Sidapvia Use In Pregnancy & Lactation

Pregnancy: Dapagliflozin/sitagliptin combination: SIDAPVIA should not be used during pregnancy. There are no adequate and well-controlled studies of SIDAPVIA or its mono components in pregnant women. When pregnancy is detected, treatment with SIDAPVIA 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 (see Pharmacology: Toxicology: Preclinical study data under Actions).
In conventional studies of embryo-foetal development in rats and rabbits, dapagliflozin was administered for intervals coinciding with the first trimester period of nonrenal organogenesis in humans. No developmental toxicities were observed in rabbits at any dose tested (1191× the maximum recommended human dose [MRHD]). In rats, dapagliflozin was neither embryolethal nor teratogenic (1441× the MRHD) in the absence of maternal toxicity.
Sitagliptin: Studies in animals have shown reproductive toxicity at high doses (see Pharmacology: Toxicology: Preclinical study data under Actions). The potential risk for humans is unknown.
Lactation: Dapagliflozin/sitagliptin combination: SIDAPVIA should not be used by a nursing woman. It is not known whether SIDAPVIA or its mono components and/or their metabolites are excreted in human milk.
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 study data under Actions).
Sitagliptin: Animal studies have shown excretion of sitagliptin in breast milk (see Pharmacology: Toxicology: Preclinical study data under Actions).
Fertility: Dapagliflozin/sitagliptin combination: The effect of SIDAPVIA or its mono components on fertility in humans has not been studied.
Dapagliflozin: In male and female rats, dapagliflozin showed no effects on fertility at any dose tested (see Pharmacology: Toxicology: Preclinical study data under Actions).
Sitagliptin: Animal data do not suggest an effect of treatment with sitagliptin on male and female fertility (see Pharmacology: Toxicology: Preclinical study data under Actions).