Indications for: QTERN
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
Not recommended in those with type 1 diabetes; may increase risk of diabetic ketoacidosis.
Swallow whole. Take in the AM. Not currently treated with dapagliflozin: initially 5mg/5mg once daily; if tolerated and need additional glycemic control, may increase to 10mg/5mg once daily.
<18yrs: not established.
Moderate to severe renal impairment (eGFR <45mL/min/1.73m2), ESRD, or on dialysis.
Correct volume depletion before initiating. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Monitor for signs/symptoms of pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs; treat as appropriate. History of angioedema to other DPP-4 inhibitors. Severe hepatic impairment. Elderly. Pregnancy (avoid during 2nd & 3rd trimesters). Nursing mothers: not recommended.
Sodium-glucose co-transporter 2 (SGLT2) inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor.
Concomitant strong CYP3A4/5 inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin): not recommended. May need a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. Greater potential for volume depletion with concomitant diuretics. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Upper RTI, UTI, dyslipidemia, headache, diarrhea, back pain, arthralgia; genital mycotic infections (esp. females), hypersensitivity reactions, pancreatitis, heart failure, hypotension, ketoacidosis, acute kidney injury, urosepsis, pyelonephritis, bladder cancer, possible severe and disabling arthralgia, bullous pemphigoid; rare: Fournier's gangrene.
Generic Drug Availability:
Tabs—30, 90, 500