AND PRECAUTIONS
5.1 Excessive Sedation and Sudden Loss of
Consciousness
5.2 ZULRESSO Risk eva luation and Mitigation Strategy(REMS)
5.3 Suicidal Thoughts and Behaviors
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 CNS Depressants
7.2 Antidepressants
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.6 Betadex Sulfobutyl Ether SodiumPharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment ofFertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing informationare not listed.
--------------------------------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESSPatients treated with ZULRESSO are at risk of excessive sedation or sudden loss ofconsciousness during administration [see Warnings and Precautions (5.1)].
Because of the risk of serious harm, patients must be monitored for excessive sedationand sudden loss of consciousness and have continuous pulse oximetry monitoring.
Patients must be accompanied during interactions with their child(ren) [see Warningsand Precautions (5.1)].
Because of these risks, ZULRESSO is available only through a restricted program undera Risk eva luation and Mitigation Strategy (REMS) called the ZULRESSO REMS [see
Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
ZULRESSO is indicated for the treatment of postpartum depression (PPD) in adults [see ClinicalStudies (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Important Considerations Prior to Initiating and During Therapy A healthcare provider must be available on site to continuously monitor the patient, andintervene as necessary, for the duration of the ZULRESSO infusion.
Monitor patients for hypoxia using continuous pulse oximetry equipped with an alarm. Assessfor excessive sedation every 2 hours during planned, non-sleep periods [see Warnings andPrecautions (5.1)].
Initiate ZULRESSO treatment early enough during the day to allow for recognition of excessivesedation [see Warnings and Precautions (5.1)].
2.2 Recommended Dosage
Administer ZULRESSO as a continuous intravenous (IV) infusion over a total of 60 hours(2.5 days) as follows:
• 0 to 4 hours: Initiate with a dosage of 30 mcg/kg/hour
• 4 to 24 hours: Increase dosage to 60 mcg/kg/hour
• 24 to 52 hours: Increase dosage to 90 mcg/kg/hour (a reduction in dosage to60 mcg/kg/hour may be considered during this time period for patients who do nottolerate90 mcg/kg/hour)
• 52 to 56 hours: Decrease dosage to 60 mcg/kg/hour
• 56 to 60 hours: Decrease dosage to 30 mcg/kg/hour
If excessive sedation occurs at any time during the infusion, stop the infusion until the symptomsresolve. The infusion may be resumed at the same or lower dose as clinically appropriate.
2.3 Preparation and Storage Instructions
ZULRESSO is supplied in vials as a c |
