Skip to Content

Insulin degludec / liraglutide Pregnancy and Breastfeeding Warnings

Insulin degludec / liraglutide is also known as: Xultophy

Medically reviewed by Drugs.com. Last updated on Jan 16, 2019.

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 increase 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.

See references

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)

The effects in the nursing infant are unknown.

Insulin degludec has been found in the milk of lactating rats at concentrations lower than plasma, while liraglutide has been found to be approximately 50% of maternal plasma concentrations. There is no data on the presence in human milk or the effects on milk production.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Xultophy (insulin degludec-liraglutide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Xultophy (insulin degludec-liraglutide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

Further information

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

Hide