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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->治疗心功能不全药物
处方药:处方药
包装规格:
计价单位:
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该药品相关信息网址1:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=669c936b-3ee6-4e36-8a22-79dd11b1255b
原产地英文商品名:
Camzyos 2.5mg/capsules 30's/bottle
原产地英文药品名:
mavacamten
中文参考商品译名:
Camzyos 2.5毫克/胶囊 30粒/瓶
中文参考药品译名:
马瓦坎滕
原产地国家批准上市年份:
2022/04/28
英文适应病症1:
Grade II obstructive hypertrophic cardiomyopathy
英文适应病症2:
Grade III obstructive hypertrophic cardiomyopathy
临床试验期:

中文适应病症参考翻译1:
II 级阻塞性肥厚型心肌病
中文适应病症参考翻译2:
III 级阻塞性肥厚型心肌病
药品信息:

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 详细处方信息以本药内容附件PDF文件(202371719020221.pdf)的“原文Priscribing Information”为准
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部分处方资料(仅供参考)

英文药名:Camzyos

药品介绍
告知患者必须使用超声心动图进行心功能监测,以监测心力衰竭[见警告和注意事项]。建议患者立即向其医疗保健提供者报告心力衰竭的任何体征或症状。建议患者在 CAMZYOS 治疗之前和期间告知其医疗保健提供者所有伴随产品,包括非处方药(如奥美拉唑、埃索美拉唑或西咪替丁)和补充剂。CAMZYOS只能通过称为CAMZYOS REMS程序的受限程序获得[请参阅警告和注意事项]。告知患者以下值得注意的要求:CAMZYOS仅由经过认证的医疗保健提供者开具处方,并且仅从参与该计划的认证药房处分发。向患者提供电话号码和网站,以获取有关如何获取产品的信息告知怀孕女性和有生殖潜力的女性对胎儿的潜在风险。建议有生殖潜力的女性告知其医疗保健提供者已知或疑似怀孕建议有生殖潜力的女性在用 CAMZYOS 治疗期间和最后一次给药后 4 个月内使用有效的避孕措施。建议使用CHCs的患者使用替代避孕方法或添加非激素避孕药,因为CAMZYOS可能会降低CHCs的疗效建议怀孕期间暴露于 CAMZYOS 的女性,有一项妊娠安全性研究来监测妊娠结局。鼓励这些患者向百时美施贵宝报告怀孕情况CAMZYOS胶囊应整个吞咽。建议患者,如果他们错过了CAMZYOS的剂量,当天应尽快服用该剂量,下一次预定剂量应在第二天的通常时间服用。患者不应在同一天服用两剂。

适应症
CAMZYOS® 适用于治疗有症状的纽约心脏协会 (NYHA) II-III 级阻塞性肥厚型心肌病 (HCM) 成人,以改善功能能力和症状。

注意事项
Inform patients that cardiac function monitoring must be performed using echocardiography to monitor for heart failure [see WARNINGS AND PRECAUTIONS]. Advise patients to report any signs or symptoms of heart failure immediately to their healthcare provider.Advise patients to inform their healthcare providers of all concomitant products, including over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine) and supplements, prior to and during CAMZYOS treatment.CAMZYOS is available only through a restricted program called the CAMZYOS REMS Program [see WARNINGS AND PRECAUTIONS]. Inform the patient of the following notable requirements:atients must enroll in the program and comply with ongoing monitoring requirements CAMZYOS is only prescribed by certified healthcare providers and only dispensed from certified pharmacies participating in the program. Provide patients with the telephone number and website for information on how to obtain the product Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. Advise patients using CHCs to use an alternative contraceptive method or add nonhormonal contraception because CAMZYOS may decrease the efficacy of CHCs Advise females who are exposed to CAMZYOS during pregnancy that there is a pregnancy safety study that monitors pregnancy outcomes.

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 详细处方信息以本药内容附件PDF文件(202371719020221.pdf)的“原文Priscribing Information”为准
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更新日期: 20230718
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