Ertugliflozin / metformin Pregnancy and Breastfeeding Warnings

Brand names: Segluromet

Medically reviewed by Drugs.com. Last updated on Mar 21, 2024.

Ertugliflozin / metformin Pregnancy Warnings

Not recommended, especially during the second and third trimesters of pregnancy

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

Risk Summary: There is insufficient data in pregnant women to determine a drug-associated risk for major birth defects and miscarriage; animal data has shown adverse renal effects with administration during the renal development period which corresponds to the late second and third trimesters of human pregnancy.

Comment:
-Poorly controlled diabetes during pregnancy increases maternal and fetal risks of adverse outcomes.
-Metformin use in some anovulatory women may result in ovulation.

Animal studies with ertugliflozin have revealed evidence of adverse renal changes. Rats receiving doses approximately 13 times the maximum clinical dose during a period of renal development (corresponding to late second and third trimester of human pregnancy) experienced increased kidney weight, renal tubule and renal pelvic dilations and renal mineralization that were not fully reversible. At maternally toxic doses, reduced fetal viability, and a higher incidence of visceral malformation (membranous ventricular septal defect) were observed. Published data on metformin use during pregnancy has not shown major birth defects, miscarriage, or adverse maternal or fetal outcomes, although this data should be considered limited as it includes small samples sizes and inconsistent comparator groups. There are no controlled data in human pregnancy.

Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases 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.

See references

Ertugliflozin / metformin Breastfeeding Warnings

Not recommended

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

Comments: Women should be advised to avoid breastfeeding because of the potential for this drug to affect postnatal renal development of breastfed infant.

Metformin is present in human milk resulting in infant doses of approximately 0.11% to 0.1% of the maternal weight adjusted dose. It is unknown if ertugliflozin is excreted into human milk; it is present in the milk of lactating rats. A risk to the developing kidney (persistent increased organ weight, renal mineralization, renal pelvic and tubular dilations) has been observed in juvenile rats directly exposed to ertugliflozin during a developmental period corresponding to human kidney maturation. Since human kidney maturation occurs in utero and during the first 2 years of life, there may be a potential for serious harm to the developing kidney if the breastfed infant is exposed to ertugliflozin.

See references

Further information

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