Repaglinide

The Basics

What is Repaglinide?

Used to treat type 2 diabetes.

Brand names for Repaglinide

Prandin

How Repaglinide is classified

Hypoglycemic Agents

Repaglinide During Pregnancy

Repaglinide pregnancy category

Category Not AssignedNote 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 Repaglinide while pregnant

Limited available data from case reports and case series with PRANDIN use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis at approximately 60 and 1 times the maximum daily clinical dose, based on body surface area. No adverse developmental effects were observed in offspring of rats administered repaglinide during late gestation and lactation at approximately 4 times the maximum daily clinical dose (see Data). The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c>7 and has been reported to be as high as 20-25% in women with a HbA1c>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 defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal And/Or Embryo/Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity. Data Animal Data Repaglinide was not teratogenic in rats or rabbits at doses 60 times (rats) and approximately 1 times (rabbit) clinical exposure (on a mg/m² basis) when administered during the period of organogenesis. Offspring of rat dams exposed to repaglinide at ≥22 times clinical exposure on a mg/m² basis during days 17 to 22 of gestation and during lactation were less viable and developed skeletal deformations consisting of shortening, thickening, and bending of the humerus during the postnatal period. This effect was not seen at doses up to 4 times clinical exposure (on a mg/m² basis).

Taking Repaglinide While Breastfeeding

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

No information is available on the use of repaglinide during breastfeeding. Repaglinide is a weak acid that is over 98% protein bound, so it is unlikely to pass into breastmilk in clinically important amounts. Monitor breastfed infants for signs of hypoglycemia such as jitteriness, excessive sleepiness, poor feeding, seizures cyanosis, apnea, or hypothermia. If there is concern, monitoring of the breastfed infant’s blood glucose is advisable during maternal therapy with repaglinide.[1] However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

No information is available on the use of repaglinide during breastfeeding. Repaglinide is a weak acid that is over 98% protein bound, so it is unlikely to pass into breastmilk in clinically important amounts. Monitor breastfed infants for signs of hypoglycemia such as jitteriness, excessive sleepiness, poor feeding, seizures cyanosis, apnea, or hypothermia. If there is concern, monitoring of the breastfed infant’s blood glucose is advisable during maternal therapy with repaglinide.[1] However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Repaglinide on milk supply

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

Possible alternatives to Repaglinide

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