Monthly buprenorphine depot injection (SUBLOCADE®) for opioid use disorder during pregnancy.

Background and objectives: Untreated opioid use disorder (OUD) in pregnancy is associated with adverse obstetrical outcomes, maternal morbidity, and maternal mortality. This article will inform clinicians about the use of monthly extended-release buprenorphine (BUP-XR, SUBLOCADE®) to treat OUD during pregnancy and postpartum.

Methods: We examined the use of monthly BUP-XR during pregnancy in patients with OUD, summarizing case studies (N = 4) from clinical practice, reviewing >5 years of pregnancy and postpartum surveillance data (quantitative [N = 322] and qualitative) and relevant literature in PubMed (N = 4).

Results: The clinical practice case studies highlight the experience from four pregnant patients with OUD who received monthly BUP-XR. All four neonates were delivered full-term with normal birthweight, no fetal anomalies, and no medication required for neonatal opioid withdrawal syndrome. Additionally, over 300 pregnancies have been reported through postmarketing surveillance, of which 68 have known outcomes consistent with information described in the product label. Findings from literature, postmarketing surveillance, and clinical practice case studies were consistent with the established safety profile of buprenorphine.

Conclusion and scientific significance: This study addresses a lack of knowledge of treatment of pregnant individuals with OUD and draws on relevant experience from prescribers treating patients with monthly BUP-XR during pregnancy and postpartum. These data support consideration of implementing BUP-XR as part of evidence-based practice that prioritizes OUD treatment access, patient stability, and patient choice during the perinatal period. Three sources of data illustrate that the use of monthly BUP-XR during pregnancy has demonstrated no increased risk and is consistent with the established buprenorphine safety profile.