Brexanolone Injection

What is this medication?

BREXANOLONE (brex ANN oh lone) treats postpartum depression (PPD). It works by balancing substances in your brain that help regulate mood.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ZULRESSO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• If you drink alcohol
• Kidney disease
• Suicidal thoughts, plans or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to brexanolone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for infusion into a vein. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before treatment with this medication. Be sure to read this information carefully.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 15 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

This medication may interact with the following:

• Alcohol
• Certain medications for anxiety or sleep
• Narcotic medications for pain
• Other antidepressants

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. During your infusion, your care team will check you for excess drowsiness every 2 hours while you are awake. It is important to tell your care team right away if you feel like you cannot stay awake or if you feel like you are going to pass out. You must have a caregiver or family member with you to help care for your child(ren) while you are receiving this medication. After receiving this medication, your care team will decide when you are ready to return home. Do not drive, use machinery, or do anything that needs mental alertness until any feelings of drowsiness or dizziness are completely gone.

Alcohol may interfere with the effects of this medication. Avoid alcoholic drinks.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. Call your care team right away if you experience these thoughts or worsening depression.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Dry mouth
• Flushing

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.