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Linagliptin Pregnancy and Breastfeeding Warnings

Linagliptin is also known as: Tradjenta

Medically reviewed on Aug 16, 2017

Linagliptin Pregnancy Warnings

UK and AU: Avoid use
US: This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B3
US FDA pregnancy category: B

This drug was not teratogenic at doses up to 30 mg/kg in the rat and 150 mg/kg in rabbit, or approximately 49 and 1943 times the clinical dose based on AUC. At doses causing maternal toxicity, postimplantation loss was reported along with slightly increased incidences of fetal visceral variation in rabbits. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Linagliptin Breastfeeding Warnings

Animal data reveal a milk-to-plasma ratio of 4:1. It is unknown whether this drug is excreted in human milk.

US: Caution is recommended. An alternative drug may be preferred, especially while nursing a newborn or a preterm infant.
UK and AU: 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
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Tradjenta (linagliptin)." Boehringer Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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. Tradjenta (linagliptin)." Boehringer Ingelheim, Ridgefield, CT.

Further information

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

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