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NovoLog Mix 70/30 and Pregnancy

No clinical studies have been conducted on NovoLog Mix 70/30 (insulin aspart protamine/insulin aspart) and pregnancy, so it is not known whether the drug is safe for pregnant women. When the insulin aspart component of the medication was given to pregnant animals, however, it did not increase the risk of problems. If you are using NovoLog Mix 70/30 and pregnancy occurs, contact your healthcare provider.

NovoLog Mix 70/30 and Pregnancy: An Overview

NovoLog® Mix 70/30 (insulin aspart protamine/insulin aspart) is a prescription diabetes medication used to treat type 1 and type 2 diabetes. At this time, it is not clear if NovoLog Mix 70/30 or any of the relatively new insulins are safe for use during pregnancy.

NovoLog Mix 70/30 and Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a "default" pregnancy Category C rating.
NovoLog Mix 70/30 has not been studied in pregnant women or animals. However, the rapid-acting insulin (insulin aspart, NovoLog®) in NovoLog Mix 70/30 has been studied in animals and does not appear to increase the risk of any problems, compared to regular human insulin. In general, any problems that were seen were caused by low blood sugar in the mother animals. Although it was thought that insulins do not cross the placenta, it is now known that some insulins, in some circumstances, may cross the placenta.
Some healthcare providers are uncomfortable recommending any of the newer insulins that have not been studied in pregnant women, including NovoLog Mix 70/30, to pregnant women. However, many healthcare providers make the logical assumption that the new insulins are just as safe (and usually more convenient) than the older insulins. This is a decision that you and your healthcare provider must make together.
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Information on NovoLog Mix 70/30

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