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Treatment with ZULRESSO: What you need to know

Once you decide ZULRESSO® (brexanolone) may be right for your patient with PPD, learn how they can be supported throughout their treatment journey.


Supporting your PPD patients, right from the start

First, register your patient through the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS) and they can begin their journey to infusion.

Second, remember to have them enroll in Sage Central. From live support to financial assistance* to helping them find a REMS-certified Treating Center to connecting them with local support groups and educational resources, Sage Central Navigators are available to help them throughout their treatment journey.

*For eligible patients only.


Learn about ZULRESSO REMS1

ZULRESSO is available only through a restricted program under a REMS called the ZULRESSO REMS because excessive sedation or sudden loss of consciousness can result in serious harm.

Notable requirements of the ZULRESSO REMS include1:

  • Healthcare facilities
    Healthcare facilities must enroll in the program and ensure that ZULRESSO is only administered to patients who are enrolled in the ZULRESSO REMS.
  • Pharmacies
    Pharmacies must be certified with the program and must only dispense ZULRESSO to healthcare facilities who are certified in the ZULRESSO REMS.
  • Patients
    Patients must be enrolled in the ZULRESSO REMS prior to administration of ZULRESSO.
  • Wholesalers and distributors
    Wholesalers and distributors must be registered with the program and must only distribute to certified healthcare facilities and pharmacies.

How to get your patient started with ZULRESSO

After you’ve made a diagnosis of postpartum depression, it’s time to connect your patient with a ZULRESSO Risk Evaluation and Mitigation Strategy (REMS)-certified Treating Center for their treatment. Sage Therapeutics strives to make this process as straightforward as possible for healthcare providers and patients alike. Here are the 3 steps to take to get your patients on their path to treatment:

  1. Counsel the patient using the patient information guide and provide a copy of the guide for them to review.

  2. Enroll the patient in the ZULRESSO REMS by ensuring trained staff complete the ZULRESSO REMS Patient Enrollment Form with them. Retain a copy of the completed form in their records.

  3. Submit the completed ZULRESSO REMS Patient Enrollment Form. Completed forms can be faxed to 833-564-7243, emailed to information@zulressorems.com, or mailed to the ZULRESSO REMS at 7751 Brier Creek Parkway, Suite 200, Raleigh, NC 27617.


Treating Centers near your community

Patients can only receive ZULRESSO at a REMS-certified Treating Center. Use the locator tool to fnd a ZULRESSO Treating Center near you.

See Treating Centers nearby

Sage Central: The complement to your care

Sage Central is a support program that offers patient support resources and programs for your PPD patients treated with ZULRESSO. If patients choose to enroll, they will have a dedicated team of case managers—known as Sage Central Navigators—who can provide information to help them throughout their treatment journey with ZULRESSO.

    Sage Central offers:

    • Live support
      Dedicated Sage Central Navigators help patients throughout their treatment journey.
    • Financial assistance
      Sage Central Navigators can help patients understand their insurance coverage and options and offer financial assistance programs to eligible patients. Eligible commercially insured patients may pay as little as $0. Learn more about financial support programs.

      Restrictions may apply.
    • Logistical support
      Sage Central Navigators can assist in finding options for a ZULRESSO REMS–certified healthcare setting.
    • Additional resources
      Sage Central Navigators can also help connect your patients to potential sources of support within their communities, as well as provide educational resources and helpful treatment considerations.

To enroll your patient, complete the Sage Central Enrollment Form. Once the completed and signed form has been received by Sage Central, a Sage Central Navigator will call your patient within 1 to 2 business days to welcome them.

Patients must be enrolled in the ZULRESSO REMS prior to administration of ZULRESSO.


INDICATION

ZULRESSO® is indicated for the treatment of postpartum depression in adults.

IMPORTANT SAFETY INFORMATION

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.

WARNINGS AND PRECAUTIONS

Excessive Sedation and Sudden Loss of Consciousness

In clinical studies, 5% of ZULRESSO-treated patients compared to 0% of placebo-treated patients experienced sedation and somnolence that required dose interruption or reduction. Loss of consciousness or altered state of consciousness was reported in 4% of ZULRESSO-treated patients compared with 0% of placebo-treated patients.

During the infusion, monitor patients for sedative effects every 2 hours during planned, non-sleep periods. Immediately stop the infusion if there are signs or symptoms of excessive sedation. After symptoms resolve, the infusion may be resumed at the same or lower dose as clinically appropriate. Immediately stop the infusion if pulse oximetry reveals hypoxia. After hypoxia, the infusion should not be resumed.

Concomitant use of opioids, antidepressants, or other CNS depressants such as benzodiazepines or alcohol may increase the likelihood or severity of adverse reactions related to sedation. Patients must be accompanied during interactions with their child(ren) while receiving the infusion because of the potential for excessive sedation and sudden loss of consciousness.

Patients should be cautioned against engaging in potentially hazardous activities requiring mental alertness, such as driving, after infusion until any sedative effects of ZULRESSO have dissipated.

ZULRESSO Risk Evaluation and Mitigation Strategy (REMS)

ZULRESSO is available only through a restricted program under a REMS called the ZULRESSO REMS because excessive sedation or sudden loss of consciousness can result in serious harm.

Notable requirements of the ZULRESSO REMS include:

  • Healthcare facilities must enroll in the program and ensure that ZULRESSO is only administered to patients who are enrolled in the
    ZULRESSO REMS
  • Pharmacies must be certified with the program and must only dispense ZULRESSO to healthcare facilities who are certified in the
    ZULRESSO REMS
  • Patients must be enrolled in the ZULRESSO REMS prior to administration of ZULRESSO
  • Wholesalers and distributors must be registered with the program and must only distribute to certified healthcare facilities and pharmacies

Further information, including a list of certified healthcare facilities, is available at www.zulressorems.com or call 1-844-472-4379.

Suicidal Thoughts and Behaviors

In pooled analyses of placebo-controlled trials of chronically administered antidepressant drugs (SSRIs and other antidepressant classes) that include approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with major depressive disorder (MDD).

ZULRESSO does not directly affect monoaminergic systems. Because of this and the comparatively low number of exposures to ZULRESSO, the risk of developing suicidal thoughts and behaviors with ZULRESSO is unknown. If depression becomes worse or patients experience emergent suicidal thoughts and behaviors, consider changing the therapeutic regimen, including discontinuing ZULRESSO.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.

Use in Specific Populations

  • Pregnancy: Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm
  • Lactation: Brexanolone is transferred to breastmilk in nursing mothers. There are no data on the effects of ZULRESSO on a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZULRESSO and any potential adverse effects on the breastfed child from ZULRESSO or from the underlying maternal condition
  • Pediatric Use: The safety and effectiveness of ZULRESSO in pediatric patients have not been established
  • Renal Impairment: No dosage adjustment is recommended in patients with mild, moderate, or severe renal impairment. Avoid use of ZULRESSO in patients with end stage renal disease (ESRD)

Controlled Substance

ZULRESSO contains brexanolone, a Schedule IV controlled substance under the Controlled Substances Act.

Please also see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO.

To report SUSPECTED ADVERSE REACTIONS, contact Sage Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION
ZULRESSO® is indicated for the treatment of postpartum depression in adults.

IMPORTANT SAFETY INFORMATION
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.

Reference

  1. ZULRESSO Prescribing Information. Cambridge, MA: Sage Therapeutics, Inc; 6/2019.