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    Recommended dosing and administration for OFEV1

    RECOMMENDED TESTING

    • Conduct liver function tests (ALT, AST, and bilirubin) in all patients prior to initiation of treatment with OFEV (nintedanib), at regular intervals during the first 3 months of treatment, and periodically thereafter or as clinically indicated1
    • Measure liver function tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice1
    • Conduct a pregnancy test in females of reproductive potential prior to initiating treatment with OFEV and during treatment as appropriate1

    RECOMMENDED DOSING

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    Dosing simplicity with one capsule, taken orally twice daily can be integrated into a patient’s morning and evening routines. Each capsule should be taken approximately 12 hours apart.1
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    No up-titration upon initiation. 150 mg taken orally twice daily is the recommended dose.1
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    Should be taken with food and swallowed whole with liquid. It should not be chewed, crushed, or opened. If contact with the content of the capsule occurs, wash hands immediately and thoroughly.1
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    Dose reduction or temporary interruption of treatment with OFEV (nintedanib) allows for the management of adverse reactions while supporting continued clinical benefit. If patient does not tolerate dose reduction, discontinue treatment with OFEV.1-3

    If a dose of OFEV is missed, treatment should resume at the next scheduled time and at the recommended dose. Advise the patient to not make up for a missed dose. Do not exceed the recommended maximum daily dosage of 300 mg.1

    The dosage of OFEV can be reduced, interrupted or discontinued to manage adverse reactions.1

    See the complete details regarding dose modification due to adverse reactions.

    RECOMMENDED DOSING FOR PATIENTS WITH HEPATIC IMPAIRMENT

    • In patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg taken orally twice daily1
    • Treatment with OFEV is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment1

    Dose reduction, temporary interruption, or discontinuation can be used to manage adverse reactions1

    DOSAGE MODIFICATION FOR THE MANAGEMENT OF ADVERSE REACTIONS:

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    Download the Daily Management Guide for tips to help patients start and stay on treatment

    Daily Management Guide

    ALT, alanine aminotransferase; AST, aspartate aminotransferase; GI, gastrointestinal; ULN, upper limit of normal.

    References

    1. Richeldi L, Costabel U, Selman M, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011;365(12):1079-1087.

    2. Richeldi L, et al. N Engl J Med. 2011;365(12):1079-1087.

    3. OFEV® Local Summary of Product Characteristics, July 2024.