Patient Information Guide
What You Need to Know About ZULRESSO
What is ZULRESSO?
ZULRESSO is a hormone based treatment and is the first drug specifically developed for moderate to severe depression after childbirth (postpartum depression or PPD) in adults. ZULRESSO has shown results in a short amount of time, within 4 or 5 days.
How is ZULRESSO given?
ZULRESSO is given directly into your vein as an intravenous (IV) solution. This can also be called an infusion. The infusion lasts 60 hours without stopping. That’s 2.5 days.
A trained Healthcare Provider will give you ZULRESSO at our ZULRESSO REMS certified Healthcare Setting. We will be able to help you with any side effects that might happen.
What are the serious risks of ZULRESSO?
- Risk of serious harm from extreme sleepiness (excessive sedation) or passing out (loss of consciousness) during the infusion
During the infusion, patients treated with ZULRESSO may get extremely sleepy. Sometimes they may not be easily awakened. This is different from normal sleep where you drift into sleep naturally and can wake up easily. Sudden loss of consciousness (passing out) can occur in
Because this could cause serious harm, you will be monitored during your treatment. Your Healthcare Provider will check you for symptoms of excessive sleepiness every 2 hours. Also, someone will need to care for your child(ren) and be in the room with you if you are with your child(ren) during the infusion.
What are breast-feeding considerations?
Brexanolone is present in breast milk.
The relative infant dose (RID) of brexanolone is 1 to 2% of the weight adjusted maternal dose.
The RID was calculated by the manufacturer following administration of brexanolone infused over 60 hours (maximum dose 90 mg/kg/hour) to 12 lactating females ≤6 months postpartum. Breast milk concentrations approximated those in the maternal plasma (average concentration 70.56 ng/mL) and rapidly declined to below the limit of detection (<10 ng/mL) in 95% of the women within 36 hours after completion of the infusion. Infants were not breastfed during the study (Hoffman 2019).
In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. The low oral bioavailability of brexanolone (<5%) should also limit potential infant exposure via breast milk.
[US Boxed Warning]: Patients 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 accompanied during interactions with their child(ren).
What are the symptoms that I should be aware of?
It is important to tell your Healthcare Provider if you have any of the following symptoms while getting ZULRESSO:
- Feeling more sleepy than usual (you cannot stay awake when you are trying to stay awake)
- Having a hard time paying attention
- Having trouble following simple instructions
- Feeling lightheaded or dizzy or like you are going to pass out
These are not all the possible side effects of ZULRESSO. See the ZULRESSO Medication Guide for more information or talk to your Healthcare Provider further.
What should I do if I start to feel the symptoms listed above?
- If you’re holding your baby, put your baby down.
- Sit or lie down.
- Tell your Healthcare Provider right away.
Your Healthcare Provider may stop your infusion with ZULRESSO. During clinical trials, once ZULRESSO was stopped, patients who passed out woke up after a short time. You and your Healthcare Provider will decide whether to continue ZULRESSO.
How should I prepare for my infusion?
- Find childcare for the 2.5 days of your treatment or call our Center for possible nanny assistance.
- Tell your Healthcare Provider about all the medicines you take.
- Especially tell your Healthcare Provider if you take:
- Other antidepressants
- Other medicines that make you sleepy, such as benzodiazepines
What is a Risk Evaluation and Mitigation Strategy (REMS)?
REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medicines with serious safety concerns. Drug companies and prescribers must take extra steps to make sure the benefits of using the drug are more than the risks. FDA must approve these steps as part of a REMS.
Why does ZULRESSO have a REMS?
ZULRESSO has a REMS because of the serious harm that could happen from extreme sleepiness or passing out during the infusion. Patients must be enrolled in the ZULRESSO REMS to get ZULRESSO.
What do I need to do to enroll in the ZULRESSO REMS?
- Complete the ZULRESSO REMS Patient Enrollment Form. Marissa or Michella at our office will help you.
- Please look over and sign the Patient Enrollment Form.
- The information you provide will be stored in a database. The database is secure and private. The database is called the REMS Patient Registry. Information about all patients who get ZULRESSO in the United States will be stored in this database. Your personal information will only be used for the ZULRESSO REMS
Call or email us if you would like more information.
FDA approves first postpartum depression drug
“There are no FDA approved antidepressants for postpartum depression, so approval of the first medication of its kind is a breakthrough for patients.”
Kristina Deligiannidis, MD, director of Women’s Behavioral Health at Northwell Health’s Zucker Hillside Hospital in New York
Clinical data supporting the effectiveness of brexanolone
“What has been consistent is that brexanolone had a very robust response — and what’s been most exciting to me, in terms of participating in this new drug development, was the rapid onset of response. The drug works quickly.”
Samantha Meltzer-Brody, MD, Professor of mood and anxiety disorders at the University of North Carolina School of Medicine in Chapel Hill
Very good news indeed
“Treatment development in psychiatry still has a long way to go. The road from basic science discoveries to novel therapies is long and winding. But here we have evidence that it sometimes leads to success, and for many women, this [approval] is good news. Very good news indeed.”
Joshua A. Gordon, MD, PhD, director of the National Institute of Mental Health
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