Byetta 5 mcg

Exenatide 5 mg.

Pregnancy and Breastfeeding Warnings
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. 

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.

References for pregnancy information
  1. "Product Information. Bydureon BCise (exenatide)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Byetta (exenatide)." Amylin Pharmaceuticals Inc, San Diego, CA.
  4. 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. Bydureon BCise (exenatide)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  4. "Product Information. Byetta (exenatide)." Amylin Pharmaceuticals Inc, San Diego, CA.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Byetta 5 mcg only for the indication prescribed.

Verified References
  • FDA Feb 11, 2018
  • CDC Feb 11, 2018
  • Mayo Clinic Feb 11, 2018
  • Drugs.com accessed Feb 11, 2018
  • Medscape accessed Feb 11, 2018
  • Epocrates accessed Feb 11, 2018
  • Webmd accessed Feb 11, 2018