Subcutaneous Extended-Release Buprenorphine Use in Pregnancy

Abstract

Background. Opioid use disorder (OUD) in pregnancy is managed by medication-assisted treatment. Sublingual buprenorphine is one option, but subcutaneous extended-release buprenorphine (Sublocade®) is an alternate form administered in monthly injections. Through an extensive literature search, we did not find any prior publication on the use of Sublocade in pregnancy. Case. Two patients with OUD switched from sublingual buprenorphine to Sublocade. One patient received a total of eight injections and then discovered she was pregnant. Based on ultrasound dating, the last 5 administrations occurred during her pregnancy. The second patient received 6 injections with the last occurring at the time of her last menstrual period. Both declined further injections, as well as oral buprenorphine. Serial urine drug screens remained positive for buprenorphine through delivery in both cases. Neither the mothers nor the neonates experienced withdrawal symptoms or adverse outcomes. No birth anomalies were found. Discussion. Though further research is needed regarding the use of Sublocade in pregnancy, it is likely that other pregnancies will occur during this treatment modality. If this long-acting form of buprenorphine medication is found to be safe, it might play a role in managing some pregnant patients with OUD.

Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report

“…For instance, the transmucosal formulation's half-life averages from 24 to 42 hours, 10 and the Food and Drug Administration label for ER-buprenorphine indicates a terminal half-life of 43 to 60 days, with some persons testing positive for buprenorphine a year after their last dose 11 . Case reports demonstrate that, even in pregnancy when buprenorphine levels decrease more rapidly, it can be present 6 months after the last ER dose is given 12 . This may help explain why patient B did not experience opioid withdrawal after discontinuation of full agonists.…”

“…It is critical to remember that there are no therapeutic windows of buprenorphine levels in serum or urine toxicology testing to guide clinical efficacy and therapeutic dosing of buprenorphine for pain or OUD treatment 12 . ER-buprenorphine's partial agonism, particularly long half-life with high binding affinity and slow dissociation at the opioid receptor, suggests that analgesia with full opioid agonists may be problematic.…”

Indicated Opioids in Pregnancy: Guidance on Providing Comprehensive Care

“…• Currently, there are limited data on pregnant and postpartum women using extended-release formulation. 28 85 A multisite double-blinded randomized controlled trial of extended-release versus sublingual buprenorphine for treatment of pregnant women with OUD is currently recruiting 86…”

“…Providers and pharmacies are required to have risk evaluation and mitigation strategy in order to dispense due to increased risk of serious harm or death that could result from intravenous injection 84 • Currently, there are limited data on pregnant and postpartum women using extended-release formulation. 28,85 A multisite double-blinded randomized controlled trial of extended-release versus sublingual buprenorphine for treatment of pregnant women with OUD is currently recruiting 86 • Only be dispensed through federally regulated outpatient treatment programs 87 • Initially dispensed daily for 6 days a week for 90 days before a patient meeting certain criteria may be transitioned to weekly dosing for the first year Obstetric side effects Infants with in-utero buprenorphine exposure have significantly shorter hospital stay, treatment duration for neonatal abstinence syndrome (NAS) and require less morphine than infants with in-utero methadone exposure 21 Has been used since the 1960's, with well documented data on its efficacy and shortand long-term safety in mothers and infants Indicated Opioids in Pregnancy Cleary et al…”

Postpartum Extended-Release Buprenorphine Tissue Necrosis

“…15 This depot has been shown to be teratogenic in animals; therefore, XRB has not been approved or studied in pregnancy. 15 However, there are numerous case reports about its continuation during pregnancy, 9,16 and there is an ongoing clinical trial comparing a weekly formulation of XRB without the N-methyl-2-pyrrolidone excipient with sublingual buprenorphine during pregnancy. 17 Among nonpregnant people, XRB is as effective as sublingual buprenorphine in reducing illicit drug use, and it is generally well-tolerated.…”