2014年10月15日，美国食品和药品监督管理局(FDA)批准Esbriet (吡非尼酮[pirfenidone])为特发性肺纤维化的治疗(IPF)。
特发性肺纤维化是一种条件其中随时间肺逐渐地成为瘢痕。其结果，有IPF患者经受气短，咳嗽，和很难参加每天体力活动。对IPF的当前治疗包括氧疗，肺功能康复，和肺移植。
FDA药品评价和研究中心药物评价II室主任Curtis J. Rosebraugh，M.D.，M.P.H. 说：“对有特发性肺纤维化患者，一种严重 ，慢性肺病，Esbriet提供一种新的治疗选择” 。“我们将通过批准影响治疗公共卫生条件的产品继续帮助推动先进药物治疗。”
FDA授予Esbriet 快速通道，优先审评，孤儿产品，和突破性治疗指定。Esbriet正在超出监管局完成药物申请审评产品处方药物使用者费用被批准目标日期11月23日。
Esbriet作用于涉及肺组织瘢痕化的多个途径。在1,247例IPF患者三项临床试验确定安全性和有效性。在用力肺活量下降– 在可能的最深呼吸后从肺可以强制呼出的空气量 –接受 Esbriet患者与接受安慰剂患者比较显著减少。
有严重肝脏问题，肾病终末期，或需要透析患者建议不用Esbriets。应与食物服用Esbriet以减小恶心和眩晕的潜能。患者应避免或暴露至阳光和太阳灯最小和涂抹防晒霜和穿防护服，因为 Esbriet可能致患者更容易晒伤。
Esbriet最常见副作用是恶心，皮疹，腹痛，上呼吸道感染，腹泻，疲乏，头痛，消化不良，眩晕，呕吐，食欲减退/厌食，胃-食道回流病，鼻窦炎，失眠，体重减轻，和关节炎。
FDA在今天还批准Ofev (nintedanib)为治疗特发性肺纤维化[ IPF]。
Esbriet由加州布里斯班InterMune公司制造。
ESBRIET Rx
Generic Name and Formulations:
Pirfenidone 267mg; hard gel caps.
Company:
InterMune
Indications for ESBRIET:
Treatment of idiopathic pulmonary fibrosis (IPF).
Adult:
Take with food at same time each day. Days 1–7: 1 cap 3 times daily; Days 8–14: 2 caps 3 times daily; Days 15 onward: 3 caps 3 times daily. Max 9 caps/day. Dose modifications due to adverse reactions: see full labeling. Concomitant strong CYP1A2 inhibitors (eg, fluvoxamine, enoxacin): 1 cap 3 times daily. Concomitant moderate CYP1A2 inhibitors (eg, ciprofloxacin 750mg twice daily): 2 caps 3 times daily.
Children:
Not established.
Pharmacological Class:
Pyridone.
Warnings/Precautions:
Perform liver function tests prior to initiating treatment, monthly for the first 6 months, and every 3 months thereafter. Permanently discontinue if ALT/AST >3 – ≤5XULN with symptoms or hyperbilirubinemia, or if ALT/AST >5XULN occurs. Severe hepatic impairment or ESRD (including dialysis): not recommended. Renal or mild-to-moderate hepatic impairment; monitor and adjust dose or discontinue as needed. Consider treatment interruption or dose reduction if significant adverse reactions (eg, GI, photosensitivity, rash) occur. Avoid/minimize sun exposure or UV light. Smokers. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Avoid smoking or concomitant drugs known to cause photosensitivity. Concomitant strong CYP1A2 inhibitors: not recommended; if needed, reduce pirfenidone dose (see Adults). Potentiated by moderate CYP1A inhibitors; if ciprofloxacin at dose 750mg twice daily cannot be avoided, reduce pirfenidone dose (see Adults). Monitor closely with ciprofloxacin at dose 250–500mg once daily. Avoid concomitant strong CYP1A2 inducers.
Adverse Reactions:
Nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, GERD, sinusitis, insomnia, weight decreased, arthralgia; elevated liver enzymes.
How Supplied:
Caps—270; Blister packs—63, 252
------------------------------------------------
产地国家: 美国
原产地英文商品名:
Esbriet 267mg/capsules 270Caps
原产地英文药品名:
pirfenidone
中文参考商品译名:
Esbriet胶囊 267毫克/胶囊 270胶囊/瓶
中文参考药品译名:
吡菲尼酮
生产厂家英文名:
InterMune
