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Treatment with Ofev should be initiated by physicians experienced in the diagnosis and treatment of IPF.
The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose. If a dose is missed, administration should resume at the next scheduled time at the recommended dose.
If a dose is missed, the patient should not take an additional dose.
The recommended maximum daily dose of 300 mg should not be exceeded.
Dose adjustments: In addition to symptomatic treatment if applicable, the management of adverse reactions to Ofev could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Ofev treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily). If a patient does not tolerate 100 mg twice daily, treatment with Ofev should be discontinued.
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations >3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Ofev may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily).
Special populations: Elderly patients (≥ 65 years): No overall differences in safety and efficacy were observed for elderly patients. No apriori dose adjustment is required on the basis of a patient's age. Patients ≥75 years may be more likely to require dose reduction to manage adverse effects.
Renal impairment: Less than 1% of a single dose of nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance).
Hepatic Impairment: Nintedanib is predominantly eliminated via biliary/faecal excretion (>90 %). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). No adjustment of the starting dose is needed for patients with mild hepatic impairment based on clinical data (Child Pugh A). The safety and efficacy of nintedanib have not been investigated with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Ofev is not recommended.
Paediatric population: The safety and efficacy of Ofev in children aged 0-18 years have not been established. No data are available.
Race: Based on population pharmacokinetic (PK) analysis, no a priori dose adjustments of Ofev are necessary. Safety data for Black patients are limited.
Body weight: Based on population pharmacokinetic (PK) analysis, no a priori dose adjustments of Ofev are necessary.
Method of administration: Ofev is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.
