奥拉帕尼片Lynparza Tablets 150mg(olaparib)

奥拉帕尼片Lynparza Tablets 150mg(olaparib)

药店国别:

产地国家:美国

处方药:是

所属类别: 150毫克/片 120片/瓶

包装规格: 150毫克/片 120片/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:AstraZeneca/Merck

原产地英文商品名:Lynparza 150mg/tablets 120tablets/bottle

原产地英文药品名:olaparib

中文参考商品译名:Lynparza口服片剂 150毫克/片 120片/瓶

中文参考药品译名:奥拉帕尼

曾用名:

简介:近日,美国食品和药物管理局(FDA)批准了PARP抑制剂LYNPARZA(olaparib 中文名:奥拉帕尼)如下:LYNPARZA片剂的新用途,用于对复发性,上皮性卵巢癌,输卵管癌或原发性腹膜癌患者进行维持治疗,这些患者对铂类化疗有完全或部分反应,无论BRCA状态如何;LYNPARZA片剂的新用途(每日两次2片),而不是胶囊(8粒,每日两粒);LYNPARZA片剂现在也表明(从目前加速批准转换)用于成年患有有害或疑似有害生殖系BRCA突变(gBRCA)晚期卵巢癌的患者,这些患者已接受过三次或更多次化疗前的治疗;根据FDA批准的伴随诊断选择用于该适应症的患者进行治疗。批准日期:2017年8月17日 公司:阿斯利康LYNPARZA(奥拉帕尼[olaparib])片剂,用于口服美国最初批准:2014年最近的重大变化

作用机制:

Lynparza是聚(ADP-核糖)聚合酶(PARP)酶的抑制剂,包括PARP1,PARP2和PARP3。PARP酶参与正常细胞功能,例如DNA转录和DNA修复。Olaparib已经显示出在体外抑制选择的肿瘤细胞系的生长并且在人癌症的小鼠异种移植模型中减少肿瘤生长,作为单一疗法或基于铂的化学疗法。在用olaparib处理后增加的细胞毒性和抗肿瘤活性在细胞系和小鼠肿瘤模型中被注意到,其中BRCA和非BRCA蛋白缺陷参与DNA损伤的同源重组修复(HRR)并与铂反应相关。 体外研究表明,奥拉帕尼诱导的细胞毒性可能涉及抑制PARP酶活性和增加PARP-DNA复合物的形成,导致DNA损伤和癌细胞死亡。

适应症和用法:

Lynparza是一种聚(ADP-核糖)聚合酶(PARP)抑制剂,表明:卵巢癌•用于对有害或疑似有害生殖系统或体细胞BRCA突变(g BRCAm或sBRCAm)晚期上皮卵巢,输卵管或原发性腹膜癌的成人患者进行维持治疗,这些患者对一线铂类化疗完全或部分应答。选择患有g BRCAm晚期上皮卵巢,输卵管或原发性腹膜癌的患者,根据FDA批准的Lynparza伴随诊断进行治疗。•用于复发上皮性卵巢癌,输卵管癌或原发性腹膜癌的成人患者的维持治疗,这些患者对铂类化疗有完全或部分反应。

•用于治疗患有有害或疑似有害生殖系统的BRCA突变(g BRCAm)晚期卵巢癌的成年患者,这些患者已接受过三次或更多次化疗前的治疗。根据FDA批准的Lynparza伴随诊断选择患者进行治疗。乳腺癌•对于在新辅助,辅助或转移性环境中接受化疗治疗的有害或疑似有害g BRCAm,人表皮生长因子受体2(HER2)阴性转移性乳腺癌的患者。激素受体(HR)阳性乳腺癌患者应该接受先前的内分泌治疗或被认为不适合进行内分泌治疗。根据FDA批准的Lynparza伴随诊断选择患者进行治疗。

剂量和给药:

•推荐的片剂剂量为300毫克,每天口服两次,有或没有食物。

•对于不良反应,请考虑剂量中断或剂量减少。•对于中度肾功能损害(CLcr 31-50 mL/min),每日两次减少剂量至200 mg。

剂量形式和强度片剂:

150mg,100mg

禁忌症:

没有。

警告和注意事项:

•骨髓增生异常综合征/急性髓性白血病(MDS/AML):在接触Lynparza单药治疗的患者中发生率<1.5%且大多数事件都有致命的结果。在基线和之后每月监测患者的血液毒性。如果确认MDS / AML,则停止。•肺炎:在接触Lynparza的患者中发生率<1%,有些病例是致命的。怀疑是肺炎的中断治疗。如果确诊肺炎则停止。•胚胎-胎儿毒性:Lynparza可导致胎儿伤害。建议胎儿的潜在风险并使用有效的避孕措施。

不良反应:

•临床试验中最常见的不良反应(≥10%)为恶心,乏力(包括虚弱),贫血,呕吐,腹痛,头晕,腹泻,中性粒细胞减少,白细胞减少,鼻咽炎/上呼吸道感染/流感,呼吸道感染,关节痛/肌痛,味觉障碍,头痛,消化不良,食欲减退,便秘和口腔炎。•最常见的实验室异常(≥25%)是血红蛋白减少,平均红细胞体积增加,淋巴细胞减少,白细胞减少,绝对中性粒细胞计数减少,血清肌酐增加和血小板减少。

药物相互作用:

•CYP3A抑制剂:避免同时使用强效或中度CYP3A抑制剂。如果不能避免抑制剂,减少奥拉帕尼剂量。•CYP3A诱导剂:避免同时使用强效或中度CYP3A诱导剂,因为可能会降低疗效。

用于特定人群哺乳期:

建议女性不要母乳喂养。

包装提供/存储和处理提供:

Lynparza有150毫克和100毫克片剂。•150毫克片剂:绿色至绿色/灰色,椭圆形,双凸面,薄膜包衣片,一面凹陷’OP150’,背面凹面平整,有:瓶装60粒(NDC 0310-0679-60)瓶装120片(NDC 0310-0679-12)。•100毫克片剂:黄色至深黄色,椭圆形,双凸面,薄膜包衣片,一面凹陷’OP100’,另一面凹凸,有:瓶装60粒(NDC 0310-0668-60)和瓶装120片(NDC 0310-0668-12)。

存储:

储存温度为20ºC至25ºC(68ºF至77ºF),允许偏差为15ºC至30ºC(59ºF至86ºF)[见USP受控室温]。 存放在原瓶中以防潮。

奥拉帕尼片英文版说明书:

LYNPARZA®(olaparib)Consumer Medicine InformationWhat is in this leafletThis leaflet answers some common questions about LYNPARZA tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.All medicines have risks and benefits. Your doctor has weighed the risks of you taking LYNPARZA tablets against the benefits they expect it will have for you.If you have any concerns about taking this medicine, ask your doctor or pharmacist.Keep this leaflet with the medicine.You may need to read it again.What LYNPARZA tablets are used forYou will have been prescribed LYNPARZA tablets if you have ovarian cancer and it has responded to treatment with platinum-based chemotherapy or if you have a certain type of breast cancer (germline BRCA-mutated, human epidermal growth factor receptor 2-negative (HER2-negative)) which has spread beyond the original tumour. A genetic test will be done to determine if you have germline BRCA mutated breast cancer.LYNPARZA belongs to a group of medicines called PARP (Poly (ADP-Ribose) Polymerase enzymes) inhibitors. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. These specific cancer cells can be identified by response to platinum chemotherapy or by looking for faulty DNA repair genes such as BRCA (BReast CAncer) genes.Ask your doctor if you have any questions about why this medicine has been prescribed for you.Your doctor may have prescribed it for another reason.This medicine is available only with a doctor’s prescription.Before you take LYNPARZA tabletsWhen you must not take itDo not take LYNPARZA tablets if you have an allergy to:any of the ingredients listed at the end of this leaflet.Some of the symptoms of an allergic reaction may include:shortness of breathwheezing or difficulty breathingswelling of the face, lips, tongue or other parts of the bodyrash, itching or hives on the skin.Do not take this medicine if you are pregnant or if you (male or female) are planning to have a baby.It may affect your developing baby if you take it during pregnancy. Your doctor will advise women to ensure they are using effective contraception when using the medicine and for at least 1 month after stopping the medicine. Male patients and their partners must use effective contraception when using the medicine for at least 3 months after stopping the medicine.Do not breast-feed if you are taking this medicine.It is not known if the active ingredient in LYNPARZA tablets passes into breast milk. Breast-feeding mothers are advised not to breast-feed during treatment with LYNPARZA tablets and for one month after receiving the last dose.Do not give this medicine to children.Safety and effectiveness in children younger than 18 years have not been established.Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.If it has expired or is damaged, return it to your pharmacist for disposal.If you are not sure whether you should start taking this medicine, talk to your doctor.Before you start to take itTell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.Tell your doctor if you have or have had any of the following medical conditions:problems with your kidneys or liver (renal or hepatic impairment)problems with your blood (e.g. anaemia, low white blood cell counts).Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.If you are a man, tell your doctor if you are planning to have a baby with your partner.Your doctor can discuss with you the risks and benefits involved. Whether you are male or female, your doctor will advise you to use an effective form of contraception while taking LYNPARZA and for at least 1 month for women and 3 months for men after stopping treatment. Female partners of male patients taking LYNPARZA must also use a suitable method of contraception. Male patients must not donate sperm whilst taking LYNPARZA and for 3 months after stopping treatment.If you have not told your doctor about any of the above, tell them before you start taking LYNPARZA tablets.Taking other medicinesTell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.You should not take LYNPARZA if you are taking any other anti-cancer agents.Some medicines or foods and LYNPARZA may interfere with each other and reduce effectiveness. These include:medicines used to treat fungal infections (antifungals) with active ingredients such as fluconazole, ketoconazole, itraconazolemedicines used to treat bacterial infections (antibiotics) with active ingredients such as clarithromycin, rifampicin, rifabutin, ciprofloxacin, erythromycinmedicines used to treat viral infections (especially HIV) with active ingredients such as ritonavir, indinavir, saquinavir, nevirapine, boceprevir, cobicistat, etravirine and efavirenzmedicines used to treat epilepsy with active ingredients such as phenytoin, carbamazepinemedicines with active ingredients such as modafinil used to treat a sleep disorder called narcolepsy (where you may experience very sleepy periods at odd times during the day)medicines to treat high blood pressure, angina (chest pain), irregular heartbeat or heart failure such as diltiazem, digoxin, furosemide, valsartan and verapamilmedicines called statins used to treat high cholesterol such as rosuvastatin and atorvastatinmedicines used to treat diabetes, such as glibenclamide and metforminbosentan, a medicine used to treat high blood pressure in the lungsmedicines used to suppress the immune system, such as ciclosporin, tacrolimus and sirolimusfentanyl, a medicine used to treat cancer painmethotrexate, a medicine used to treat cancer, rheumatoid arthritis and psoriasisquetiapine, a medicine used to treat mental disorderscolchicine, a medicine used to treat goutdabigatran, a medicine to prevent blood clotsgrapefruit, Seville oranges and star fruitSt John’s Wort, used to treat depression.Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.If you have not told your doctor about any of these things, tell them before you take any LYNPARZA tablets.How to take LYNPARZA tabletsYour doctor has prescribed LYNPARZA tablets for you. Please note LYNPARZA is also available as a 50 mg capsule. The doses of LYNPARZA tablets and capsules are not the same. Taking the wrong dose or a capsule instead of a tablet could lead to LYNPARZA not working properly or to more side effects.Follow all directions given to you by your doctor or pharmacist carefully.They may differ from the information contained in this leaflet.If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.How much to takeThe usual dose is two 150 mg tablets taken twice each day (a total of 4 tablets each day).Your doctor may prescribe a different dose if you have problems with your kidneys, or are taking certain medicines that may interact with LYNPARZA tablets or if you experience certain side effects while you are taking LYNPARZA tablets.Your doctor will tell you how many tablets of LYNPARZA to take and it is important that you take the total recommended daily dose.How to take itSwallow the tablets whole with a glass of water. Do not chew, crush, dissolve or divide the tablets as this may affect how quickly the drug gets into your body.When to take itTake LYNPARZA tablets at about the same time each morning and evening.Taking it at the same time each day will have the best effect. It will also help you remember when to take it.LYNPARZA tablets can be taken with or without food.How long to take itContinue taking your medicine for as long as your doctor tells you.It is important to keep taking your medicine even if you feel well.Continue taking your medicine until you finish the pack.If you forget to take itIf you forget to take LYNPARZA, take your next normal dose at its scheduled time. Do not take a double dose (two doses at the same time) to make up for forgotten tablets.If you are not sure what to do, ask your doctor.If you have trouble remembering to take your medicine, ask your doctor or pharmacist for some hints.If you take too much (overdose)Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much LYNPARZA. Do this even if there are no signs of discomfort or poisoning.You may need urgent medical attention.While you are using LYNPARZA tabletsThings you must doIf you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking LYNPARZA.Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.It may affect other medicines used during surgery.If you become pregnant while taking this medicine or within 1 month after receiving the last dose of LYNPARZA, tell your doctor immediately.If you are a man and your partner becomes pregnant while you are taking this medicine or within 3 months of stopping this medicine, tell your doctor immediately.Ensure you are using effective contraception. Even if you stop treatment, you should continue to use effective contraception for at least a further 1 month for female patients and 3 months for male patients.Male patients must use a condom whilst taking LYNPARZA and for 3 months after receiving the last dose when having sexual intercourse with a female partner, even if they are pregnant. Your female partner must also use a suitable method of contraception. Male patients must not donate sperm whilst taking LYNPARZA and for 3 months after receiving the last dose.Keep all of your doctor’s appointments so that your progress can be checked.Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects. Your doctor will test your blood every month for the first year of treatment and periodically thereafter.Things you must not doDo not take LYNPARZA tablets to treat any other complaints unless your doctor tells you to.Do not give your medicine to anyone else, even if they have the same condition as you.Do not stop taking your medicine or lower the dosage without checking with your doctor.If you stop taking it suddenly, your condition may worsen.Your doctor may interrupt your treatment or reduce your dose if you are having unwanted side effects.Things to be careful ofBe careful driving or operating machinery until you know how LYNPARZA affects you.This medicine may cause dizziness and tiredness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.Side effectsTell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LYNPARZA tablets.All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.Do not be alarmed by the following lists of side effects. You may not experience any of them.Ask your doctor or pharmacist to answer any questions you may have.Tell your doctor straight away if you notice any of the following:feeling or being sick (nausea or vomiting)dizziness, tiredness or weaknessindigestion or heartburnloss of appetiteheadachechange in taste of food (if it worries you)diarrhoeasore mouthcoughpain in the stomach area under the ribsshortness of breath and/or a dry cough which can be due to inflammation of the lungs (pneumonitis).rash itchy swollen reddened skinThe above list includes serious side effects that may require medical attention and can be life-threatening, especially if not treated.If any of the following happen, tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:tightness of the chest, wheezing, coughing or difficulty breathing.swelling of the face, lips, tongue or other parts of the body.severe skin reaction which may include rash, itching, redness, blistering or peeling of the skin.These are very serious side effects. If you have them, you may have had a serious allergic reaction to LYNPARZA. You may need urgent medical attention or hospitalisation.Some other serious side effects may only become known through tests. Your doctor will test your blood every month for the first year of treatment and periodically thereafter. The blood tests may show:a condition where there is damage to the blood-forming cells in your bone marrow (myelodysplastic syndrome/acute myeloid leukaemia)decrease in the number of red blood cells (anaemia) which can be associated with shortness of breath, fatigue, pale skin, or fast heart beatdecrease in the number of white blood cells which can be associated with fever or infectionincrease in blood creatinine which can mean your kidneys are not working as welldecrease in the number of platelets, which can result in bruising or bleeding for longer than normal if injured.These conditions may also be life-threatening, especially if not treated.Tell your doctor or pharmacist if you notice anything that is making you feel unwell.Your doctor may prescribe other medicines to control unwanted side effects.After using LYNPARZA tabletsStorageKeep your tablets in the blister pack until it is time to take them.If you take the tablets out of the blister they may not keep well.Keep your tablets in a cool dry place where the temperature stays below 30°C.Do not store LYNPARZA tablets or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.Heat and dampness can destroy some medicines.Keep it where children cannot reach it.A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.DisposalIf your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.Product descriptionWhat it looks likeLYNPARZA 100 mg tablet is a yellow to dark yellow, oval, bi-convex, film-coated tablet, marked with ‘OP100’ on one side and plain on the other.LYNPARZA 150 mg tablet is a green to green/grey oval, bi-convex, film-coated tablet, marked with ‘OP150’ on one side and plain on the other.LYNPARZA tablets are available in blisters containing 56 film-coated tablets, packed in cartons containing 7 blisters of 8 tablets.IngredientsLYNPARZA tablets contain 100 mg or 150 mg of olaparib as the active ingredient and the following inactive ingredients:copovidonecolloidal anhydrous silicamannitolsodium stearylfumaratehypromellosemacrogol 400titanium dioxideiron oxide yellowiron oxide black (150 mg tablet only)This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.Manufacturer/Distributor/ SupplierLYNPARZA is sponsored and supplied in Australia by:AstraZeneca Pty Ltd

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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