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Insulin degludec Pregnancy and Breastfeeding Warnings

Insulin degludec is also known as: Tresiba

Medically reviewed on June 22, 2018

Insulin degludec Pregnancy Warnings

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

US FDA pregnancy category: Not Assigned

Comments:
-Insulin requirements generally decrease in the first trimester and increase during the second and third trimester.
-Intensified blood glucose control and monitoring is recommended throughout pregnancy and when contemplating pregnancy.

Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity. Pregnancies complicated by hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. 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 Breastfeeding Warnings

Animal studies in rats have shown insulin degludec is secreted in rat milk in a concentration that is lower than in plasma. Insulin is a protein that is inactivated if taken by mouth. No metabolic effects are expected in the nursing infant. If absorbed, it would be destroyed in the digestive tract of the infant.

Lactation onset occurs later in women with type 1 diabetes, and there is an even greater delay in those with poor glucose control. However, once established lactation persists as long in mothers with diabetes as in mothers without. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production

Use with caution

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

Comments:
-No metabolic effects are anticipated in the breastfed newborn.
-Breast-feeding mothers may require adjustments in insulin dose.

See references

References for pregnancy information

  1. "Product Information. Tresiba FlexTouch (insulin degludec)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  2. 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. Tresiba FlexTouch (insulin degludec)." 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.

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