Lantus

Lantus Use In Pregnancy & Lactation

insulin glargine

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Full Prescribing Info
Use In Pregnancy & Lactation
For insulin glargine no clinical data on exposed pregnancies from randomized controlled clinical trials are available. A large number (more than 1000 retrospective and prospective pregnancy outcomes) of exposed pregnancies from Post-Marketing Surveillance indicate no specific adverse effects of insulin glargine on pregnancy or on the health of the foetus and newborn child. Furthermore a meta-analysis of eight observational clinical studies including 331 women using insulin glargine and 371 women using insulin NPH was performed to assess the safety of insulin glargine and insulin NPH in gestational or pregestational diabetes. No significant differences in safety related maternal or neonatal outcomes were seen between insulin glargine and insulin NPH during pregnancy.
Women with preexisting or gestational diabetes must maintain good metabolic control during pregnancy to prevent adverse outcomes associated with hyperglycemia. Lantus can be used during pregnancy, if clinically needed. In the first three months, insulin requirements may decrease and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements then decrease again rapidly (increased risk of hypoglycaemia). Therefore, careful blood sugar monitoring is essential. If pregnant or planning a pregnancy, please inform the physician.
Adjustments in dosage and diet may be necessary in breast-feeding women.
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