Canagliflozin

The Basics

What is Canagliflozin?

Used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in people with type 2 diabetes.

Brand names for Canagliflozin

Invokana

How Canagliflozin is classified

Hypoglycemic Agents, Sodium-Glucose Cotransporter 2 Inhibitors, SGLT2 Inhibitors

Canagliflozin During Pregnancy

Canagliflozin 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 Canagliflozin while pregnant

Based on animal data showing adverse renal effects, INVOKANA is not recommended during the second and third trimesters of pregnancy. Limited data with INVOKANA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations]. In animal studies, adverse renal pelvic and tubule dilatations that were not reversible were observed in rats when canagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at an exposure 0.5times the 300 mg clinical dose, based on AUC. 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, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Animal Data Canagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 4, 20, 65, or 100 mg/kg increased kidney weights and dose dependently increased the incidence and severity of renal pelvic and tubular dilatation at all doses tested. Exposure at the lowest dose was greater than or equal to 0.5-times the 300 mg clinical dose, based on AUC. These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development. The renal pelvic dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. In embryo-fetal development studies in rats and rabbits, canagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. No developmental toxicities independent of maternal toxicity were observed when canagliflozin was administered at doses up to 100 mg/kg in pregnant rats and 160 mg/kg in pregnant rabbits during embryonic organogenesis or during a study in which maternal rats were dosed from gestation day (GD) 6 through PND 21, yielding exposures up to approximately 19-times the 300 mg clinical dose, based on AUC.

Taking Canagliflozin While Breastfeeding

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

No information is available on the clinical use of canagliflozin during breastfeeding. Canagliflozin is is an uncharged molecule that is 99% protein bound in plasma, so it is unlikely to pass into breastmilk in clinically important amounts. The manufacturer does not recommend canagliflozin during breastfeeding because of a theoretical risk to the infant’s developing kidney. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

No information is available on the clinical use of canagliflozin during breastfeeding. Canagliflozin is is an uncharged molecule that is 99% protein bound in plasma, so it is unlikely to pass into breastmilk in clinically important amounts. The manufacturer does not recommend canagliflozin during breastfeeding because of a theoretical risk to the infant’s developing kidney. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Canagliflozin on milk supply

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

Possible alternatives to Canagliflozin

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