NovoMix 30 FlexPen Use In Pregnancy & Lactation

There is limited clinical experience with biphasic insulin aspart 30 in pregnancy. Biphasic insulin aspart 30 has not been investigated in pregnant women. However, data from 2 randomized, controlled clinical trials (157 and 14 insulin aspart-exposed pregnancies respectively, in basal-bolus regimen) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the fetus/newborn when compared to soluble human insulin (see Pharmacology: Pharmacodynamic under Actions).
In addition, the data from a clinical trial including 27 women with gestational diabetes randomized to treatment with insulin aspart vs soluble human insulin (insulin aspart: 14; soluble human insulin: 13) showed similar safety profiles between treatments.
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 1st trimester and increase subsequently during the 2nd and 3rd trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels.
There are no restrictions on treatment with biphasic insulin aspart 30 during lactation. Insulin treatment of the breastfeeding mother presents no risk to the baby.
However, the biphasic insulin aspart 30 dosage, may need to be adjusted.