英文药名: Torisel(Temsirolimus Injection) 中文药名: 坦罗莫司注射剂, 驮瑞塞尔 品牌药生产厂家: Pfizer Company: Antineoplastic (mTOR kinase inhibitor) Active ingredient: Temsirolimus 25mg/mL; ethanolic soln for IV infusion after two dilutions (first w. supplied diluent); contains alcohol, polysorbate 80. Indication: Advanced renal cell carcinoma. Pharmacology: Clinical trials: In a study conducted in 626 previously untreated patients with advanced renal cell carcinoma, treatment with temsirolimus was compared to temsirolimus + interferon-α and to interferon-α alone. There was a statistically significant improvement in overall survival in the patients given temsirolimus (10.9 months) compared to those given interferon-α (7.3 months). Adults: 25mg once weekly. Infuse IV over 30?0min, using an infusion pump. Continue until disease progression or unacceptable toxicity occurs. Premedicate with IV antihistamine (eg, diphenydramine). Hold dose if ANC <1000/mm3, platelets <75000/mm3, or NCI CTCAE ≥grade 3 adverse reaction occurs; may restart at a dose reduced by 5mg/week (no lower than 15mg/wk) if adverse reactions resolve to ≤grade 2. See Interactions. Children: Not recommended. Precautions: Sirolimus or related allergy. Hepatic insufficiency. Perioperative period (may interfere with wound healing). CNS tumors. Monitor CBCs weekly and chemistry panels every 2 weeks, blood glucose, lipids, renal function, and for worsening respiratory or GI symptoms (eg, acute abdomen, blood in stool). Elderly. Pregnancy (Cat.D) (avoid pregnancy during and for 3 months after therapy, male patients should use appropriate contraception), nursing mothers: not recommended. Interactions: Avoid strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice); if used, consider reducing temsirolimus dose to 12.5mg/week (allow 1 week after discontinuing CYP3A4 inhibitor before readjusting temsirolimus dose). Avoid strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifampicin, phenobarbital, St. John's Wort); if used, consider increasing temsirolimus dose to 50mg/week. Avoid live vaccines, close contact with vaccinees. Additive toxicity with sunitinib (rash, gout/cellulitis), anticoagulants (intracerebral bleeding). Adverse reactions: Rash, asthenia, mucositis, nausea, edema, anorexia, infection, pain, anemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, elevated alkaline phosphatase, elevated serum creatinine, lymphopenia, hypophosphatemia, thrombocytopenia, elevated AST, leukopenia; hypersensitivity/infusion reactions (anaphylaxis, dyspnea, flushing, chest pain), immunosuppression, interstitial lung disease, bowel perforation, acute renal failure, abnormal wound healing; others (see literature). How supplied: Kit (vial + diluent)? 规格:TORISEL (TEMSIROLIMUS)25MG/ML+1.8ML DILU KIT 药品介绍 【商品名】Torisel 【注意事项】 【药物相互作用】 【临床评价】 一项考察晚期RcC患者用药剂量的II期随机、双盲、对照试验中,11l例事先进行过治疗的晚期RcC患者,随机接受本品25,75或250mg治疗,每周1次。初级评价指标为客观应答率(ORR);次级评价指标是总生存期(OS)及非进展生存期(PFS)。 结果3剂量组的ORR分别为5.0%,7.9%和8.1%;临床有效率分别为52.8%,55.3%和43.2%。所有患者中位总生存期为15个月,各剂量组生存期分布未见统计学意义上的差别。 对626例先前未进行治疗的晚期肾癌(RCC)患者进行了本品多中心、开放、随机III期临床疗效与安全性评价试验,旨在研究本品的总生存期(OS)、非进展生存期(PFs)及客观应答率(ORR)。患者平均年龄59岁(23—86岁);男性69%,女性31%;种族分布:白人91%,黑人4%,亚裔2%,其他3%。随机分成三组,即本品试验组209例(25mg,每周1次,静脉输注30一60min以上),本品(15mg)和d—IFN(最大剂量6Mu)联合用药组210例,及单独应用俚-IFN组(最大剂量18Mu)207例。 抗悪性腫瘍剤(mTOR阻害剤)「トーリセル点滴静注液25mg」新発売 |