Ofev (nintedanib) Disease Interactions

The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, permanently discontinue these agents and institute appropriate measures. Immediately withhold treatment in patients diagnosed with ILD/pneumonitis and permanently discontinue therapy if no other potential causes of ILD/pneumonitis have been identified.

Arterial thromboembolic events, including myocardial infarction have been reported in patients taking nintedanib. It is recommended to exercise caution when treating patients at higher cardiovascular risk, including known coronary artery disease and to consider treatment interruption in patients who develop signs or symptoms of acute myocardial ischemia.

Nintedanib may increase the risk of bleeding. Nintedanib should only be used in patients with known risk of bleeding if the anticipated benefit outweighs the potential risk. Close monitoring is recommended.

Nintedanib may increase the risk of gastrointestinal perforation. Use caution when treating patients who have had recent abdominal surgery. It is recommended to discontinue therapy with nintedanib in patients who develop gastrointestinal perforation. Nintedanib should only be used in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk. Care and close monitoring is recommended.

The use of nintedanib is associated with elevations of liver enzymes. Treatment with nintedanib is not recommended in patients with moderate or severe hepatic impairment. Patients with mild hepatic impairment can be treated with a reduced dose of nintedanib. It is recommended to conduct liver function tests prior to treatment with nintedanib and periodically thereafter as clinically indicated. Dosage modifications or interruption may be necessary for liver enzyme elevations as clinically indicated and according to medical practices.

Based on a population pharmacokinetics analysis of nintedanib, exposure to nintedanib is not influenced by mild or moderate renal impairment. No dose adjustment is required in patients with mild to moderate renal impairment. Care and close monitoring is recommended when using this agent in patients with severe renal impairment and end-stage renal disease as the safety, efficacy, and, pharmacokinetics of nintedanib have not been studied these patients.

Smoking is associated with decreased exposure to nintedanib. Patients that are smokers might alter the efficacy profile of nintedanib. Encourage patients that are smokers to stop smoking prior to treatment because it might alter the efficacy profile of nintedanib and to avoid smoking while on therapy.