Lixisenatide

The Basics

What is Lixisenatide?

Once-daily injectable GLP-1 receptor agonist for the treatment of diabetes type II.

Brand names for Lixisenatide

N/A

How Lixisenatide is classified

Hypoglycemic Agents, Incretins, Glucagon-Like Peptide-1 Agonists, GLP-1 Agonists

Lixisenatide During Pregnancy

Lixisenatide pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Lixisenatide while pregnant

Based on animal reproduction studies, there may be risks to the fetus from exposure to lixisenatide, a component of SOLIQUA 100/33, during pregnancy. SOLIQUA 100/33 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The limited available data with SOLIQUA 100/33 and lixisenatide in pregnant women are not sufficient to inform a drug-associated risk of major birth defects and miscarriage. Published studies with insulin glargine use during pregnancy have not reported a clear association withinsulin glargine and major birth defect or miscarriage risk . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations]. Lixisenatide administered to pregnant rats and rabbits during organogenesis was associated withvisceral closure and skeletal defects at systemic exposures that decreased maternal food intakeand weight gain during gestation, and that are 1-time and 6-times higher than the 20 mcg/dayhighest clinical dose, respectively, based on plasma AUC .The estimated background risk of major birth defects is 6%-10% in women with pre-gestationaldiabetes with an HbA1c >7 and has been reported to be as high as 20%-25% in women with aHbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defectsand miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Human dataInsulin glarginePublished data do not report a clear association with insulin glargine and major birth defects,miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used duringpregnancy. However, these studies cannot definitely establish the absence of any risk because ofmethodological limitations including small sample size and some lacking comparator groups.Animal dataAnimal reproduction studies were not conducted with the combined products in SOLIQUA100/33. The following data are based on studies conducted with the individual components ofSOLIQUA 100/33.

Taking Lixisenatide While Breastfeeding

What are recommendations for lactation if you're taking Lixisenatide?

No information is available on the clinical use of lixisenatide during breastfeeding. Because lixisenatide is a large peptide molecule with a molecular weight of 4858 daltons, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, lixisenatide should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

No information is available on the clinical use of lixisenatide during breastfeeding. Because lixisenatide is a large peptide molecule with a molecular weight of 4858 daltons, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, lixisenatide should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Possible effects of Lixisenatide on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Lixisenatide

Acarbose, Glipizide, Glyburide, Insulin, Metformin, Miglitol.