Sponsored by Sage Therapeutics, Inc., and Biogen Inc.

Sponsored by Sage Therapeutics, Inc., and Biogen Inc.
Important Safety Information Prescribing Information
ZURZUVAE (zuranolone) capsules (IV) 20mg 25 mg 30 mg
How to get your adult patients with postpartum depression (PPD) started on ZURZUVAE
IMPORTANT SAFETY INFORMATION
WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES

ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects.

Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE.
Please see additional Important Safety Information below.
How to get your patients started

Supporting patients with PPD means acting early and efficiently, including ensuring smooth access to treatment.1 If you’re considering prescribing ZURZUVAE® (zuranolone) for eligible adult patients with PPD, here are three steps to help patients initiate therapy. With broad coverage and patient support resources, therapy may be more accessible for your patients than you think.

Let’s help patients take the next step toward care—without unnecessary delay.

[Trisha Joseph, PMHNP-BC]

Compensated by Sage Therapeutics and Biogen.
How to get your patients started
*Source: Managed Markets Insight & Technology, LLC database as of [November 2024].
Sage Therapeutics and Biogen do not endorse any particular plan. This is not a promise or guarantee by Sage Therapeutics and Biogen concerning coverage and/or availability of the product for any particular patient. Because formularies change and many health plans offer more than one formulary, it is important to check directly with the health plan to confirm coverage for individuals.
Get your patients started with these 3 steps
Step 1
Send prescription to the appropriate specialty pharmacy
within the ZURZUVAE network and submit completed prior authorization
Verify specialty pharmacy options or requirements with your patient’s insurance to prevent potential delays in the process.
Step 2
Alert your patient to expect and answer all calls from the specialty pharmacy to confirm their insurance, contact, and shipping information
Step 3
ZURZUVAE is shipped to patient upon approval
ZURZUVAE is available through a participating specialty pharmacy network
Accredo®   |   Alto Pharmacy®   |   CVS Specialty®   |  
Special Care Pharmacy Services§   |   Walmart Specialty Pharmacy
Specialty pharmacy network as of November 2024. Individual patient insurance coverage is not guaranteed. A patient’s insurance coverage may require the use of a specific specialty pharmacy.
§ Special Care Pharmacy Services is for Puerto Rico residents only.
Learn how eligible adult patients with PPD
could pay as little as $0
  
Only commercially insured patients with a valid, on-label ZURZUVAE prescription are eligible. Additional restrictions may apply. For full terms and conditions, visit ZurzuvaeForYouTermsAndConditions.com.

IMPORTANT SAFETY INFORMATION (continued)

WARNINGS AND PRECAUTIONS

Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities
ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects
Advise patients not to drive a motor vehicle or engage in other potentially hazardous activities requiring complete mental alertness, such as operating machinery, until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence or the degree of driving impairment caused by ZURZUVAE
Central Nervous System Depressant Effects
ZURZUVAE can cause CNS depressant effects such as somnolence and confusion
Somnolence developed in 36% of patients who received ZURZUVAE (50 mg) and in 6% of patients who received placebo daily. Some ZURZUVAE-treated patients developed confusional state. One of these cases was severe, and was also associated with somnolence, dizziness, and gait disturbance
A higher percentage of ZURZUVAE-treated patients, compared to placebo-treated patients, experienced somnolence, dizziness, or confusion that required dosage reduction, interruption, or discontinuation
Because ZURZUVAE can cause CNS depressant effects, patients may be at higher risk of falls
Other CNS depressants such as alcohol, benzodiazepines, opioids, tricyclic antidepressants, or drugs that increase zuranolone concentration, may increase impairment of psychomotor performance or CNS depressant effects such as somnolence, cognitive impairment, and the risk of respiratory depression in ZURZUVAE-treated patients
To reduce the risk of CNS depressant effects and/or mitigate CNS depressant effects that occurs with ZURZUVAE treatment:
If patients develop CNS depressant effects, consider dosage reduction or discontinuation of ZURZUVAE
If use with another CNS depressant is unavoidable, consider dosage reduction
Reduce the ZURZUVAE dosage in patients taking strong CYP3A4 inhibitors
Suicidal Thoughts and Behavior
In pooled analyses of placebo-controlled trials of chronically administered antidepressant drugs (SSRIs and other antidepressant classes) that included 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)
ZURZUVAE does not directly affect monoaminergic systems. Consider changing the therapeutic regimen, including discontinuing ZURZUVAE, in patients whose depression becomes worse or who experience emergent suicidal thoughts and behaviors
Embryo-fetal Toxicity
Based on findings from animal studies, ZURZUVAE may cause fetal harm when administered to a pregnant woman
Advise a pregnant woman of the potential risk to an infant exposed to ZURZUVAE in utero. Advise females of reproductive potential to use effective contraception during treatment with ZURZUVAE and for one week after the final dose
ADVERSE REACTIONS
The most common adverse reactions (≥5% and greater than placebo) in ZURZUVAE-treated patients were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection
DRUG INTERACTIONS
CNS Depressant Drugs and Alcohol
Caution should be used when ZURZUVAE is administered in combination with other CNS drugs or alcohol. If use with another CNS depressant is unavoidable, consider dosage reduction
Strong CYP3A4 Inhibitors
Reduce the ZURZUVAE dosage when used with a strong CYP3A4 inhibitor
CYP3A4 Inducers
Avoid concomitant use of ZURZUVAE with CYP3A4 inducers
USE IN SPECIFIC POPULATIONS
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including ZURZUVAE, 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/​research/​pregnancyregistry/​antidepressants/
Based on findings from animal studies, ZURZUVAE may cause fetal harm. Advise pregnant women of the potential risk to a fetus. Available data on ZURZUVAE use in pregnant women from the clinical development program are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Lactation
Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk. There are no data on the effects of zuranolone on a breastfed infant and limited data on the effects on milk production
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition
Hepatic Impairment
The recommended ZURZUVAE dosage in patients with severe hepatic impairment (Child-Pugh C) is lower than patients with normal hepatic function
Renal Impairment
The recommended ZURZUVAE dosage in patients with moderate and severe renal impairment is lower than those with normal renal function
DRUG ABUSE AND DEPENDENCE
ZURZUVAE contains zuranolone, a Schedule IV controlled substance
Zuranolone has abuse potential with associated risks of misuse, abuse, and substance use disorder including addiction
ZURZUVAE may produce physical dependence
INDICATION

ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults.

Please see full Prescribing Information, including Boxed Warning.
Don’t wait—take the first step today
How to get your patients started
Questions? Call 1-844-987-9882 for more
information on patient support services
References: 1. American College of Obstetricians and Gynecologists. Screening and diagnosis of mental health conditions during pregnancy and postpartum: ACOG clinical practice guideline no. 4. Obstet Gynecol. 2023;141:1232–1261. 2. Data on File. Biogen and Sage Therapeutics, Inc. [2024].
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Pricing Disclosures for Prescribers
SAGE THERAPEUTICS, the SAGE THERAPEUTICS logo, and ZURZUVAE are registered trademarks of Sage Therapeutics, Inc. BIOGEN and the BIOGEN logo are registered trademarks of Biogen Inc. The ZURZUVAE logo is a trademark of Sage Therapeutics, Inc. All other trademarks referenced herein are the property of their respective owners.
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