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Empagliflozin / linagliptin Pregnancy and Breastfeeding Warnings

Empagliflozin / linagliptin is also known as: Glyxambi

Empagliflozin / linagliptin Pregnancy Warnings

Studies in rats have shown adverse renal changes when empagliflozin was administered during a period of renal development. Doses of approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilations. Administration of both components during the period of organogenesis was not teratogenic in rats in doses up to 253 and 353 times the expected clinical exposure for empagliflozin and linagliptin, respectively. There are no adequate well-controlled studies in pregnant women with this combination drug or with its components. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is not recommended during the second and third trimesters of pregnancy US FDA pregnancy category: Not Assigned Risk Summary: Animal data has shown adverse renal effects with empagliflozin administration during the renal development period which corresponds to the late second and third trimesters of human pregnancy. Adverse developmental effects were not observed when this combination drug was administered to pregnant rats during organogenesis. Comment: Poorly controlled diabetes during pregnancy increases maternal and fetal risks for adverse outcomes.

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Empagliflozin / linagliptin Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

While it is unknown if this drug is excreted into human milk, there is potential for serious harm to the developing kidney if the breastfed infant is exposed. Human kidney maturation occurs in utero during the first 2 years of life. This drug was found in rat milk and appears to accumulate (mean milk to plasma ratio ranging from 0.634 to 5; mean maximal milk to plasma ratio occurring 8 hours postdose). Juvenile rats directly exposed to this drug have shown renal pelvic and tubular dilations during maturation.

See references

References for pregnancy information

  1. "Product Information. Glyxambi (empagliflozin-linagliptin)." Boehringer Ingelheim, Ridgefield, CT.

References for breastfeeding information

  1. "Product Information. Glyxambi (empagliflozin-linagliptin)." Boehringer Ingelheim, Ridgefield, CT.

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