2015年3月26日，卫材（Eisai）新型口服抗癌药Lenvima（lenvatinib）在获日本批准用于不可切除性甲状腺癌的治疗。这也是该药继今年2月获美国批准之后，攻下的又一重要市场。此前，lenvatinib在美国、日本、欧盟均被授予孤儿药地位及优先审查资格。该药作为一种具有重大公共卫生利益的创新药物，将帮助解决甲状腺癌领域存在的严重未满足的医疗需求。
卫材表示，Lenvima将成为不可切除性甲状腺癌临床治疗的新标准
根据卫材官方信息，在一项大型III期SELECT研究中，与安慰剂相比，lenvatinib显著延长了放射性碘难治性分化型甲状腺癌的无进展生存期（PFS：18.3个月vs 3.6个月）；同时，lenvatinib治疗组有显著更高比例的患者实现肿瘤体积缩小（65% vs 2%）。此外，在日本开展的另一项II期研究中，lenvatinib针对甲状腺髓样癌和未分化型甲状腺癌也表现出了很好的疗效和耐受性。
基于这些结果，Lenvima获日本监管机构批准，成为治疗不可切除性甲状腺癌（包括分化型甲状腺癌、甲状腺髓样癌、未分化型甲状腺癌）的首个分子靶向治疗药物。
LENVIMA Capsules 4mg（Lenvatinib Mesilate，レンビマカプセル 4mg）
Brand name : LENVIMA Capsules 4mg
　Active ingredient: Lenvatinib mesilate
　Dosage form: yellowish red capsule, full length: 14.3 mm, No.4 capsule
　Print on wrapping: (face) レンビマ4mg, (back) Lenvima, ∈ LENV4mg, レンビマ
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LENVIMA Capsules 10mg（Lenvatinib Mesilate，レンビマカプセル10mg）
Brand name : LENVIMA Capsules 10mg
　Active ingredient: Lenvatinib mesilate
　Dosage form: yellowish red to yellow capsule, full length: 14.3 mm, No.4 capsule
　Print on wrapping: (face) レンビマ10mg, (back) Lenvima, ∈ LENV10mg, レンビマ
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Effects of this medicine
This medicine exerts anti-tumor effects by inhibiting tumor proliferation and vascularization through inhibition of kinases associated with tumor progression.
It is usually used to treat radically unresectable 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 24 mg of the active ingredient at a time, once a day. The dosage may be adjusted according to your symptoms. This preparation contains 10 mg of the active ingredient in a capsule. Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should not 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
•Measure your blood pressure periodically.
•This medicine may cause fatigue, asthenia or dizziness. Pay close attention when performing dangerous operations such as driving a car.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hypertension, diarrhea, loss of appetite, weight loss, nausea, fatigue, stomatitis, and hand-foot syndrome (pain, redness and swelling, sloughed skin, or blisters in palms/soles). 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.
•significant elevation of blood pressure, semi-consciousness, severe headache [hypertension]
•anemic symptoms such as lightheadedness and dizziness, vomiting of blood, black stool [hemorrhage]
•disturbance of consciousness, headache or chest pain, breathing difficulty [arterial thromboembolism, venous thromboembolism]
•palpitation, breathing difficulty, disturbed pulse [cardiac disorder]
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.
•Keep in press-through package (PTP) sheet just before taking.
•Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.
Eisai Co., Ltd.Internal
Published: 6/2015
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.
http://www.info.pmda.go.jp/go/pack/4291039M1020_1_01/
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产地国家：日本
原产地英文商品名:
LENVIMA Capsules（レンビマカプセル）4mg/cap 20cap/box
原产地英文药品名:
Lenvatinib Mesilate
中文参考商品译名:
LENVIMA胶囊（レンビマカプセル）4毫克/胶囊 20胶囊/盒
中文参考药品译名:
乐伐替尼
生产厂家中文参考译名:
卫材
生产厂家英文名:
Eisai Co.，Ltd.

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产地国家：日本
原产地英文商品名:
LENVIMA Capsules（レンビマカプセル）10mg/cap 20cap/box
原产地英文药品名:
Lenvatinib Mesilate
中文参考商品译名:
LENVIMA胶囊（レンビマカプセル）10毫克/胶囊 20胶囊/盒
中文参考药品译名:
乐伐替尼
生产厂家中文参考译名:
卫材
生产厂家英文名:
Eisai Co.，Ltd.