英文药名: Nexavar(Sorafenib Tosilate Tablets) 中文药名: 索拉非尼司特片（索拉非尼） 生产厂家: 拜耳制药 药品介绍 2014年6月20日，抗癌药物多吉美（Nexavar，通用名：索拉非尼，sorafenib）获日本劳动卫生福利部（MHLW）批准，用于不可切除性分化型甲状腺癌（DCT）的治疗。此前，MHLW已于2013年9月授予Nexavar治疗甲状腺癌的孤儿药地位。 Nexavar新适应症的获批，是基于III期DECISION临床试验的数据，结果表明，与安慰剂相比，Nexavar显著延长了患者的疾病无进展生存期（PFS））（10.8个月 vs 5.8个月，p＜0.0001），达到了研究的主要终点。 此次获批，是Nexavar在日本的第三个适应症，之前该药已获批用于肝细胞癌和晚期肾细胞癌的治疗 FDA和欧盟分别于2013年11月和2014年6月批准Nexavar用于局部晚期或转移性放射性碘(RAI)难治性分化型甲状腺癌（DCT）的治疗，是美国和欧盟首个获批专门用于放射性碘难治性分化型甲状腺癌的药物。 关于多吉美（Nexavar） Nexavar是一种口服抗癌药物，目前已获全球100多个国家批准，用于肝癌和晚期肾癌的治疗。在欧洲，Nexavar获批用于肝细胞癌（HCC）及既往经α干扰素或白介素2（IL-2）治疗失败或被认为不适用这类疗法的晚期肾细胞癌（RCC）的治疗。 在临床前研究中，Nexavar已被证明能够抑制参与细胞增殖和血管生成过程中的多种激酶，包括Raf激酶、VEGFR-1、VEGFR-2、VEGFR-3、PDGFR-B、KIT、FLT-3和RET。 目前，拜耳和Onyx制药、国际研究团体、政府机构及个体研究者也在调查Nexavar在其他癌症中的疗效。 日本原处方资料附件：http://www.info.pmda.go.jp/go/pack/4291017F1025_1_25/ Nexavar 200mg（ネクサバール錠200mg） NEXAVAR(Sorafenib Tosilate tablets) Brand name : Nexavar 200mg 　Active ingredient: Sorafenib tosilate 　Dosage form: red tablet, diameter: 10 mm, thickness: 4.5 mm 　Print on wrapping: NEXAVAR 200 mg Effects of this medicine This medicine shows anti-tumor effects by inhibiting tumor proliferation and vascularization through inhibition of kinases associated with tumor progression. It is usually used for treatment of renal cell carcinoma (radically unresectable or metastatic), unresectable hepatocellular carcinoma, and radically unresectable differentiated thyroid cancer. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. •If you are pregnant, possibly pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, for adults, take 2 tablets (400 mg as sorafenib) at a time 2 times a day. The dosage may be decreased according to the patient's condition. Strictly follow the instructions. •If you miss a dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time. •If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine •High-fat diets may lower the level of this medicine in plasma and reduce its effect. Avoid taking this medicine between 1 hour before and 2 hours after high-fat meals. •Teratogenic effects have been reported in animal studies. Use an effective contraceptive method if you are a woman of child-bearing potential. Furthermore, avoid breastfeeding, as transfer to breast milk has been reported in animal studies. Possible adverse reactions to this medicine The most commonly reported adverse reactions include hand-and-foot syndrome (pain, redness, swelling, peeling skin, blisters, etc., in the palm and sole), alopecia, diarrhea, rash/desquamation, pain, hypertension, fatigue, weight loss, loss of appetite, stomatitis, itch, nausea, hoarseness (hoarse voice), and dry skin. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •conjunctival hyperemia, mucosal erosions of the mouth, lips, vulva, etc., systemic rash accompanied by fever, blister [toxic epidermal necrolysis, Stevens-Johnson syndrome] •yellowness in the skin and/or the white of the eyes, nausea, vomiting [liver disorder such as hepatitis fulminant, hepatic failure] •fever, headache, dry cough, breathing difficulty [acute lung disorder, interstitial pneumonitis] •marked increase in blood pressure, decreased consciousness, severe headache [high blood pressure crisis] •chest pain, pressured feeling in chest, breathing difficulty [myocardial ischemia, myocardial infarction] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Keep out of the reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. Ask the pharmacy or medical institution how to discard them. Bayer Yakuhin, Ltd.Internal Revised: 6/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895  ------------------------------------------ 产地国家：日本 原产地英文商品名: Nexavar（ネクサバール錠）200mg/Tablet 56tablets(28tablets×2)/box 原产地英文药品名: Sorafenib Tosilate 中文参考商品译名: Nexavar片（ネクサバール錠）200毫克/片 56片（28片×2）/盒 中文参考药品译名: 索拉非尼司特 生产厂家中文参考译名: 拜耳药品 生产厂家英文名: Bayer 曾用名: 索拉非尼、多吉美