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Dulaglutide Pregnancy and Breastfeeding Warnings

Dulaglutide is also known as: Trulicity

Medically reviewed on February 6, 2017.

Dulaglutide Pregnancy Warnings

May cause fetal harm; use only if potential benefit justifies risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned

Risk Summary: Based on animal reproductive studies, there may be risks to the fetus; there are maternal and fetal risks associated with poorly controlled diabetes during pregnancy that include risks for major birth defects, stillbirth, and macrosomia related morbidity,

Comments: Patients who are pregnant, or planning on becoming pregnant should consider a treatment switch to insulin.

Animal studies have revealed evidence of fetal growth reductions and/or skeletal anomalies and ossification deficits associated with decreased maternal weight and food consumption; these events may be attributed to the pharmacology of drug. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Dulaglutide Breastfeeding Warnings

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: Data not available

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Trulicity (dulaglutide)." Eli Lilly and Company, Indianapolis, IN.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  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. "Product Information. Trulicity (dulaglutide)." Eli Lilly and Company, Indianapolis, IN.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.