Ertugliflozin

Pregnancy: There isn't enough data on Ertugliflozin in pregnant women to say whether it carries a risk of harm to the baby's development. Poorly controlled diabetes in pregnancy is itself a risk to both the mother and the fetus. In rats, adverse kidney changes were seen when ertugliflozin was given during the period of kidney development that matches the late second and third trimesters of human pregnancy. Doses approximately 13 times the maximum clinical dose caused dilatation of the renal pelvis and tubules and renal mineralization, and these changes were not fully reversible. No fetal harm was seen in rats or rabbits at exposures approximately 300 times higher than the maximal clinical dose of 15 mg/day, when it was given during organogenesis. Because of the adverse kidney effects in animals, Ertugliflozin is not recommended during the second and third trimesters of pregnancy.

Lactation: Nobody knows yet whether Ertugliflozin passes into human milk, what it does to a breastfed infant, or whether it affects milk production. It is present in the milk of lactating rats. Human kidneys mature in the womb and during the first 2 years of life, which is when exposure through breast milk may happen, so there may be a risk to the developing kidney. Because a breastfed infant could have serious adverse reactions, women should be advised that Ertugliflozin is not recommended while breastfeeding.