Steglujan(Ertugliflozin and Sitagliptin Tablets)
STEGLUJAN Rx
Generic Name and Formulations:
Ertugliflozin, sitagliptin; 5mg/100mg, 15mg/100mg; tabs.
Company:
Merck & Co., Inc.
Select therapeutic use: Diabetes
RECENT UPDATES Monograph added.
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.
Adult:
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.
Children:
<18yrs: not established.
Contraindications:
Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or dialysis.
Warnings/Precautions:
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, eva luate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). eva luate 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. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; eva luate 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. 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.
Interactions:
Consider a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. Hypotension with concomitant diuretics. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control. Concomitant digoxin; monitor.
Pharmacological Class:
Sodium-glucose co-transporter 2 (SGLT2) inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor.
Adverse Reactions:
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.
Generic Availability:
NO
How Supplied:
Tabs—30, 90, 500 |
