| 部份中文利妥昔单抗处方资料（仅供参考） 治疗类别 抗CD20单克隆抗体的抗癌剂 药品英文名 Rituximab 药品别名 美罗华、利妥昔单抗、MabThera、Rituxan 药物剂型 注射剂：500mg(50ml)，100mg(10ml)。 药理作用 本品与纵贯细胞膜的CD20抗原特异性结合。该抗原位于前B细胞和成熟B淋巴细胞，但在造血干细胞、后B细胞、正常血浆细胞，或其他正常组织中不存在。该抗原表达于95%以上的B淋巴细胞型的非霍奇金淋巴瘤。在与抗体结合后，CD20不被内在化或从细胞膜上脱落。CD20不以游离抗原形式在血流中循环，因此，也就不会与抗原竞争性结合。本品与B淋巴细胞上的CD20结合，并引发B细胞溶解的免疫反应。细胞溶解的可能机制包括补体依赖性细胞毒性(CDC)和抗体依赖性细胞的细胞毒性(ADCC)。此外，体外研究表明，本品可使药物抵抗性的人体淋巴细胞对一些化疗药物的细胞毒敏感。 药动学 给予125mg/m2，250mg/m2或375mg/m2的本品，静脉输注，每周1次，共4次。接受本品者的血清抗体浓度随剂量的增加而上升。在给予375mg/m2的患者中，在第一次输注后，本品的血浆t1/2为68.1h，血药峰值为238.7μg/ml，平均血浆清除率为每小时0.0459L。在第4次输注后，平均血清半衰期最高浓度和血浆清除率分别为每小时189.9，480.7和0.0145L。此外，本品的血药浓度在缓解患者中的增高具有统计学意义，其典型意义是在3～6个月后仍可测到本品。在第1次给药后，中位外周B淋巴细胞数明显降低至正常水平以下，6个月后开始恢复，在治疗完成的9～12个月后恢复正常。 适应证 主要适用于中低度非霍奇金淋巴瘤，使用前需要对淋巴瘤病理切片进行CD20表达的检测，以求治疗的准确性和保证疗效。适用于复发或化疗抵抗性B淋巴细胞型的非霍奇金淋巴瘤患者。 禁忌证 1.对本品或鼠蛋白过敏者、孕妇、哺乳者禁用。 2.儿童禁用。 注意事项 1.有明显心脏病如心绞痛、心衰、哮喘、低血压等患者慎用。 2.输注速度不可过快，也不可进行静脉注射。 3.用药期间如发生变态反应或其他严重反应，应考虑减量或停药。 4.考虑本品可能引起低血压，因此，在开始使用本品时，应暂停使用抗高血压药或减量。 5.应准备好抢救过敏性休克的措施。 6.血细胞和血小板计数明显下降时，应停药。 7.用药期间，应定期检查血常规和血小板计数。 8.本品不可静脉推注。 9.避光，在2～8℃冰箱中保存。 不良反应 由于接受治疗的患者大多数都曾接受过多种抗癌治疗，其预后均较差，以下列出的不良反应不一定都是使用本品引起的，临床应进行细致分析。 1.与输注直接相关的不良反应有发热、寒战，主要发生在第1次输注中，通常在给药后2h内发生。继而发生荨麻疹、皮疹、疲劳、头痛、瘙痒、支气管痉挛、呼吸困难、舌或喉头水肿(血管神经性水肿)、鼻炎、呕吐、一过性低血压、潮红、心律失常和肿瘤部位疼痛。 2.原有心脏病的发作，如心绞痛和充血性心衰加重。不良反应有可能随继续用药而减轻。 3.少数患者有出血倾向，常较轻且可逆。严重的血小板减少和中性粒细胞减少的发生率为1.8%。严重贫血的发生率为1.4%。 4.全身不良反应还有腹胀、腹痛、背痛、胸痛、颈痛、盗汗、汗多、皮肤干燥和输注部位疼痛。 5.心血管系统的不良反应有高血压、直立性低血压、心动过缓、心动过速、血管扩张。 6.胃肠道可见腹泻、厌食和消化不良。 7.白细胞减少、淋巴结病、高血糖、周围水肿、LDH增高、体重减轻、低血钙和血尿酸升高。 8.关节痛、肌痛、骨痛、张力过高。 9.神经系统的不良反应可见眩晕、焦虑、抑郁、感觉异常、躁动、失眠、精神紧张、嗜睡和神经炎。 10.泪腺分泌紊乱、耳痛、味觉障碍、排尿困难和血尿可能发生。 用法用量 1.作为成年患者的单一治疗药，推荐剂量为375mg/m2，静脉输注前1h先给予止痛药(对乙酰氨基酚)和抗过敏药(苯海拉明)。首剂输注速度为每小时50mg，以后每30分钟增加每小时50mg，最高可达每小时400mg。每周1次，连用4次。 2.如患者耐受，可将输入速度提高为每小时100mg，以后每30分钟增加每小时100mg，最高可达每小时400mg。 药物相应作用 美罗华不可与其他药物混用。 RITUXAN® (rituximab) is indicated for the treatment of: •Low-grade or follicular CD20-positive non-Hodgkin's lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment •Follicular CD20-positive non-Hodgkin's lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy •Low-grade or follicular CD20-positive non-Hodgkin's lymphoma as a single-agent follow-up therapy for patients who responded to initial treatment with CVP chemotherapy •CD20-positive diffuse large B-cell non-Hodgkin's lymphoma as an initial treatment in combination with CHOP chemotherapy •CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred •Rheumatoid arthritis with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called tumor necrosis factor (TNF) antagonist has been used and did not work well enough •Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) with glucocorticoids People with serious infections should not receive RITUXAN. It is not known if RITUXAN is safe or effective in children. Important Safety Information What is the most important information I should know about RITUXAN? Tell your doctor right away about any side effect you experience. RITUXAN can cause serious side effects that can lead to death, including: •Infusion Reactions: may occur during or within 24 hours of your infusion. Your doctor should give you medicines before your treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain•Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on your skin, lips or mouth; peeling skin; rash; or pustules•Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If you have had hepatitis B or are a carrier of HBV, receiving RITUXAN could cause the virus to become an active infection again. You should not receive RITUXAN if you have active HBV liver disease. Your doctor will do blood tests to check for HBV infection prior to treatment and will monitor you during and for several months following your treatment•Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment, or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of your body, or blurred or lost visionWhat are the additional possible serious side effects of RITUXAN? Tell your doctor right away about any side effect you experience. RITUXAN can cause serious side effects that can lead to death, including: •Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, and can lead to death. Your doctor may give you medicines before your treatment to help prevent TLS•Serious Infections: can happen during and after treatment and can lead to death. These infections may be bacterial, fungal, or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen, or painful•Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. Your doctor may need to stop your treatment•Kidney Problems: your doctor should do blood tests to check how well your kidneys are working•Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom•Low Blood Cell Counts: your blood cell counts may be monitored during treatmentThe most common side effects of RITUXAN are infusion reactions, chills, infections, body aches, tiredness, and low white blood cells. Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if RITUXAN may harm your unborn baby or pass into your breast milk. Women should use birth control while using RITUXAN and for 12 months after treatment. Tell your doctor about any side effect that bothers you or that does not go away. These are not all of the possible side effects of RITUXAN. For more information, ask your doctor or pharmacist. Please see the RITUXAN full Prescribing Information, including the Medication Guide, for additional important safety information at www.RITUXAN.com. https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=4952 ---------------------------------------------------------------- 产地国家: 日本 原产地英文商品名: RITUXAN Injection（リツキサン注）10mg/mL（10mL）/Vial 原产地英文药品名: Rituximab(genetical recombination) 中文参考商品译名: RITUXAN（リツキサン注）100毫克/10毫升（10mL）/瓶 中文参考药品译名: 利妥昔单抗基因重组 生产厂家中文参考译名: Zenyaku Kogyo Co 生产厂家英文名: Zenyaku Kogyo Co ---------------------------------------------------------------- 产地国家: 日本 原产地英文商品名: RITUXAN Injection（リツキサン注）10mg/mL（10mL）/Vial 原产地英文药品名: Rituximab(genetical recombination) 中文参考商品译名: RITUXAN（リツキサン注）100毫克/10毫升（10mL）/瓶 中文参考药品译名: 利妥昔单抗基因重组 生产厂家中文参考译名: 中外制药有限公司 生产厂家英文名: Chugai Pharmaceutical Co. ---------------------------------------------------------------- 产地国家: 日本 原产地英文商品名: RITUXAN Injection（リツキサン注）10mg/mL（50mL）/Vial 原产地英文药品名: Rituximab(genetical recombination) 中文参考商品译名: RITUXAN（リツキサン注）100毫克/10毫升/瓶 中文参考药品译名: 利妥昔单抗基因重组 生产厂家中文参考译名: Zenyaku Kogyo Co. 生产厂家英文名: Zenyaku Kogyo Co. ---------------------------------------------------------------- 产地国家: 日本 原产地英文商品名: RITUXAN Injection（リツキサン注）10mg/mL（50mL）/Vial 原产地英文药品名: Rituximab(genetical recombination) 中文参考商品译名: RITUXAN（リツキサン注）100毫克/10毫升/瓶 中文参考药品译名: 利妥昔单抗基因重组 生产厂家中文参考译名: 中外制药 生产厂家英文名: Chugai Pharmaceutical Co |
RITUXAN Injection（利妥昔单抗基因重组注射剂）简介：
部份中文利妥昔单抗处方资料（仅供参考）治疗类别抗CD20单克隆抗体的抗癌剂药品英文名 Rituximab 药品别名 美罗华、利妥昔单抗、MabThera、Rituxan 药物剂型 注射剂：500mg(50ml)，100mg(10ml)。 药理作用 ... 责任编辑：admin |
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