Zulresso

Zulresso is a prescription medication used to treat post-partum depression. Zulresso belongs to a group of drugs called steroid hormone derivatives, which help regulate chemicals in the brain known to play a role in mood.  

This medication is available in an injectable form to be given into intravenously (IV) by a healthcare professional.

Common side effects of Zulresso include sedation/sleepiness, dry mouth, loss of consciousness and flushing/hot flashes.

Zulresso is a prescription medicine used to treat postpartum depression.

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

Serious side effects have been reported with Zulresso. See the "Zulresso Precautions" section for more information.

Common side effects of Zulresso include the following:

• sedation/sleepiness 
• dry mouth
• loss of consciousness  
• flushing/hot flashes

This is not a complete list of Zulresso side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tell your doctor about your medications before, during, and after treatment with Zulresso. Especially tell your doctor if you take:

• Nervous system depressants (such as Xanax, lorazepam, others)
• antidepressants (such as Prozac, citalopram, sertraline, others)
• opioids (such as Percocet, morphine, others)

This is not a complete list of Zulresso drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Zulresso including the following:

• Excessive sedation and loss of consciousness. Zulresso may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness). Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake. 

During your Zulresso infusion, tell your healthcare provider right away if you feel like you cannot stay awake during the time you are normally awake or if you feel like you are going to pass out. Your healthcare provider may lower your dose or stop the infusion until your symptoms go away. 

You must have a caregiver or family member with you to help care for your child(ren) during your Zulresso infusion.

• Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, Zulresso is only available through a restricted program called the Zulresso REMS.
• Increased risk of suicidal thoughts or actions. Zulresso and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. 

Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings. 

Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. 

Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

• attempts to commit suicide
• thoughts about suicide or dying
• new or worse depression
• other unusual changes in behavior or mood

Do not take Zulresso if

• you are pregnant
• you take antidepressants, opioids, benzodiazepianes (or other CNS depressants)
• you have end stage renal (kidney) disease
• you are allergic to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zulresso, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Zulresso, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Zulresso or to any of its ingredients
• drink alcohol
• have a history of kidney disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given Zulresso and had some babies born with problems and some miscarraiges. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the risks to the unborn child.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/.

Tell your doctor if you are breastfeeding or planning to breastfeed.

Zulresso has been detected in human breast milk. Because of the possibility of adverse reactions in nursing infants from Zulresso, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Zulresso exactly as prescribed.

This medication is available in an injectable form to be given directly into the vein (IV) by a healthcare professional. It is intended to be used inpatient in a medical facility. You must be monitored for greater than 60 hours while treatment with this medication is given.

This medication should be given directly into the vein (IV) by a healthcare professional. Zulresso is administered continuously as an IV infusion over 60 hours (2.5 days). The dose you receive will be determined based on individual factors such as height and weight. The dose will be raised after the first 4 hours of the infusion, then again after 24 hours. 

To receive this medication, you must remain in the direct supervision and care of a healthcare provider throughout the entire 60 hour infusion.

If side effects become intolerable, you may need to wait longer between doses, receive a lower dose, or permanently stop the medicine if potentially serious side effects occur.

If Zulresso is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS

Patients treated with ZULRESSO are at risk of excessive sedation or sudden loss of consciousness during administration.

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).

Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.