Miscellaneous respiratory disorders:

Indications for OFEV:

Idiopathic pulmonary fibrosis (IPF). To slow the rate of decline in pulmonary function in systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Adult:

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.

Children:

Not established.

Warnings/Precautions:

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 >5xULN or >3xULN with signs of liver injury; interrupt or adjust dose based on liver enzyme elevations (see full labeling). 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. Increased risk of bleeding. Recent abdominal surgery. History of diverticular disease. Discontinue if GI perforation develops. Smokers. Embryo-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Advise females of reproductive potential to use highly effective contraception (hormonal + barrier method) during and ≥3 months after the last dose. Nursing mothers: not recommended.

Pharmacologic Class:

Kinase inhibitor.

Interactions:

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.

Adverse Reactions:

Diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, hypertension; liver injury, arterial thromboembolic events, bleeding, GI perforation.

Generic Availability:

NO

How Supplied:

Caps—60

Pricing for OFEV

150mg capsule (Qty: 60)
Appx. price $11870
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