Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of insulin glulisine in pregnant women.
Animal reproduction studies have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Caution should be exercised when prescribing to pregnant women. Careful monitoring of glucose control is essential.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly.
Breast-feeding: It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration. Breast-feeding mothers may require adjustments in insulin dose and diet.
Fertility: Animal reproduction studies with insulin glulisine have not revealed any adverse effects on fertility.