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Insulin degludec Pregnancy and Breastfeeding Warnings

Insulin degludec is also known as: Tresiba

Insulin degludec Pregnancy Warnings

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus US FDA pregnancy category: C Comments: Insulin requirements generally increase during the second and third trimester and rapidly decline after delivery; careful monitoring of glucose control is essential.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Insulin degludec Breastfeeding Warnings

Animal studies in rats have shown that insulin degludec is secreted in their 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 Breast-feeding mothers may require adjustments in insulin dose.

See references

References for pregnancy 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.

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.

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