Pregnancies complicated by gestational diabetes or pre-existing type 1 or type 2 diabetes mellitus are associated with a higher rate of adverse outcomes compared with pregnancies in the background population. These outcomes include miscarriage, pre-term delivery, pre-eclampsia, perinatal mortality and congenital malformations.1
Insulin glulisine is a rapid-acting insulin analogue indicated for the treatment of adults, adolescents and children 8 years or older with diabetes mellitus where treatment with insulin is required.2
During clinical trials, 2 pregnancies were reported while being exposed to glulisine. No malformations or complications were reported in either pregnancy. The outcomes of the pregnancies are presented in Table 1. The use of glulisine during pregnancy is not contraindicated, however there is no specific recommendation for this population.
Table 1. Summary of Pregnancies in Women Exposed to Glulisine
Doder, et al.,1 analysed and summarised the experience with insulin glulisine in pregnancy from different sources, such as the Sanofi pharmacovigilance and clinical trials databases combined with the findings of an updated, comprehensive literature search. Cumulatively, a total of 303 pregnancy exposures to insulin glulisine were received. Of these 303 pregnancy exposures, there were 116 live births, 12 spontaneous abortions, two late foetal intra-uterine deaths (>28 weeks), three elective abortions and 170 cases without a known pregnancy outcome. There were six cases of congenital malformations; of these, there were five live births; in the other case a live birth was not confirmed. The congenital malformations reported to date do not reveal a pattern of defects. In conclusion, the evidence to date does not suggest a causal association between insulin glulisine and an increased risk of pregnancy complications or congenital malformations.
Table 2. Outcome Reports of 303 Pregnancy Exposures (Cumulative Cases to 30 June 2014)
ᵃ Three cases of pre-term births also have congenital anomalies.
Conclusions:
There are no adequate data on the use of insulin glulisine in pregnant women. A limited amount of data on pregnant women (less than 300 pregnancy outcomes reported) exposed to marketed insulin glulisine indicates no safety issues in use of insulin glulisine during pregnancy or on the foetus and newborn child. The use of glulisine during pregnancy is not contraindicated, however there is no specific recommendation for this population. 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. Patients with diabetes must inform their doctor if they are pregnant or are contemplating pregnancy. 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.
Image: Illustration (downloaded from https://www.freepik.com/free-photo/young-latin-woman-pregnant-measuring-glucose-home_49701274.htm#fromView=search&page=1&position=0&uuid=4e051b01-78a7-4daa-bcdf-09589e47e929&query=pregnant+woman+with+diabetes)
References :
1. Doder Z, Vanechanos D, Oster M, Landgraf W, Lin S. Insulin Glulisine in Pregnancy - Experience from Clinical Trials and Post-marketing Surveillance. Eur Endocrinol. 2015;11(1):17-20. doi:10.17925/EE.2015.11.01.17
2. Apidra® Indonesia Local Product Information 2023
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ID-API-2025-09-KZWE (09/25)
