Ofev

Moderate or severe hepatic impairment: not recommended. Increased risk of liver enzyme elevation in low body weight (<65kg), age, Asian, or female patients. Obtain ALT, AST, bilirubin prior to initiation, regularly during the first 3 months, and periodically thereafter or as clinically indicated. Discontinue if AST/ALT >5×ULN or >3×ULN with signs of liver injury; interrupt or adjust dose based on liver enzyme elevations (see full labeling). GI disorders; discontinue if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment. Cardiovascular risk. Known coronary artery disease. Consider treatment interruption if signs/symptoms of acute myocardial ischemia or new/worsening proteinuria develops. Increased risk of bleeding. Recent abdominal surgery. History of diverticular disease. Discontinue if GI perforation develops. Smokers. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception (hormonal + barrier methods, or alternatives) at initiation, during and ≥3 months after the last dose. Pregnancy: avoid; exclude status prior to initiation. Nursing mothers: not recommended.