Benefit should outweigh risk

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

Risk Summary: There are no available data in pregnant women to inform a drug-associated risk; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments:
-Insulin requirements generally decrease in the first trimester and increase during the second and third trimester; after delivery, insulin requirements generally return to pre-pregnancy values.
-Intensified blood glucose control and monitoring are recommended throughout pregnancy and when contemplating pregnancy.

Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity. Pregnancies complicated by hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. The estimated background risk of major birth defects in women with pre-gestational diabetes and an HbA1c greater than 7 is 6% to 10% and has been reported to be as high as 20% to 25% in women with an HbA1c greater than 10. The estimated background risk of miscarriage is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in is 2% to 4% and 15% to 20%, respectively. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. 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.

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Animal studies in rats have shown insulin degludec is secreted in rat milk in a concentration that is lower than in plasma. Insulin is a protein that is inactivated if taken by mouth. No metabolic effects are expected in the nursing infant. If absorbed, it would be destroyed in the digestive tract of the infant.

Lactation onset occurs later in women with type 1 diabetes, and there is an even greater delay in those with poor glucose control. However, once established lactation persists as long in mothers with diabetes as in mothers without. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production

Use with caution

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No metabolic effects are anticipated in the breastfed newborn.
-Breast-feeding mothers may require adjustments in insulin dose.

See references