Generic Name and Formulations:
Dapagliflozin 5mg, 10mg; tabs.
Indications for FARXIGA:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations Of use:
Not for treating type 1 diabetes or diabetic ketoacidosis.
Take in the AM. Initially 5mg once daily; if tolerated and need additional glycemic control; may increase to 10mg once daily. Renal impairment: if eGFR <60mL/min/1.73m2: do not initiate; if persistently between 30–<60mL/min/1.73m2: not recommended.
<18yrs: not established.
Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or on dialysis.
Correct volume depletion before initiating. Monitor for signs/symptoms of hypotension (esp. elderly, patients with renal impairment, or on loop diuretics). 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). Evaluate renal function prior to starting and monitor periodically thereafter. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Increased risk of genital mycotic infections or UTIs; monitor and treat if occurs. Monitor for increases in LDL-C; treat if occur. Active bladder cancer: do not use. Severe hepatic impairment. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.
Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. Hypotension with concomitant loop diuretics. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Female genital mycotic infections, nasopharyngitis, UTIs (may be serious), back pain, increased urination; hypersensitivity reactions, volume depletion, renal impairment, ketoacidosis, urosepsis, pyelonephritis.