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Metformin / saxagliptin Pregnancy and Breastfeeding Warnings

Metformin / saxagliptin is also known as: Kombiglyze XR

Metformin / saxagliptin Pregnancy Warnings

Animal studies have shown reproductive toxicity at high doses of saxagliptin; metformin has not shown harm with regard to pregnancy, embryonic or fetal development, parturition or postnatal development in animal studies. Limited data in pregnant women have not shown an increase in congenital malformations with metformin use. There are no adequate and well controlled data in human pregnancy with either combination use or use of the individual components. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

UK: Use is not recommended AU and US: To be used only if clearly needed AU TGA pregnancy category: C US FDA pregnancy category: B

See references

Metformin / saxagliptin Breastfeeding Warnings

AU and UK: Use is contraindicated US: Caution is advised Excreted into human milk: Unknown (saxagliptin); Yes (metformin) Excreted into animal milk: Yes (saxagliptin); Yes (metformin) The effects in the nursing infant are unknown.

There are no studies with the combined use of saxagliptin-metformin. Animal studies have shown the excretion of both saxagliptin and metformin in animal milk. Metformin has been detected in low levels in human milk. Well-conducted studies have estimated that an infant would receive less than 0.5% of their mother's weight-adjusted metformin dosage, and while the dose is low, detectable levels have been found in the serum of breastfed infants. For this reason, metformin should be used with caution while nursing newborn and premature infants and those with renal impairment.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Kombiglyze XR (metformin-saxagliptin)." Bristol-Myers Squibb, Princeton, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Kombiglyze XR (metformin-saxagliptin)." Bristol-Myers Squibb, Princeton, NJ.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

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