From the Guidelines
Ozanimod is contraindicated in patients with certain conditions or taking certain medications, as outlined in Table 1, due to potential increased risks of adverse effects. According to the clinician's guide to using ozanimod for the treatment of ulcerative colitis, published in the Journal of Crohn's and Colitis in 2023 1, patient selection and suitability are crucial to minimize risks. The contraindications for ozanimod include:
- Certain cardiovascular conditions, such as recent myocardial infarction, unstable angina, or stroke
- Concomitant use of monoamine oxidase inhibitors
- Severe untreated sleep apnea
- Pregnancy, due to potential fetal harm
- Severe hepatic impairment (Child-Pugh class C)
- Concomitant use with strong CYP2C8 inhibitors or inducers These contraindications are in place to prevent serious adverse effects, such as bradycardia, heart conduction problems, liver injury, and increased infection risks. It is essential to carefully evaluate patient suitability and select those who can safely benefit from ozanimod treatment, as recommended in the 2023 study 1.
From the FDA Drug Label
• In the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure (4) • Presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker. (4) • Severe untreated sleep apnea. (4) • Concomitant use of a monoamine oxidase inhibitor. (4,7)
The contraindications of Ozanimod are:
- Recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure, or Class III or IV heart failure
- Presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker
- Severe untreated sleep apnea
- Concomitant use of a monoamine oxidase inhibitor 2
From the Research
Contraindications of Ozanimod
- Ozanimod is contraindicated in patients with:
- There is no mention of other contraindications in the provided studies, but it is essential to consider the potential risks and interactions of ozanimod with other medications or medical conditions.
- The studies primarily focus on the efficacy and safety of ozanimod in treating relapsing multiple sclerosis and ulcerative colitis, with an emphasis on its cardiac safety profile 4, 5, 6, 7.
- Ozanimod has been shown to be generally well-tolerated, with common adverse events including transient asymptomatic bradycardia, first-degree atrioventricular blocks, transient asymptomatic hepatotoxicity, macular edema in patients with preexisting risk factors, and increased risk of nasopharyngitis 3.