Pregnancy: There is no clinical experience with the use of Ryzodeg in pregnant women.
Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually decrease in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements usually return rapidly to pre-pregnancy values.
Breast-feeding: There is no clinical experience with Ryzodeg during breast-feeding. In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma.
It is unknown whether insulin degludec/insulin aspart is excreted in human milk. No metabolic effects are anticipated in the breast-fed newborn/infant.
Fertility: Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.