Zulresso Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Zulresso Injection (brexanolone) is a prescription antidepressant given by IV infusion to treat postpartum depression in people 15 years and older. It works like a natural hormone that drops sharply after childbirth, helping to calm an overactive stress response. The infusion requires continuous monitoring by a healthcare provider due to risks of excessive sedation. Note: the Zulresso brand and its generics have been discontinued in the United States.

What is Zulresso Injection

Zulresso is a prescription medicine given by IV infusion that is used to treat postpartum depression in people 15 years and older. It belongs to the antidepressant drug class and is classified as a neuroactive steroid GABA A receptor positive modulator. The Zulresso brand and its generics have been discontinued in the United States.

Zulresso Injection uses

• Treats postpartum depression after childbirth.
• Helps reduce persistent sadness after delivery.
• May improve mood and emotional well-being.
• May reduce anxiety associated with postpartum depression.
• May help improve daily functioning when symptoms improve.

Benefits of Zulresso Injection

• Treats postpartum depression.
• May reduce persistent sadness after childbirth.
• May improve emotional well-being.
• May help restore interest in daily activities.
• May improve functioning when postpartum depression symptoms improve.

How Zulresso Injection works

Zulresso works like a natural hormone called allopregnanolone, which rises during pregnancy and drops sharply after birth. By boosting the activity of GABA receptors in the brain, it may help calm an overactive stress response and ease symptoms of postpartum depression, although its exact mechanism is not completely understood.

Zulresso Injection dosage

Zulresso is given as a continuous IV infusion over a total of 60 hours (2.5 days). A healthcare provider must stay on site to continuously monitor you for the entire infusion. Treatment should start early enough in the day so that excessive sleepiness can be noticed and managed. You will be checked for signs of excessive sleepiness every 2 hours while you are awake, and your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during the infusion. A family member or other caregiver must be available to care for your children during the entire infusion, since you cannot be the primary caregiver while receiving the medicine. This medicine is not approved for use in anyone younger than 15 years old.

Use exactly as prescribed by your doctor or pharmacist.

Available forms and strengths

• Injection

Side effects of Zulresso Injection

Common

• Drowsiness/sleepiness
• Dry mouth
• Loss of consciousness (passing out)
• Flushing or hot flushes of the skin or face

Serious

• Hives
• Difficulty breathing
• Swelling of the face, lips, tongue, or throat
• Excessive drowsiness or feeling like you cannot stay awake
• Lightheadedness or feeling like you might pass out
• Sudden changes in mood or behavior
• New or worsening depression
• Thoughts of hurting yourself

Warnings and precautions

• This medicine carries a boxed warning (the most serious type of warning) for excessive sedation and sudden loss of consciousness during the infusion. Continuous monitoring and oxygen level checks are required, and you must have someone else care for your children during treatment.
• Because of these serious risks, this medicine can only be given through a special restricted program at certified healthcare facilities, and patients must be enrolled before receiving it.
• This medicine and other antidepressants may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. Depression itself is one of the most important causes of suicidal thoughts or actions.
• Combining this medicine with alcohol, opioids, benzodiazepines, or other antidepressants can increase the chances or severity of sedation-related side effects.
• This medicine contains a controlled substance and has some potential for abuse or dependence.
• Tell your doctor if you are pregnant or planning to become pregnant, because this medicine may harm an unborn baby. There is a pregnancy registry that tracks outcomes in women exposed to this medicine during pregnancy.
• This medicine passes into breast milk, but only in low amounts, and infant exposure is expected to be low. Talk with your doctor about the risks and benefits of breastfeeding while receiving this medicine.
• Tell your doctor if you have kidney problems. This medicine should not be used in people with end-stage renal disease because an inactive ingredient can build up in the body.
• No dose change is needed for people with liver problems; minor changes in drug levels were seen in patients with moderate to severe liver impairment but did not affect how well the medicine was tolerated.
• Do not drink alcohol while receiving this medicine, since alcohol can increase the risk of dangerous sedation.
• Do not drive or do other activities that require alertness after your infusion until any sleepiness has completely gone away, since this medicine can make you dizzy and very sleepy.

Storage

• Store the undiluted product at 36°F to 46°F (2°C to 8°C)
• Do not freeze
• Store protected from light
• After dilution, the product can be stored in infusion bags under refrigerated conditions for up to 96 hours
• Each prepared bag of diluted medicine may be used for up to 12 hours of infusion time at room temperature; discard any unused medicine after 12 hours of infusion
• Keep this and all other medicines out of the reach of children

When to see a doctor

• Get emergency medical help right away if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
• Tell your healthcare provider right away during the infusion if you feel like you cannot stay awake or feel like you might pass out.
• Call your doctor right away if you notice sudden changes in mood or behavior, new or worsening depression, or thoughts of hurting yourself.
• If you think you have taken too much or experience severe drowsiness, fainting, or slowed breathing, seek emergency medical attention right away.

Alternatives

• Fluoxetine
• Sertraline
• Zuranolone