Sitagliptin Pregnancy and Breastfeeding Warnings
Sitagliptin is also known as: Januvia
Sitagliptin Pregnancy Warnings
Reproduction studies in rats and rabbits with doses approximately 12 times the human exposure at the maximum recommended human dose (MRHD) did not impair fertility or harm the fetus. Teratogenicity was not observed at doses up to 30 and 20 times MRHD in rats and rabbits, respectively, although at doses up to 100 times MRHD, an increase in the incidence of rib malformations was observed. There are no adequate and well-controlled studies in pregnancy 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.
AU and UK: Use is not recommended US: Use during pregnancy only if clearly needed. AU TGA pregnancy category: B3 US FDA pregnancy category: B Comments: In the US, Merck Sharp & Dohme Corporation maintains a pregnancy registry to monitor pregnancy outcomes of women exposed to this drug while pregnant; health care providers are encouraged to report any prenatal exposure (1-800-989-8999).
Sitagliptin Breastfeeding Warnings
This drug is secreted in the milk of lactating rats at milk to plasma ratio of 4:1. Pups of rats administered this drug at 1000 mg/kg/day from gestation day 6 through lactation day 20 showed reduced birth weight and postnatal weight gain (observed prior to and after weaning). No functional or behavioral toxicity was observed. Due to lack of human data, an alternate drug may be preferred.
US: Use caution AU and UK: Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
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