Ertugliflozin / sitagliptin Pregnancy and Breastfeeding Warnings

Brand names: Steglujan

Medically reviewed by Drugs.com. Last updated on Aug 26, 2022.

Ertugliflozin / sitagliptin 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 ertugliflozin 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.
-Health care providers are encouraged to report prenatal exposure to sitagliptin by calling the Pregnancy Registry at 1-800-986-8999.

Animal studies have revealed evidence of adverse renal changes with ertugliflozin. 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 renal pelvic and tubule dilations and renal mineralization that were not fully reversible. In rats and rabbits exposed to sitagliptin doses approximately 30 and 20 times the human exposure at the maximum recommended human dose, respectively, no adverse developments were observed. There are no controlled data in human pregnancy.

Poorly controlled diabetes during pregnancy is associated with increased risk for major birth defects, still birth, and macrosomia related mortality. The estimated background risk of major birth defects in women with pre-gestational diabetes and a HbA1c greater than 7 is 6% to 10%; in women with a HbA1c greater than 10, this risk has been reported to be as high as 20% to 25%.

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.

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Ertugliflozin / sitagliptin Breastfeeding Warnings

Not recommended

Excreted into human milk: Unknown
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 in the breastfed infant.

While it is unknown if this drug is excreted into human milk, there is potential for serious harm to the developing kidney if the breastfed infant is exposed. Human kidney maturation occurs in utero and during the first 2 years of life. Ertugliflozin has been found in rat milk. Juvenile rats directly exposed to ertugliflozin during a developmental period corresponding to human kidney maturation showed an increased risk to the developing kidney (persistent increased organ weight, renal mineralization, renal pelvic and tubular dilations). Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1.

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Further information

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