Mekinist

Mekinist (Trametinib) 是一种靶向治疗药物，用于黑色素瘤和非小细胞肺癌的治疗。它通过抑制霍奇金淋巴瘤激酶(BRAF)信号通路的活性，帮助控制疾病并延长生存期。

2014年1月10日，美国食品药品监督管理局(FDA)批准Mekinist(trametinib)与Tafinlar (dabrafenib)联用治疗有不可切除的(不能用外科去除)和转移(晚期)晚期黑色素瘤患者。

2013年5月， FDA批准两药作为单药治疗不可切除的或转移黑色素瘤患者。

Mekinist 可单独使用或与达拉非尼 (Tafinlar) 联合使用，用于治疗某些类型的黑色素瘤（一种皮肤癌）。

Mekinist 还与达拉非尼联合使用，用于预防手术后某种黑色素瘤复发。Mekinist 还与达拉非尼联合使用，用于治疗某些类型的非小细胞肺癌 (NSCLC) 和甲状腺癌。

Mekinist 还与达拉非尼联合使用，用于治疗成人和 6 岁以上儿童的某些类型实体肿瘤，以及治疗 1 岁或以上儿童的某种类型的神经胶质瘤（某种类型的癌性脑瘤）。

曲美替尼属于一类称为激酶抑制剂的药物。曲美替尼通过阻断向癌细胞发出增殖信号的异常蛋白质的作用起作用。这有助于阻止癌细胞扩散。

当癌症已经扩散到身体的其他部位，无法进行手术治疗，或为了防止癌症在手术后复发，通常会使用 Mekinist 治疗。

Mekinist is used alone or in combination with dabrafenib (Tafinlar) to treat certain types of melanoma (a type of skin cancer).

Mekinist is also used in combination with dabrafenib to prevent the return of a certain type of melanoma after surgery. Mekinist is also used in combination with dabrafenib to treat certain types of non-small-cell lung cancer (NSCLC) and thyroid cancer.

Mekinist is also used in combination with dabrafenib to treat certain types of solid tumors in adults and children 6 years of age older and to treat a certain type of glioma (a certain type of cancerous brain tumor) in children 1 year of age or older.

Trametinib belongs to a class of medications called kinase inhibitors. Mekinist works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Mekinist is often given when the cancer has spread to other parts of the body, when surgery is not an option, or to keep the cancer from coming back after surgery.

Your doctor will make sure you have the correct tumor type to be treated with Mekinist.

活性成分：曲美替尼。
非活性成分：片剂 - 片剂核心：胶体二氧化硅、交联羧甲基纤维素钠、羟丙甲纤维素、硬脂酸镁（植物来源）、甘露醇、微晶纤维素和十二烷基硫酸钠。
片剂包衣：羟丙甲纤维素、氧化铁红（2 毫克片剂）、氧化铁黄（0.5 毫克片剂）、聚乙二醇、聚山梨醇酯 80（2 毫克片剂）和二氧化钛。
口服溶液：倍他曲松磺丁基醚钠、柠檬酸一水合物、磷酸氢二钠、对羟基苯甲酸甲酯、山梨酸钾、三氯蔗糖和草莓香精。

活性成分：曲美替尼。
非活性成分：片剂 - 片芯：胶体二氧化硅、羧甲基纤维素钠交联物、羟丙甲纤维素、植物来源的硬脂酸镁、甘露醇、微晶纤维素和月桂硫酸钠。
包衣：羟丙甲纤维素、氧化铁红（2毫克片剂）、氧化铁黄（0.5毫克片剂）、聚乙二醇、聚山梨醇酯80（2毫克片剂）和二氧化钛。
口服溶液：磺丁基倍他环糊精钠、一水合柠檬酸、无水磷酸二氢钠、对羟基苯甲酸甲酯、山梨酸钾、蔗糖和草莓味。

• Lumakras
• Afatinib
• Lorviqua
• Durvalumab
• Imfinzi
• Opdivo
• Tagrisso
• Tecentriq
• Crizalk
• Lorlatinib
• Osimertinib
• Alecensa
• Alunbrig
• Gavreto
• Zykadia
• Krazati
• Braftovi
• Proleukin
• Vitrakvi
• Keytruda

将 Mekinist 与达拉非尼合用可能会增加您患上某种皮肤癌的风险。如果您发现新的皮肤症状，如发红、疣、无法愈合的溃疡或大小或颜色发生变化的痣，请告知您的医生。

Using Mekinist with dabrafenib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice new skin symptoms such as redness, warts, sores that will not heal, or a mole that has changed in size or color.

Your healthcare provider should check your skin before you start treatment, and every two months while taking Mekinist to look for any new skin cancers.

Your healthcare provider may continue to check your skin for six months after you stop treatment.

Mekinist 的常见副作用可能包括：

恶心、呕吐、腹泻、食欲不振、便秘；

发烧，发冷，疲倦，胃痛；

头痛;

出血；

血压升高；

肌肉、骨骼或关节疼痛；

咳嗽，呼吸急促；

手臂、脸和腿肿胀；

皮疹，痤疮，皮肤干燥。

Mekinist 还可能会引起严重的副作用。如果您出现以下情况，请立即赴医院就诊：

出现过敏反应的迹象（荨麻疹、呼吸困难、面部或喉咙肿胀）或严重的皮肤反应（发烧、喉咙痛、眼睛灼热、皮肤疼痛、红色或紫色皮疹并伴有起泡和剥落）；

出现严重的药物反应，并且会影响身体的多个部位，请寻求医疗救治。症状可能包括皮疹、发烧、腺体肿胀、肌肉疼痛、严重虚弱、异常瘀伤或皮肤或眼睛发黄；

出现严重的胃痛、出血、腹泻、发烧或恶心；

异常瘀伤或出血，新的感染迹象（发烧，虚弱，咳嗽，腹泻，排尿困难）；

皮疹；

咳嗽，呼吸急促；

严重头痛、视力模糊、颈部或耳朵疼痛；

高血糖——口渴增加，排尿增加，口干，口气有水果味；

眼睛问题的迹象——眼睛疼痛或肿胀、视力变化、看到灯光周围有光晕、在视野中看到彩色“点”；

体内出血的迹象——虚弱、头晕、头痛、尿液呈红色或粉红色、大便带血或柏油样、咳血或呕吐物呈咖啡渣状；

血栓的迹象——胸痛、突然咳嗽或呼吸困难、手臂或腿部疼痛或肿胀、皮肤苍白、手臂或腿部感觉寒冷；

心脏问题的迹象-呼吸短促（即使轻微用力）、心跳加速、脚或脚踝肿胀。

Get emergency medical help if you have signs of an allergic reaction to Mekinist (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Some people taking Mekinist have developed a perforation (a hole or tear) or swelling in the stomach or intestines. Call your doctor if you have severe stomach pain, bleeding, diarrhea, fever, or nausea.

Mekinist may cause serious side effects. Call your doctor at once if you have:

• unusual bruising or bleeding, new signs of infection (fever, weakness, cough, diarrhea, problems urinating);

• a skin rash;

• cough, feeling short of breath;

• severe headache, blurred vision, pounding in your neck or ears;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• signs of eye problems - eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;

• signs of bleeding inside the body - weakness, dizziness, headache, red or pink urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of a blood clot - chest pain, sudden cough or trouble breathing, pain or swelling in an arm or leg, pale skin, cold feeling in an arm or leg; or

• signs of a heart problem - shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Mekinist side effects may include:

• nausea, vomiting, diarrhea, loss of appetite, constipation;

• fever, chills, tiredness, stomach pain;

• headache;

• bleeding;

• increased blood pressure;

• muscle, bone, or joint pain;

• cough, shortness of breath;

• swelling in your arms, face, and legs; or

• rash, acne, dry skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

为了确保 Mekinist 对您安全，请告知医生您是否曾出现过以下情况：

心脏问题，高血压；

糖尿病;

肺部或呼吸问题；

胃或肠道疾病；

眼睛问题（尤其是视网膜）；

出血问题，血栓；

肝脏或肾脏疾病。

如果母亲或父亲正在使用 Mekinist，曲美替尼可能会伤害未出生的婴儿。

如果您是女性，您可能需要进行妊娠测试以确保您没有怀孕。使用 Mekinist 期间以及最后一次服药后至少 4 个月内，请采取避孕措施。如果您在怀孕，请告知您的医生。如果怀孕了，请立即告知医生。

如果您是男性，如果您的性伴侣能够怀孕，请在治疗期间使用避孕套。在最后一次服药后至少 4 个月内继续使用避孕药。

使用 Mekinist 期间以及最后一次服药后至少 4 个月内请勿母乳喂养。

To make sure Mekinist is safe for you, tell your doctor if you have ever had:

• heart problems, high blood pressure;

• diabetes;

• lung or breathing problems;

• a stomach or intestinal disorder;

• eye problems (especially with your retina);

• bleeding problems, blood clot; or

• liver or kidney disease.

Using Mekinist may increase your risk of developing other cancers. Ask your doctor about this risk.

Trametinib can harm an unborn baby if the mother or the father is using Mekinist.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using Mekinist and for at least 4 months after your last dose. Tell your doctor if you become pregnant.

• If you are a man, use condoms during treatment if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.

• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using Mekinist, and for at least 4 months after your last dose.

其他药物可能会与曲美替尼发生相互作用，包括处方药和非处方药、维生素 和 草药产品。请告知医生您使用的所有其他药物。

每天空腹服用一次，至少在饭前 1 小时或饭后 2 小时服用。

将药片整个吞下，不要压碎、咀嚼或掰开。

如果服用 Mekinist 后不久出现呕吐，请勿再服用另一剂。请按计划服用下一剂。

在准备第一剂口服混悬液之前，请遵循所有说明。摇匀口服混悬液（液体）。使用提供的测量装置（不是厨房勺）测量剂量。口服混悬液也可以通过喂食管给药。

Take Mekinist exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take once per day on an empty stomach, at least 1 hour before or 2 hours after a meal.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking Mekinist, do not take another dose. Take your next dose as scheduled

Follow all instructions for the oral suspension before preparing your first dose. Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon). The oral suspension can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

You will need frequent medical tests to help determine if it is safe for you to keep receiving Mekinist. Your dose or medication schedule may be changed based on the results. Make sure to not miss any follow-up appointment.

Check your skin regularly during treatment and up to 6 months after taking Mekinist. Tell your doctor if you notice any new skin change such as redness, sores that will not heal, a new wart, or a mole that has changed in size or color.

Store the tablet in the refrigerator, do not freeze. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative. Do not store tablets in a pill box.

Store the mixed oral suspension at room temperature away from moisture and heat. Throw the oral suspension away after 35 days.

尽快服药，但如果下次服药时间在 12 小时以内，则跳过未服用的剂量。不要一次服用两剂。

尽快服药，但如果下次剂量在12小时内就要服用，则跳过漏服的剂量。不要一次使用两次剂量。

请立即就医或向您的主治医生咨询。

请立即寻求紧急医疗救助。

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