Animal studies have revealed evidence of teratogenicity, fetotoxicity, and abortion when this drug was administered in pregnant animals during organogenesis at clinically relevant exposures based on AUC. These adverse embryo-fetal effects in animals coincided with pharmacological reductions in maternal weight and food consumption. There are no controlled data in human pregnancy.

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increase the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk; based on animal data, this drug may cause fetal harm.

Comments:
-There are risks to mother and fetus associated with poorly controlled diabetes in pregnancy.
-Use of this drug may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying; this delay is largest after the first dose and diminishes over time.
-Patients using oral hormonal contraceptives should be advised to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with this drug.

See references

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-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 side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-The quantity of this drug in breast milk or absorbed by the breastfed child is expected to be low due to the large molecular weight of this drug and its probable partial destruction within the infant gastrointestinal tract.

See references