Dosing and administration

Dosing simplicity: Just 1 capsule taken twice daily¹

Additional dosing information:¹

OFEV® capsules should be:

Taken approximately 12 hours apart with food
Swallowed whole with a glass of water

If a dose is missed, treatment should resume at the next scheduled time and at the recommended dose.

The maximum daily dose of 300 mg should not be exceeded.

Dose reduction or temporary treatment interruption can help to manage AEs while maintaining clinical efficacy in patients with idiopathic pulmonary fibrosis (IPF)²

Pooled incidence of dose reduction and treatment interruption in INPULSIS®-1 and -2 trials in patients with IPF³

28% of patients receiving OFEV® had ≥1 dose reduction. The mean duration of dose reduction was 4.4 months^3*
6% of patients (40/178) had ≥1 dose increase back to the full dose of OFEV® (150 mg twice daily)³
76% of patients in the OFEV® group received 150 mg twice daily as their last dose at the end of the 52-week trial³

24% of patients receiving OFEV® required ≥1 treatment interruption. The mean duration of treatment interruption was 25.1 days (18.8)^3†

Regardless of dose adjustment or treatment interruption to manage side effects, the efficacy of OFEV® was maintained²

OFEV® may be resumed at the full dose (150 mg twice daily) or reintroduced at a reduced dose (100 mg twice daily), which subsequently may be increased to the full dose¹

Footnotes:

AE, adverse event; FVC, forced vital capacity; IPF, idiopathic pulmonary fibrosis.
*
4% of patients receiving placebo had ≥1 dose reduction. The mean duration of dose reduction was 3.2 months.3,4
†
10% of patients in the placebo group required ≥1 treatment interruption. The mean duration of treatment interruption in the placebo group was 25.6 days (15.3).3

References

OFEV® summary of product characteristics. Boehringer lngelheim International GmbH. July 2020.
Richeldi L, et al. Effect of dose reductions, treatment interruptions and dose intensity on decline in lung function with nintedanib in patients with idiopathic pulmonary fibrosis (IPF): results from the INPULSIS® trials. Abstract presented at: the Pulmonary Fibrosis Foundation Summit 2015; November 12-14, 2015; Washington, DC.
Corte T, et al. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015;16:116. doi:10.1186/s12931-015-0276-5.
OFEV® Summary of Clinical Safety. Boehringer Ingelheim. 2014.

OFEV®