达沙替尼,达沙替尼片dasatinib (Sprycel Oral Tablet 100Mg)

药店国别:

产地国家:美国

处方药:

所属类别: 100毫克/片 30片/瓶

包装规格: 100毫克/片 30片/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Bristol Myers Squibb

原产地英文商品名:SPRYCEL 100mg/Tablet 30Tablets/bottle

原产地英文药品名:DASATINIB

中文参考商品译名:扑瑞赛 100毫克/片 30片/瓶

中文参考药品译名:达沙替尼

曾用名:

简介

部份中文施达赛处方资料(仅供参考)

用名称:达沙替尼片

商品名称:施达赛(Sprycel)

通别名:扑瑞赛

英文名称:dasatinib

批准日期:2015年5月

公司:百时美施贵宝

药品简介

Sprycel(达沙替尼 dasatinib)片剂,口服使用最初美国批准:2006年

作用机理

达沙替尼,在纳摩尔浓度,抑制下列激酶:BCR-ABL,SRC家族(Src,LCK,YES,FYN)中,c-KIT,EPHA2和PDGFRβ。基于建模研究,达沙替尼被预测为结合到ABL激酶的多个构象。在体外,达沙替尼是表示伊马替尼敏感和抗病的变体白血病细胞系活性。

达沙替尼抑制慢性粒细胞性白血病(CML)和急性淋巴细胞白血病(ALL)细胞系过表达BCR-ABL的生长。根据测定的条件下,达沙替尼能够克服由BCR-ABL激酶结构域的突变,涉及SRC家族激酶(LYN,HCK)和多药耐药性基因的过表达备用信号传导途径的激活导致伊马替尼抗性。

适应症和用法

和Sprycel是用于治疗所示的激酶抑制剂•初诊成人费城染色体阳性(Ph+)的慢性期慢性粒细胞性白血病(CML)。•慢性,加速,或骨髓或淋巴急变期的Ph+CML阻力或不能耐受伊马替尼,包括既往治疗的成年人。•费城染色体阳性的急性淋巴细胞白血病(PH+ALL)阻力或不耐受之前治疗的成年人。

用法用量

•慢性期CML:100毫克,每天一次。

•加速期CML,骨髓或淋巴急变期CML,或PH+ALL:140毫克,每天一次。

•管理口服,有或没有一顿饭。不要挤压或剪切。

剂型和规格片剂:20毫克,50毫克,70毫克,80毫克,100毫克和140毫克。

禁忌症:没有。

警告和注意事项

•骨髓抑制和出血事件:严重的血小板减少,可能会出现中性粒细胞减少和贫血。如果与抑制血小板功能或抗凝剂药物同时使用要小心。定期监测全血细胞计数。和输血时表示中断和Sprycel。

•液体潴留:体液潴留,有时严重,包括胸腔积液。与支持治疗措施和/或调整剂量管理。

•心功能不全:监测患者的体征或症状,并进行适当处理。

•肺动脉高压(PAH):和Sprycel可能增加PAH的风险,这可能是在停药可逆的。考虑基准风险和治疗过程中患者的评估和体征PAH的症状。停止和Sprycel如果PAH被确认。

•QT延长:使用和Sprycel慎用谁已经或可能发展的QT间期延长的患者。

•严重皮肤病反应:皮肤粘膜严重皮肤病反应,个别病例报道。

•肿瘤溶解综合征:有报道肿瘤溶解综合征。保持充足的水分和前开始治疗与和Sprycel正确的尿酸水平。

•胚胎-胎儿毒性:可引起胎儿造成伤害。的潜在风险劝告胎儿和避免怀孕。

不良反应

患者初诊慢性期CML最常见的不良反应(≥15%)包括骨髓抑制,水肿和腹泻。患者耐药或不耐受之前伊马替尼治疗最常见的不良反应(≥15%)包括骨髓抑制,液体潴留事件,腹泻,头痛,乏力,呼吸困难,皮疹,恶心,出血,肌肉骨骼疼痛。

药物相互作用

•CYP3A4抑制剂:可能增加达沙替尼药物水平;剂量减少可能是必要的。

•CYP3A4诱导剂:可降低达沙替尼药物水平;增加剂量可能是必要的。

•抗酸剂:可降低达沙替尼药物水平;避免同时管理。

•H2受体拮抗剂/质子泵抑制剂:可能会降低达沙替尼药物水平。

特殊人群中使用

•哺乳:不推荐

•肝损伤:使用和Sprycel在肝损伤患者慎用。

英文版说明

SprycelGeneric Name: dasatinib (da SAT in ib)Brand Names: Sprycel———————————————————————What is Sprycel?Sprycel (dasatinib) is a cancer medication that slows the growth and spread of cancer cells in the body.Sprycel is used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) when other cancer treatments have not been effective.Sprycel may also be used for purposes not listed in this medication guide.———————————————————————Important information about SprycelDo not use Sprycel if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving Sprycel, whether you are a man or a woman.Sprycel use by either parent may cause birth defects.Before taking Sprycel, tell your doctor if you have liver disease, low levels of potassium or magnesium in your blood, heart disease or a heart rhythm disorder, or if you have a personal or family history of "Long QT syndrome."Do not crush, chew, or break a Sprycel tablet. Swallow it whole.Breaking the pill may cause too much of the drug to be released at one time. There are many other drugs that can interact with Sprycel.Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.Sprycel can lower blood cells that help your body fight infections.This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.———————————————————————Before taking SprycelYou should not use Sprycel if:you have not first received a medication called imatinib (Gleevec); orif you are pregnant or planning to become pregnant during treatment with Sprycel.To make sure you can safely take Sprycel, tell your doctor if you have any of these other conditions:liver disease;low levels of potassium or magnesium in your blood;heart disease or a heart rhythm disorder; ora personal or family history of "Long QT syndrome."FDA pregnancy category D. Do not use Sprycel if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment. Use birth control to prevent pregnancy while you are receiving Sprycel, whether you are a man or a woman. Sprycel use by either parent may cause birth defects. A man taking Sprycel should use a condom during any sexual activity. It is not known whether dasatinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking Sprycel. This medication may affect fertility (your ability to have children), whether you are a man or a woman.Sprycel tablets contain lactose. Talk to your doctor before using this medication if you are lactose-intolerant.———————————————————————How should I take Sprycel?Take Sprycel exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.This medicine is usually taken once in the morning and once in the evening. Follow your doctor's instructions. You may take the medication with or without food.Your doctor may occasionally change your dose to make sure you get the best results.Take Sprycel tablets with a full glass of water. Do not crush, chew, or break a Sprycel tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. Do not use a pill that has been accidentally broken. Dasatinib from a crushed or broken Sprycel tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin withsoap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.Sprycel can lower blood cells that help your body fight infections.This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.Store Sprycel at room temperature away from moisture and heat.———————————————————————What happens if I miss a dose?Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.———————————————————————What happens if I overdose?Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.——————————————————————–What should I avoid while taking Sprycel?Avoid taking an antacid within 2 hours before or 2 hours after you take Sprycel. Use only the type of antacid your doctor recommends.Some antacids can make it harder for your body to absorb Sprycel.Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.Grapefruit and grapefruit juice may interact with Sprycel and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.———————————————————————Sprycel side effectsGet emergency medical help if you have any of these signs of an allergic reaction to Sprycel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;easy bruising, unusual bleeding (nose, mouth, vagina, or rectum),purple or red pinpoint spots under your skin;fever, chills, body aches, flu symptoms, sores in your mouth and throat;black, bloody, or tarry stools;coughing up blood or vomit that looks like coffee grounds; orswelling in your hands, ankles, or feet.Less serious Sprycel side effects may include:headache;tired feeling;nausea, diarrhea; ormild skin rash;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.———————————————————————What other drugs will affect Sprycel?Tell your doctor about all other medicines you use, especially:alfentanil (Alfenta), fentanyl (Actiq, Duragesic);bosentan (Tracleer);conivaptan (Vaprisol);cyclosporine (Gengraf, Neoral, Sandimmune);dexamethasone (Decadron, Hexadrol);ergotamine (Ergomar, Cafergot, Migergot);imatinib (Gleevec);isoniazid (for treating tuberculosis);pimozide (Orap);rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), orrifapentine (Priftin);St. John's wort;an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);an antidepressant such as nefazodone;antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);phenobarbital (Solfoton) and other barbiturates;a blood thinner such as warfarin (Coumadin);heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine(Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Kaletra, Norvir);medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil);medication used to prevent blood clots, such as bivalirudin(Angiomax), clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole(Persantine, Aggrenox), enoxaparin (Lovenox), fondaparinux (Arixtra), lepirudin (Refludan), ticlopidine (Ticlid);medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline); orstomach acid reducers such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), rabeprazole (Aciphex), or ranitidine (Zantac).This list is not complete and there are many other drugs that can interact with Sprycel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.———————————————————————Where can I get more information?Your pharmacist can provide more information about Sprycel.Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as asupplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

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