Pronunciation:

brex-AN-oh-lone

Brand Names:

• Zulresso

Dosage Forms:

• Solution

Warnings:

Warning: Excessive Sedation and Sudden Loss of ConsciousnessPatients are at risk of excessive sedation or sudden loss of consciousness during administration of brexanolone.Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).Brexanolone is available only through a restricted program called the ZULRESSO REMS .

Classifications:

Therapeutic—

Antidepressant

Uses of This Medicine:

Brexanolone injection is used to treat postpartum depression (unusual physical, emotional, and behavioral changes in women after giving birth).

This medicine is available only under a restricted distribution program called Zulresso® REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of brexanolone injection in children younger than 15 years of age. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of brexanolone injection in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression or
• Mental illness—Use with caution. May make these conditions worse.

• End-stage kidney disease—Avoid use in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. 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).

Your doctor will check you for excessive drowsiness or symptoms of sleepiness during infusion and for every 2 hours while you are awake.

It is very important that you understand the requirements of the Zulresso® REMS program, and become familiar with the Zulresso® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that this medicine is working properly and to check for unwanted effects.

This medicine may cause excessive drowsiness or sleepiness 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. You must have a caregiver or family member with you to help care for your child or children during treatment with this medicine.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor before receiving this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with brexanolone may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Dizziness or lightheadedness

drowsiness

fainting

feeling of constant movement of self or surroundings

relaxed and calm feeling

sensation of spinning

sleepiness or unusual drowsiness

Less common

Fast, pounding, or irregular heartbeat or pulse

loss of consciousness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptom of overdose

Prolonged drowsiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dry mouth

Less common

Acid or sour stomach

belching

diarrhea

feeling of warmth

heartburn

indigestion

mouth or throat pain

redness of the face, neck, arms, and occasionally, upper chest

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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