QTERN Use In Pregnancy & Lactation

Pregnancy: Saxagliptin/dapagliflozin combination: There are no adequate and well-controlled studies of Saxagliptin/Dapagliflozin (QTERN) or its mono-components in pregnant women. Saxagliptin/Dapagliflozin (QTERN) should not be used during pregnancy. If pregnancy is detected, treatment with Saxagliptin/Dapagliflozin (QTERN) should be discontinued.
Dapagliflozin: In the time period corresponding to the second and third trimesters of pregnancy with respect to human renal maturation, maternal exposure to dapagliflozin in rat studies was associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny.
In conventional studies of embryo-fetal development in rats and rabbits, dapagliflozin was administered for intervals coinciding with the first trimester period of non-renal organogenesis in humans. No developmental toxicities were observed in rabbits at any dose tested (1191 x the maximum recommended human dose [MRHD]). In rats, dapagliflozin was neither embryolethal nor teratogenic (1441 x the MRHD) in the absence of maternal toxicity.
Saxagliptin: Saxagliptin crosses the placenta into the fetus following dosing in pregnant rats.
Lactation: Saxagliptin/dapagliflozin combination: It is not known whether Saxagliptin/Dapagliflozin (QTERN) or its mono-components and/or their metabolites are excreted in human milk. Saxagliptin/Dapagliflozin (QTERN) must not be used by a nursing woman.
Dapagliflozin: Studies in rats have shown excretion of dapagliflozin in milk. Direct and indirect exposure of dapagliflozin to weanling juvenile rats and during late pregnancy are each associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny, although the long-term functional consequences of these effects are unknown. These periods of exposure coincide with a critical window of renal maturation in rats. As functional maturation of the kidneys in humans continues in the first 2 years of life, dapagliflozin-associated dilated renal pelvis and tubules noted in juvenile rats could constitute potential risk for human renal maturation during the first 2 years of life. Additionally, the negative effects on body-weight gain associated with lactational exposure in weanling juvenile rats suggest that dapagliflozin must be avoided during the first 2 years of life (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Saxagliptin: Saxagliptin is secreted in the milk of lactating rats.