Brexanolone Dosage

Applies to the following strengths: 5 mg/mL

Usual Adult Dose for Postpartum Depression

Hours 0 to 4: 30 mcg/kg/hr IV via continuous infusion
Hours 4 to 24: 60 mcg/kg/hr IV via continuous infusion
Hours 24 to 52: 90 mcg/kg/hr IV via continuous infusion (consider keeping at 60 mcg/kg/hr if increase is not well tolerated)
Hours 52 to 56: 60 mcg/kg/hr IV via continuous infusion
Hours 56 to 60: 30 mcg/kg/hr IV via continuous infusion
Duration of therapy: 60 hours

Comments:

To allow for proper monitoring of excessive sedation, treatment should begin early enough during the day.
If excessive sedation occurs at any time, stop the infusion until the symptoms resolve, then resume at the same or lower dose.
Patients should be constantly monitored by a healthcare provider for the duration of the infusion.

Use: Treatment of postpartum depression

Usual Pediatric Dose for Postpartum Depression

To allow for proper monitoring of excessive sedation, treatment should begin early enough during the day.
If excessive sedation occurs at any time, stop the infusion until the symptoms resolve, then resume at the same or lower dose.
Patients should be constantly monitored by a healthcare provider for the duration of the infusion.

Use: Treatment of postpartum depression in patients 15 years of age and older

Renal Dose Adjustments

Mild to severe renal disease (estimated glomerular filtration rate [eGFR] 15 to 89 mL/min/1.73 m2): No adjustment recommended.
End stage renal disease (eGFR less than 15 mL/min/1.73 m2): Avoid use

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Hypoxia occurring during administration:

The infusion should be immediately stopped.
The infusion should not be resumed after hypoxia resolves.

Signs/symptoms of excessive sedation/loss of consciousness during non-sleep periods:

The infusion should be immediately stopped.
If clinically appropriate, the infusion may be resumed at the same or lower dose after symptoms resolve.

Precautions

US BOXED WARNINGS:
EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS:

Patients are at risk of excessive sedation or sudden loss of consciousness during administration.
Dur to the risk of serious harm, patients must be monitored for excessive sedation/sudden loss of consciousness and have continuous pulse oximetry monitoring.
Patients must be accompanied during interactions with their child(ren).
This drug is only available through a restricted program under a REMS.

CONTRAINDICATIONS: None.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for DRUG and/or SHARED SYSTEM. It includes elements to assure safe use, and an implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

Safety and efficacy have not been established in patients younger than 15 years old.

US Controlled Substance: Schedule IV

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

A health care provider must be available on site to continuously monitor the patient and intervene if necessary, during the infusion.
Patients must be monitored for hypoxia using continuous pulse oximetry.
Assess for excessive sedation every 2 hours during planned, non-sleeping periods.
Initiate treatment early in the day to allow recognition of excessive sedation.

Storage requirements:

The manufacturer product information should be consulted.

Reconstitution/preparation techniques:

The manufacturer product information should be consulted.

IV compatibility:

The manufacturer product information should be consulted.

Monitoring:

NERVOUS SYSTEM: Sedative effects every 2 hours during non-sleep periods
RESPIRATORY: Pulse oximetry during infusion

Patient advice:

Inform patients that this drug may cause excessive sedation and sudden loss of consciousness and they should avoid driving or operating machinery if these side effects occur.
Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.