Ofev Generic Name & Formulations
Nintedanib 100mg, 150mg; caps.
Idiopathic pulmonary fibrosis (IPF). Chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. To slow the rate of decline in pulmonary function in systemic sclerosis-associated ILD (SSc-ILD).
Ofev Dosage and Administration
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.
Ofev Boxed Warnings
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.
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. Caution with concomitant corticosteroids, NSAIDs; may increase risk of GI perforation.
Ofev Adverse Reactions
Diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, hypertension; liver injury, arterial thromboembolic events, bleeding.
Ofev Clinical Trials
Ofev Patient Counseling