Nintedanib (Ofev) Dosing for Idiopathic Pulmonary Fibrosis
The recommended dosing for Ofev (nintedanib) in the treatment of idiopathic pulmonary fibrosis (IPF) is 150 mg twice daily, taken approximately 12 hours apart with food. 1, 2
Dosing Protocol
- Standard dose: 150 mg twice daily with food
- Dose adjustment: If not tolerated, reduce to 100 mg twice daily 1, 2
- Administration: Take with food to improve tolerability
- Duration: Treatment should be continued long-term as the evidence does not suggest an optimal duration of therapy 1
Efficacy Evidence
Nintedanib has demonstrated significant efficacy in slowing IPF progression:
- Reduces the annual rate of FVC decline by approximately 125.2 ml compared to placebo (difference: 125.2 ml; 95% CI, 77.7-172.8) 1
- Decreases the proportion of patients with >10% absolute decline in FVC (RR, 1.16; 95% CI, 1.06-1.27) 1
- May reduce acute exacerbations (HR, 0.64; 95% CI, 0.39-1.05), though this did not reach statistical significance in all studies 1, 3
Adverse Effects Management
Gastrointestinal Effects
- Diarrhea: Most common adverse effect (occurs in 60-63% of patients) 2, 4
- Proactive management with hydration and anti-diarrheal medications
- Only 4.4% of patients discontinue treatment due to diarrhea 4
- Nausea/vomiting: Take medication with food to minimize
Liver Function
- Monitoring: Regular liver function tests before and during treatment 2, 4
- Management of elevated liver enzymes:
- Dose reduction to 100 mg twice daily
- Treatment interruption until normalization
- Permanent discontinuation for severe elevations
Dose Modifications
- Dose reduction: 27.9% of patients require dose reduction to 100 mg twice daily 4
- Treatment interruption: 23.7% of patients require temporary interruption 4
- Discontinuation: 19.3% of patients discontinue permanently due to adverse events 4
Clinical Considerations
- Patient selection: Most appropriate for patients with mild to moderate IPF 1
- Drug interactions: Use caution with P-glycoprotein and CYP3A4 inhibitors/inducers 2
- Monitoring: Regular assessment of liver function, symptoms, and disease progression
- Patient education: Inform patients that nintedanib slows but does not stop or reverse disease progression 2
Important Caveats
- Nintedanib should be started at the first identification of clinical or physiological impairment or documentation of decline in lung function 1
- The medication appears to be most effective when initiated early in the disease course, before irreversible fibrosis has developed
- Treatment effect may not be evident until after 3 months of therapy 3, 5
- Combination therapy with pirfenidone has been studied but requires further evaluation for long-term safety 6, 7
Remember that nintedanib is not a cure for IPF but has been shown to significantly slow disease progression, potentially improving survival outcomes in patients with this progressive and often fatal condition.