diluted product is not used immediately after dilution, store under refrigerated conditions for upto 96 hours [see Dosage and Administration (2.3)].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Excessive Sedation and Sudden Loss of Consciousness
Patients may experience loss of consciousness or altered state of consciousness during theZULRESSO infusion. Advise patients to report signs of excessive sedation that may occurduring the infusion. Patients must not be the primary caregiver of dependents and must beaccompanied during interactions with their child(ren) [see Warnings and Precautions (5.1)].
ZULRESSO Risk eva luation and Mitigation Strategy (REMS)
ZULRESSO is available only through a restricted program called the ZULRESSO REMS [seeWarnings and Precautions (5.2)].
Inform the patient of the following notable requirements:
• Patients must be enrolled in the ZULRESSO REMS Program prior to administration.
• Patients must be monitored during administration of ZULRESSO and report anysigns and symptoms of excessive sedation to a healthcare provider.
Potential for Abuse
Advise patients that ZULRESSO can be abused or lead to dependence [see Drug Abuse andDependence (9)].
Concomitant Medications
Caution patients that opioids or other CNS depressants, such as benzodiazepines, taken incombination with ZULRESSO may increase the severity of sedative effects [see Warnings andPrecautions (5.1, 5.2), Drug Interactions (7.1)].
Suicide Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidal thoughts and behavior andinstruct them to report such symptoms to the healthcare provider [see Warnings and Precautions(5.3)].
Pregnancy
Advise women to notify their healthcare provider if they could possibly be pregnant prior totherapy with ZULRESSO. Advise pregnant women and females of reproductive potential of thepotential risk to a fetus. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZULRESSO during pregnancy [see Use in SpecificPopulations (8.1)].
Manufactured for:
Sage Therapeutics, Inc.,
Cambridge, MA 02142 USA
ZULRESSO, the ZULRESSO logo, SAGE THERAPEUTICS, and the SAGE THERAPEUTICSlogo are trademarks of Sage Therapeutics, Inc. All other trademarks referenced herein are the
properties of their respective owners.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf
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