Animal studies have revealed evidence of adverse fetal and neonatal outcomes during pregnancy. Reduced fetal growth and skeletal ossification deficits were observed in rats exposed to this drug during organogenesis at doses approximating clinical exposures. In mice, exposure during gestation and lactation caused increased neonatal deaths at exposures 3 times the maximum recommended human dose. There are no adequate and well-controlled studies in pregnant women.

Clinical considerations: Poorly controlled diabetes increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; and fetal risks for major birth defects, stillbirth, and macrosomia related morbidity. In women with pre-gestational diabetes, the estimated risk of major birth defects in those with a HbA1c greater than 7 is 6% to 10% and as high as 20% to 25% in those with a HbA1c greater than 10. In the US, the estimated background risk of major birth defects in clinically recognized pregnancies is 2% to 4%.

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.

Not recommended unless potential benefit justifies potential risk to the fetus

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

Risk Summary: Limited data are not sufficient to determine a drug-associated risk for major birth defects or miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Animal data suggests risks to the fetus during pregnancy.

Comments:
-Based on animal data, pregnant women should be advised of the potential risk to a fetus.
-Some authorities advise against use in pregnancy and recommend women of childbearing potential use contraception; additionally, women planning a pregnancy should discontinue the prolonged-release formulation at least 3 months prior to pregnancy due its long washout period.

See references

Benefit should outweigh risk

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

Comments:
-There is no information on use of this drug during breastfeeding.
-Some authorities advise against use during lactation due to lack of data on use.

Lactating mice receiving this drug subcutaneously twice a day have shown rat milk concentrations of up to 2.5% the concentration in maternal plasma. Information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production are not available; however, since it is a large peptide, the amount in milk is likely to be very low and absorption unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed child from this drug or from
the underlying maternal condition.

See references