Levemir Use In Pregnancy & Lactation

Pregnancy: Treatment with Levemir can be considered during pregnancy, if the benefit justifies possible risks.
One randomised controlled clinical trial in pregnant women with type 1 diabetes compared Levemir (n=152) to NPH insulin (n=158), both in combination with insulin aspart. The results showed similar efficacy of insulin detemir and NPH insulin and a similar overall safety profile during pregnancy, on pregnancy outcomes as well as on the foetus and the newborn (see Pharmacology: Pharmacodynamics under Actions).
Post-marketing data from an additional approximately 300 outcomes from pregnant women exposed to Levemir indicate no adverse effects of insulin detemir on pregnancy and no malformative or foeto/neonatal toxicity of insulin detemir.
Animal data do not indicate reproductive toxicity (see Toxicology: Preclinical safety data under Actions).
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.
Lactation: 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.