奥法木单抗注射溶液Arzerra 100mg/5ml(ofatumumab)

药店国别:

产地国家:美国

处方药:

所属类别: 100毫克/5毫升/瓶 3瓶/盒

包装规格: 100毫克/5毫升/瓶 3瓶/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Novartis

原产地英文商品名:ARZERRA 100MG/5ML/VIAL 3VIALS/BOX

原产地英文药品名:OFATUMUMAB

中文参考商品译名:ARZERRA 100毫克/5毫升/瓶 3瓶/盒

中文参考药品译名:奥法木单抗

简介

近日,美国食品和药物管理局(FDA)已批准Arzerra(ofatumumab)注射用于治疗≥2疗程后完全或部分反应的患者,用于复发或进行性慢性淋巴细胞白血病(CLL)。

批准日期:2016年10月24日

公司:NovartisARZERRA(奥法木单抗[ofatumumab])注射液,用于静脉注射

美国最初批准:2009年

警告:

乙型肝炎病毒再激活和进展性多发性脑白质病完全预测信息用于完整的BOXED警告。乙型肝炎病毒(HBV)再激活,在某些情况下导致暴发性肝炎,肝功能衰竭和死亡。进行性多灶性白质脑病(PML)导致死亡。最近的重大变化CLL的适应症和用法,延长治疗:1/2016

作用机制

Ofatumumab特异性结合CD20分子的小细胞和大细胞外环。 CD20分子在正常B淋巴细胞(前B-至成熟B-淋巴细胞)和B-细胞CLL上表达。CD20分子不会从细胞表面脱落,并且在抗体结合后不会内化。ofatumumab的Fab结构域与CD20分子结合,Fc结构域介导免疫效应功能,从而在体外产生B细胞裂解。数据表明细胞裂解的可能机制包括补体依赖性细胞毒性和抗体依赖性,细胞介导的细胞毒性。

适应症和用法

ARZERRA(ofatumumab)是一种CD20指导的溶细胞单克隆抗体,用于治疗慢性淋巴细胞白血病(CLL):与苯丁酸氮芥合用,用于治疗以前未接受治疗的CLL患者,对其进行基于氟达拉滨的治疗被认为是不合适的。与氟达拉滨和环磷酰胺联合用于治疗复发性CLL患者。对于复发或进行性CLL至少两行治疗后完全或部分反应的患者的延长治疗。用于治疗氟达拉滨和阿仑单抗难治的CLL患者。剂量和给药稀释并作为静脉输注给药。不要皮下注射或静脉推注或推注。以前未经处理的CLL与苯丁酸氮芥推荐的剂量和时间表相结合:第1天为300毫克,第8天为1,000毫克(第1周期)在随后的28天循环的第1天1,000mg,持续至少3个循环直至最佳反应或最多12个循环。复发CLL与氟达拉滨和环磷酰胺联合推荐的剂量和时间表为:第1天300毫克,第8天1,000毫克(第1周期)在随后的28天循环的第1天1,000mg,最多6个循环CLL推荐剂量和时间表的延长治疗是:第1天300毫克,然后是1周后第1天1,000毫克,然后是7周后1,000毫克,此后每8周一次,最多2年。耐火CLL推荐的剂量和时间表是:初始剂量为300毫克,随后1周后每周2,000毫克,共7剂,随后4周后每4周2,000毫克,共4剂。管理可以提供充分监测和治疗输液反应的设施。用对乙酰氨基酚,抗组胺药和皮质类固醇预先给药。剂量形式和强度100毫克/5毫升一次性小瓶静脉输注。1,000mg/50mL一次性小瓶,用于静脉输注。禁忌症没有。

警告和注意事项

输液反应:用皮质类固醇,对乙酰氨基酚和抗组胺药预先给药。在输注期间监测患者。如果输液反应发生,则中断输液。肿瘤裂解综合征:预测高风险患者的TLS;预先用抗高尿酸血症和水合作用治疗。血细胞减少:发生中性粒细胞减少,贫血和血小板减少症。也可发生迟发性和延长性中性粒细胞减少症。定期监测全血细胞计数。

不良反应

以前未经治疗的CLL:常见的不良反应(≥10%)是输液反应和中性粒细胞减少症。复发CLL:常见的不良反应(>10%)是输液反应,中性粒细胞减少,白细胞减少和发热性中性粒细胞减少症。CLL的延长治疗:常见的不良反应(≥10%)是输液反应,中性粒细胞减少和上呼吸道感染。难治性CLL:常见的不良反应(≥10%)是中性粒细胞减少,肺炎,发热,咳嗽,腹泻,贫血,疲劳,呼吸困难,皮疹,恶心,支气管炎和上呼吸道感染。

包装提供/存储和处理

ARZERRA(ofatumumab)是一种无菌,透明,乳白色,无色,无防腐剂的液体浓缩物(20 mg /mL),用于稀释和静脉内给药,提供一次性玻璃瓶,带橡胶塞(不是用天然橡胶胶乳制成)和 一个铝制的overseal。 每个小瓶在50mL溶液中含有100mgofatumumab在5mL溶液中或1,000mgofatumumab在50mL溶液中。ARZERRA如下:纸箱内容NDC3个一次性使用100mg/5mL样品瓶样品瓶:NDC 0078-0669-613个样品瓶:NDC 0078-0669-131个一次性1,000mg/50mL小瓶样品瓶和纸箱:NDC0078-0690-61将ARZERRA冷藏在2°至8°C(36°至46°F)之间。 不要冻结。 应保护小瓶免受光照。

奥法木单抗注射溶液英文版说明书

ARZERRA(ofatumumab) Injection, for intravenous infusionARZERRA (ofatumumab) is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. The effectiveness of ARZERRA is based on the demonstration of durable objective responses. No data demonstrate an improvement in disease-related symptoms or increased survival with ARZERRA.Important Safety InformationHighlights of Warnings and PrecautionsInfusion Reactions: Premedicate with an intravenous corticosteroid(as appropriate), an oral analgesic, and an oral or intravenous antihistamine. Monitor patients closely during infusions. Interrupt infusion if infusion reactions occur.Cytopenias: Monitor blood counts at regular intervals for neutropenia and thrombocytopenia.Progressive Multifocal Leukoencephalopathy (PML): Monitor neurologic function and discontinue ARZERRA if PML is suspected.Hepatitis B Infection and Reactivation: Screen high-risk patients.Discontinue ARZERRA in patients who develop viral hepatitis or reactivation of viral hepatitis.Infusion ReactionsARZERRA can cause serious infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac ischemia/infarction, back pain, abdominal pain, pyrexia, rash, urticaria, and angioedema.Infusion reactions occur more frequently with the first 2 infusions.Premedicate with acetaminophen, an antihistamine, and a corticosteroid. Interrupt infusion for infusion reactions of any severity. Institute medical management for severe infusion reactions including angina, or other signs and symptoms of myocardial ischemia. In a study of patients with moderate to severe chronic obstructive pulmonary disease, an indication for which ARZERRA is not approved, 2 of 5 patients developed Grade 3 bronchospasm during infusion. Infusion reactions occurred in 44% of patients on the day of the first infusion (300 mg), 29% on the day of the second infusion (2,000 mg), and less frequently during subsequentinfusions.CytopeniasProlonged (>1 week) severe neutropenia and thrombocytopenia can occur with ARZERRA. Monitor complete blood counts (CBC) and platelet counts at regular intervals during therapy, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Of 108 patients with normal neutrophil counts at baseline, 45 (42%) developed >Grade 3 neutropenia. Nineteen (18%) developed Grade 4 neutropenia. Some patients experienced new onset Grade 4 neutropenia >2 weeks in duration.Progressive Multifocal LeukoencephalopathyProgressive multifocal leukoencephalopathy (PML), including fatal PML, can occur with ARZERRA.Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms.Discontinue ARZERRA if PML is suspected and initiate eva luation for PML including consultation with a neurologist, brain MRI, and lumbar puncture.Hepatitis B Infection and ReactivationFulminant and fatal hepatitis B virus (HBV) infection and reactivation can occur in patients following treatment with ARZERRA.Screen patients at high risk of HBV infection before initiation of ARZERRA.Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBV infection during treatment with ARZERRA and for 6 to 12 months following the last infusion of ARZERRA.Discontinue ARZERRA in patients who develop viral hepatitis or reactivation of viral hepatitis, and institute appropriate treatment.Insufficient data exist regarding the safety of administration of ARZERRA in patients with active hepatitis.Intestinal ObstructionObstruction of the small intestine can occur in patients receiving ARZERRA. Perform a diagnostic eva luation if obstruction issuspected.ImmunizationsThe safety of immunization with live viral vaccines during or following administration of ARZERRA has not been studied.Do not administer live viral vaccines to patients who have recently received ARZERRA. The ability to generate an immune response to any vaccine following administration of ARZERRA has not been studied.Most Common Adverse ReactionsIn the pivotal study (total population, n=154) the most common adverse reactions (>10%, all grades) were neutropenia, followed by pneumonia (23%), pyrexia (20%), cough (19%), diarrhea (18%), anemia (16%), fatigue (15%), dyspnea (14%), rash (14%), nausea (11%), bronchitis (11%), and upper respiratory tract infections (11%).Most Common Serious Adverse ReactionsIn the pivotal study (total population, n=154), where ARZERRA was administered at 2,000 mg beginning with the second dose for 11 doses, the most common serious adverse reactions were infections(including pneumonia and sepsis), neutropenia, and pyrexia.A total of 108 patients (70%) experienced bacterial, viral, or fungal infections. A total of 45 patients (29%) experienced >Grade 3 infections, of which 19 (12%) were fatal.The proportion of fatal infections in the fludarabine- and alemtuzumab-refractory group was 17%.

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