Generic Name and Formulations:
Nintedanib 100mg, 150mg; caps.
Boehringer Ingelheim Pharmaceuticals
Indications for OFEV:
Treatment of idiopathic pulmonary fibrosis (IPF).
Swallow whole. Take with food. 150mg twice daily (approx. 12hrs apart); max 300mg/day. Mild hepatic impairment: 100mg twice daily (approx. 12hrs apart). Dose modifications due to adverse reactions: see full labeling.
Moderate or severe hepatic impairment: not recommended. Increased risk of liver enzyme elevation in low body weight, age, Asian, or female patients. Perform liver function tests prior to treatment, then as clinically indicated. Interrupt therapy if serious liver injury with symptoms and/or hyperbilirubinemia or jaundice occurs. GI disorders: treat at first signs with adequate hydration, antidiarrheals, or antiemetics; 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 develop. Risk of bleeding. Recent abdominal surgery. Discontinue if GI perforation develops. Smokers. Severe renal impairment (CrCl <30mL/min) or ESRD. Verify pregnancy status prior to initiation. Pregnancy: avoid. Females of reproductive potential should use effective contraception during treatment and at least 3 months after last dose. Nursing mothers: not recommended.
Avoid concomitant P-gp and CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin, St. John’s wort). May be potentiated by P-gp and CYP3A4 inhibitors (eg, ketoconazole, erythromycin); monitor closely. Increased risk of bleeding with anticoagulants; monitor and adjust as necessary. Avoid smoking.
Diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, hypertension; arterial thromboembolic events, bleeding, GI perforation.