Mayzent Approval History
Reviewed by J.Stewart BPharm. Last updated on Apr 10, 2019.
Mayzent (siponimod) is a sphingosine-1-phosphate receptor modulator for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
- Mayzent is taken as a once daily maintenance dose after an initial titration period.
- Warnings and Precautions:
- Mayzent may increase the risk of infections, so patients should have a complete blood count taken before treatment is initiated.
- The drug may cause macular edema, so patients should contact their physician if they experience a change in vision.
- Mayzent may cause transient decreases in heart rate and may cause a decline in lung function.
- Liver enzymes should be checked before initiation of the drug and health care professionals should closely monitor patients with severe liver impairment.
- Health care professionals should monitor the patient’s blood pressure during treatment.
- Women of childbearing potential should use effective contraception during and for 10 days after stopping the drug due to the potential risk of fetal harm.
- Health care professionals should monitor patients for posterior reversible encephalopathy syndrome and monitor patients that had treatment with immunosuppressive/immune-modulating therapies because there may be unintended additive immunosuppression with Mayzent.
- Common adverse reactions (incidence greater than 10%) were headache, hypertension, and transaminase increase.
Development History and FDA Approval Process for Mayzent
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.