Glyxambi

Glyxambi Use In Pregnancy & Lactation

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Use In Pregnancy & Lactation
The effects of GLYXAMBI on pregnancy, breast-feeding and fertility are not known. Effects related to the individual active substances are described as follows.
Pregnancy: There are no data from the use of empagliflozin and linagliptin in pregnant women.
Animal studies show that empagliflozin and linagliptin cross the placenta during late gestation, but do not indicate direct or indirect harmful effects with respect to early embryonic development with either empagliflozin or linagliptin (see Pharmacology: Toxicology: Preclinical safety data under Actions). Animal studies with empagliflozin have shown adverse effects on postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure it is preferable to avoid the use of GLYXAMBI during pregnancy.
Breast-feeding: No data in humans are available on excretion of empagliflozin and linagliptin into milk. Available non-clinical data in animals have shown excretion of empagliflozin and linagliptin in milk. A risk to newborns or infants cannot be excluded. GLYXAMBI should not be used during breast-feeding.
Fertility: No studies on the effect on human fertility have been conducted with GLYXAMBI or with the individual active substances. Non-clinical studies with empagliflozin and linagliptin as single agents do not indicate direct or indirect harmful effects with respect to fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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