NovoRapid Use In Pregnancy & Lactation

insulin aspart


Novo Nordisk


Zuellig Pharma
Full Prescribing Info
Use In Pregnancy & Lactation
There is limited clinical experience with NovoRapid in pregnancy. An open-label, randomised study compared the safety and efficacy of Novorapid versus human insulin in the treatment of pregnant women with type 1 diabetes [322 exposed pregnancies (NovoRapid: 157, human insulin: 165)]. Two-thirds of the enrolled patients were already pregnant when they entered the study. Since only 1/3 of the patients enrolled before conception, the study was not large enough to evaluate the risk of congenital malformations. Mean HBA1c of ~6% was observed in both groups during pregnancy and there was no significant difference in the incidence of maternal hypoglycaemia.
Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) is 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 the treatment with NovoRapid during lactation. Insulin treatment of the nursing mother presents no risk to the baby. However, the NovoRapid dosage may need to be adjusted.
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