Source: European Medicines Agency (EU) Revision Year: 2025 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).
Ofev is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1).
Ofev is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs) (see section 4.2 and 5.1).
Ofev is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Adults: Treatment should be initiated by physicians experienced in the management of diseases for which Ofev is approved.
Paediatric patients: Treatment should be initiated only after involvement of a multidisciplinary team (physicians, radiologists, pathologists) experienced in the diagnosis and treatment of fibrosing interstitial lung diseases (ILDs).
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 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 diarrhoea, nausea and/or vomiting persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required. The treatment may be resumed at a reduced dose (100 mg twice daily in adult patients) or at the full dose (150 mg twice daily in adult patients). In case of persisting severe diarrhoea, nausea and/or vomiting despite symptomatic treatment, therapy with Ofev should be discontinued (see section 4.4).
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations >3× 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 sections 4.4 and 4.8).
For specific dose reduction recommendations for the management of adverse reactions in paediatric population, see Table 1.
Growth must be regularly monitored, and evaluation of epiphyseal growth plate alteration via annual bone imaging is recommended in patients with open epiphyses. Treatment interruption should be considered in patients who develop signs of growth impairment or epiphyseal growth plates alterations (see sections 4.4 and 4.8).
Oral dental examination must regularly be performed at least every 6 months until development of dentition is completed (see sections 4.4 and 4.8).
The recommended dose of Ofev for paediatric patients aged 6 to 17 years of age is based on the patient's weight and is administered twice daily, approximately 12 hours apart (see Table 1). The dose should be adjusted according to weight as treatment progresses.
Table 1. Ofev dose and reduced dose recommendation in milligrams (mg) by body weight in kilograms (kg) for paediatric patients aged 6 years to 17 years old:
| Weight range | Ofev dose | Ofev reduced dose* |
|---|---|---|
| 13.5** - 22.9 kg | 50 mg (two 25 mg capsules) twice daily | 25 mg (one 25 mg capsule) twice daily |
| 23.0 - 33.4 kg | 75 mg (three 25 mg capsules) twice daily | 50 mg (two 25 mg capsules) twice daily |
| 33.5 - 57.4 kg | 100 mg (one 100 mg capsule or four 25 mg capsules) twice daily | 75 mg (three 25 mg capsules) twice daily |
| 57.5 kg and above | 150 mg (one 150 mg capsule or six 25 mg capsules) twice daily | 100 mg (one 100 mg capsule or four 25 mg capsules) twice daily |
* Reduced dose is recommended in children and adolescents with mild hepatic impairment (Child Pugh A) and for the management of adverse reactions in the paediatric population. For more information on the management of adverse drug reactions, see above.
** Weight below 13.5 kg: Treatment should be interrupted in case the patient experiences a weight decrease below 13.5 kg.
No overall differences in safety and efficacy were observed for elderly patients. No a-priori dose adjustment is required in elderly patients. Patients ≥75 years may be more likely to require dose reduction to manage adverse effects (see section 5.2).
Adjustment of the starting dose in adult and paediatric patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in adult and paediatric patients with severe renal impairment (<30 mL/min creatinine clearance).
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 paediatric patients with mild hepatic impairment (Child Pugh A), a reduced starting dose is recommended (see table 1). In adult and paediatric 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 adult and paediatric patients with hepatic impairment classified as Child Pugh B and C. Treatment of adult and paediatric 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 nintedanib have not been studied in paediatric patients below 6 years old. Therefore, treatment of children below 6 years old with nintedanib is not recommended. Nintedanib has not been studied in patients with a weight below 13.5 kg and therefore, it is not recommended in this population (see section 5.1).
Ofev is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed. The capsule should not be opened or crushed (see section 6.6). Ofev capsules may be taken with a small amount (one 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.
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.
Ofev 25 mg soft capsules: 4 years.
Ofev 100 and 150 mg soft capsules: 3 years.
Blister: Do not store above 25°C. Store in the original package in order to protect from moisture.
Bottle: Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture.
Ofev 25 mg soft capsules:
Ofev 25 mg soft capsules are available in the following pack-sizes:
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.
In the event of coming in contact with the content of the capsule, hands should be washed off immediately with plenty of water (see section 4.2).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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