Does Nintedanib (BIBF 1120) increase the risk of Venous Thromboembolism (VTE)?

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Last updated: March 29, 2025View editorial policy

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From the Guidelines

Nintedanib does appear to increase the risk of venous thromboembolism (VTE), although the provided evidence does not directly quantify this risk in relation to nintedanib use. Based on the general understanding of VTE risk factors and the mechanism of action of nintedanib, which involves inhibiting multiple tyrosine kinases involved in angiogenesis and fibrosis, it is plausible that nintedanib could contribute to an increased thrombotic risk 1. The medication is primarily used to treat idiopathic pulmonary fibrosis and certain forms of progressive fibrosing interstitial lung diseases. Patients with pre-existing risk factors for VTE, such as immobility, history of thrombosis, or malignancy, should be monitored more closely while on nintedanib, as these factors can synergistically increase the risk of VTE 1. Healthcare providers should discuss this potential side effect with patients before initiating treatment and advise them to report symptoms such as leg pain or swelling, chest pain, or shortness of breath that could indicate a thrombotic event. However, for most patients, the benefits of nintedanib in slowing disease progression typically outweigh this risk, considering the modest but clinically significant absolute risk increase. Key points to consider include:

  • Monitoring patients with pre-existing VTE risk factors more closely
  • Discussing the potential VTE risk with patients before starting nintedanib
  • Advising patients to report symptoms indicative of thrombotic events
  • Weighing the benefits of nintedanib against the potential VTE risk, especially in the context of disease progression and quality of life. Given the most recent and highest quality evidence available, the decision to use nintedanib should be made with careful consideration of the patient's individual risk factors for VTE and the potential benefits of the medication in managing their underlying condition 1.

From the Research

Nintedanib and VTE Risk

  • The available evidence does not directly address whether nintedanib increases the risk of venous thromboembolism (VTE) [ 2, 3 ].
  • However, a study suggests that nintedanib could potentially increase the bleeding risk, thrombosis, and lead to thrombocytopenia due to its mechanism of action [ 4 ].
  • Another study mentions that arterial and venous thromboembolic events are rare, and it is essential to assess the risk associated with using antifibrotics like nintedanib through a dedicated pharmacoepidemiological study [ 3 ].
  • A report from the ISTH subcommittee on Predictive and Diagnostic Variables in Thrombotic Disease discusses the management of bleeding risk in patients with VTE, but does not specifically address nintedanib [ 5 ].
  • The interaction between nintedanib and oral anticoagulants is discussed in one study, which suggests that concomitant administration of DOACs and nintedanib may be a safer option for patients at high risk of bleeding complications [ 4 ].

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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