If you are:
Possibly Safe: INSUFFICIENT HUMAN DATA AVAILABLE
FDB Only When Necessary: INSUFFICIENT HUMAN DATA AVAILABLE
Precaution: NO KNOWN INFANT ADVERSE OUTCOMES; MFR ADVISES CAUTION
Precaution: INSUFFICIENT HUMAN DATA; EXCRETED IN RATS
An adult over 60:
management or monitoring precaution: Renal-Begin at the low end of the dosing range for CrCL<51 mL/min. Cardiovascular-As of 02/11/14, the FDA is investigating a possible association with use of saxagliptin and heart failure. "Preliminary" data is presented in NEJM 2013;369:1317-1326. Monitor patients for new onset or worsening heart failure.
management or monitoring precaution: Renal-Increased risk for drug induced metabolic acidosis with increasing age and declining renal function. Metformin is contraindicated in patients with an eGFR below 30 mL/min. Cardiovascular-Heart failure patients may have a higher risk for metabolic acidosis.
Giving saxagliptin-metformin Tablet, Extended Release Multiphase 24 hr (Tablet, ER hr) to a child under 12:
management or monitoring precaution: Safety and efficacy not established.
management or monitoring precaution: Rare reports of cholestatic and hepatocellular injury. No pediatric safety/efficacy of extended release dose form.