Alogliptin / metformin Pregnancy and Breastfeeding Warnings

Alogliptin / metformin is also known as: Kazano

Alogliptin / metformin Pregnancy Warnings

Coadministration of aloglipitin and metformin to animals showed no treatment-related fetal abnormalities at 28 and 2 times the clinical dose of alogliptin and metformin, respectively. Alogliptin was not teratogenic when administered to animals during organogenesis at doses up to 149 and 180 times the clinical dose. In addition, no harm to the developing embryo or adverse effects on the growth and development of offspring was observed when alogliptin was given to animals at approximately 95 times the clinical exposure. Following oral administration to pregnant animals, placental transfer of alogliptin was observed. Animal fertility studies showed that alogliptin had no adverse effects on embryonic development, mating, or fertility at doses approximately 172 times the clinical dose. Animal studies showed that metformin was not teratogenic at doses representing an exposure of about 2 and 6 times the maximum recommended human dose (MRHD) of 200 mg based on body surface area. Studies showed that metformin had no effect on animal fertility at doses approximately 3 times the maximum recommended human daily dose. There are no controlled data in human pregnancy. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant.

FDA pregnancy category: B Use alogliptin-metformin only if clearly needed and benefit outweighs potential risk.

Alogliptin / metformin Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown (alogliptin and metformin) Excreted into animal milk: Yes (alogliptin and metformin) The effects in the nursing infant are unknown.

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