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Insulin glargine Pregnancy and Breastfeeding Warnings

Insulin glargine is also known as: Basaglar, Lantus, Lantus OptiClik Cartridge, Lantus SoloStar, Toujeo Max SoloStar, Toujeo SoloStar

Medically reviewed on August 14, 2017

Insulin glargine Pregnancy Warnings

There are no controlled data in human pregnancy, however in more than 1000 pregnancy outcomes, no specific adverse effects of insulin glargine on pregnancy and no specific malformations nor fetal or neonatal toxicity were reported. In animal studies in rats and rabbits, the effects of insulin glargine did not differ greatly from those observed with regular human insulin, although 5 fetuses from 2 litters in the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.

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 B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

AU TGA pregnancy category: B3
US FDA pregnancy category: C

See references

Insulin glargine Breastfeeding Warnings

Use is considered acceptable; caution is recommended.

Excreted into human milk: Yes

Comments: Women who are breastfeeding may require adjustments in insulin dose and diet.

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. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production.

See references

References for pregnancy information

  1. "Product Information. Toujeo SoloStar (insulin glargine)." sanofi-aventis, Bridgewater, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Lantus (insulin glargine)" Aventis Pharmaceuticals, Swiftwater, PA.
  5. "Product Information. Basaglar (insulin glargine)." Eli Lilly Canada Inc, Toronto, ON.

References for breastfeeding information

  1. "Product Information. Lantus (insulin glargine)" Aventis Pharmaceuticals, Swiftwater, PA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Basaglar (insulin glargine)." Eli Lilly Canada Inc, Toronto, ON.
  5. "Product Information. Toujeo SoloStar (insulin glargine)." sanofi-aventis, Bridgewater, NJ.
  6. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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