DEMONSTRATED SAFETY PROFILE OF MAYZENT®1
ADVERSE REACTIONS THAT OCCURRED IN ≥5% OF PATIENTS TAKING MAYZENT, AND AT A RATE ≥1% HIGHER THAN IN PATIENTS RECEIVING PLACEBO
The most common adverse reactions (incidence ≥10%) were headache (15%), hypertension (13%), and transaminase increases (11%).
Treatment discontinuation rates due to adverse events were similar across treatment arms.
8.5% of patients taking MAYZENT discontinued treatment due to adverse events vs 5.1% with placebo
Additional safety considerations1
Patients undergo a genotype test to identify their specific variant of CYP2C9, the principal enzyme that metabolizes MAYZENT*
This genotype test identifies the appropriate MAYZENT maintenance dose
FDO FOR CERTAIN PATIENTS ONLY
An FDO is required only for patients with preexisting cardiac conditions
Most patients will not need an FDO during initiation
Initiation of MAYZENT treatment results in a transient decrease in heart rate and AV conduction delays
For all patients, a dose titration is recommended for initiation of MAYZENT treatment to help reach their maintenance dose
AV=atrioventricular; FDO=first-dose observation.
*Patients with a CYP2C9*3/*3 genotype should not be treated with MAYZENT.
Reference: 1. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; March 2019.