Usual Adult Dose for Depression

Hours 0 to 4: 30 mcg/kg/hr IV via continuous infusion
Hours 4 to 24: 60 mcg/kg/hr IV via continuous infusion
Hours 24 to 52:90 mcg/kg/hr IV via continuous infusion
Hours 52 to 56: 60 mcg/kg/hr IV via continuous infusion
Hours 56 to 60: 30 mcg/kg/hr IV via continuous infusion
Duration of therapy: 60 hours

Comments:

• To allow for proper monitoring of excessive sedation, treatment should begin early enough during the day.
• Patients should be constantly monitored by a healthcare provider for the duration of the infusion.

Renal Dose Adjustments

Mild to severe renal disease (estimated glomerular filtration rate [eGFR] 15 to 89 mL/min/1.73 m2): No adjustment recommended.
End stage renal disease (eGFR less than 15 mL/min/1.73 m2): Not recommended.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Hypoxia occurring during administration:

• The infusion should be immediately stopped.
• The infusion should not be resumed after hypoxia resolves.

• The infusion should be immediately stopped.
• If clinically appropriate, the infusion may be resumed at the same or lower dose after symptoms resolve.

Precautions

CONTRAINDICATIONS: None.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for DRUG and/or SHARED SYSTEM. It includes elements to assure safe use, and implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:
EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS:

• Patients are at risk of excessive sedation or sudden loss of consciousness during administration.
• Dur to the risk of serious harm, patients must be monitored for excessive sedation/sudden loss of consciousness and have continuous pulse oximetry monitoring.
• Patients must be accompanied during interactions with their child(ren).
• This drug is only available through a restricted program under a REMS.

Dialysis

Data not available

Other Comments

Storage requirements:

• The manufacturer product information should be consulted.

• The manufacturer product information should be consulted.

• The manufacturer product information should be consulted.

• NERVOUS SYSTEM: Sedative effects every 2 hours during non-sleep periods
• RESPIRATORY: Pulse oximetry during infusion

• Inform patients that this drug may cause excessive sedation and sudden loss of consciousness and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• How is Zulresso administered for the treatment of Postpartum Depression?