ZULRESSO (brexanolone)

ZULRESSO (brexanolone)

OFFICE ADMINISTERED - INTRAVENOUS SOLUTION

Indications for Prior Authorization:

• Indicated for the treatment of postpartum depression (PPD) in adults.

Patients must meet the following criteria for the indication(s) above:

• Patient is 18 years of age or older, AND
• Diagnosis of postpartum depression (PPD), AND
• Documentation of HAM-D score range, PHQ-9 score, or MADRS score range indicating moderate-to-severe PPD, AND
• Tried and failed an 8-week trial of a selective serotonin reuptake inhibitor (SSRI) (e.g. paroxetine, sertraline, citalopram), serotonin-norepinephrine reuptake inhibitor (SNRI) (e.g. desvenlafaxine, duloxetine, venlafaxine), tricyclic antidepressant (TCA) (e.g. nortriptyline), bupropion, or mirtazapine, AND
• No more than 6 months have passed since giving birth, AND
• Avoid use in patients with end stage renal disease (ESRD)

Dosing:

• Administered as a continuous intravenous infusion over 60 hours (2.5 days):
• Recommended dose:
  • 0-4 hours: 30 mcg/kg/hour
  • 4-24 hours: increase dose to 60 mcg/kg/hour
  • 24-52 hours: increase dose to 90 mcg/kg/hour
  • 52-56 hours: decrease dose to 60 mcg/kg/hour
  • 56-60 hours: decrease dose to 30 mcg/kg/hour
• Dose does not exceed 90 mcg/kg per hour over 60 hours

Approval:

• 1 IV infusion