Brexanolone is used to treat postpartum depression.

Brexanolone is available only under a special program because it can cause excessive drowsiness or sudden loss of consciousness. You must be registered in the program and understand the risks and benefits of brexanolone.

Brexanolone may also be used for purposes not listed in this medication guide.

Brexanolone is given in a hospital or clinic setting where you can be watched closely for side effects.

Brexanolone can make you very drowsy, and may cause you to pass out. Tell your caregivers if you feel light-headed or feel like you cannot stay awake.

Brexanolone is given as an infusion into a vein. A healthcare provider will give you this injection in a hospital or clinic setting.

Brexanolone is usually given around the clock for a total of 60 hours (2.5 days).

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

Your infusion may be stopped or permanently discontinued if this medicine slows your breathing.

Brexanolone can make you very drowsy, and may cause you to pass out. Tell your caregivers if you feel light-headed or feel like you cannot stay awake.

Your child(ren) will need to be cared for by a family member or other caregiver during the entire time you are being treated with brexanolone.

Usual Adult Dose for 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
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.
-Patients should be constantly monitored by a healthcare provider for the duration of the infusion.

Use: Treatment of postpartum depression

Brexanolone is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

• kidney disease; or

• if you drink large amounts of alcohol.

Some young people have thoughts about suicide while using an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Brexanolone may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of brexanolone on the baby.

It may not be safe to breastfeed while using brexanolone. Ask your doctor about any risk.

Brexanolone is used as a single dose and does not have a daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause severe drowsiness, fainting, or slowed breathing.

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until your drowsiness has worn off completely. Drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Brexanolone may cause serious side effects. Call your doctor at once if you have:

• excessive drowsiness (feeling like you cannot stay awake, or feeling like you might pass out);

• sudden changes in mood or behavior;

• new or worsening depression; or

• thoughts of hurting yourself.

Common side effects of brexanolone may include:

• drowsiness;

• feeling like you might pass out;

• dry mouth; or

• flushing (sudden warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using brexanolone with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect brexanolone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.