Levemir Use In Pregnancy & Lactation

Pregnancy: The use of Levemir in pregnant women with diabetes has been investigated in a clinical trial and in a prospective non-interventional post-authorisation safety study. Furthermore, a large amount of post-marketing data in pregnant women (more than 4,500 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of Levemir.
Treatment with Levemir can be considered during pregnancy, if clinically needed.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester. After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Breast-feeding: It is unknown whether insulin detemir is excreted in human milk. No metabolic effects of ingested insulin detemir on the breast-fed newborn/infant are anticipated since insulin detemir, as a peptide, is digested into amino acids in the human gastrointestinal tract.
Breast-feeding women may require adjustments in insulin dose and diet.
Fertility: Animal studies do not indicate harmful effects with respect to fertility.