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Dapagliflozin / metformin Pregnancy and Breastfeeding Warnings

Dapagliflozin / metformin is also known as: Xigduo XR

Medically reviewed on Apr 13, 2018

Dapagliflozin / metformin Pregnancy Warnings

This drug should not be used during the second and third trimesters of pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: C

In animal studies, dapagliflozin exposure during periods of animal development corresponding to the late second and third trimesters of human development, showed increased kidney weights and renal pelvic and tubular dilation. There are no adequate and well-controlled studies of this drug or its individual components in pregnant women.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Dapagliflozin / metformin Breastfeeding Warnings

In rat studies, direct and indirect exposure to dapagliflozin during late pregnancy and weaning having been associated with an increased incidence and/or severity of renal pelvic and tubular dilations. These periods of exposure coincide with a critical window of renal maturation in rats. Additionally, this drug is associated with weight loss. There are no studies in lactating animals using the combined components of this drug nor are there reports in human lactation.

AU: Contraindicated during lactation
US, UK: Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown (dapagliflozin); Yes, in small amounts (metformin)
Excreted into animal milk: Yes (dapagliflozin); Yes (metformin)

A risk to the newborns/infants cannot be excluded.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Xigduo XR (dapagliflozin-metFORMIN)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. "Product Information. Xigduo XR (dapagliflozin-metFORMIN)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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