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Insulin lispro Pregnancy and Breastfeeding Warnings

Insulin lispro is also known as: Admelog, Humalog, Humalog Junior KwikPen, Humalog KwikPen

Medically reviewed by Last updated on Jan 23, 2018.

Insulin lispro Pregnancy Warnings

Use is considered acceptable

AU TGA pregnancy category: A
US FDA pregnancy category: B

Comment: Intensified treatment and monitoring of pregnant women with diabetes is recommended throughout pregnancy and when contemplating pregnancy.

Pregnancies complicated by hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. There are limited clinical studies with insulin lispro, however published studies with human insulins suggest optimizing overall glycemic control, including postprandial control, before conception and during pregnancy improves fetal outcome. Data from a large number of exposed pregnancies does not show any adverse effect of insulin lispro on pregnancy or on the health of the fetus or newborn. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. Insulin requirements may decrease during the first trimester; generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential.

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.

See references

Insulin lispro Breastfeeding Warnings

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.

Use is considered acceptable

Excreted into human milk: Yes

Breast-feeding mothers may require adjustments in insulin dose.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Humalog (insulin lispro)." Lilly, Eli and Company, Indianapolis, IN.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Humalog (insulin lispro)." Lilly, Eli and Company, Indianapolis, IN.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.