Ofev 100 mg soft capsules
One capsule contains 100 mg nintedanib (as esilate)
Excipient(s) with known effect:
Each capsule contains 1.2 mg of soya lecithin.
For the full list of excipients, see section 6.1.
Soft capsule.
Ofev 100 mg soft capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”.
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.
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 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).
Special populations
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