There are no adequate and well-controlled studies in pregnant women with this combination drug or its individual components. In rat studies, no treatment-related fetal abnormalities were observed with coadministration of alogliptin 100 mg/kg and metformin 150 mg/kg which based on AUC are approximately 28 times and 2 times clinical doses, respectively. However, at notably higher doses of metformin administered concomitantly with alogliptin , 5 abnormal fetuses were noted in 2 litters (4 fetuses in the same litter). Microphthalmia, small eye bulge and cleft palate were observed at doses of metformin approximately 20-fold and 5- to 6-fold the maximum recommended human dose for alogliptin and metformin, respectively. Placental transfer of alogliptin into the fetuses of pregnant rats has been observed. In women with pregestational diabetes, the estimated background risk of major birth defects is 6% to 10% in women with HbA1c greater than 7 and up to 25% in women with HbA1c greater than 10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

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.

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

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

Risk Summary: Data are insufficient to inform a drug-associated risk for major birth defects and miscarriage with this combination drug; published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defects or miscarriage risk; there are risk to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments:
-Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications; fetal risks include major malformations, still birth, and macrosomia related morbidity.
-Some authorities advise against use during pregnancy due to teratogenic potential in small numbers of fetuses.

See references

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 infant from this drug or from the underlying maternal condition.

Excreted into human milk: Unknown (alogliptin); Yes (metformin)
Excreted into animal milk: Yes (alogliptin); Yes (metformin)

Comments:
-Some authorities recommend against use in breastfeeding women due to the potential risks in breastfed infants.

There are no adequate and well-controlled studies in nursing mothers with this combination drug or with alogliptin. Published studies with metformin report infant doses of approximately 0.11% to 1% of the maternal weight-adjusted dosage. Milk metformin levels appear relatively constant, so timing of breastfeeding with drug administration is expected to be of little benefit. In one large study, no adverse effects were observed in breastfed infants with the mother's use of metformin, although low detectable serum levels were found in some breastfed infants. There is no information on the presence of alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production.

See references