利妥昔单抗，利妥昔单抗透明质酸酶组合注射剂（Rituxan Hycela 1600mg/26800 vial）

药店国别：无 产地国家：美国 处方药：是 所属类别： 1600毫克/26800毫克/瓶 包装规格： 1600毫克/26800毫克/瓶 计价单位：瓶 生产厂家中文参考译名：无 生产厂家英文名：Genentech and Biogen 原产地英文商品名：Rituxan Hycela 1600mg/26800/vial 原产地英文药品名：rituximab and hyaluronidase human 中文参考商品译名：Rituxan Hycela组合注射剂 1600毫克/26800毫克/瓶 中文参考药品译名：利妥昔单抗透明质酸酶 曾用名：无

简介

靶向CD20的抗体新药妥昔单抗与透明质酸酶组合 rituximab/hyaluronidase human（商品名：Rituxan Hycela）获FDA批准于治疗多种恶性血液肿瘤2017年6月22日，美国食品和药物管理局批准罗氏的Rituxan Hycela，即利妥昔单抗和人类透明质酸酶组合，用于治疗成人患者的滤泡淋巴瘤，弥漫性大B细胞淋巴瘤和慢性淋巴细胞性白血病。 这项批准使患者能够皮下注射利妥昔单抗，与给药时间需数小时的静脉内输注相比可减少缩至5到7分钟。这种新产品还提供平滑剂量选择。 Rituxan Hycela 获批的适应证与利妥昔已批准的适应证类似，包括作为单药治疗复发性或难治性滤泡性淋巴瘤（FL）。与一线化疗联合使用于初次治疗的FL患者，与化疗相结合的情况下，作为单药维持治疗对利妥昔单抗完全或部分反应的患者。 适应症 ①滤泡型淋巴瘤（FL）单药治疗复发性、难治性滤泡型淋巴瘤；与化疗药物联合治疗，当达到完全或部分缓解后，改用美罗华单药维持环磷酰胺、长春新碱、泼尼松（CVP）化疗后无进展，使用美罗华单药治疗 ②弥漫性大B细胞淋巴瘤（DLBCL）与环磷酰胺、多柔比星、长春新碱、泼尼松（CHOP）或其他蒽环类化疗药物联用 ③慢性淋巴细胞白血病（CLL）与氟达拉滨、环磷酰胺（FC）化疗药物联用 使用限制 患者至少接受一次利妥昔单抗治疗后才可以改用利妥昔单抗透明质酸酶；不用于治疗非恶性疾病。剂量利妥昔单抗透明质酸酶仅用于皮下注射，使用前患者需先静脉注射一次安全剂量的利妥昔单抗且没有不良反应。如果患者不能耐受则继续静注利妥昔单抗，不改用利妥昔单抗透明质酸酶。 ①滤泡型淋巴瘤（FL）推荐剂量为RITUXAN HYCELA 1,400mg/23,400单位（1,400mg利妥昔单抗和23,400单位透明质酸酶）皮下注射，不考虑患者体表面积。治疗复发性、难治性滤泡型淋巴瘤第1周使用利妥昔单抗，后3周每周1次利妥昔单抗透明质酸酶。共4周。 未经治疗的滤泡型淋巴瘤化疗第1个疗程第1天使用利妥昔单抗，后第2-8个化疗疗程的第1天使用利妥昔单抗透明质酸酶。每个疗程21天。一线CVP化疗后无进展的滤泡型淋巴瘤在6-8个化疗疗程后，接着的化疗疗程第1天合并利妥昔单抗，后3周每周1次利妥昔单抗透明质酸酶在化疗第1天注射。6个月内最多注射16次。 ② 弥漫性大B细胞淋巴瘤（DLBCL）推荐剂量为RITUXAN HYCELA 1,400mg/23,400单位（1,400mg利妥昔单抗和23,400单位透明质酸酶）皮下注射，不考虑患者体表面积。联合CHOP化疗方案，在化疗的第2个疗程第一天使用，最多可用7个疗程。 ③ 慢性淋巴细胞白血病（CLL）推荐剂量为RITUXAN HYCELA 1600mg/ 26800单位（1600mg利妥昔单抗和26800单位透明质酸酶的人）。联合FC化疗方案，在化疗的第2个疗程（28天一个疗程）第一天使用，最多可用6个疗程。用药前预先使用对乙酰氨基酚及抗组胺类药物。或者考虑使用糖皮质激素预先处理。 CLL治疗时或治疗达到12个月时预防支原体肺炎和疱疹病毒感染剂型注射剂：每11.7ml有1,400mg利妥昔单抗和23,400单位透明质酸酶（120mg/2,000单位/ml）在单剂量小瓶。 注射液：每13.4ml含1,600mg利妥昔单抗和26,800单位透明质酸酶（120mg/2,000单位/ml）在单剂量小瓶。 警告和注意事项 严重的皮肤毒性乙型肝炎病毒重新激活进行性多灶性白质脑病(PML)超敏反应肿瘤溶解综合征(TLS)感染心血管 不良事件：肾毒性肠梗阻和穿孔免疫接种胚胎-胎儿毒性

英文版说明

Rituxan Hycela(rituximab and hyaluronidase human)RITUXAN HYCELALeukemias, lymphomas, and other hematologic cancers Only 4 drugs may be compared at onceGeneric Name and Formulations:Rituximab, hyaluronidase human 1400mg/23400 Units, 1600mg/26800 Units; soln for SC inj; preservative-free.Company:Genentech and BiogenSelect therapeutic use: Leukemias, lymphomas, and other hematologic cancersIndications for RITUXAN HYCELA:Relapsed or refractory, follicular lymphoma (FL) as a single agent. Previously untreated FL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease) FL as a single agent after first-line CVP chemotherapy. Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with CHOP or other anthracycline-based chemotherapy regimens. Chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide.Limitations Of use:Start treatment only after receiving at least 1 full dose of a rituximab product by IV infusion. Not for treating non-malignant conditions.Adult:Give by SC inj into abdomen. Premedicate with an antihistamine and acetaminophen prior to each dose; may consider glucocorticoids. Monitor for at least 15mins after each dose. Relapsed or refractory FL: 1400mg/23400 Units over 5mins once weekly for 3 or 7 weeks following a full dose of IV rituximab at Week 1. May give retreatment once weekly for 3 weeks following a full dose of IV rituximab at Week 1. Previously untreated FL: 1400mg/23400 Units over 5mins on Day 1 of Cycles 2–8 of chemotherapy (every 21 days) for up to 7 cycles following a full dose of IV rituximab on Day 1 of Cycle 1; if complete or partial response, initiate Rituxan Hycela maintenance 8 weeks following completion of Rituxan Hycela in combination with chemotherapy. Administer Rituxan Hycela as a single-agent every 8 weeks for 12 doses. Non-progressing FL after first-line CVP chemotherapy: 1400mg/23400 Units over 5mins once weekly for 3 weeks at 6-month intervals following completion of 6–8 cycles of CVP and a full dose of IV rituximab at Week 1; max 16 doses. DLBCL: 1400mg/23400 Units over 5mins on Day 1 of Cycles 2–8 of CHOP chemotherapy for up to 7 cycles following a full dose of IV rituximab on Day 1 of Cycle 1. CLL: 1600mg/26800 Units over 7mins on Day 1 of Cycles 2–6 (every 28 days) for 5 cycles following a full dose of IV rituximab on Day 1 of Cycle 1. Give PCP and antiherpetic viral prophylaxis during and up to 12 months after CLL therapy.Children:Not established.Warnings/Precautions:Discontinue if severe injection or mucocutaneous reactions occur (eg, urticaria, hypotension, angioedema, hypoxia, pulmonary infiltrates, acute respiratory failure, paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid or vesiculobullous dermatitis, toxic epidermal necrolysis). Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Tumor lysis syndrome (esp. with high tumor burden); monitor renal function, fluid balance, electrolyte abnormalities (correct if occurs); discontinue if SCr rises or oliguria occurs. Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Discontinue and treat if serious infections (eg, bacterial, fungal, viral) occur. Pre-existing cardiac or pulmonary conditions, prior cardiopulmonary adverse events, high malignant cell count; monitor during and after treatment. Elderly. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for at least 12 months after last dose. Pregnancy (monitor newborns/infants for infection). Nursing mothers: not recommended (during and for at least 6 months after last dose).Interactions:Live virus vaccines: not recommended. Renal toxicity with concomitant cisplatin.Pharmacological Class:CD20-directed cytolytic monoclonal antibody + endoglycosidase.Adverse Reactions:Infections, neutropenia, nausea, constipation, cough, fatigue, alopecia, anemia, thrombocytopenia, pyrexia, vomiting, injection site erythema, mucocutaneous reactions (may be fatal), hypersensitivity, PML, tumor lysis syndrome, renal toxicity, bowel obstruction/perforation (when concomitant chemotherapy), HBV reactivation, arrhythmias (discontinue if serious).Generic Availability:NOHow Supplied:Single-dose vial—1