以下內(nèi)容僅供參考,實(shí)際診斷及用藥請遵從醫(yī)生指導(dǎo),使用前請仔細(xì)閱讀VICTRELIS/波普瑞韋膠囊說明書;祝廣大病患者早日康復(fù)!
 【藥品名稱】
商品名:  VICTRELIS
通用名:  波普瑞韋膠囊
英文名:  boceprevir
化學(xué)名：(1R,5S)-N-[3-Amino-1-(cyclobutylmethyl)-2,3dioxopropyl]-3-[2(S)-[[[(1,1-dimethylethyl)amino]carbonyl]amino]-3,3-dimethyl-1-oxobutyl]-6,6-dimethyl-3azabicyclo[3.1.0]hexan-2(S)-carboxamide.
【性狀】
Boceprevir是一種白色至淡白色無定形粉。自由溶于甲醇，乙醇和異丙醇和略溶于水。
【分子式】
C27H45N5O5
【分子量】
519.7
【結(jié)構(gòu)式】
由兩個(gè)非鏡像異構(gòu)體的接近等同混合物制造。
【成分】
可得到為硬明膠膠囊為口服給藥的VICTRELIS 200 mg膠囊。每個(gè)膠囊含200 mg  boceprevir和下列無活性成分：十二烷基硫酸鈉，微晶纖維素，乳糖一水合物，交聯(lián)羧甲基纖維素鈉，預(yù)糊化淀粉[pre-gelatinized starch]，和硬脂酸鎂。紅色膠囊由明膠，二氧化鈦，D&C黃#10，F(xiàn)D&C藍(lán)#1，和FD&C紅#40。黃膠囊體含明膠，二氧化鈦，D&C黃#10，F(xiàn)D&C紅#40，和FD&C黃#6。膠囊用紅和黃墨水印。紅墨水含蟲膠和紅氧化鐵，而黃墨水由蟲膠，二氧化鈦，聚乙烯吡啶酮和D&C黃#10鋁色淀組成。.
【作用機(jī)制】
VICTRELIS是一種針對丙型肝炎病毒的直接作用抗病毒藥。是丙型肝炎病毒(HCV)非-結(jié)構(gòu)蛋白3(NS3)絲氨酸蛋白酶的一種抑制劑。
【適應(yīng)證】
VICTRELIS是一種丙型肝炎病毒(HCV)NS3/4A蛋白酶抑制劑適用于與聚乙二醇干擾素α和利巴韋林[ribavirin]聯(lián)用基因型1感染慢性丙型肝炎CHC)的zl，在有代償性肝病(≥18歲)成年患者，包括肝硬變，既往未zl或既往干擾素和利巴韋林zl已失敗患者。
VICTRELIS必須不作為單藥zl使用。
【用法用量】
800 mg 每天口服三次給藥(每7-9小時(shí))與食物(一餐或小吃).
（1）VICTRELIS必須與聚乙二醇干擾素α和利巴韋林聯(lián)用給藥。
（2）為特殊給藥指導(dǎo)參考聚乙二醇干擾素α和利巴韋林包裝插件。
【規(guī)格】
200mg*336粒/盒 16800元/盒
 【禁忌證】
（1）因?yàn)閂ICTRELIS必須與聚乙二醇干擾素α和利巴韋林給藥，也應(yīng)用對聚乙二醇干擾素α和利巴韋林所有禁忌證。
（2）因?yàn)槔晚f林可能致出生缺陷和胎兒死亡，妊娠婦女中和女性伴侶妊娠男性禁忌boceprevir與聚乙二醇干擾素α和利巴韋林聯(lián)用。
（3）與高度依賴CYP3A4/5qc的yw共同給藥，和因?yàn)樯哐獫{濃度伴隨嚴(yán)重和/或危及生命事件。
（4）強(qiáng)CYP3A4/5誘導(dǎo)劑where顯著減低boceprevir血漿濃度可能伴隨減低療效。
【警告和注意事項(xiàng)】
VICTRELIS與利巴韋林和聚乙二醇干擾素α使用：
（1）利巴韋林可能致出生缺陷和胎兒死亡：在女性患者和男性患者的女性伴侶中避免妊娠。zl前患者必須有妊娠檢驗(yàn)陰性；使用兩種或更多方式避孕，和每月妊娠檢驗(yàn)。
（2）貧血 –VICTRELIS增添至聚乙二醇干擾素α和利巴韋林與單獨(dú)聚乙二醇干擾素α和利巴韋林比較是伴隨另外的血紅蛋白濃度減低。
（3）中性粒細(xì)胞減少 - VICTRELIS增添至聚乙二醇干擾素α和利巴韋林可能導(dǎo)致伴隨單獨(dú)聚乙二醇干擾素α和利巴韋林zl中性粒細(xì)胞減少惡化。
【不良反應(yīng)】
在臨床試驗(yàn)中接受VICTRELIS與PegIntron和REBETOL聯(lián)用成年受試者中最常報(bào)道的不良反應(yīng)(大于35%受試者)是疲乏，貧血，惡心，tt和味覺障礙。
【yw相互作用】
（1）VICTRELIS是一種CYP3A4/5強(qiáng)抑制劑和部分被CYP3A4/5代謝。zl前和期間必須考慮yw-yw相互作用潛在可能。
【特殊人群中使用】
（1）肝硬變：尚未在有代償肝硬變患者或有一種器官移植患者中研究安全性和療效。
（2）與人類免疫缺陷病毒(HIV)合并感染：尚未確定有HCV和HIV合并感染患者中安全性和療效
（3）與乙型肝炎病毒(HBV)合并感染：尚未有HCV和HBV合并感染患者中研究安全性和療效。
（4）兒童：尚未在兒童患者中研究安全性和療效。
（5）可得到利巴韋林妊娠注冊。
【貯藏】
VICTRELIS 膠囊應(yīng)貯存在冰箱2-8°C(36-46°F)直至發(fā)放。避免暴露于過熱。對使用患者，冰箱貯存VICTRELIS膠囊可保持穩(wěn)定至標(biāo)簽上失效期。VICTRELIS也可貯存在室溫至25°C(77°F) 3個(gè)月。保持容器密閉。
【包裝】
VICTRELIS 200 mg膠囊由紅色帽與黃墨水印Merck標(biāo)志，和黃色體部用紅墨水印有“314” 組成。膠囊被包裝在有28含12膠囊瓶的紙箱(NDC 0085-0314-02).膠囊：200mg，12粒*28瓶/盒
【生產(chǎn)廠家】
美國默克制藥公司

【英文版】
The FDA has approved Merck’s hepatitis C drug Victrelis, the first oral treatment for the disease.
Victrelis (boceprevir) has been licensed to treat hepatitis C genotype 1 infection, in combination with current treatments peginterferon alfa (Roche’s Pegasys) and ribavirin.
ABOUT VICTRELIS? (boceprevir)
VICTRELIS is a prescription medicine used with the medicines peginterferon alfa and ribavirin (peg/riba) to treat long-lasting (chronic) hepatitis C genotype 1 infection in adults with stable (compensated) liver disease who have not been treated before or who have failed previous treatment. Do not take VICTRELIS alone. It is not known if VICTRELIS is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION ABOUT VICTRELIS
VICTRELIS plus peg/riba may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines.
Females and males must use 2 forms of birth control during treatment and for 6 months after treatment with VICTRELIS plus peg/riba. Hormonal forms of birth control, such as birth control pills, vaginal rings, implants and injections, may not work as well during treatment with VICTRELIS and you may become pregnant.
Females must have a pregnancy test before starting treatment with VICTRELIS plus peg/riba, every month while being treated, and every month for 6 months after all treatment is over.
Read more Important Safety Information below
Eligible patients may save on their out-of-pocket cost on up to 12 qualifying prescriptions of VICTRELIS. The coupon savings is valid for the eligible patient's co-pay, co-insurance or other out-of-pocket costs, up to a maximum benefit of 20% of the catalog price of VICTRELIS (as set by the manufacturer at the time of purchase), provided that coupon savings may not exceed the patient's actual out-of-pocket cost.

VICTRELIS is a prescription medication. Only your health care provider can decide if VICTRELIS is right for you.
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Indications:
Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. Not for use as monotherapy.

Adult Dose:
≥18yrs: Take with food. 800mg three times daily. Start after 4 weeks therapy with peginterferon and ribavirin. Without cirrhosis: continue treatment as indicated by HCV-RNA levels at Weeks 8, 12, and 24 (see literature). With cirrhosis: continue for 44 weeks. Do not reduce dose. Discontinue if HCV-RNA levels indicate futility (see literature).

Children's Dose:
<18yrs: not recommended.

Pharmacological Class:
HCV NS3/4A protease inhibitor.

Contraindications:
Concomitant potent CYP3A4/5 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) or narrow therapeutic index CYP3A4/5 substrates (eg, alfuzosin, cisapride, ergot derivatives, lovastatin, simvastatin, drosperinone, pimozide, sildenafil or tadalafil for PAH, triazolam, oral midazolam). Pregnant women and men whose partners are pregnant (note: ribavirin is Cat. X). Review peginterferon and ribavirin contraindications.

Warnings/Precautions:
Female patients and partners must have (–) pregnancy test before therapy, use appropriate effective contraception, and undergo monthly pregnancy test. Monitor CBC w. differential, HCV-RNA. Co-infection with HBV or HIV. Decompensated cirrhosis. Organ transplant recipients. Pregnancy (Cat. B). Nursing mothers: not recommended.

Interactions:
See literature. Concomitant rifabutin, salmeterol, efavirenz, concomitant colchicine in renal or hepatic impairment: not recommended. Potentiates CYP3A4/5 substrates (eg, amiodarone, bepridil, propafenone, quinidine, flecainide, trazodone, desipramine, azole antifungals, clarithromycin). Antagonizes ethinyl estradiol. Antagonized by potent CYP3A4/5 inhibitors. Monitor warfarin, digoxin, dihydropyridine calcium channel blockers, bosentan, protease inhibitors, immunosuppressants, opioids. Concomitant ketoconazole, itraconazole: max 200mg/day. Concomitant atorvastatin: max 20mg/day. Colchicine, PDE5 inhibitors for ED (eg, sildenafil, tadalafil, vardenafil), alprazolam, IV midazolam: reduce doses and monitor. Corticosteroids: avoid, monitor if needed.

Adverse Reactions:
Fatigue, nausea, headache, dysgeusia, worsening anemia, neutropenia.

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