OFEV Rx

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OFEV

Miscellaneous respiratory disorders
Only 4 drugs may be compared at once

Generic Name and Formulations:

Nintedanib 100mg, 150mg; caps.

Select therapeutic use:

Indications for OFEV:

Treatment of idiopathic pulmonary fibrosis (IPF).

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. 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. Increased risk of bleeding. Recent abdominal surgery. History of diverticular disease. 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.

Pharmacological 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; arterial thromboembolic events, bleeding, GI perforation.

Generic Availability:

NO

How Supplied:

Caps—60

OFEV 150mg capsules (Qty:60)

appx. price $9378.00