Zeposia and Diabetes Mellitus: Required Precautions
Patients with diabetes mellitus require an ophthalmic evaluation before starting Zeposia (ozanimod) and regular follow-up eye examinations throughout treatment due to increased risk of macular edema. 1
Primary Risk: Macular Edema
Diabetes is a pre-existing risk factor that increases susceptibility to macular edema during ozanimod therapy. The clinical trial data demonstrate:
- Low overall incidence (≤0.6% in UC trials, 0.4% in MS trials) with long-term treatment 1
- Most macular edema cases occurred in patients with pre-existing risk factors or comorbid conditions, including diabetes 1
- Three of four confirmed cases in MS patients had pre-existing risk factors 1
Mandatory Monitoring Protocol
Pre-Treatment Requirements
- Obtain baseline ophthalmic evaluation before initiating Zeposia in all diabetic patients 1, 2
- This evaluation should be performed by an eye care professional 2
During Treatment Monitoring
- Perform regular follow-up ophthalmic evaluations throughout ozanimod treatment in diabetic patients 1
- Monitor for any vision changes, including: 1
- Distorted contour and color of objects
- Unequal size with monocular view
- Any other visual disturbances
Patient Education
- Instruct diabetic patients to immediately contact their healthcare provider if they experience any changes in vision while taking Zeposia 2
- Advise patients that their risk of macular edema is increased due to diabetes 2
Clinical Context and Safety Profile
The evidence from extensive clinical trial experience provides reassurance:
- Over 2,196 patient-years of exposure in UC trials showed macular edema incidence ≤0.6% 1
- Up to 5 years of treatment in MS trials demonstrated 0.4% incidence 1
- No cases required treatment discontinuation when appropriately monitored 1
Critical Pitfall to Avoid
Do not initiate Zeposia in diabetic patients without baseline ophthalmologic assessment. This screening is essential to establish baseline retinal status and identify any pre-existing diabetic retinopathy that would require more intensive monitoring. 1, 2
The combination of pre-treatment screening and regular monitoring allows safe use of ozanimod in diabetic patients while maintaining vigilance for this rare but important complication. 1