括增强的吞噬能力,引发与呼吸爆发有关的细胞代谢,抗体依赖性杀伤以及增加的吞噬能力) 细胞表面抗原的表达)。G-CSF不是物种特异性的,并且已显示对嗜中性粒细胞谱系以外的造血细胞类型的产生或活性具有最小的直接体内或体外影响。
适应症和用途
NIVESTYM是一种白细胞生长因子,显示为
在非骨髓性恶性肿瘤患者中,接受骨髓抑制性抗癌药物与严重的中性粒细胞减少症伴发烧的发生率显着相关,可降低发热的中性粒细胞减少症所显示的感染发生率。
在急性髓样白血病(AML)患者的诱导或巩固化疗后,减少中性粒细胞恢复的时间和发烧时间。
在患有非骨髓性恶性肿瘤的患者接受清髓性化学疗法然后进行骨髓移植(BMT)的患者中,减少中性粒细胞减少症和中性粒细胞减少症相关的临床后遗症(如发热性中性粒细胞减少症)的持续时间。
动员自体造血祖细胞进入外周血,通过白细胞分离术收集。
减少先天性中性粒细胞减少,循环性中性粒细胞减少或特发性中性粒细胞减少的有症状患者严重中性粒细胞减少(例如发烧,感染,口咽溃疡)后遗症的发生率和持续时间。
剂量和给药
接受骨髓抑制性化疗或AML诱导和/或巩固化疗的癌症患者。
推荐的起始剂量为每天皮下注射5mcg/kg,短期静脉输注(15至30分钟)或连续静脉输注。有关建议的剂量调整和给药时间,请参见“完整处方信息”。
接受骨髓移植的癌症患者。
每天不超过24小时静脉滴注10mcg/kg/天。有关建议的剂量调整和给药时间,请参见“完整处方信息”。
接受自体外周血祖细胞收集和治疗的患者。
皮下注射10mcg/kg/天。
在首次白细胞分离术之前至少给药4天,并持续到最后一次白细胞分离术为止。
先天性中性粒细胞减少症患者。
推荐的起始剂量是每天两次皮下注射6mcg /kg。
周期性或特发性中性粒细胞减少症的患者。
推荐的起始剂量为每天5mcg/kg皮下注射。
不建议使用NIVESTYM预装注射器直接给药少于0.3mL(180mcg)的药物,因为这可能会导致给药错误。
剂量形式和强度
小瓶
注射:单剂量小瓶中300mcg/mL
进样:单剂量小瓶中480mcg/1.6mL
预装注射器
注射:在单剂量预填充注射器中为300mcg/0.5mL
注射:在单剂量预填充注射器中为480mcg/0.8mL
禁忌症
有对人类粒细胞集落刺激因子(如非格司亭产品或聚乙二醇非格司亭产品)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ARDS引起呼吸窘迫的患者。
在ARDS患者中停用NIVESTYM。
严重的过敏反应,包括过敏反应:严重过敏反应的患者应永久停用NIVESTYM。
致命的镰状细胞危机:已经发生。
肾小球肾炎:如果可能有因果关系,请评估并考虑减少剂量或中断NIVESTYM。
不良反应
患者最常见的不良反应:
非骨髓性恶性肿瘤接受骨髓抑制性抗癌药物(与安慰剂相比,发生率差异≥5%)会导致发热,疼痛,皮疹,咳嗽和呼吸困难。
AML(发生率差异≥2%)包括疼痛,鼻epi和皮疹。
非骨髓性恶性肿瘤接受清髓性化疗后再行BMT(发生率差异≥5%)的皮疹。
正在进行的外周血祖细胞动员和采集(发生率≥5%)是骨痛,发热和头痛。
患有严重的慢性中性粒细胞减少症(SCN)(发生率差异≥5%)的人有疼痛,贫血,鼻出血,腹泻,感觉不足和脱发
包装供应/存储和处理方式
小瓶
注射剂:单剂量小瓶,其中包含300mcg/mL的无菌,透明,无色,不含防腐剂的非格司亭-aafi溶液。分装10个小瓶的包装(NDC 0069-0293-10)。
注射剂:单剂量小瓶,其中包含480mcg/1.6mL(300mcg/mL)的无菌,透明,无色,不含防腐剂的非格司亭-aafi溶液。分装10个小瓶(NDC 0069-0294-10)。
预装注射器
注射:带有BD UltraSafe Plus™被动式针头保护器的单剂量预填充注射器,其中包含300mcg/0.5mL无菌,透明,无色,不含防腐剂的非格司亭-aafi溶液。
一包预装注射器(NDC 0069-0291-01)。
一包10个预装注射器(NDC 0069-0291-10)。
注射:带有BD UltraSafe Plus™被动式针头保护器的单剂量预装注射器,其中包含480mcg/0.8mL无菌,透明,无色,不含防腐剂的非格司亭aaafi溶液。
一包预装注射器(NDC 0069-0292-01)。
一包10个预装注射器(NDC 0069-0292-10)。
NIVESTYM注射器柱塞塞和针头盖不是由天然橡胶乳胶制成的[请参见剂量和用法]。
存储
将NIVESTYM放在原始纸箱中的2°至8°C(36°至46°F)的冰箱中存放,以避光。请勿将NIVESTYM放在阳光直射的地方。避免冻结;如果冻结,则在给药前在冰箱中解冻。如果冷冻超过一次,则丢弃NIVESTYM。避免晃动。尚未研究通过气动管的运输。
生物仿制药是指根据证明其与FDA批准的生物产品(称为参考产品)高度相似的数据批准该生物产品,并且该生物仿制药和参考产品之间在临床上没有有意义的区别。
NIVESTYM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)已证明具有生物相似性 处方信息。
完整说明资料附件:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d23ab39c-b6ec-41cf-a529-9dd2852c9d9a
NIVESTYM(filgrastim-aafi) injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2018
NIVESTYM (filgrastim-aafi) is biosimilar* to NEUPOGEN (filgrastim).
IMPORTANT SAFETY INFORMATION AND INDICATIONS
CONTRAINDICATIONS
NIVESTYMTM is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim products or pegfilgrastim products.
WARNINGS AND PRECAUTIONS
Splenic Rupture
Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. eva luate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) has been reported in patients receiving filgrastim products. eva luate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue NIVESTYMTM in patients with ARDS.
Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue NIVESTYMTM in patients with serious allergic reactions. NIVESTYMTM is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim.
Sickle Cell Disorders
Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue NIVESTYMTM if sickle cell crisis occurs.
Glomerulonephritis
Glomerulonephritis has occurred in patients receiving filgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of filgrastim products. If glomerulonephritis is suspected, eva luate for cause. If causality is likely, consider dose-reduction or interruption of NIVESTYMTM.
Alveolar Hemorrhage and Hemoptysis
Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization has been reported in healthy donors treated with filgrastim products for peripheral blood progenitor cell (PBPC) mobilization. Hemoptysis resolved with discontinuation of filgrastim products. The use of NIVESTYMTM for PBPC mobilization in healthy donors is not an approved indication.
Capillary Leak Syndrome
Capillary leak syndrome (CLS) has been reported after G-CSF administration, including filgrastim 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 the need for intensive care.
Patients with Severe Chronic Neutropenia (SCN)
Confirm the diagnosis of SCN before initiating NIVESTYMTM therapy. Myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Based on available data including a post-marketing surveillance study, the risk of developing MDS and AML appears to be confined to the subset of patients with congenital neutropenia. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim product administration in patients with abnormal cytogenetics or MDS are unknown. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing NIVESTYMTM should be carefully considered.
Thrombocytopenia
Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts.
Leukocytosis
Patients with Cancer Receiving Myelosuppressive Chemotherapy:
White blood cell counts of 100,000/mm3 or greater were observed in approximately 2% of patients who received filgrastim at dosages above 5 mcg/kg/day. In patients with cancer receiving NIVESTYMTM as an adjunct to myelosuppressive chemotherapy, to avoid the potential risks of excessive leukocytosis, it is recommended that NIVESTYMTM therapy be discontinued if the absolute neutrophil count (ANC) surpasses 10,000/mm3 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy. Dosages of NIVESTYMTM that increase the ANC beyond 10,000/mm3 may not result in any additional clinical benefit. In patients with cancer receiving myelosuppressive chemotherapy, discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to pretreatment levels in 1 to 7 days.
Peripheral Blood Progenitor Cell Collection and Therapy:
During the period of administration of NIVESTYMTM for PBPC mobilization in patients with cancer, discontinue NIVESTYMTM if the leukocyte count rises to >100,000/mm3.
Cutaneous Vasculitis
Cutaneous vasculitis has been reported in patients treated with filgrastim products. In most cases, the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term filgrastim therapy. Hold NIVESTYMTM therapy in patients with cutaneous vasculitis. NIVESTYMTM may be started at a reduced dose when the symptoms resolve and the ANC has decreased.
Potential Effect on Malignant Cells
NIVESTYMTM is a leukocyte growth factor that primarily stimulates neutrophils. The granulocyte colony-stimulating factor (G-CSF) receptor through which NIVESTYMTM acts has also been found on tumor cell lines. The possibility that NIVESTYMTM acts as a growth factor for any tumor type, cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established.
When NIVESTYMTM is used to mobilize PBPC, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of reinfusion of tumor cells has not been well studied, and the limited data available are inconclusive.
Simultaneous Use with Chemotherapy and Radiation Not Recommended
The safety and efficacy of NIVESTYMTM given simultaneously with cytotoxic chemotherapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, do not use NIVESTYMTM in the period of 24 hours before through 24 hours after the administration of cytotoxic chemotherapy.
The safety and efficacy of NIVESTYMTM have not been eva luated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of NIVESTYMTM with chemotherapy and radiation therapy.
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.
Aortitis
Aortitis has been reported in patients receiving filgrastim 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 (eg, c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NIVESTYMTM if aortitis is suspected.
ADVERSE REACTIONS
The most common adverse reactions in patients:
with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥5% difference in incidence compared to placebo) are anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, peripheral edema, decreased hemoglobin, decreased appetite, oropharyngeal pain, and alopecia
with AML (≥2% difference in incidence) are epistaxis, back pain, pain in extremity, erythema, maculopapular rash, diarrhea, constipation, and transfusion reaction
with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥5% difference in incidence) are rash, hypersensitivity, thrombocytopenia, anemia, hypertension, sepsis, bronchitis, and insomnia
undergoing peripheral blood progenitor cell mobilization and collection (≥5% incidence) are bone pain, pyrexia, increased blood alkaline phosphatase, and headache
with severe chronic neutropenia (≥5% difference in incidence) are arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia
INDICATIONS
Patients with Cancer Receiving Myelosuppressive Chemotherapy
NIVESTYMTM 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 significant incidence of severe neutropenia with fever
Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy
NIVESTYMTM is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
Patients with Cancer Undergoing Bone Marrow Transplantation
NIVESTYMTM is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation
Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy
NIVESTYMTM is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
Patients with Severe Chronic Neutropenia
NIVESTYMTM is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia。 

】【打印繁体】【投稿】【收藏】 【推荐】【举报】【评论】 【关闭】 【返回顶部
分享到QQ空间
分享到: 
上一篇Nivestym 480mcg/1.6ml(filgrast.. 下一篇Nivestym 300mcg/0.5ml(filgrast..

相关栏目

最新文章

图片主题

热门文章

推荐文章