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
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