Pregnancy: May cause fetal harm.
Avoid use in patients with end stage renal disease
- TRADE NAME: Zulresso (Sage Therapeutics)
- INDICATIONS: Indicated for the treatment of postpartum depression (PPD) in adults.
- SYNONYM: Zulresso
- CLASS: GABA A receptor positive modulator
- HALF-LIFE: ~ 9 hours
- FDA APPROVAL DATE: 03/19/2019
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
Antidepressants, CNS depressants - PREGNANCY: Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm. There are no available data on ZULRESSO use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS
PATIENTS ARE AT RISK OF EXCESSIVE SEDATION OR SUDDEN LOSS OF CONSCIOUSNESS DURING ADMINISTRATION OF ZULRESSO (BREXANOLONE). BECAUSE OF THE RISK OF SERIOUS HARM, PATIENTS MUST BE MONITORED FOR EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS AND HAVE CONTINUOUS PULSE OXIMETRY MONITORING. PATIENTS MUST BE ACCOMPANIED DURING INTERACTIONS WITH THEIR CHILD(REN). ZULRESSO IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE ZULRESSO REMS.
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Page last updated 08/21/2024
