Skip to Content

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: 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. 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.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide