HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZULRESSO safely and effectively. See full prescribing information forZULRESSO.
ZULRESSOTM (brexanolone) injection, for intravenous use, [controlledsubstance schedule pending]
Initial U.S. Approval: [pending controlled substance scheduling]
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF
CONSCIOUSNESS
See full prescribing information for complete boxed warning.
• Patients are at risk of excessive sedation or sudden loss ofconsciousness during administration of ZULRESSO. (5.1)
• Because of the risk of serious harm, patients must be monitored forexcessive sedation and sudden loss of consciousness and havecontinuous pulse oximetry monitoring. Patients must beaccompanied during interactions with their child(ren). (5.1)
• ZULRESSO is available only through a restricted program calledthe ZULRESSO REMS. (5.1, 5.2)
INDICATIONS AND USAGE
ZULRESSO is a neuroactive steroid gamma-aminobutyric acid (GABA) Areceptor positive modulator indicated for the treatment of postpartumdepression (PPD) in adults. (1)
DOSAGE AND ADMINISTRATION
• A healthcare provider must be available on site to continuously monitor thepatient, and intervene as necessary, for the duration of the infusion (2.1).
• Administered as a continuous intravenous infusion over 60 hours (2.5 days)as follows (2.2):
o 0 to 4 hours: Initiate with a dosage of 30 mcg/kg/hour
o 4 to 24 hours: Increase dosage to 60 mcg/kg/hour
o 24 to 52 hours: Increase dosage to 90 mcg/kg/hour (alternativelyconsider a dosage of 60 mcg/kg/hour for those who do not tolerate90 mcg/kg/hour)
o 52 to 56 hours: Decrease dosage to 60 mcg/kg/hour
o 56 to 60 hours: Decrease dosage to 30 mcg/kg/hour
• Dilution required prior to administration. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/20 mL (5 mg/mL) single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Suicidal Thoughts and Behaviors: Consider changing the therapeuticregimen, including discontinuing ZULRESSO, in patients whose PPDbecomes worse or who experience emergent suicidal thoughts andbehaviors. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% and at least twice the rate ofplacebo) were sedation/somnolence, dry mouth, loss of consciousness, and
flushing/hot flush. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contactSage Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
• Pregnancy: May cause fetal harm. (8.1)
• Avoid use in patients with end stage renal disease (ESRD). (8.7)
See 17 for PATIENT COUNSELING INFORMATION and MedicationGuide
Revised: 3/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: EXCESSIVE SEDATION AND SUDDEN
LOSS OF CONSCIOUSNESS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Considerations Prior to Initiating andDuring Therapy
2.2 Recommended Dosage
2.3 Preparation and Storage Instructions
2.4 Administration Instructions
2.5 Recommendations in Patients with End Stage RenalDisease
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS