Canagliflozin Pregnancy and Breastfeeding Warnings

Canagliflozin is also known as: Invokana

Canagliflozin Pregnancy Warnings

Animal studies showed increased kidney weights and renal pelvic and tubular dilatation at greater than or equal to 0.5 times clinical exposure from a 300 mg dose during animal development corresponding to late second and third of human development, and a small number of fetuses with reduced ossification at doses associated with maternal toxicity. Canagliflozin did not affect animal fertility despite minor alterations in reproductive parameters (decreased sperm velocity, increased number of abnormal sperm, slightly fewer corpora lutea, fewer implantation sites, and smaller litter sizes) at the highest dosages. There are no controlled data in human pregnancy. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Use of canagliflozin is not recommended during pregnancy especially during the second and third trimesters. The potential benefit should outweigh the potential risk.

Canagliflozin Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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