Brexanolone Injection

Name: Brexanolone Injection

Why is this medication prescribed?

Brexanolone injection is used for the treatment of postpartum depression (PPD) in adults. Brexanolone injection is in a class of medications called neurosteroid antidepressants. It works by changing the activity of certain natural substances in the brain.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving brexanolone,

  • tell your doctor and pharmacist if you are allergic to any other medications, or any of the ingredients in brexanolone injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants, benzodiazepines including alprazolam (Xanax), diazepam (Diastat, Valium), midazolam, or triazolam (Halcion); medications for mental illness, medications for pain such as opioids, medications for seizures, sedatives, sleeping pills, and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had kidney disease.
  • tell your doctor if you are pregnant or if you think you may be pregnant, or are breast-feeding.
  • you should know that alcohol can make the side effects from brexanolone worse. Do not drink alcohol while receiving brexanolone.
  • you should know that your mental health may change in unexpected ways when you receive brexanolone or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is changed. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What side effects can this medication cause?

Brexanolone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • dry mouth
  • heartburn
  • mouth or throat pain
  • flushing
  • hot flashes
  • dizziness or a spinning sensation
  • fatigue

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • racing heartbeat

Brexanolone may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What other information should I know?

Ask your pharmacist any questions you have about brexanolone.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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