Insulin degludec / liraglutide Pregnancy and Breastfeeding Warnings

Brand names: Xultophy

Medically reviewed by Drugs.com. Last updated on Mar 27, 2024.

Insulin degludec / liraglutide Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category Not Assigned

Risk Summary: Animal studies with liraglutide have shown reproductive toxicity; the risk in human is unknown. Poorly controlled diabetes during pregnancy is associated with increased risk of complications in mothers and increased fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

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

Animal reproduction studies with insulin degludec have not revealed evidence of embryotoxicity and teratogenicity. Its effects appear to be similar to those observed with human insulin. Animal data with liraglutide have revealed evidence of increased embryofetal death and fetal abnormalities (including minor fetal skeletal abnormalities, retarded fetal weight, and visceral abnormalities). There are no controlled data in human pregnancy.

Clinical Considerations: The estimated background risk of major birth defects in women with pre-gestational diabetes and a HbA1c greater than 7 is 6% to 10% and has been reported to be as high as 20% to 25% in women with a HbA1c greater than 10. In the U.S. general population, the estimated background risk of major birth defects in clinically recognized pregnancies is 2% to 4%. Poorly controlled diabetes increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications, and increases the fetal risk for stillbirth, and macrosomia related morbidity.

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.

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Insulin degludec / liraglutide Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown (insulin degludec); Unknown (liraglutide)
Excreted into animal milk: Yes (insulin degludec); Yes (liraglutide)

Comments:
-The effects in the nursing infant are unknown.
-Some authorities recommend avoiding use due to lack of experience during breastfeeding.

Animal studies in rats have shown insulin degludec is secreted in rat milk at concentrations lower than plasma. No metabolic effects are expected with insulin use in the nursing infants as insulin is a protein that is inactivated if taken by mouth. Liraglutide excretion in rat milk has been observed at concentrations approximately 50% of maternal plasma concentrations; it is a large peptide molecule and likely will not be absorbed, but if absorbed will probably be destroyed in the infant's gastrointestinal tract. There is no data on the 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 on the breastfed infant from the drug or from the underlying maternal condition.

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Further information

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