Brexanolone Injection

IMPORTANT WARNING:

Brexanolone injection may cause you to feel very sleepy or have a sudden loss of consciousness during treatment. You will receive brexanolone injection in a medical facility. Your doctor will check you for signs of sleepiness every 2 hours while you are awake. Tell your doctor right away if you have extreme tiredness, if you feel like you cannot stay awake during the time you are normally awake, or if you feel like you are going to faint.

You must have a caregiver or family member help you with your child(ren) during and after receiving brexanolone injection.

Do not drive a car or operate machinery until you no longer feel sleepy or drowsy after your infusion of brexanolone.

Because of the risks with this medication, brexanolone is available only through a special restricted distribution program. A program called Zulresso Risk Evaluation and Mitigation Strategies (REMS) program. You, your doctor, and your pharmacy must be enrolled in the Zulresso REMS program before you can receive it. You will receive brexanolone in a medical facility under the observation of a doctor or other healthcare professional.

Keep all appointments with your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with brexanolone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Brexanolone comes as a solution to be injected intravenously (into your vein). It is usually given as a one-time infusion over 60 hours (2.5 days) in a medical facility.

Your doctor may temporarily or permanently stop your treatment or adjust your dose of brexanolone depending on your response to treatment and any side effects that you experience.

Brexanolone may be habit-forming. While receiving brexanolone, discuss your treatment goals with your healthcare provider.

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 SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine 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 should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• sedation
• loss of consciousness

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.