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Insulin degludec / liraglutide Pregnancy and Breastfeeding Warnings

Insulin degludec / liraglutide is also known as: Xultophy

Insulin degludec / liraglutide Pregnancy Warnings

Use is not recommended 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 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. 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

Use is not recommended. 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.

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