Drug Interaction Report

MONITOR: Concomitant use of pitolisant with NSAIDs and/or corticosteroids may increase the risk of gastrointestinal adverse effects such as dyspepsia, abdominal pain or discomfort, and gastritis due to potential additive irritant effects on the gastrointestinal mucosa. Clinical studies with pitolisant reported gastric disorders caused by hyperacidity in 3.5% of patients. However, the effects were described as mostly mild to moderate in severity. Data are not available on the potential for serious gastrointestinal (GI) toxicity, including inflammation, bleeding, ulceration, and perforation.

MANAGEMENT: Caution is advised if pitolisant is used in combination with NSAIDs and/or corticosteroids, particularly in patients with a prior history of peptic ulcer disease or GI bleeding and in elderly or debilitated patients. If concomitant therapy is required, patients should be advised to report signs and symptoms of adverse GI effects, including abdominal pain or discomfort, dyspepsia, gastroesophageal reflux disease, gastritis, or the appearance of black, tarry stools.