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Alogliptin / metformin Pregnancy and Breastfeeding Warnings

Alogliptin / metformin is also known as: Kazano

Alogliptin / metformin Pregnancy Warnings

There are no adequate and well-controlled studies in pregnant women with this combination drug or its individual components. In rat studies, no treatment-related fetal abnormalities were observed with coadministration of alogliptin 100 mg/kg and metformin 150 mg/kg which based on AUC are approximately 28 times and 2 times clinical doses, respectively. However, at notably higher doses of metformin (500 mg/kg/day) administered concomitantly with the same alogliptin dose, 5 abnormal fetuses were noted in 2 litters (4 fetuses in the same litter). Placental transfer of alogliptin into the fetuses of pregnant rats has been observed. 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: This drug should not be used during pregnancy AU: This drug should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. US: This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: B

See references

Alogliptin / metformin Breastfeeding Warnings

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

There are no adequate and well-controlled studies in nursing mothers with this combination drug or with alogliptin. Metformin levels are expected to be 0.5% of their mother's weight-adjusted dosage and are expected to be relatively constant, so timing of breastfeeding with drug administration is expected to be of little benefit. In one large study, no adverse effects were observed in breastfed infants with the mother's use of metformin, although low detectable serum levels were found in some breastfed infants. As there is no information available on the use of alogliptin, an alternate drug may be preferred, especially while nursing a newborn or preterm infant and metformin should be used with caution while nursing a newborn or premature infant, especially those with renal impairment.

See references

References for pregnancy information

  1. "Product Information. Kazano (alogliptin-metFORMIN)." Takeda Pharmaceuticals America, Lincolnshire, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Kazano (alogliptin-metFORMIN)." Takeda Pharmaceuticals America, Lincolnshire, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

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