产地国家：加拿大 处方药：是 所属类别： 200毫克/胶囊 168胶囊/盒 包装规格： 200毫克/胶囊 168胶囊/盒 计价单位：盒 生产厂家英文名：MERCK 原产地英文商品名：VICTRELIS 200mg/cap 168caps/box 原产地英文药品名：boceprevir 中文参考商品译名：VICTRELIS 200毫克/胶囊 168胶囊/盒 中文参考药品译名：波普瑞韦

简介

新一代丙型肝炎药物Victrelis上市FDA首次批准了新一代丙型肝炎治疗药物Victrelis上市。Victrelis是默克制药公司研制的用于治疗基因1型丙型肝炎的新药。临床试验数据显示，当这种药物与现在药物共同使用时，能有效治愈60%以上的患者，比较而言，单独使用现有药物的治愈率在20%至40%之间;而且，新药在提高治愈率的同时还能缩短治疗时间。Victrelis明显提高了患者达到无病毒查出水平的机会。对许多患者来说，Victrelis能缩短其治疗时间。Victrelis也被称为boceprevir，是一种新型的丙型肝炎病毒蛋白毒抑制剂。丙型肝炎病毒蛋白毒是病毒复制所需要的。通过抑制这种病毒酶从而阻止病毒的复制，Victrelis借用了HIV治疗中的成功战略。在治疗中，默克新药Victrelis必须和现有药物共同使用，科学家们希望在未来几年内，能将3种或4种新药整合为一种药物，而且不再需要注射α-干扰素药物。临床试验数据显示，新药能在更短的治疗期内清除部分患者体内的病毒。在默克的临床试验中，44%以前未接受过治疗的患者能在28周的时间完成治疗，而不是通常所需要的48周。这种新药也有副作用。在默克公司的临床试验中，大约50%的患者在服用Victrelis后出现了贫血症状，这个比例是只使用现有药物患者的2倍;服用Victrelis的患者发生白血细胞数量低的风险也更高。而且，患者需要服用大量的药片。Victrelis需要每天服用3次共12个胶囊。VICTRELIS(boceprevir)胶囊美国初始批准：2011 优先审评药物 适应证和用途 VICTRELIS是一种丙型肝炎病毒(HCV)NS3/4A蛋白酶抑制剂适用于与聚乙二醇干扰素α和利巴韦林[ribavirin]联用基因型1感染慢性丙型肝炎CHC)的治疗，在有代偿性肝病(≥18岁)成年患者，包括肝硬变，既往未治疗或既往干扰素和利巴韦林治疗已失败患者。VICTRELIS必须不作为单药治疗使用。 剂量和给药方法 800 mg 每天口服三次给药(每7-9小时)与食物(一餐或小吃).(1)VICTRELIS必须与聚乙二醇干扰素α和利巴韦林联用给药。(2)为特殊给药指导参考聚乙二醇干扰素α和利巴韦林包装插件。 剂型和规格胶囊：200mg 禁忌证 (1)因为VICTRELIS必须与聚乙二醇干扰素α和利巴韦林给药，也应用对聚乙二醇干扰素α和利巴韦林所有禁忌证。(2)因为利巴韦林可能致出生缺陷和胎儿死亡，妊娠妇女中和女性伴侣妊娠男性禁忌boceprevir与聚乙二醇干扰素α和利巴韦林联用。(3)与高度依赖CYP3A4/5清除的药物共同给药，和因为升高血浆浓度伴随严重和/或危及生命事件。(4)强CYP3A4/5诱导剂where显著减低boceprevir血浆浓度可能伴随减低疗效。 警告和注意事项 VICTRELIS与利巴韦林和聚乙二醇干扰素α使用：(1)利巴韦林可能致出生缺陷和胎儿死亡：在女性患者和男性患者的女性伴侣中避免妊娠。治疗前患者必须有妊娠检验阴性;使用两种或更多方式避孕，和每月妊娠检验。(2)贫血 –VICTRELIS增添至聚乙二醇干扰素α和利巴韦林与单独聚乙二醇干扰素α和利巴韦林比较是伴随另外的血红蛋白浓度减低。(3)中性粒细胞减少 - VICTRELIS增添至聚乙二醇干扰素α和利巴韦林可能导致伴随单独聚乙二醇干扰素α和利巴韦林治疗中性粒细胞减少恶化。不良反应在临床试验中接受VICTRELIS与PegIntron和REBETOL联用成年受试者中最常报道的不良反应(大于35%受试者)是疲乏，贫血，恶心，头痛和味觉障碍。 药物相互作用 (1)VICTRELIS是一种CYP3A4/5强抑制剂和部分被CYP3A4/5代谢。治疗前和期间必须考虑药物-药物相互作用潜在可能。 特殊人群中使用 (1)肝硬变：尚未在有代偿肝硬变患者或有一种器官移植患者中研究安全性和疗效。(2)与人类免疫缺陷病毒(HIV)合并感染：尚未确定有HCV和HIV合并感染患者中安全性和疗效。(3)与乙型肝炎病毒(HBV)合并感染：尚未有HCV和HBV合并感染患者中研究安全性和疗效。(4)儿童：尚未在儿童患者中研究安全性和疗效。(5)可得到利巴韦林妊娠注册。

英文版说明书

Generic Name: boceprevir (boe SEP re vir)Brand Names: VictrelisWhat is Victrelis?Victrelis (boceprevir) is an antiviral medication that prevents certain virus cells from multiplying in your body.Victrelis is used in combination with peginterferon alfa and ribavirin to treat hepatitis C in adults.Victrelis may also be used for purposes not listed in this medication guide.Important informationVictrelis must be used in combination with peginterferon alfa and ribavirin. Do not take Victrelis as your only medication to treat hepatitis C.Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant.Certain other drugs may interact with boceprevir or should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.Before taking this medicineYou should not use Victrelis if you are allergic to boceprevir.Do not take Victrelis as your only hepatitis medicine. Victrelis must be used in combination with peginterferon alfa and ribavirin. Read the medication guide or patient instructions provided with each medicine you take. In some cases, you may not be able to use this drug combination.To make sure you can safely take Victrelis, tell your doctor if you have:•liver problems other than hepatitis C (including hepatitis B);•a history of liver or other organ transplant; or•low white blood cell (WBC) or red blood cell (RBC) counts, or low levels of platelets in in your blood;Some medicines can cause unwanted or dangerous effects when used with boceprevir. Your doctor may need to change your treatment plan if you use any of the following drugs:•cisapride;•drospirenone (Yasmin, Yaz, Angeliq, and others);•pimozide;•rifampin;•St. John's wort;•alfuzosin, doxazosin, silodosin, tamsulosin;•lovastatin or simvastatin;•oral midazolam or triazolam;•ergonovine, ergotamine, dihydroergotamine, methylergonovine;•the seizure medications carbamazepine, phenobarbital, or phenytoin; or•sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension.FDA pregnancy category X. Victrelis is given together with interferon alfa and ribavirin. Although boceprevir is not expected to harm an unborn baby, ribavirin is known to cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. If you are a woman, you may need to have a negative pregnancy test before using these medications and every month during your treatment.See also: Pregnancy and breastfeeding warnings (in more detail)•Use at least 2 non-hormonal forms of birth control while either sexual partner is using Victrelis with interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.•If you are a woman, do not use Victrelis with interferon alfa and ribavirin if you are pregnant.•If you are a man, do not use Victrelis with interferon alfa and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.•Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking this medicine.•Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Victrelis with interferon alfa and ribavirin.It is not known whether boceprevir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.How should I take Victrelis?Victrelis is used in combination with peginterferon alfa and ribavirin. Follow all directions on your prescription label. Your doctor may occasionally change your doses to make sure you get the best results. Do not take these medicines in larger or smaller amounts or for longer than recommended.Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.Take Victrelis with food. The usual dose is 4 capsules taken 3 times per day, every 7 to 9 hours. Follow your doctor's instructions.Your total daily dose of 12 capsules is contained in a single bottle. A carton of Victrelis contains 28 bottles for a 4-week supply.To be sure this medicine is helping your condition, you will need frequent blood tests. Treatment may be discontinued based on the results of these tests.Store Victrelis capsules in the refrigerator, do not freeze. Throw away any unused capsules after the expiration date on the label has passed.You may also store the capsules at room temperature for up to 3 months. Protect the capsules from heat.What happens if I miss a dose?Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. 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 Victrelis?Taking this medicine will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.Victrelis side effectsGet emergency medical help if you have any of these signs of an allergic reaction to Victrelis: hives; difficult breathing; swelling of your face, lips, tongue, or throat.Stop using Victrelis and call your doctor at once if you have:•tired feeling, weakness, confusion;•easy bruising or bleeding (nosebleed, bleeding gums);•pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or•fever, chills, body aches, flu symptoms, sores in your mouth and throat.Common Victrelis side effects may include:•hadache;•altered sense of taste; or•nausea.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.See also: Side effects (in more detail)What other drugs will affect Victrelis?Many drugs can interact with boceprevir. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Victrelis, especially:•a blood thinner (warfarin, Coumadin, Jantoven);•hormone replacement therapy, birth control pills, implants, vaginal rings, or injections;•sildenafil (Viagra) and other erectile dysfunction medicines;•an antibiotic or antifungal medicine--clarithromycin, itraconazole, ketoconazole, posaconazole, rifabutin, voriconazole; asthma or allergy medicine--budesonide, fluticasone, salmeterol (Advair, Serevent); steroid medicine--dexamethasone, prednisone, prednisolone;•an antidepressant--desipramine, escitalopram; narcotic medication--buprenorphine, methadone, naloxone; a sedative--alprazolam, trazodone;•cholesterol-lowering drugs--atorvastatin, pravastatin; heart or blood pressure medicine--amlodipine, amiodarone, digoxin, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, propafenone, quinidine, verapamil; or•HIV or AIDS medicines--atazanavir, darunavir, efavirenz, etravirine, lopinavir, raltegravir, ritonavir; medicine to prevent organ transplant rejection--cyclosporine, sirolimus, tacrolimus.This list is not complete and many other drugs can interact with boceprevir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.