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Adults: Treatment should be initiated by physicians experienced in the diagnosis and treatment of conditions for which OFEV is indicated.
Posology: 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 effects to OFEV (see Precautions and Adverse Reactions) 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) (see Precautions and Adverse Reactions).
Special populations: Elderly patients (≥ 65 years): No overall differences in safety and efficacy were observed for elderly patients. No a-priori 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 (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Less than 1 % of a single dose of nintedanib is excreted via the kidney (see Pharmacology: Pharmacokinetics under Actions). 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 CrCL).
Hepatic Impairment: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90 %). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B; see Pharmacology: Pharmacokinetics under Actions). In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Ofev is 100 mg twice daily approximately 12 hours apart. In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered. The safety and efficacy of nintedanib have not been investigated in patients 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 (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Ofev in children aged 0-18 years have not been established. No data are available.
Method of administration: OFEV is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed.
OFEV capsules may be taken with a small amount (teaspoonful) of cold or room temperature soft food, such as apple sauce or chocolate pudding, and must be swallowed unchewed immediately, to ensure the capsule stays intact.
The capsule should not be opened or crushed. If contact with the content of the capsule occurs, hands should be washed immediately and thoroughly.
