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Pronunciation: brex AN oh lone

Brand: Zulresso

What is the most important information I should know about brexanolone?

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.

What is brexanolone?

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 this medicine.

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

What should I discuss with my healthcare provider before receiving brexanolone?

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 this medicine. Ask your doctor about any risk.

How is brexanolone given?

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.

What happens if I miss a dose?

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

What happens if I overdose?

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

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

What should I avoid after receiving brexanolone?

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.

What are the possible side effects of brexanolone?

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

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 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.

What other drugs will affect brexanolone?

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.

Where can I get more information?

Your pharmacist can provide more information about brexanolone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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