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: Insufficient human data is available to determine a drug associated risk for major birth defects and miscarriage; based on animal reproductive studies, there may be risks to the fetus.

Comments:
-Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications and increased fetal risks for major birth defects, stillbirth, and macrosomia related morbidity.
-Patients who are pregnant, or planning on becoming pregnant should consider a treatment switch to insulin.

Administration of this drug to rats during the period or organogenesis resulted in early embryonic deaths, fetal growth reductions, and fetal abnormalities at doses estimated to be 14-times the maximum recommended human dose (MRHD). Rabbits administered 13-times the MRHD, experienced major fetal abnormalities. In both rats and rabbits, decreased maternal food intake and decreased weight gain attributed to the pharmacology of the drug were observed. The estimated background risk of major birth defects in women with pre-gestational diabetes and HbA1c greater than 7 is 6% to 10%. For women with pre-gestational diabetes and HbA1c greater than 10, this risk has been estimated as high as 20% to 25%. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4%. 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

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

Dulaglutide is a large protein molecule and therefore, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. However, until more data becomes available, other agents may be preferred. If used, use with caution, especially while nursing a newborn or preterm infant.

See references