animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Mechanism of action for the treatment of PPD is not fully understood It is believed to be related to positive allosteric modulation of both synaptic and extrasynaptic GABA-A receptors Absorption Plasma concentration (mean steady-state) 52 ng/mL (at 60 mcg/kg/hr) 79 ng/mL (at 90 mcg/kg/hr) Distribution Vd: 3 L/kg Protein bound: >99% Metabolism Extensively metabolized by non-CYP based pathways via keto-reduction (AKRs), glucuronidation (UGTs), and sulfation (SULTs) 3 major circulating metabolites are pharmacologically inactive Elimination Half-life: ~9 hr Total plasma clearance: ~1 L/hr/kg Excretion: 47% feces (primarily as metabolites); 42% urine (<1% unchanged) IV Preparation Supplied in vials as a concentrated solution that requires dilution prior to administration After dilution, product can be stored in infusion bags under refrigerated conditions for up to 96 hr; however, the diluted product can be used for only 12 hr at room temperature Each 60-hr infusion requires preparing at least 5 infusion bags (additional bags needed if weight ≥90 kg Visually inspect vials for particulate matter and discoloration; solution should appear clear and colorless; do not use if discolored or particulate matter observed For each infusion bag Prepare and store only in polyolefin, non-DEHP, and nonlatex bag Dilute drug in the infusion bag immediately after the initial puncture of the vial Withdraw 20 mL (100 mg) from the vial and place in the infusion bag, and then dilute with sterile water for injection 40 mL, and then further dilute with 0.9% NaCl 40 mL (total volume of 100 mL) to achieve a target concentration of 1 mg/mL Immediately refrigerate infusion bag until use IV Administration Brexanolone is available only through a restricted program that requires the drug be administered by a health-care provider in a certified healthcare facility to provide constant monitoring and provide necessary intervention if needed Patient must have continuous pulse oximetry with an alarm and be monitored q2hr during planned nonsleep periods Infuse by continuous IV infusion using a programmable peristaltic infusion pump to ensure accurate infusion rate Administer via a dedicated IV line; do not inject other medications into the infusion bag or mix with brexanolone Fully prime infusion administration sets with admixture before inserting into the pump and connecting the venous catheter Use a PVC, non-DEHP, nonlatex infusion set; do not use in-line filter infusion sets Storage Unopened vial: Store at 2-8°C (36-46°F); do not freeze and protect from light Diluted solution in infusion bag: Store room temperature for up to 12 hr or refrigerate for up to 96 hr No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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