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替拉匹韦薄膜衣片TELAPREVIR(INCIVEK 375MG TAB)说明书

产地国家:美国

处方药:是

所属类别: 375毫克/片 168片/瓶

包装规格: 375毫克/片 168片/瓶

计价单位:瓶

生产厂家英文名:VERTEX PHARMACEUTICALS IN

原产地英文商品名:INCIVEK 375MG TAB 168/EA

原产地英文药品名:TELAPREVIR

中文参考商品译名:INCIVEK 375毫克/片 168片/瓶

中文参考药品译名:替拉匹韦

简介

新型抗丙型药物telaprevir(商品名 Incivek)获美国FDA批准用于有或未接受基于干扰素药物治疗对其感染或对既往治疗反应不佳的患者。Incivek丸剂的用法为每日三次,进餐时服用,前12周需与聚乙二醇干扰素α和病毒唑联合使用。大多数接受Incivek和标准治疗(聚乙二醇干扰素α联用病毒唑)联合使用24周就可产生早期应答,而推荐的标准治疗需要使用48周。这种治疗药物属于蛋白酶抑制剂的一种,通过与病毒结合组织其复制行为发挥作用。Incivek 和聚乙二醇干扰素α以及病毒唑治联合使用中报道最常见的副作用包括皮疹、红细胞数量减少(贫血)、恶心、疲劳、头痛、腹泻、瘙痒、肛门或直肠刺激和疼痛。出现的皮疹可能非常严重,需要停止使用Incivek或治疗方法中的全部三种药物。批准日期:2011年5月23日:公司:Vertex Pharmaceuticals IncorporatedINCIVEKTM (telaprevir)膜衣片 仅口使用美国初始批准:2011

作用机制

Telaprevir是一种对丙型肝炎病毒的直接-作用抗病毒药(DAA)[见微生物学]。

适应证和用途

INCIVEK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和利巴韦林联用,对有代偿肝病成年患者中基因型1慢性丙型肝炎(CHC)的治疗,包括肝硬变,未治疗过患者或既往曾被基于干扰素治疗治疗过患者,包括既往零反应者(注:治疗期间丙型肝炎病毒负荷达到很小或无减低),部分反应者,和复发者。

(1)INCIVEK必须不用作单药治疗和必须只与聚乙二醇干扰素α和利巴韦林联用。

(2)既往零反应者的高比例(尤其是有肝硬变患者)不达到持续病毒学反应(SVR)和有telaprevir出现对用INCIVEK治疗伴耐药取代。

(3)对既往用包括INCIVEK或其它HCV NS3/4A蛋白酶抑制剂治疗方案已治疗失败患者,INCIVEK疗效尚未确定。

剂量和给药方法

(1)750 mg一天服用3次(间隔7-9小时)与食物(非低脂肪)。

(2)对所有患者INCIVEK必须与聚乙二醇干扰素α和利巴韦林二者给予共12周,接着反应-指导方案或12或36另外周的聚乙二醇干扰素α和利巴韦林依赖于病毒反应和既往反应状态。

(3)对聚乙二醇干扰素α和利巴韦林专门剂量说明,参阅其相应处方资料。

剂型和规格:375mg/片

禁忌证

(1)因为INCIVEK必须与聚乙二醇干扰素α和利巴韦林给药,对聚乙二醇干扰素α和利巴韦林所有禁忌证也应用。

(2)妊娠妇女和男性其女性伴侣妊娠:因为利巴韦林可能引起出生缺陷和胎儿死亡,在妊娠妇女和在男性其女性伴侣妊娠禁忌用telaprevir与聚乙二醇干扰素α和利巴韦林联用。

(3)与以下药物共同给药:1)对清除高度依赖于CYP3A和for which升高血浆浓度是伴随严重和/或危及生命事件。2)强烈诱导CYP3A 可能导致脚底保留和丧失INCIVEK疗效。

警告和注意事项

(1)妊娠:使用利巴韦林和Peg干扰素α:利巴韦林可能引起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。初始治疗前患者必须有阴性妊娠检验,采用至少2种有效避孕方法,和每月进行妊娠检验。

(2)严重皮肤反应:严重皮肤反应包括药物皮疹有嗜酸粒细胞增多和全身症状和曾报道Stevens-Johnson综合征。对严重皮肤反应,应立即终止INCIVEK联合治疗的所有化合物。

(3)皮疹:有轻至中度皮疹患者应监视进展。如皮疹进展和成为严重,应终止INCIVEK。

(4)贫血:INCIVEK联合治疗前和期间定期监视血红蛋白。调整利巴韦林剂量;如需要终止INCIVEK。

不良反应

最常见对INCIVEK不良药物反应 (发生率用NCIVEK比对照至少较高5%)是皮疹,瘙痒,贫血,恶心,痔疮,腹泻,肛门直肠不适,味觉障碍,疲乏,呕吐,和肛门瘙痒。药物相互作用INCIVEK治疗与其它药物联用共同给药可能改变其它药物的浓度和可能改变telaprevir浓度的其它药物。

药物相互作用

潜能治疗期间和前咨询完整处方资料。

特殊人群中使用

(1)肝受损:尚未确定在有Child-Pugh评分大于或等于7(类型B和C)患者中安全性和疗效(2)共感染:尚未确定在HCV/HIV和HCV/HBV共感染患者中安全性和疗效。(3)儿童:尚未确定在儿童患者中安全性和疗效。(4)实体器官移植:尚未确定在进行实体器官移植患者中安全性和疗效。(5)可以得到利巴韦林妊娠注册。

产品特点

特拉匹韦(Telaprevir)是直接蛋白酶抑制剂,它通过结合病毒并防止其增殖来起作用。特拉匹韦和PEG化的干扰素&alPHa以及利巴韦林联合使用,用于治疗基因1型慢性丙肝。

开发上市情况

2011年5月23日,Vertex制药公司特拉匹韦项目获FDA批准上市,商品名为Incivek。2011年9月21日,欧盟批准Janssen制药的丙肝治疗新药特拉匹韦上市,商品名为Incivo。2011年8月,Incivek在加拿大也获得批准。

英文版说明书

IndicationINCIVEK(telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.It is not known if INCIVEK is safe and effective in children under 18 years of age.IMPORTANT SAFETY INFORMATIONWho should not take INCIVEKDo not take INCIVEK if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.Do not take INCIVEK if you are taking certain medicines as there could be serious side effects.If these drugs are taken together, this can cause you to have too much or not enough INCIVEK or your other medicines in your body. It can also cause side effects thatcan be serious or life-threatening. These medicines include: alfuzosin hydrochloride (Uroxatral), atorvastatin (Lipitor, Caduet), ergot containing medicines such as methylergonovine(Methergine), lovastatin (Advicor, Altoprev, Mevacor), pimozide(Orap), rifampin (Rifadin, Rifamate, Rifater), sildenafil citrate (Revatio) or tadalafil (Adcirca) for the lung problem pulmonary artery hypertension (PAH), simvastatin (Zocor, Vytorin&, Simcor), St. John’s wort (Hypericum perforatum), or triazolam(Halcion).Talk to your healthcare provider before taking INCIVEK if any of the above applies to you. Your healthcare provider may need to change the amount of medicines you take.Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. INCIVEK and other medicines can affect each other.Serious Side EffectsINCIVEK can cause serious side effects, including:Birth defects or death of an unborn babyINCIVEK combined with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby.If you or your sexual partner is pregnant or plan to become pregnant, do not take these medicines. You or your partner should not become pregnant while taking INCIVEK with peginterferon alfa and ribavirin and for 6 months after treatment is over.You must have a negative pregnancy test before starting treatment, every month during treatment, and for 6 months after your treatment ends. You must use 2 effective methods of birth control during treatment and for 6 months after all treatment has ended.These 2 forms of birth control should not contain hormones, as these may not work as well during treatment with INCIVEK. Talk to your healthcare provider about the forms of birth control you should use during this time.Two weeks after stopping INCIVEK, you can use a hormonal form of birth control as one of your two forms of birth control.If you or your partner becomes pregnant during treatment or within 6 months after stopping these medicines, tell your healthcare provider right away. Contact the Ribavirin Pregnancy Registry right away by calling 1-800-593-2214. The Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while pregnant.Skin reactions: Mild skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become severe and require treatment in a hospital.Call your healthcare provider right away if you develop any skin changes with these symptoms: rash with or without itching, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes like”pink eye” (conjunctivitis), swelling of your face, or fever.Your healthcare provider will decide if these changes may be a sign of a serious skin reaction. Your healthcare provider will also decide if you need treatment for your rash or to stop INCIVEK or your other medicines. Never stop taking INCIVEK combination treatment without talking to your healthcare provider first.Do not take INCIVEK alone to treat chronic hepatitis C infection.It must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.Low red blood cell count (anemia) that can be severe. Tell your healthcare provider if you have any of these symptoms of anemia: dizziness, shortness of breath, tiredness, or weakness.Your healthcare provider will do blood tests regularly to check your red blood cell count during treatment. If your anemia is severe your healthcare provider may tell you to stop taking INCIVEK. If this happens, do not start taking it again.What should I tell my healthcare provider before taking INCIVEK?Tell your healthcare provider if you:have certain blood problems such as anemiahave liver problems other than hepatitis C infectionhave hepatitis B, HIV infection, or any problems with your immune systemhave a history of gout or high uric acid levels in your bloodhave had an organ transplantplan to have surgeryhave any other medical conditionare breastfeedingHow should I take INCIVEK?Take INCIVEK exactly as your healthcare provider tells you. Take two INCIVEK pills 3 times a day, 7 to 9 hours apart, with food. Eat a meal or snack containing about 20 grams of fat within 30 minutes before you take each dose. Talk to your healthcare provider about examples of food you can eat.If you miss a dose within 4 hours of when you usually take it, take your dose with food as soon as possible. If you miss a dose and it is more than 4 hours after the time you usually take it, skip that dose only and take the next dose at your normal time.Do not stop taking INCIVEK unless your healthcare provider tells you to. If yourhealthcare provider tells you to stop, you should not start taking it again, even if the reason for stopping goes away. If you take too much INCIVEK, call your healthcare provider or local Poison Control Center, or go to the nearest emergency room right away.Common Side Effects of INCIVEK Combination TreatmentThe most common side effects include itching, nausea, diarrhea, vomiting, anal or rectal problems (including hemorrhoids, discomfort or burning around or near the anus, itching around or near the anus), taste changes, and tiredness. Tell your healthcare provider about any side effect that bothers you or doesn’t go away.These are not all the possible side effects of INCIVEK. For more information, ask your healthcare provider or pharmacist.

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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