From the Guidelines
The recommended dosage of Ofev (nintedanib) for idiopathic pulmonary fibrosis (IPF) is 150 mg taken orally twice daily, approximately 12 hours apart with food. This dosage is based on the results of the INPULSIS-1 and INPULSIS-2 trials, which demonstrated that nintedanib slowed disease progression in patients with IPF, as measured by the annual rate of decline in forced vital capacity (FVC) 1. The capsules should be swallowed whole with water and not chewed or crushed. This medication is intended for long-term use as IPF is a chronic progressive disease. Dose reductions may be necessary for managing side effects, with a reduced dose of 100 mg twice daily available if patients cannot tolerate the standard dose.
Common side effects of nintedanib include diarrhea (occurring in about 60% of patients), nausea, abdominal pain, vomiting, and elevated liver enzymes 1. Diarrhea can often be managed with antidiarrheal medications like loperamide. Regular liver function monitoring is essential, with tests recommended prior to treatment initiation, monthly for three months, then every three months thereafter. Treatment should be temporarily interrupted for AST or ALT elevations >3 times the upper limit of normal. Nintedanib works by inhibiting multiple tyrosine kinases involved in fibrosis pathways, slowing disease progression rather than improving symptoms. The medication should be used cautiously in patients with cardiovascular disease, and is contraindicated in patients with severe liver impairment or known hypersensitivity to nintedanib.
Key considerations for the use of nintedanib in patients with IPF include:
- Monitoring for adverse events, particularly diarrhea and nausea
- Regular liver function testing to minimize the risk of liver injury
- Dose reduction or temporary interruption of treatment as needed to manage side effects
- Caution in patients with cardiovascular disease or other comorbidities that may be exacerbated by nintedanib. The use of nintedanib in patients with IPF has been shown to slow disease progression, as demonstrated by the results of the INPULSIS trials 1, and is a recommended treatment option for patients with this condition.
From the Research
Recommended Dosage and Treatment Regimen for Ofev (Nintedanib) in Patients with Idiopathic Pulmonary Fibrosis (IPF)
- The recommended dosage of Ofev (nintedanib) for patients with IPF is 150 mg twice daily 2, 3, 4, 5.
- The treatment regimen for Ofev (nintedanib) in patients with IPF typically involves a continuous dosing schedule, with the medication taken twice daily 2, 3, 4, 5.
- In clinical trials, patients with IPF who received Ofev (nintedanib) 150 mg twice daily showed a significant reduction in the annual rate of decline in forced vital capacity (FVC) compared to those who received placebo 2, 5.
- The safety and tolerability of Ofev (nintedanib) in patients with IPF have been evaluated in several clinical trials, with the most common adverse event being diarrhea 2, 3, 5.
Management of Adverse Events
- Diarrhea is the most frequent adverse event associated with Ofev (nintedanib) treatment, occurring in approximately 60% of patients 2, 3, 5.
- To manage diarrhea, patients may require dose reductions or treatment interruptions 3.
- Monitoring of liver enzymes is also recommended before and periodically during Ofev (nintedanib) treatment to manage potential liver enzyme elevations 3.
Combination Therapy with Pirfenidone
- There is limited evidence on the safety and efficacy of combination therapy with Ofev (nintedanib) and pirfenidone in patients with IPF 6, 4.
- A Phase 2 trial conducted in Japan demonstrated that combination therapy with Ofev (nintedanib) and pirfenidone was tolerable for 1 month 4.
- Further evaluation of the long-term safety and efficacy of combination therapy with Ofev (nintedanib) and pirfenidone is needed 4.