苹果酸舒尼替尼(sunitinib malate)它是第一个批准的MRCC一线用药，也是第一个能够选择性地针对多种酪氨酸激酶受体的新型靶向药物 最先是由美国辉瑞公司开发的一种口服小分子多靶点酪氨酸激酶受体抑制剂。分别于2006年1月和2007年1月及2008年6月由美国FDA和欧洲EMEA及日本批准上市，商品名为Sutent，为口服硬明胶胶囊制剂，用于治疗胃肠道问质肿瘤(GIST)和晚期肾细胞瘤。 苹果酸舒尼替尼本品能抑制至少8种与肿瘤相关的受体酪氨酸激酶，以及肿瘤血管生长因子，对于肿瘤生长、细胞表达、转移显示出很强的抑制作用，在化疗或放疗的同时，使用舒尼替尼有助于增强抗肿瘤疗效。它对乳腺癌，结肠直肠癌、前列腺癌和非小细胞肺癌的临床试验正在进行中。 スーテントカプセル12.5mg 治疗类别名称 抗肿瘤药/激酶抑制剂 商標名 SUTENT Capsule 一般名 スニチニブリンゴ酸塩（Sunitinib Malate） 化学名 N-［2-（Diethylamino）ethyl］-5-［（Z）-（5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene）methyl］-2,4-dimethyl-1H-pyrrole-3-carboxamide mono［（2S）-2-hydroxysuccinate］ 分子式 C22H27FN4O2・C4H6O5 分子量 532.56 構造式 性状 スニチニブリンゴ酸塩は黄色～だいだい色の粉末である。ジメチルスルホキシドにやや溶けやすく、N,N-ジメチルホルムアミドにやや溶けにくく、水又はメタノールに溶けにくく、エタノール（99.5）に極めて溶けにくい。 0.1mol/L塩酸試液に溶ける。 分配係数（logD） 2.7（pH7.4、1-オクタノール／水） 包装 胶囊12.5毫克：14粒×4片（PTP） 生产和销售 辉瑞日本公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/4291018M1029_2_08/ SUTENT Capsule 12.5mg（スーテントカプセル12.5mg） Brand name : SUTENT Capsule 12.5mg 　Active ingredient: Sunitinib malate 　Dosage form: capsule with deep red-brown cap and body, φ5.3 mm, length 14.3 mm 　Print on wrapping: スーテント12.5mg, SUTNET12.5mg, STN12.5 Effects of this medicine This medicine has an anti-tumor effect by suppressing the receptor associated with tumor proliferation and vascularization. Usually, used for treatment of imatinib-resistant gastrointestinal stromal tumor, radically unresectable or metastatic renal cell carcinoma and pancreatic neuroendocrine tumors. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reaction (itch, rash etc.) to any medicine. If you have: heart problems such as heart failure. •If you are pregnant, breastfeeding or possibly pregnant. •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>> •For imatinib-resistant gastrointestinal stromal tumor and radically unresectable or metastatic renal cell carcinoma: in general, for adults, take 4 capsules (50 mg of sunitinib) once a day for consecutive 4 weeks. Then, discontinue taking for 2 weeks. This treatment course is repeated. The dosage should be adjusted according to your symptoms. For pancreatic neuroendocrine tumors: in general, for adults, take 3 capsules (37.5 mg of sunitinib) once a day. The dosage should be adjusted according to your symptoms. However, the daily dosage is up to 4 capsules(50 mg) once a day. Strictly follow the instructions in either case. •If you missed a dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time. •If you accidentally took more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking the medicine unless your doctor instructs you to do so. Precautions while taking this medicine •This medicine may cause dizziness, drowsiness or loss of consciousness. Be very careful when working at heights, driving a car or operating machinery. •Avoid taking food containing St. John's wort (a kind of herb) with the medicine, because the effect of the medicine may be decreased. •Avoid drinking grapefruit juice with the medicine, because the effect of the medicine may be increased. Possible adverse reactions to this medicine The most commonly reported adverse reactions include skin discoloration, hand-and-foot syndrome (tingling, hot flash, swelling), loss of appetite, fatigue, diarrhea, anemia, hypertension and abnormal liver function. 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. •anemia, fever, bleeding tendency [myelosuppression] •throat pain, rash, bacterial infection  [infections] •nose bleeding, subcutaneous bleeding, oral bleeding [bleeding] •dullness, palpitation, fainting  [heart failure, arrhythmia] •sweating, dullness, impotent feeling [thyroid dysfunction] 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. If you dispose of unused medicines, seek advice of your pharmacist about proper disposal of drugs. Pfizer Pharmaceuticals Inc.Internal Revised: 8/2012 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.