The site you are about to enter is intended for US healthcare providers only
.
Please confirm that you are a US healthcare provider.
You are now leaving ZULRESSO.com,
the official site for ZULRESSO® (brexanolone).
This link will take you to another Sage Therapeutics, Inc. website.
You are now leaving Zulresso.com,
the official site for ZULRESSO® (brexanolone) and entering one that is not owned or controlled by Sage Therapeutics, Inc..
Sage Therapeutics, Inc. makes no representation as to the information contained on sites we do not own or control. Sage Therapeutics, Inc. does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.
What you need to know about
treatment with ZULRESSO
ZULRESSO® (brexanolone) is administered continuously by intravenous infusion (into the vein) over 2.5 days (60 hours). You are treated with ZULRESSO in a healthcare setting, a Treating Center, where you can be monitored by a healthcare provider throughout your treatment because of the risk of excessive sedation or sudden loss of consciousness.
Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness during treatment, ZULRESSO is administered at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare facility where you will be monitored by a healthcare provider in accordance with guidelines determined by the ZULRESSO REMS program.
While different Treating Centers may have particular rules and protocols, typically, you'll be able to receive visits from your family and see your baby. However, you will need to arrange for full-time childcare for the duration of your treatment.
Before starting treatment:
- Speak with your healthcare provider about any concerns or questions you have
- Choose someone close to you, like a partner or another loved one, and let them know how they can help during your treatment
Tell your healthcare provider if you take other antidepressants, opioids, or CNS depressants such as benzodiazepines. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.
Please remember that your healthcare provider and the team at your Treating Center should always be your primary resources for any questions regarding your treatment.
We are here for you
Sage Central is a source for patient support resources and information. Once enrolled, you will have a dedicated team of support specialists—known as Sage Central Navigators—who can provide information to help you throughout your treatment journey with ZULRESSO.
After you sign up with Sage Central, a Navigator will call you within 1 to 2 business days to welcome you, begin to guide you through the treatment process, and provide helpful information.
How can our Navigators help? They can:
- Answer questions about the ZULRESSO treatment process
- Explain your insurance benefits and coverage options
- Provide information to help you prepare for your infusion
- Review financial assistance programs for eligible patients
Please remember that your healthcare provider should always be your primary resource for any questions regarding your treatment. Visit SageCentralSupport.com to learn more.
ZULRESSO Patient Brochure.
Looking for more information about treatment with ZULRESSO? Download the Patient Brochure.
.jpg)
What is ZULRESSO?
ZULRESSO® is a prescription medicine used to treat Postpartum Depression in individuals 15 years and older.
It is not known if ZULRESSO is safe and effective in individuals less than 15 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ZULRESSO?
ZULRESSO can cause serious side effects, including:
- Excessive sedation and sudden 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 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.
Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:
- Drink alcohol
- Have kidney problems
- Are pregnant or think you may be pregnant. It is not known if ZULRESSO will harm your unborn baby.
- There is a pregnancy registry for women who are exposed to ZULRESSO during pregnancy. The purpose of the registry is to collect information about the health of women exposed to ZULRESSO and their baby. If you become pregnant during treatment with ZULRESSO, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1‑844‑405‑6185 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
- Are breastfeeding or plan to breastfeed. ZULRESSO passes into breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby while receiving ZULRESSO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ZULRESSO and some medicines may interact with each other and cause serious side effects.
Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as benzodiazepines).
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.
How will I receive ZULRESSO?
ZULRESSO is given to you by continuous intravenous (IV) infusion into your vein. The infusion will last for a total of 60 hours (2.5 days).
What should I avoid while receiving ZULRESSO?
- ZULRESSO may make you feel dizzy and sleepy. Do not drive a car or do other dangerous activities after your ZULRESSO infusion until your feeling of sleepiness has completely gone away. See “What is the most important information I should know about ZULRESSO?”
- Do not drink alcohol while receiving ZULRESSO.
What are the possible side effects of ZULRESSO?
ZULRESSO can cause serious side effects, including:
- See “What is the most important information I should know about ZULRESSO?”
- 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.
How can I watch for and try to prevent suicidal thoughts and 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.
The most common side effects of ZULRESSO include:
- Sleepiness, dry mouth, passing out, flushing of the skin or face.
These are not all the side effects of ZULRESSO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please also see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO® and discuss any questions you may have with your healthcare provider.
ZULRESSO® (brexanolone) is a prescription medicine used to treat Postpartum Depression in individuals 15 years and older.
IMPORTANT SAFETY INFORMATION
ZULRESSO can cause serious side effects, including: Excessive sedation and sudden 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