iagnosed, appropriate treatment should be initiated.
Progressive Multifocal Leukoencephalopathy(PML)is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. No cases of PML were identified in active-controlled MS clinical trials with Zeposia. PML has been reported in patients treated with S1P receptor modulators and other MS therapies and has been associated with some risk factors.If PML is suspected, withhold Zeposia and perform an appropriate diagnostic eva luation.If confirmed, treatment with Zeposia should be discontinued
In clinical studies, patients who received Zeposia were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS. Concomitant use of Zeposia with any of these therapies would be expected to increase the risk of immunosuppression. When switching to Zeposia from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects
Use of live attenuated vaccines should be avoided during and for 3 months after treatment with Zeposia.If live attenuated vaccine immunizations are required, administer at least 1month prior to initiation of Zeposia
Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of Zeposia may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of Zeposia without dose escalation may result in greater decreases in heart rate. If treatment with Zeposia is considered, advice from a cardiologist should be sought for those individuals:
with significant QT prolongation
with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs
with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension
with a history of Mobitz type II second-degree or higher AV block, sick-sinus syndrome, or sinoatrial heart block .
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