Ofev Dosage/Direction for Use

Dosage: Adults: Treatment should be initiated by physicians experienced in the diagnosis and treatment of conditions for which OFEV is indicated.
The recommended dose of OFEV is 150 mg twice daily administered approximately 12 hours apart.
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 (see Precautions, Adverse Reactions) of 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 in adult patients) or a reduced dose (100 mg twice daily in adult patients). If an adult patient does not tolerate 100 mg twice daily, treatment with OFEV should be discontinued.
If case of interruptions due to transaminase (AST or 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 in adult patients) which subsequently may be increased to the full dose (150 mg twice daily in adult patients). (See Precautions, Adverse Reactions.)
Special populations: Paediatric population: Treatment of paediatric patients with nintedanib for fibrosing Interstitial Lung Diseases (ILDs) is not registered.
Elderly patients (≥65 years): No overall differences in safety and efficacy were observed for elderly patients compared to patients aged below 65 years. No adjustment of the initial dosing is required in elderly patients. Patients ≥75 years may be more likely to require dose reduction to manage adverse effects (see Pharmacology: Pharmacokinetics under Actions).
Race: Based on population pharmacokinetic (PK) analyses, no a priori dose adjustments of OFEV are necessary (see Special populations as previously mentioned, Precautions and Pharmacology: Pharmacokinetics under Actions). Safety data for Black patients are limited.
Body weight: Based on population PK analyses, no a priori dose adjustments of OFEV are necessary in adult patients (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 adult 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.
Method of Administration: OFEV capsules should be taken orally, preferably with food, swallowed whole with water and should not be chewed. 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 be given an additional dose.
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.