Pregnancy of Brospina in details
Brospina crosses the placenta; Brospina and norbuprenorphine can be detected in newborn serum, urine, hair, and meconium following in utero exposure (Di Trana 2019).
According to some studies, maternal use of opioids may be associated with birth defects (including neural tube defects, congenital heart defects, and gastroschisis), poor fetal growth, stillbirth, and preterm delivery (CDC [Dowell 2016]). Opioids used as part of obstetric analgesia/anesthesia during labor and delivery may temporarily affect the fetal heart rate (ACOG 209 2019).
[US Boxed Warning]: Prolonged use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available. Symptoms of neonatal abstinence syndrome (NAS) following opioid exposure may be autonomic (eg, fever, temperature instability), gastrointestinal (eg, diarrhea, vomiting, poor feeding/weight gain), or neurologic (eg, high-pitched crying, hyperactivity, increased muscle tone, increased wakefulness/abnormal sleep pattern, irritability, sneezing, seizure, tremor, yawning) (Dow 2012; Hudak 2012). The onset and duration of neonatal withdrawal symptoms are dependent upon the specific opioid used, maternal dosing, and rate of elimination by the newborn. NAS associated with Brospina may correlate to concentrations of norbuprenorphine in the cord blood (Shah 2016). Opioids may cause respiratory depression and psycho-physiologic effects in the neonate; newborns of mothers receiving opioids during pregnancy and/or labor should be monitored.
Opioid agonist pharmacotherapy is recommended for pregnant women with an opioid use disorder. Transmucosal Brospina is a recommended treatment option (ACOG 711 2017; SAMHSA 2018). Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of sublingual Brospina may be altered (Bastian 2017; Caritis 2017; Zhang 2018). Use of the subcutaneous implant is not currently recommended in pregnant women (SAMHSA 2018). Maintenance doses of Brospina will not provide adequate pain relief during labor. Women receiving Brospina for the treatment of opioid use disorder should be maintained on their daily dose of Brospina in addition to receiving the same pain management options during labor and delivery as opioid-naive women; Opioid agonist-antagonists should be avoided for the treatment of labor pain in women maintained on Brospina due to the risk of precipitating acute withdrawal (ACOG 711 2017; SAMHSA 2018). Use of a multimodal approach to pain relief which can maximize non-opioid interventions is recommended. Monitor for maternal over sedation and somnolence (Krans 2019).
Brospina breastfeeding
Low levels of this drug are found in breast milk; the estimated maximum intake of an exclusively breastfed infant would be 2.4% of the maternal weight-adjusted dosage. There are numerous reports of breast fed infants of mothers in abstinence programs who have shown no adverse effects. Infants should be monitored for drowsiness, adequate weight gain, and developmental milestones. Women who received this drug for opiate abuse during pregnancy and are stable should be encouraged to breastfeed their infants postpartum, unless there is another contraindication. The amount of drug in breast milk may not be sufficient to prevent neonatal withdrawal and treatment of infant for neonatal abstinence syndrome (NAS) may be required. If breastfeeding is stopped abruptly, observe for signs and symptoms of opioid withdrawal in the infant.
AU: Use is contraindicated UK and US: Benefit should outweigh risk Excreted into human milk: Yes Comments: This drug has been used without apparent harmful effects in the nursing infant.
See references
References for pregnancy information
- "Product Information. Butrans (Brospina)." Purdue Pharma LP, Stamford, CT.
- "Product Information. Buprenex (Brospina)." Reckitt and Colman Pharmaceutical, Richmond, VA.
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Subutex (Brospina)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References for breastfeeding information
- "Product Information. Butrans (Brospina)." Purdue Pharma LP, Stamford, CT.
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
- "Product Information. Subutex (Brospina)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- "Product Information. Buprenex (Brospina)." Reckitt and Colman Pharmaceutical, Richmond, VA.
- Cerner Multum, Inc. "Australian Product Information." O 0
References
- DailyMed. "BUPRENORPHINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Subutex: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Buprenorphine: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
