Naloxone / oxycodone Pregnancy and Breastfeeding Warnings

Brand names: Targiniq ER

Naloxone / oxycodone Pregnancy Warnings

Benefit should outweigh risks

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk Summary: Based on animal data, there is a potential risk to the fetus; naloxone may precipitate opioid withdrawal in a fetus due to the immaturity of the fetal blood barrier; prolonged use of opioids during pregnancy can result in physical dependence in the neonate.

Comments:
-Women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
-Monitor neonates exposed to opioid analgesics for signs of excess sedation and respiratory depression.

Animal studies have shown decreased pup weight in rats receiving oxycodone throughout pregnancy at doses 0.8 times the maximum recommended daily dose; published data reveal neurobehavioral effects in the rat pups exposed to clinically relevant doses and below of oxycodone during pregnancy. There are no data on the use of naloxone-oxycodone during childbirth. Prolonged use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. The onset, duration, and severity of the condition will vary based on use (duration of use, timing, and amount of last maternal use) and rate of elimination in the newborn. Both naloxone and oxycodone pass into the placenta. There are no controlled data in human pregnancy.

Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Naloxone / oxycodone Breastfeeding Warnings

Not Recommended

Excreted into human milk: Unknown (naloxone); Yes (oxycodone)

Comments: Breastfeeding should be avoided because of the potential for serious adverse reactions in the breastfed infant.

Lactation studies have not been conducted with this combination product. Oxycodone is present in breastmilk and infant sedation is common and well documented with infant use. Maternal use of opioid narcotics during breastfeeding can cause central nervous system depression, and even death; newborn infants are particularly sensitive to even small dosages of narcotic analgesics. It is unknown if naloxone is present in breastmilk. Because naloxone is not orally bioavailable, it is unlikely to affect the breastfed infant, although there may be a possibility it could precipitate opioid withdrawal. The manufacturer advises against breastfeeding during therapy with this drug.

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Further information

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