From the FDA Drug Label
Based on the mechanism of action (VEGFR inhibition), OFEV may increase the risk of bleeding. In IPF studies (Study 1, Study 2, and Study 3), bleeding events were reported in 10% of patients treated with OFEV and in 7% of patients treated with placebo In the chronic fibrosing ILDs with a progressive phenotype study (Study 5), bleeding events were reported in 11% of patients treated with OFEV and in 13% of patients treated with placebo. In the SSc-ILD study (Study 4), bleeding events were reported in 11% of patients treated with OFEV and in 8% of patients treated with placebo
Nintedanib is a VEGFR inhibitor and may increase the risk of bleeding. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary [see Warnings and Precautions (5.6)].
The risk of bleeding associated with Ofev (nintedanib) is increased due to its mechanism of action as a VEGFR inhibitor. Bleeding events were reported in 10-11% of patients treated with OFEV in clinical trials, with the most frequent bleeding event being epistaxis. Patients on full anticoagulation therapy should be monitored closely for bleeding and anticoagulation treatment adjusted as necessary 1 1.
From the Research
Ofev (nintedanib) can increase the risk of bleeding in patients, and it is essential to monitor bleeding risk factors during treatment. This medication, commonly used to treat idiopathic pulmonary fibrosis and other fibrotic lung diseases, works by inhibiting multiple tyrosine kinases involved in blood vessel formation, which can interfere with normal blood clotting mechanisms. Patients taking Ofev should be aware of potential bleeding complications, which can range from minor nosebleeds to more serious gastrointestinal bleeding. The risk is higher in patients who are also taking anticoagulants or antiplatelet medications, have a history of bleeding disorders, or have recently undergone surgery. If you experience any unusual bleeding while taking Ofev, such as blood in stool, urine, or vomit, severe bruising, or prolonged bleeding from cuts, contact your healthcare provider immediately.
Key Considerations
- Regular monitoring of bleeding risk factors is crucial during Ofev treatment 2
- The risk of bleeding is higher in patients taking anticoagulants or antiplatelet medications, with a history of bleeding disorders, or recent surgery
- Temporary discontinuation of Ofev may be necessary before planned surgical procedures to reduce bleeding risk
- Despite bleeding concerns, the benefits of Ofev in treating progressive fibrotic lung disease often outweigh the risks when properly monitored
Management of Bleeding Risk
- Patients should be educated on recognizing signs of bleeding and seeking immediate medical attention if necessary
- Healthcare providers should regularly assess bleeding risk factors and adjust treatment plans accordingly
- The use of proton pump inhibitors may be considered to reduce the risk of gastrointestinal bleeding, as suggested by a recent meta-analysis 3
Conclusion is not allowed, so the answer will continue without one.
Some studies have investigated the use of proton pump inhibitors to prevent gastrointestinal bleeding, with mixed results 4, 5, 6. However, the most recent and highest-quality study on this topic found that proton-pump inhibitors were associated with a reduced incidence of clinically important upper gastrointestinal bleeding 3. In terms of specific management strategies, a practical guide on handling patients with bleeding events while on oral antithrombotic treatment has been published, providing recommendations for healthcare providers 2. Overall, the risk of bleeding associated with Ofev (nintedanib) is a significant concern, and healthcare providers should carefully monitor patients and adjust treatment plans as needed to minimize this risk.