米泊美生钠注射液 KYNAMRO (mipomersen sodium) FDA药品说明书翻译.pdf

FULL PRESCRIBING INFORMATION WARNING: RISK OF HEPATOTOXICITY 警告：肝毒性风险 KYNAMRO can cause elevations in transaminases. In the KYNAMRO clinical trial in patients with HoFH, 4 (12%) of the 34 patients treated with KYNAMRO compared with 0% of the 17 patients treated with placebo had at least one elevation in alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR) or partial thromboplastin time (PTT) [see Warnings and Precautions (5.1)]. 本药可导致氨基转移酶升高。在本药的临床试验中，34 名接受本药治疗纯合子型家族性高 胆固醇血症(HoFH)的患者，有4 名(12%)患者至少出现1 次丙氨酸氨基转移酶(ALT) ≥3 倍 正常值上限(ULN)，而17 名接受安慰剂的患者无（0%）人出现。未同时出现有临床意义的 总胆红素、国际标准化比值(INR)或部分凝血活酶时间(PPT)升高。 KYNAMRO also increases hepatic fat, with or without concomitant increases in transaminases. In the trials in patients with heterozygous familial hypercholesterolemia (HeFH) and hyperlipidemia, the median absolute increase in hepatic fat was 10% after 26 weeks of treatment, from 0% at baseline, measured by magnetic resonance imaging (MRI). Hepatic steatosis is a risk factor for advanced liver disease; including steatohepatitis and cirrhosis [see Warnings and Precautions (5.1)]. 本药还可增加肝脏脂肪，伴或不伴氨基转移酶升高。在本药治疗杂合子型家族性高胆固醇 血症(HeFH)和高脂血症的临床试验中，接受本药治疗26 周后，由核磁共振成像(MRI)测定， 肝脏脂肪平均绝对值由基线的0%增加至10%。肝脏脂肪变性是肝病晚期(包括脂肪肝和肝 硬化)的风险因素之一。 Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT, AST regularly as recommended. During treatment, withhold the dose of KYNAMRO if the ALT or AST are ≥3 x ULN. Discontinue KYNAMRO for clinically significant liver toxicity [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. 开始治疗前应检测ALT、AST、碱性磷酸酶和总胆红素，之后建议定期检测ALT 和AST 。 治疗期间，如ALT 或AST ≥3 倍ULN，应暂停用药。如出现临床显著的肝毒性，应停药。 Because of the risk of hepatotoxicity, KYNAMRO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called t