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Empagliflozin / linagliptin Pregnancy and Breastfeeding Warnings

Empagliflozin / linagliptin is also known as: Glyxambi

Empagliflozin / linagliptin Pregnancy Warnings

Rat studies have shown adverse renal changes when empagliflozin was administered during a period of renal development corresponding to late second and third trimesters of human development. Renal pelvic and tubule dilations were observed at doses approximately 13-times the maximum clinical dose. Administration of both components during the period of organogenesis was not teratogenic in rats dosed 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. Clinical considerations: Poorly controlled diabetes increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth, and macrosomia related morbidity. Insulin is generally recommended as the drug of choice during pregnancy. 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.

Not recommended during the second and third trimesters of pregnancy US FDA pregnancy category: Not Assigned Risk Summary: Animal data have shown adverse renal effects with empagliflozin during the renal development period which corresponds to the late second and third trimesters of human pregnancy. Adverse developmental effects were not observed during organogenesis. Comment: Poorly controlled diabetes during pregnancy increases maternal and fetal risks for adverse outcomes.

See references

Empagliflozin / linagliptin Breastfeeding Warnings

Use is not recommended Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: A risk for serious adverse reactions exist due to the potential effect of empagliflozin on postnatal renal development.

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 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.
  2. EMA. European Medicines Agency. European Union "European Medicines Agency. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp&mid=WC0b01ac058067c852" ([2013 - ]):

References for breastfeeding information

  1. EMA. European Medicines Agency. European Union "European Medicines Agency. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp&mid=WC0b01ac058067c852" ([2013 - ]):
  2. "Product Information. Glyxambi (empagliflozin-linagliptin)." Boehringer Ingelheim, Ridgefield, CT.

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