Ofev Dosage/Direction for Use

Adults: Oncology: Treatment with Nintedanib esilate (Ofev) should be initiated and supervised by a physician experienced in the use of anticancer therapies.
For posology, method of administration, and dose modifications of docetaxel, refer to the corresponding product information for docetaxel.
The recommended dose of Nintedanib esilate (Ofev) is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21-day docetaxel treatment cycle.
Nintedanib esilate (Ofev) must not be taken on the same day of docetaxel chemotherapy administration (=day 1).
The recommended maximum daily dose of 400 mg should not be exceeded.
Patients may continue therapy with Nintedanib esilate (Ofev) after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.
Idiopathic Pulmonary Fibrosis (IPF), other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD): Treatment should be initiated by physicians experienced in the diagnosis and treatment of conditions for which Nintedanib esilate (Ofev) is indicated.
The recommended dose of Nintedanib esilate (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: Oncology: As initial measure for the management of adverse reactions (see Table 12 and Table 13) treatment with Nintedanib esilate (Ofev) should be temporarily interrupted until the specific adverse reaction has resolved to levels that allow continuation of therapy (to grade 1 or baseline). Nintedanib esilate (Ofev) treatment may be resumed at a reduced dose. Dose adjustments in 100 mg steps per day (i.e. a 50 mg reduction per dosing) based on individual safety and tolerability are recommended as described in Table 12 and Table 13.
In case of further persistence of the adverse reaction(s), i.e. if a patient does not tolerate 100 mg twice daily, treatment with Nintedanib esilate (Ofev) should be permanently discontinued.
In case of specific elevations of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) values to >3 x upper limit normal (ULN) in conjunction with an increase of total bilirubin to ≥2 x ULN and alkaline phosphatase (ALKP) <2 x ULN (see Table 13) treatment with Nintedanib esilate (Ofev) should be interrupted. Unless there is an alternative cause established, Nintedanib esilate (Ofev) should be permanently discontinued (see Precautions). (See Tables 12 and 13.)

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Idiopathic Pulmonary Fibrosis (IPF), other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD): In addition to symptomatic treatment if applicable, the management of adverse reactions (see Precautions and Adverse Reactions) of Nintedanib esilate (Ofev) could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Nintedanib esilate (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 Nintedanib esilate (Ofev) should be discontinued.
In 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 Nintedanib esilate (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 and Adverse Reactions).
Special populations: Paediatric population: Oncology: The safety and efficacy of nintedanib in paediatric patients have not been studied in clinical trials for the oncology indication. Therefore, treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology in children or adolescents with nintedanib is not recommended.
Idiopathic Pulmonary Fibrosis (IPF), other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD): 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 (see Pharmacology: Pharmacokinetics under Actions).
Race: Based on population pharmacokinetic (PK) analyses, no a priori dose adjustments of Nintedanib esilate (Ofev) are necessary (see Special populations under 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 Nintedanib esilate (Ofev) are necessary (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).
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 Nintedanib esilate (Ofev) is not recommended see Pharmacology: Pharmacokinetics under Actions.
Oncology: No adjustment of the starting dose is needed for patients with mild hepatic impairment based on clinical data (Child Pugh A, see Precautions).
Idiopathic Pulmonary Fibrosis (IPF), other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD): In adult patients with mild hepatic impairment (Child Pugh A), the recommended dose of Nintedanib esilate (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.
Method of Administration: Nintedanib esilate (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.
Nintedanib esilate (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.