roduction. Ertugliflozin (see Data) and metformin are present in the milk of lactating rats. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney, based on data with ertugliflozin. Because of the potential for serious adverse reactions in a breastfed infant, advise women that the use of SEGLUROMET is not recommended while breastfeeding.
Data
Human Data
There is no information regarding the presence of SEGLUROMET in human milk, the effects on the breastfed infant, or the effects on milk production. Ertugliflozin is present in the milk of lactating rats (see Data). Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. Published studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. There are no reports of adverse effects on breastfed infants exposed to metformin. Because of the potential for serious adverse reactions in a breastfed infant, advise women that the use of SEGLUROMET is not recommended while breastfeeding.
Data
Ertugliflozin
The lacteal excretion of radiolabeled ertugliflozin in lactating rats was eva luated 10 to 12 days after parturition. Ertugliflozin derived radioactivity exposure in milk and plasma were similar, with a milk/plasma ratio of 1.07, based on AUC. Juvenile rats directly exposed to ertugliflozin during a developmental period corresponding to human kidney maturation were associated with a risk to the developing kidney (persistent increased organ weight, renal mineralization, and renal pelvic and tubular dilatations).
Metformin hydrochloride
Published clinical lactation studies report that metformin is present in human milk, which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants.
8.3 Females and Males of Reproductive Potential
Discuss the potential for unintended pregnancy with premenopausal women as therapy with metformin may result in ovulation in some anovulatory women.
8.4 Pediatric Use
Safety and effectiveness of SEGLUROMET in pediatric patients under 18 years of age have not been established.
8.5 Geriatric Use
SEGLUROMET
No dosage adjustment of SEGLUROMET is recommended based on age. Elderly patients are more likely to have decreased renal function. Because renal function abnormalities can occur after initiating ertugliflozin, and metformin is known to be substantially excreted by the kidneys, care should be taken in dose selection in the elderly. Assess renal function in elderly patients prior to initiating dosing and periodically thereafter. [See Dosage and Administration (2.2) and Warnings and Precautions (5.1, 5.4).] SEGLUROMET is expected to have diminished efficacy in elderly patients with renal impairm
