Suganon Use In Pregnancy & Lactation

Fertility: No study result of the effect on human fertility has been performed. In fertility and early embryonic development study in rats, the no-observed-adverse-effect-level (NOAEL) was 100 mg/kg/day for male fertility and 300 mg/kg/day for female fertility and early embryonic development. The exposure of NOAEL for male and female fertility is approximately 300 times and 950 times the maximum-recommended-human-dose (MRHD), respectively.
Teratogenicity: When administered up to evogliptin 1,000 and 250 mg/kg in the reproductive toxicity studies in rats and rabbits, respectively, no anomaly or mutation in fetus was shown. The NOAEL for reproductive toxicity in fetus was 300 mg/kg/day for rats and 250 mg/kg/day for rabbits, which is approximately 950 and 1,100 times the MRHD, respectively, based on AUC comparison.
Carcinogenesis: As a result of a two-year carcinogenicity study conducted in male and female rats with doses of evogliptin 5, 30, and 100 mg/kg/day, there was no incidence of tumor in both male and female rats. Based on AUC comparisons, the dose of 100 mg/kg/day in rats results in exposures approximately 250 times the maximum recommended human dose (MRHD) of 5 mg. A two-year carcinogenicity study was conducted in male and female mice with doses of evogliptin 10, 30, and 100 mg/kg/day. Any type of tumor in any organ was not shown in up to 100 mg/kg/day, an exposure of 90 times or higher than the MRHD.
Pregnancy: No comparative study result is available in pregnant women. Results of animal studies showed that evogliptin was detected in the blood stream of fetus across the placenta up to 61.7% in pregnant rats and 14.1% in pregnant rabbits 2 hours after administration. Therefore, use in pregnant women is not recommended.
Lactation: It is not evaluated whether SUGANON is excreted in human milk. Since animal studies confirmed that evogliptin is secreted in the milk, SUGANON should not be used in nursing mothers.