Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data.

Background: Brexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years. Brexanolone is available commercially only through a restricted program (ZULRESSO Risk Evaluation and Mitigation Strategy; REMS) due to risk of excessive sedation or sudden loss of consciousness during administration.

Objective: The aim of this analysis was to assess the postmarketing safety of brexanolone in adults with PPD.

Multi-drug resistance gene-1 (MDR-1) haplotypes and the CYP3A5*1 genotype have no influence on ciclosporin dose requirements as assessed by C0 or C2 measurements.

The intestinal efflux pump P-glycoprotein (P-gp), the product of the multi-drug resistance-1 (MDR-1) gene, significantly influences the pharmacokinetics of several drugs. Ciclosporin is a substrate for P-gp and is metabolized by cytochrome P450 (CYP) 3A enzymes. P-gp activity is affected by several known single nucleotide polymorphisms (SNPs) and haplotypes.