Apomorphine Pregnancy and Breastfeeding Warnings

Brand names: APO-Go, APO-Go Pen, Apokyn, Kynmobi, Onapgo, Uprima

Apomorphine Pregnancy Warnings

Subcutaneous solution:
-According to some authorities: Use is not recommended unless clearly needed.
-According to some authorities: Safety has not been established during pregnancy; use is not recommended in pregnant patients or those likely to become pregnant.

Sublingual film:
-According to some authorities: Use is not recommended during pregnancy or in patients of childbearing potential not using contraception.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: No adequate data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Solution for infusion in cartridge (APO-go POD): According to some authorities, if this product is used during pregnancy, neonates should be closely monitored immediately after delivery due to the risk of depressed respiration.

Animal studies have revealed evidence of adverse developmental effects. When clinically relevant doses were administered subcutaneously during pregnancy, increased neonatal deaths and increased incidence of malformation (of the heart and/or great vessels) were observed in rats and rabbits, respectively; such doses were also associated with maternal toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Apomorphine Breastfeeding Warnings

If this drug is required by the mother, it is not a reason to discontinue nursing; however, an alternate drug may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding to the child.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No information is available on the use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-This drug inhibits prolactin release in animals and may interfere with the onset of lactation.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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