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 a HbA1c less than 7% is 6% to 10% compared with 20% to 25% in women with a HbA1c greater than 10%. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. During pregnancy, insulin requirements may decrease during the first trimester; increase during the second and third trimesters, and rapidly decline after delivery.

In pregnant rats receiving carrier particle (vehicle without insulin) subcutaneously at doses of 10, 30, and 100 mg/kg/day (14 to 21 times the expected human exposure) from gestation day 6 through 17 (organogenesis), no major malformations were observed. Pregnant rats given carrier particle subcutaneously at doses of 10, 30, and 100 mg/kg/day from gestation day 7 through lactation day 20, showed decreased epididymis and testes weight with no decrease in fertility and rat pups receiving 30 mg/kg/day or more (6 times expected human exposure) showed impaired learning. Pregnant rabbits receiving carrier particles subcutaneously at doses of 2, 10, and 100 mg/kg/day during organogenesis showed adverse maternal effects at all dose groups. There are no controlled data in human pregnancy.

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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus

US FDA pregnancy category: Not assigned

Risk Summary: Insufficient to determine drug-associated risks due to limited data in pregnant women

Comments:
-Due to adverse effects with carrier particles (vehicle) in some animal studies, questions remain regarding the safety of carrier particles during pregnancy.
-For women who are pregnant, and for women who are contemplating pregnancy, intensified blood glucose control and close monitoring of blood glucose is essential.

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The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential risks on the breastfed infant

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

Comments: In rats, approximately 10% of the inhaled insulin carrier is excreted in milk; therefore it is highly likely that inhaled insulin is excreted in human milk.

Studies have not been done specifically looking at the presence of oral inhaled insulin in human milk, the effect on the breastfed infant, or effects on milk production. Carrier particles (vehicle) have been found in rat milk. Potential adverse effects related to inhalation administration of insulin are unlikely to be associated with exposure in breastmilk.

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