乐伐替尼硬胶囊Lenvima 10mg hard capsules

药店国别:

产地国家:英国

处方药:

所属类别: 10毫克/胶囊 30胶囊/盒

包装规格: 10毫克/胶囊 30胶囊/盒

计价单位:盒

生产厂家中文参考译名:

生产厂家英文名:Eisai Co.,Ltd.

原产地英文商品名:LENVIMA 10mg/cap 30cap/box

原产地英文药品名:lenvatinib

中文参考商品译名:LENVIMA胶囊 10毫克/胶囊 30胶囊/盒

中文参考药品译名:乐伐替尼

曾用名:

简介:部份中文乐伐替尼处方资料(仅供参考)英文名:lenvatinib商标名:Lenvima Capsules中文名:乐伐替尼胶囊原研公司:卫材(Eisai)研发批准日期:2017年2月7日(肝细胞癌) 2016年5月20日(肾细胞癌)2015年6月12日(甲状腺癌)药品简介LENVIMA(lenvatinib)胶囊,为口服使用美国初次批准:2015

作用机制

Lenvatinib是一种受体酪氨酸激酶(RTK)抑制剂,抑制血管内皮生长因子(VEGF)受体VEGFR1(FLT1),VEGFR2(KDR),和VEGFR3(FLT4)的激酶活性。Lenvatinib还抑制牵连其他RTKs病理性血管生成,肿瘤生长,和癌进展除了它们的正常细胞功能,包括纤维母细胞生长因子(FGF)受体FGFR1,2,3,和4;血小板衍生生长因子受体α (PDGFRα),KIT,和RET。

适应证和用途

LENVIMA是一种激酶抑制剂适用为有局部地复发或转移,进展性,放射性碘-难治性分化型甲状腺癌患者的治疗。

剂量和给药方法

⑴ 推荐剂量:24mg口服,每天一次.

⑵ 在有严重肾或肝受损患者,剂量是14mg每天一次.

剂型和规格胶囊:

4mg和10mg.

禁忌证

无。

警告和注意事项

⑴ 高血压:用LENVIMA治疗前控制血压。对尽管优化高血压治疗的3级高血压不给LENVIMA。对危及生命高血压终止药物。

⑵ 心力衰竭:监视心脏代偿失调的临床症状和体征。对3级不给LENVIMA心功能不全。对4级心功能不全终止药物。

⑶ 动脉血栓栓塞事件:一次动脉血栓栓塞事件后终止LENVIMA。

⑷ 肝毒性: LENVIMA开始前和治疗自始至终定期地监视肝功能检验. 对3级或更大肝受损不给LENVIMA。对肝衰竭终止治疗。

⑸ 蛋白尿:用LENVIMA开始治疗前,和自始至终定期地,监视蛋白尿。对24小时尿蛋白≥2 克不给LENVIMA。对肾病综合征终止用药。

⑹ 肾衰竭和肾受损: 对3或4级肾衰竭/受损不给LENVIMA。

⑺ 胃肠道穿孔和瘘管形成:发生胃肠道穿孔或危及生命瘘管患者中终止LENVIMA。

⑻ QT间期延长:在所有患者中监视和纠正电解质异常。对发生3级或更大QT间期延长不给LENVIMA。

⑼ 低钙血症:监视血钙水平至少每月和需要时给予替代钙。

⑽ 可逆性后部白质脑病综合征(RPLS): 对RPLS不给LENVIMA直至完全解决。

⑾ 出血事件:对3级出血不给LENVIMA。对4级出血终止治疗。

⑿ 甲状腺刺激激素抑制的受损:每月监视TSH水平和有DTC患者需要时调整甲状腺取代药物。

⒀ 胚胎胎儿毒性:可能致胎儿危害。忠告对胎儿潜在风险和使用有效避孕。

不良反应

对LENVIMA最常见不良反应(发生率大于或等于30%)是高血压,疲乏,腹泻,关节痛/肌肉痛,食欲减退,体重减轻,恶心,口炎,头痛,呕吐,蛋白尿,掌,跖红肿综合征,腹痛,和发音困难。

特殊人群中使用

哺乳:终止哺乳喂养。

乐伐替尼英文版说明书

LenvimaGeneric Name: lenvatinibBrand Names: LenvimaLENVIMA™ (lehn-veema)(lenvatinib)capsulesRead this Patient Information leaflet before you start taking LENVIMA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.What is LENVIMA?LENVIMA is a prescription medicine used to treat people with differentiated thyroid cancer (DTC, a type of thyroid cancer) that can no longer be treated with radioactive iodine and is progressing.It is not known if LENVIMA is safe and effective in children.What should I tell my healthcare provider before taking LENVIMA?Before you take LENVIMA, tell your healthcare provider if you:•have high blood pressure•have heart problems•have a history of blood clots in your arteries (type of blood vessel), including stroke, heart attack, or change in vision•have or have had kidney or liver problems•have a history of a tear (perforation) in your stomach or intestine, or an abnormal connection between two parts of your gastrointestinal tract (fistula)•have headaches, seizures, or vision problems•have any bleeding problems•are pregnant or plan to become pregnant. LENVIMA can harm your unborn baby.◦Females who are able to become pregnant should use an effective method of birth control during treatment with LENVIMA and for at least 2 weeks after the last dose of LENVIMA. Talk with your healthcare provider about birth control methods you can use during this time.◦Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with LENVIMA.•are breastfeeding or plan to breastfeed. It is not known if LENVIMA passes into your breast milk. Do not breastfeed during treatment with LENVIMA.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Know the medicines you take. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.How should I take LENVIMA?•Take LENVIMA exactly as your healthcare provider tells you to take it.•Your healthcare provider will tell you how much LENVIMA to take and when to take it. Your healthcare provider may change your dose during treatment, stop treatment for some time, or completely stop treatment with LENVIMA if you have side effects.•Take LENVIMA 1 time each day at the same time, with or without food.•If you miss a dose of LENVIMA, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take the next dose at your regular time.•If you take too much LENVIMA, call your healthcare provider or go to the nearest hospital emergency room right away.What are the possible side effects of LENVIMA?LENVIMA may cause serious side effects, including:•high blood pressure (hypertension). High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose of LENVIMA, or stop your treatment with LENVIMA.•heart problems. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles.•problem with blood clots in your blood vessels (arteries). Get emergency medical help right away if you get any of the following symptoms:◦severe chest pain or pressure◦pain in your arms, back, neck or jaw◦shortness of breath◦numbness or weakness on one side of your body◦trouble talking◦sudden severe headache◦sudden vision changes•liver problems. LENVIMA may cause liver problems that may lead to liver failure and death. Your healthcare provider will check your liver function before and during treatment with LENVIMA. Tell your healthcare provider right away if you have any of the following symptoms:◦your skin or the white part of your eyes turns yellow (jaundice)◦dark “tea colored” urine◦light-colored bowel movements (stools)•increased protein in your urine (proteinuria). Proteinuria is a common side effect of LENVIMA and can be serious. Your healthcare provider should check your urine for protein before and during your treatment with LENVIMA. If you develop protein in your urine, your healthcare provider may decrease your dose of LENVIMA or stop your treatment.•kidney problems. Kidney failure has happened with LENVIMA treatment. Your healthcare provider should do regular blood tests to check your kidneys.•an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two parts of your gastrointestinal tract (fistula). Get emergency medical help right away if you have severe stomach (abdomen) pain.•changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider will do blood tests during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an ECG.•low levels of blood calcium (hypocalcemia). Your healthcare provider will check your blood calcium levels during treatment with LENVIMA.•a condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS). Call your healthcare provider right away if you get: severe headache, seizures, weakness, confusion, or blindness or change in vision.•bleeding. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment with LENVIMA, including:◦severe and persistent nose bleeds◦vomiting blood◦red or black (looks like tar) stools◦coughing up blood or blood clots◦heavy or new onset vaginal bleeding•change in thyroid hormone levels. You may have changes in your thyroid hormone levels when taking LENVIMA. Your healthcare provider may need to change your dose of thyroid medicine while you are taking LENVIMA. Your healthcare provider should check your thyroid hormone levels every month during treatment with LENVIMA.The most common side effects of LENVIMA include:•tiredness•diarrhea•joint and muscle pain•decreased appetite•weight loss•nausea•mouth sores•headache•vomiting•rash, redness, itching or peeling of your skin on your hands and feet•stomach-area (abdomen) pain•hoarsenessLENVIMA may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of LENVIMA. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store LENVIMA?•Store LENVIMA at room temperature, between 68°F to 77°F

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