ZEPOSIA

Ozanimod 0.92mg, Oral capsule

Tobacco

· Severity: Major

· Notes for Consumers: Do not smoke or use tobacco products while taking this medication. When used together, your medication may not work as well for you.

· Notes for Professionals: Advise patients to avoid smoking tobacco while taking ozanimod. During pharmacokinetic studies, the steady-state exposure (AUC) of one of the major active metabolites of ozanimod, CC112273, was approximately 50% lower in tobacco smokers than in nonsmokers. The clinical impact of smoking on ozanimod treatment is not known.

Ozanimod 0.92mg, Oral capsule

Tyramine-containing foods

· Severity: Major

· Notes for Consumers: Certain foods containing large amounts of tyramine might increase the risk of side effects with Ozanimod. Avoid eating aged, fermented, cured, smoked and pickled foods, such as aged or smoked meats (like sausages or smoked or pickled fish) and aged cheeses. Taking these foods along with Ozanimod might increase your blood pressure. Ask your dietician or health care provider for a complete list of foods to avoid.

· Notes for Professionals: Patients should be advised to avoid foods containing a large amount of tyramine while taking recommended doses of ozanimod. Certain foods that may contain very high amounts (i.e., more than 150 mg) of tyramine could cause severe hypertension because of a potential tyramine interaction in patients taking ozanimod, even at the recommended doses. Ozanimod metabolites inhibit MAO in vitro. MAO in the gastrointestinal tract and liver (primarily type A) provides protection from exogenous amines (e.g., tyramine). If tyramine were absorbed intact, it could lead to severe hypertension, including hypertensive crisis. Aged, fermented, cured, smoked, and pickled foods containing large amounts of exogenous amines (e.g., aged cheese, pickled herring) may cause release of norepinephrine resulting in a rise in blood pressure (tyramine reaction).

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>