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Empagliflozin / metformin Pregnancy and Breastfeeding Warnings

Empagliflozin / metformin is also known as: Synjardy, Synjardy XR

Empagliflozin / metformin Pregnancy Warnings

This drug is not recommended during the second and third trimesters of pregnancy based on animal data showing adverse renal effects. In rats and rabbits administered empagliflozin in doses up to 300 mg/kg/day (48 and 128 times the maximum clinical dose in rats and rabbits, respectively) during intervals corresponding to first trimester in humans, adverse developmental effects were not observed, however administration at 13-times the maximum clinical dose at intervals corresponding to late second and third trimester of human development, have shown increased kidney weight and renal tubular and pelvic dilation. Teratogenicity has not been observed in animals. There are no controlled data in human pregnancy. Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortion, preterm delivery, stillbirth, and delivery complications; the fetal risk for major birth defects, still birth, and macrosomia related morbidity are increased with poorly controlled diabetes during pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. 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 AU TGA pregnancy category: D 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 Comments: -Poorly controlled diabetes during pregnancy increases maternal and fetal risks for adverse outcomes. -Anovulatory premenopausal women should be informed of the risk for unintended pregnancy as metformin therapy may result in ovulation.

See references

Empagliflozin / metformin Breastfeeding Warnings

While it is unknown if empagliflozin 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. Empagliflozin 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 empagliflozin have shown renal pelvic and tubular dilations during maturation.

Use is not recommended Excreted into human milk: Yes (metformin); Unknown (empagliflozin) Excreted into animal milk: Yes (metformin, empagliflozin) Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Synjardy (empagliflozin-metFORMIN)." Boehringer Ingelheim, Ridgefield, CT.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Synjardy (empagliflozin-metFORMIN)." Boehringer Ingelheim, Ridgefield, CT.

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