Indications for: STEGLUJAN
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin are appropriate.
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis. Not studied in patients with a history of pancreatitis.
Swallow whole. Take in the AM. Initially 5mg/100mg once daily; if tolerated and need additional glycemic control; may increase to max 15mg/100mg 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 dialysis.
Correct volume depletion and assess for volume contraction before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, 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). Consider temporarily discontinuing prior to scheduled surgery (for ≥4 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). 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. Consider risks/benefits in those with 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. Monitor for genital mycotic infections, UTIs (including urosepsis, pyelonephritis), increases in LDL-C; treat as appropriate. Before initiating, consider factors that may increase risk of amputation (eg, history of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers). Monitor for infection (including osteomyelitis), new pain/tenderness, sores or ulcers of the lower limbs; discontinue if occur. History of angioedema to other DPP-4 inhibitors. Severe hepatic impairment: not recommended. Elderly. Pregnancy (avoid during 2nd & 3rd trimesters). Nursing mothers: not recommended.
Sodium-glucose co-transporter 2 (SGLT2) inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor.
May need a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) 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. Concomitant digoxin; monitor.
Genital mycotic infections (esp. females), upper RTIs, nasopharyngitis, headache, UTIs, vaginal pruritus, increased urination, back pain, weight decrease, thirst; hypotension, hypoglycemia, pancreatitis, ketoacidosis, renal impairment, increases in LDL-C, possible severe and disabling arthralgia, bullous pemphigoid; rare: Fournier's gangrene.
Generic Drug Availability:
Tabs—30, 90, 500