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Dapagliflozin / saxagliptin Pregnancy and Breastfeeding Warnings

Dapagliflozin / saxagliptin is also known as: Qtern

Medically reviewed on Aug 30, 2018

Dapagliflozin / saxagliptin Pregnancy Warnings

Not recommended

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

Comments:
-If pregnancy is detected, this drug should be discontinued.
-Poorly controlled diabetes is a risk to both the mother and fetus therefore, alternative therapy will be necessary to control blood sugars.

Animal studies with saxagliptin have shown reproductive toxicity at high doses; rat studies with dapagliflozin have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. There are no adequate and well controlled studies in pregnant women from the use of this combination product.

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

Dapagliflozin / saxagliptin Breastfeeding Warnings

Not recommended

Excreted into human milk: Dapagliflozin (unknown); Saxagliptin (unknown)
Excreted into animal milk: Dapagliflozin (yes); Saxagliptin (yes)

The effects in the nursing infant are unknown.

Juvenile rats exposed to dapagliflozin showed a risk of renal pelvic and tubular dilations during maturation. Since kidney maturation occurs during the first 2 years of life, there may be a risk to the developing kidney of the breastfed infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Qtern (dapagliflozin-saxagliptin)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Qtern (dapagliflozin-saxagliptin)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

Further information

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

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