Jardiance Use In Pregnancy & Lactation



Boehringer Ingelheim


Agencia Lei Va Hong
Full Prescribing Info
Use In Pregnancy & Lactation
Effects on fertility: No studies on the effect on human fertility have been conducted for JARDIANCE. Studies in rats at doses up to 700 mg/kg/day, do not indicate direct or indirect harmful effects with respect to fertility. In female rats this dose was 90- and 155-fold the systemic AUC exposure anticipated with a human dose of 10 and 25 mg.
Use in pregnancy (Category D): There are limited data from the use of JARDIANCE in pregnant women. It is recommended to avoid the use of JARDIANCE during pregnancy unless clearly needed.
Empagliflozin administered during the period of organogenesis was not teratogenic at doses up to 300 mg/kg in the rat or rabbit, which corresponds to approximately 48- and 122-times or 128- and 325-times the clinical dose of empagliflozin based on AUC exposure associated with the 25 mg and 10 mg doses, respectively. Doses of empagliflozin causing maternal toxicity in the rat also caused the malformation of bent limb bones at exposures approximately 155- and 393-times the clinical dose associated with the 25 mg and 10 mg doses, respectively. Maternally toxic doses in the rabbit also caused increased embryofetal loss at doses approximately 139- and 353-times the clinical dose associated with the 25 mg and 10 mg doses, respectively.
Empagliflozin administered to female rats from gestation day 6 to lactation day 20 resulted in reduced weight gain in offspring at >30 mg/kg/day (maternal exposures approximately 4- and 11-times those seen with a clinical dose of 25 mg and 10 mg, respectively). No adverse effects on postnatal development were noted at 10 mg/kg/day (maternal exposures approximately equivalent to those seen with a clinical dose of 25 mg).
Specialised studies in rats with other members of the pharmacological class have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Similar effects have been seen for empagliflozin at approximately 11 times the clinical AUC exposure associated with the 25 mg dose. These findings were absent after a 13-week drug-free recovery period. JARDIANCE should be used in pregnancy only if the expected benefit to the patients justifies the potential risk to the fetus.
Use in lactation: No data in humans are available on excretion of empagliflozin into milk. Available nonclinical data in animals have shown excretion of empagliflozin in milk. Reduced body weight was observed in rats exposed to empagliflozin in utero and through the consumption of maternal milk (see Use in pregnancy (Category D) as previously mentioned). Adverse effects on renal development have been observed in juvenile rats treated with other members of this pharmacological class. Similar effects were seen with empagliflozin but the findings were absent after a 13 week drug-free recovery. A risk to human newborns/infants cannot be excluded. It is recommended to discontinue breast feeding during treatment with JARDIANCE.
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