Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216, Ingelheim am Rhein, Germany
Ofev is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
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.
In addition to symptomatic treatment if applicable, the management of adverse reactions to Ofev (see sections 4.4 and 4.8) 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 sections 4.4 and 4.8).
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 section 5.2).
Less than 1% of a single dose of nintedanib is excreted via the kidney (see section 5.2). 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).
Nintedanib is predominantly eliminated via biliary/faecal excretion (>90%). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B; see section 5.2). 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 section 5.2).
The safety and efficacy of Ofev in children aged 0-18 years have not been established. No data are available.
Ofev is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.
There is no specific antidote or treatment for Ofev overdose. Two patients in the oncology programme had an overdose of maximum 600 mg twice daily up to eight days. Observed adverse reactions were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms. Both patients recovered from these adverse reactions. In the INPULSIS trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days. A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events. In case of overdose, treatment should be interrupted and general supportive measures initiated as appropriate.
Shelf life: 3 years.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Ofev 100 mg soft capsules:
Ofev 100 mg soft capsules are available in the following pack-sizes:
Ofev 150 mg soft capsules:
Ofev 150 mg soft capsules are available in the following pack-sizes:
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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