Brexanolone (brex-AN-oh-lone)

Treats postpartum depression (PPD).

Brand Name(s):

Zulresso

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so the needle will have to stay in place for a total of 60 hours (2 1/2 days).
• A nurse or other health provider will give you this medicine.
• Your doctor will check you for excessive drowsiness during infusion and for every 2 hours while you are awake.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, depression, or mental illness.
• This medicine may increase risk of thoughts or behavior of suicide.
• This medicine may cause dizziness, excessive drowsiness, and sudden loss of consciousness. Do not drive or do anything else that could be dangerous after your infusion until your feeling of sleepiness has completely gone away.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, dizziness, fast heartbeat, trouble breathing
• Prolonged drowsiness or sleepiness, loss of consciousness
• Thoughts or attempts of killing yourself, changes in mood or behavior

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088