Animal data does not show adverse fetal developmental effects at exposures 7 (rabbits) and 709 (rats) times the estimated human dose. In studies with daily subcutaneous administration during the period of organogenesis, maternal toxicity (decreased weight gain, lower fetal body weight, and delayed bone ossification) was observed at doses 475 times or greater the human dose in rats and 100 times the human dose in rabbits. 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.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no data on use of this drug in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Comments:
-Untreated hypoglycemia during pregnancy can cause complications; these complications may be fatal.

See references

Caution is recommended

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production; it is unlikely to cause harm to an exposed infant.

While there is no information on the presence of this drug in human or animal milk, this drug is a peptide that would be expected to be broken down to its constituent amino acids in the infant's digestive tract.

See references