Novolog mix 70/30 flexpen Pregnancy Warnings
Pregnancies complicated by hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. When compared to human insulin, insulin aspart has not shown any adverse effect on pregnancy or on the health of the fetus. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. There are no adequate and well-controlled studies of the use of combination insulin aspart protamine suspension-insulin aspart in pregnant women.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Use is considered acceptable
AU TGA pregnancy category: A
US FDA pregnancy category: B
Comments: Careful monitoring of glucose control is essential; insulin requirements may decrease during the first trimester; generally increase during the second and third trimesters, and rapidly decline after delivery
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Novolog mix 70/30 flexpen Breastfeeding Warnings
Use is considered acceptable
Excreted into human milk: Yes
Breast-feeding mothers may require adjustments in insulin dose.
Exogenous insulins, including the newer biosynthetic insulins (i.e. aspart, detemir, glargine, glulisine, lispro) appear to be excreted into breast milk. Insulin is a protein that is inactivated if taken by mouth. If absorbed, it would be destroyed in the digestive tract of the infant.
Lactation onset occurs later in women with type 1 diabetes, and there is an even greater delay in those with poor glucose control. However, once established lactation persists as long in mothers with diabetes as in mothers without. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production.
See references
