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Exenatide Pregnancy and Breastfeeding Warnings

Exenatide is also known as: Bydureon, Bydureon BCise, Byetta

Exenatide Pregnancy Warnings

Animal studies have revealed evidence of adverse fetal and neonatal outcomes during pregnancy. Reduced fetal growth and skeletal ossification deficits were observed in rats exposed to this drug during organogenesis at doses that approximate clinical exposures. In mice, exposure during gestation and lactation cause increased neonatal deaths. There are no adequate and well-controlled studies in pregnant women. Clinical considerations: Poorly controlled diabetes increases the 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. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.

Not recommended unless potential benefit justifies potential risk to the fetus AU TGA pregnancy category: C US FDA pregnancy category: Not assigned Risk Summary: Limited data are not sufficient to determine a drug-associated risk for major birth defects or miscarriage; there are risks associated with poorly controlled diabetes. Comments: -Animal data suggests risks to the fetus during pregnancy. -US: A Pregnancy Registry has been implemented to monitor pregnancy outcomes of women exposed to exenatide during pregnancy. Healthcare providers are encouraged to register patients by calling 1-800-633-9081.

See references

Exenatide Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes

Lactating mice receiving this drug subcutaneously twice a day have shown rat milk concentrations of up to 2.5% the concentration in maternal plasma. Information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production are not available.

See references

References for pregnancy information

  1. "Product Information. Bydureon BCise (exenatide)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Byetta (exenatide)." Amylin Pharmaceuticals Inc, San Diego, CA.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Byetta (exenatide)." Amylin Pharmaceuticals Inc, San Diego, CA.
  4. "Product Information. Bydureon BCise (exenatide)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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