比美替尼薄膜片Mektovi film-coated tablets 15mg(binimetinib)

药店国别： 产地国家：法国 处方药：是 所属类别： 15毫克/片 84片/盒 包装规格： 15毫克/片 84片/盒 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：Pierre Fabre Limited 原产地英文商品名：Mektovi film-coated 15mg/tablets 84tablets/box 原产地英文药品名：binimetinib 中文参考商品译名：Mektovi薄膜片 15毫克/片 84片/盒 中文参考药品译名：比美替尼 曾用名： 简介： 部分中文MEKTOVI处方资料(仅供参考)MEKTOVI(binimetinib)片剂，用于口服薄膜片 作用机制 Binimetinib是有丝分裂原激活的细胞外信号调节激酶1(MEK1)和细胞因子的可逆抑制剂MEK2活动。MEK蛋白是细胞外信号相关激酶(ERK)的上游调节因子途径。在体外，binimetinib抑制细胞中的细胞外信号相关激酶(ERK)磷酸化免疫测定以及BRAF-突变型人黑素瘤细胞的活力和MEK依赖性磷酸化线。 Binimetinib还抑制BRAF突变小鼠体内ERK磷酸化和肿瘤生长异种移植模型。Binimetinib和encorafenib靶向RAS/RAF/MEK/ERK途径中的两种不同激酶。相比单独一种药物，共同给予encorafenib和binimetinib导致更强的抗增殖作用.BRAF突变阳性细胞系的体外活性和对肿瘤的更强的抗肿瘤活性在小鼠中BRAF V600E突变体人黑素瘤异种移植物研究中的生长抑制。另外，binimetinib和encorafenib的组合延迟了BRAF V600E突变体中抗性的出现小鼠中的人黑色素瘤异种移植物与单独的任一种药物相比。 适应症和用法 MEKTOVI是一种激酶抑制剂，与encorafenib联合用于治疗患有BRAF V600E或V600K突变的不可切除或转移性黑色素瘤患者，通过FDA批准的检测。 剂量和给药 在开始MEKTOVI之前确认肿瘤标本中存在BRAF V600E或V600K突变。推荐剂量为每天口服45毫克，与恩诺非尼联合使用。带或不带食物的MEKTOVI。对于中度或重度肝功能损害的患者，推荐剂量为每天两次口服30毫克。剂量形式和强度片剂：15毫克。 禁忌症 没有。 警告和注意事项 心肌病：在开始治疗前，治疗一个月后评估左心室射血分数(LVEF)，然后每2至3个月评估一次。 MEKTOVI的安全性还没有建立在LVEF低于50%的患者中。静脉血栓栓塞：可发生深静脉血栓形成和肺栓塞。眼部毒性：发生了浆液性视网膜病，视网膜静脉阻塞(RVO)和葡萄膜炎。定期进行眼科评估并进行任何视力障碍。间质性肺病(ILD)：评估可能的ILD的新的或进行性的不明原因的肺部症状或发现。肝毒性：在临床指示之前和治疗期间监测肝功能检查。横纹肌溶解症：监测肌酸磷酸激酶和肌酐，并按临床指示。出血：可能发生严重的出血事件。胚胎 - 胎儿毒性：可能导致胎儿伤害。建议女性具有胎儿潜在风险的生殖潜力并使用有效的感染。 不良反应 MEKTOVI最常见的不良反应(≥25%)与encorafenib联合使用，包括疲劳，恶心，腹泻，呕吐和腹痛。 用于特定人群哺乳期： 建议不要母乳喂养。 比美替尼薄膜片英文版说明书 What Mektovi is and what it is used forMektovi is an anti-cancer medicine that contains the active substance binimetinib. It is used in adults in combination with another medicine containing encorafenib to treat a type of skin cancer called melanoma when it hasa particular change (mutation) in a gene responsible for producing a protein called BRAF, andspread to other parts of the body or cannot be removed by surgery.Mutations in the BRAF gene can produce proteins that cause the melanoma to grow. Mektovi targets another protein called “MEK” that stimulates cancer cell growth. When Mektovi is used in combination with encorafenib (which targets the changed “BRAF” protein), the combination slows down or stops the growth of your cancer.2. What you need to know before you take MektoviBefore starting treatment your doctor will check for BRAF mutation.As Mektovi is to be used in combination with encorafenib, read the encorafenib leaflet carefully as well as this leaflet.Do not take Mektoviif you are allergic to binimetinib or any of the other ingredients of this medicine (listed in section 6).Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking Mektovi about all of your medical conditions, particularly if you have any of the following:heart problemsbleeding problems or if you are taking medicines that may cause bleedingeye problems including glaucoma or increased pressure in your eyesmuscle problemshigh blood pressureblood clotslung or breathing problemsliver problemsTell your doctor if you have ever had blockage in the vein carrying blood away from the eye (retinal vein occlusion), as Mektovi is not recommended in such cases.Tell your doctor if you have had a different type of cancer than melanoma, as binimetinib when taken with encorafenib may worsen certain other types of cancers.Tell your doctor, pharmacist or nurse immediately if you get the following while you are taking this medicine:Heart problems: Mektovi can make your heart work less well, or make existing heart problems worse. Your doctor will check that your heart is working properly before and during your treatment with this medicine. Talk to your doctor immediately if you have any symptoms of heart problems such as feeling dizzy, tired, lightheaded, if you have shortness of breath, if you feel like your heart is pounding, racing, beating irregularly or if you have swelling in the legs.Bleeding problems: Mektovi may cause serious bleeding problems. Talk to your doctor immediately if you have any symptoms of bleeding problems such as coughing up of blood, blood clots, vomit containing blood or that looks like “coffee grounds”, red or black stools that look like tar, passing blood in the urine, stomach (abdominal) pain, unusual vaginal bleeding. Also tell you doctor if you have headache, dizziness or weakness.Eye problems: Mektovi can cause serious eye problems. Talk to your doctor immediately if you get blurred vision, loss of vision or other vision changes (such as coloured dots in your vision), halo (seeing blurred outline around objects). Your doctor will examine your eyes for any problems with your sight while you are taking Mektovi.Muscle problems: Mektovi can cause breakdown of muscle (rhabdomyolysis). You doctor will run blood tests to check for muscle problems before and during treatment. As a precaution, drink plenty of fluids during treatment. Talk to your doctor immediately if you get muscle pain, cramps, stiffness, spasm, dark urine.High blood pressure: Mektovi can raise blood pressure. Your doctor or nurse will check your blood pressure before and during treatment with Mektovi. Talk to your doctor immediately if you get severe headache, feel dizzy, lightheaded or if your blood pressure measured on a home blood pressure device is much higher than usual.Blood clots: Mektovi can cause blood clots in your arms or legs, and if a clot travels to your lungs it could lead to death. Talk to your doctor immediately if you get chest pain, sudden shortness of breath, trouble breathing, pain in your legs with or without swelling, swelling in your arms and legs, or a cool, pale arm or leg. If necessary, your doctor may interrupt your treatment or stop it altogether.Lung or breathing problems: This medicine may cause lung or breathing problems including inflammation of the lungs (pneumonitis or interstitial lung disease); signs and symptoms can include: cough, shortness of breath or fatigue. If necessary, your doctor may interrupt your treatment or stop it altogether.Skin changes: Mektovi, when taken with encorafenib, may cause other types of skin cancer such as cutaneous squamous cell carcinoma. Your doctor will check your skin before initiation of treatment, every 2 months during treatment, and for up to 6 months after you stop taking these medicines to look for any new skin cancer. Tell your doctor immediately if you detect any skin changes during and after the treatment including: new wart, skin sore or reddish bump that bleeds or does not heal, or a change in size or colour of a mole.Additionally, your doctor needs to check for squamous cell carcinoma on your head, neck, mouth and lymph glands, and you will have CT scans regularly. This is a precaution in case a squamous cell carcinoma develops inside your body. Genital examinations (for women) and anal examinations are also recommended before the initiation and at the end of your treatment.Liver problems: Mektovi can cause abnormal blood tests related to your liver (raised levels of liver enzymes). Your doctor will run blood tests to check your liver before and during treatment.Children and adolescentsMektovi is not recommended for children and adolescents under 18 years of age. This medicine has not been studied in this age group.Other medicines and MektoviTell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.Some medicines may affect how Mektovi works, or make it more likely that you will have side effects. In particular, tell your doctor if you are taking anything in this list or any other medicines:some medicines to treat bacterial infections such as rifampicin, ciprofloxacinsome medicines typically used to treat epilepsy such as phenobarbital, phenytoin, carbamapezinesome medicines to treat HIV such as indinavir, atazanavira medicine for carcinoma treatment called sorafeniban herbal treatment for depression: St. John’s wortmedicine used to treat depression such as duloxetinemedicine typically used to treat high cholesterol such as pravastatina medicine used to treat breathing problems, theophylline.Pregnancy and breast-feedingPregnancyMektovi is not recommended during pregnancy. It may cause permanent harm or birth defects to an unborn baby.If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.If you are a woman who could become pregnant, you must use reliable contraception while you are taking Mektovi, and you must continue to use reliable contraception at least 1 month after taking your last dose. Contact your doctor straightaway if you become pregnant while taking Mektovi.Breast-feedingMektovi is not recommended while breast-feeding. It is not known if Mektovi passes into breast milk. If you are breast-feeding, or planning to breast-feed, ask your doctor for advice before taking this medicine.Driving and using machinesMektovi can affect your ability to drive or use machines. Avoid driving or using machines if you have any problems with your vision or have any other side effects that can affect your ability to drive or use machines (see section 4), while taking Mektovi. Talk to your doctor if you are not sure you can drive.Mektovi contains lactoseIf you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.3. How to take MektoviHow much to takeAlways take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.The recommended dose of Mektovi is 45 mg (3 tablets of 15 mg) twice daily, taken about 12 hours apart (corresponding to a daily dose of 90 mg). You will also receive treatment with another medicine, encorafenib.If you get serious side effects (such as heart, eye or skin problems) your doctor may lower the dose or stop treatment temporarily or permanently.How to take MektoviSwallow the tablets whole with water. Mektovi can be taken with food or between meals.If you are sickIf you vomit at any time after taking Mektovi, do not take an additional dose. Take the next dose as scheduled.If you take more Mektovi than you shouldIf you take more tablets than you should, contact your doctor, pharmacist or nurse straightaway. If possible, show them this leaflet and the medicine package.If you forget to take MektoviIf you miss a dose of Mektovi, take it as soon as you remember. However, if the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time. Then continue taking your tablets at regular times as usual.Do not take a double dose to make up for a forgotten dose.If you stop taking MektoviIt is important to take Mektovi for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.4. Possible side effectsLike all medicines, this medicine can cause side effects, although not everybody gets them.Serious side effectsMektovi may cause serious side effects. Tell your doctor immediately if you have any of the following serious side effects, either for the first time or if they get worse (see also section 2).Heart problems: Mektovi can affect how well your heart works (left ventricular ejection fraction decrease); signs and symptoms can include:feeling dizzy, tired or lightheadedshortness of breathfeeling like your heart is pounding, racing or beating irregularlyswelling in the legsHigh blood pressure: Mektovi can increase blood pressure. Tell your doctor immediately if you get severe headache, feel dizzy or lightheaded or if your blood pressure measured on a home blood pressure device is much higher than usual.Blood clots: Mektovi may cause blood clots (venous thromboembolism including pulmonary embolism); signs and symptoms can include:chest painsudden shortness of breath or trouble breathingpain in your legs with or without swellingswelling in your arms and legsa cool, pale arm or legEye problems: Mektovi can cause fluid to leak under the retina in the eye, leading to detachment of different layers in the eye (retinal pigment epithelial detachment) which could lead to:blurred vision, loss of vision, or other vision changes (such as coloured dots in your vision)halo (seeing blurred outline around objects)eye pain, swelling or rednessMuscle problems: Mektovi can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include:muscle pain, cramps, stiffness or spasmdark urineBleeding problems: Mektovi can cause serious bleeding problems. Tell your doctor right away if you have any unusual bleeding or signs of bleeding, including:headaches, dizziness or weaknesscoughing up of blood or blood clotsvomit containing blood or that looks like “coffee grounds”red or black stools that look like tarpassing blood in the urinestomach (abdominal) painunusual vaginal bleedingOther skin cancers: When Mektovi is taken with encorafenib, the patient may develop different types of skin cancer such as cutaneous squamous cell carcinoma. Usually, these skin cancers (see also section 2) are confined to a small area and can be removed with surgery and treatment with Mektovi (and encorafenib) can continue without interruption.Other side effects when Mektovi and encorafenib are taken together:Besides the serious side effects mentioned above, people taking Mektovi and encorafenib together may also get the following side effects.Very common (may affect more than 1 in 10 people)reduced red blood cell count (anaemia)problem with the nerves resulting in pain, loss of sensation or tingling in hands and feetheadachedizzinessbleeding at various sites in the bodyproblems with your vision (visual impairment)stomach paindiarrhoeabeing sick (vomiting)feeling sick (nausea)constipationitchingdry skinhair loss or thinning (alopecia)skin rash of various typesthickening of the outer layers of the skinjoint pain (arthralgia)muscle pain, weakness or spasmback painpain in the extremitiesfeverswelling of the hands or feet (peripheral oedema), localised swellingfatigueabnormal blood test results for liver functionabnormal blood test result related to blood creatine kinase, indicating damage to heart and muscleCommon (may affect up to 1 in 10 people)some types of skin tumours such as skin papilloma and basal cell carcinomaallergic reaction that may include swelling of the face and difficulty breathingchanges in the way things tasteinflammation of the eye (uveitis)inflammation of the colon (colitis)redness, chapping or cracking of the skininflammation of the fatty layer under the skin, symptoms include tender skin nodulesskin rash with a flat discoloured area or raised bumps like acne (dermatitis acneiform)redness, skin peeling or blisters on hand and feet (palmar plantar erythrodysesthesia or hand and foot syndrome)kidney failureabnormal kidney test results (creatinine elevations)abnormal blood test results for liver function (blood alkaline phosphatase)abnormal blood test results for pancreas function (amylase, lipase)increased skin sensitivity to sunlightUncommon (may affect up to 1 in 100 people)weakness and paralysis of face musclesinflammation of the pancreas (pancreatitis) causing severe abdominal painReporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly viaUnited Kingdom:Yellow Card Schemewebsite: www.mhra.gov.uk/yellowcardor search for MHRA Yellow Card in the Google Play or Apple App Store.Ireland:HPRA PharmacovigilanceEarlsfort TerraceIRL - Dublin 2Tel: +353 1 6764971Fax: +353 1 6762517website: www.hpra.iee-mail: medsafety@hpra.ieBy reporting side effects you can help provide more information on the safety of this medicine.5. How to store MektoviKeep this medicine out of the sight and reach of children.Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.The expiry date refers to the last day of that month.This medicine does not require any special storage conditions.Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.6. Contents of the pack and other informationWhat Mektovi containsThe active substance is binimetinib. Each film-coated tablet contains 15 mg of binimetinib.The other ingredients are:Tablet core: lactose monohydrate, cellulose microcrystalline (E460i), silica colloidal anhydrous (E551), croscarmellose sodium (E468) and magnesium stearate (E470b). See section 2 “Mektovi contains lactose”.Tablet film-coat: polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E533b), iron oxide yellow (E172) and iron oxide black (E172).What Mektovi looks like and contents of the packMektovi film-coated tablets are yellow/dark yellow, unscored biconvex, oval film-coated tablets debossed with “A” on one side and “15” on the other side.Mektovi is available in packs of 84 tablets (7 blisters of 12 tablets each).Marketing Authorisation HolderPierre Fabre Médicament45, place Abel Gance92100 Boulogne-BillancourtFranceManufacturerPierre Fabre Médicament ProductionAquitaine Pharm International 1Avenue du Béarn64320 IdronFranceThis leaflet was last revised in September 2018.