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ZULRESSO™ (brexanolone) injection CIV Formulary Kit
Formulary Kit Components
- Formulary Kit Introduction Letter
- US Food and Drug Administration (FDA) Approval Letter for ZULRESSO
- Product Fact Sheet
- Medical Benefit Coverage Considerations
ZULRESSO™ (brexanolone) CIV is indicated for the treatment of postpartum depression (PPD) in adults.
IMPORTANT SAFETY INFORMATION for ZULRESSO
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS
Patients treated with ZULRESSO are at risk of excessive sedation or sudden loss of consciousness during administration.
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).
Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.
WARNINGS AND PRECAUTIONS
Excessive Sedation and Sudden Loss of Consciousness
In clinical studies, 5% of ZULRESSO-treated patients compared to 0% of placebo-treated patients experienced sedation and somnolence that required dose interruption or reduction. Loss of consciousness or altered state of consciousness was reported in 4% of ZULRESSO-treated patients compared with 0% of placebo-treated patients.
During the infusion, monitor patients for sedative effects every 2 hours during planned, non-sleep periods. Immediately stop the infusion if there are signs or symptoms of excessive sedation. After symptoms resolve, the infusion may be resumed at the same or lower dose as clinically appropriate. Immediately stop the infusion if pulse oximetry reveals hypoxia. After hypoxia, the infusion should not be resumed.
Concomitant use of opioids, antidepressants, or other CNS depressants such as benzodiazepines or alcohol may increase the likelihood or severity of adverse reactions related to sedation. Patients must be accompanied during interactions with their child(ren) while receiving the infusion because of the potential for excessive sedation and sudden loss of consciousness.
Patients should be cautioned against engaging in potentially hazardous activities requiring mental alertness, such as driving, after infusion until any sedative effects of ZULRESSO have dissipated.
ZULRESSO Risk Evaluation and Mitigation Strategy (REMS)
ZULRESSO is available only through a restricted program under a REMS called the ZULRESSO REMS because excessive sedation or sudden loss of consciousness can result in serious harm.
Notable requirements of the ZULRESSO REMS include:
- Healthcare facilities must enroll in the program and ensure that ZULRESSO is only administered to patients who are enrolled in the ZULRESSO REMS
- Pharmacies must be certified with the program and must only dispense ZULRESSO to healthcare facilities who are certified in the ZULRESSO REMS
- Patients must be enrolled in the ZULRESSO REMS prior to administration of ZULRESSO
- Wholesalers and distributors must be registered with the program and must only distribute to certified healthcare facilities and pharmacies
Further information, including a list of certified healthcare facilities, is available ator call 1-844-472-4379.
Suicidal Thoughts and Behaviors
In pooled analyses of placebo-controlled trials of chronically administered antidepressant drugs (SSRIs and other antidepressant classes) that include approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with major depressive disorder (MDD).
ZULRESSO does not directly affect monoaminergic systems. Because of this and the comparatively low number of exposures to ZULRESSO, the risk of developing suicidal thoughts and behaviors with ZULRESSO is unknown. If depression becomes worse or patients experience emergent suicidal thoughts and behaviors, consider changing the therapeutic regimen, including discontinuing ZULRESSO.
The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.
Use in Specific Populations
- Pregnancy: Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including ZULRESSO, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at
- Lactation: Brexanolone is transferred to breastmilk in nursing mothers. There are no data on the effects of ZULRESSO on a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZULRESSO and any potential adverse effects on the breastfed child from ZULRESSO or from the underlying maternal condition
- Pediatric Use: The safety and effectiveness of ZULRESSO in pediatric patients have not been established
- Renal Impairment: No dosage adjustment is recommended in patients with mild, moderate, or severe renal impairment. Avoid use of ZULRESSO in patients with end stage renal disease (ESRD)
ZULRESSO contains brexanolone, a Schedule IV controlled substance under the Controlled Substances Act.
Please also seefor ZULRESSO.
To report SUSPECTED ADVERSE REACTIONS, contact Sage Therapeutics, Inc.
at 1-844-4-SAGERX (1-844-472-4379) or FDA at 1-800-FDA-1088 or .
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ZULRESSO, the ZULRESSO logo, SAGE THERAPEUTICS, and the SAGE THERAPEUTICS logo are trademarks of Sage Therapeutics, Inc. All other trademarks referenced herein are the property of their respective owners.
©2019 Sage Therapeutics, Inc. All rights reserved. 06/19 PP-US-PPD-0034