Generic Name and Formulations:
Ertugliflozin 5mg, 15mg; tabs.
Merck & Co., Inc.
Indications for STEGLATRO:
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 mellitus or diabetic ketoacidosis.
Take in the AM (with or without food). Initially 5mg once daily; if tolerated and need additional glycemic control; may increase to max 15mg once daily. Renal impairment: if eGFR 30–<60mL/min/1.73m2: do not initiate; if persistently between 30–<60mL/min/1.73m2: continued use is 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, low systolic BP, or on 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. Consider factors that may predispose to acute kidney injury including hypovolemia, chronic renal insufficiency, CHF, and on 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 (including urosepsis, pyelonephritis); monitor and treat if occurs. Before initiating, consider factors that may increase risk of amputation (eg, history of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers). Monitor for infections, new pain/tenderness, sores or ulcers of the lower limbs; discontinue if occur. Monitor for increases in LDL-C; treat if occur. Severe hepatic impairment: not recommended. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.
Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. Possible hypotension with concomitant diuretics; monitor. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Genital mycotic infections (esp. females), UTIs, headache, vaginal pruritus, increased urination, nasopharyngitis, back pain, weight decrease, thirst.
Tabs—30, 90, 500