Adult: As monotherapy or in combination with other antidiabetic agents: As an adjunct to diet and exercise: 5 mg once daily in the morning, may be increased to 15 mg once daily, if necessary.
What are the brands available for Ertugliflozin in Malaysia?
Steglatro
Renal Impairment
eGFR <45 mL/min/1.73 m2: Not recommended. In some countries, ertugliflozin should be discontinued when eGFR is persistently <30 mL/min/1.73m2 or CrCl is persistently <30 mL/min and should not be used in patients with severe renal impairment, ESRD, and patients on dialysis. Recommendations may vary between countries (refer to specific local guidelines).
Hepatic Impairment
Severe: Not recommended.
Administration
Ertugliflozin tab: May be taken with or without food.
Special Precautions
Patient with history of hypotension; conditions that may lead to fluid loss (e.g. gastrointestinal illness); risk factors for diabetic ketoacidosis (e.g. low β-cell function reserve, history of pancreatitis or pancreatic surgery, conditions leading to restricted food intake or severe dehydration, reduction or missed insulin doses, increased insulin requirements due to acute illness, surgery, or alcohol abuse); risk factors for acute kidney injury (e.g. hypovolaemia, chronic renal insufficiency, heart failure); history of genital mycotic infections. Not indicated in patients with diabetic ketoacidosis or type 1 diabetes mellitus. Hospitalised and patients undergoing surgery. Renal and severe hepatic impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Genital mycotic infections (e.g. vulvovaginal mycotic infection, vulvovaginal candidiasis, vulvovaginitis, candida balanitis, balanoposthitis); increased risk of bone fractures and lower limb amputation (particularly of the toe and foot); acute kidney injury, UTI (including urosepsis and pyelonephritis); symptomatic hypotension, volume depletion. Gastrointestinal disorders: Thirst. Investigations: Decreased eGFR; increased blood creatinine, BUN, LDL-C, and haemoglobin; weight decreased. Metabolism and nutrition disorders: Hypoglycaemia. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache. Renal and urinary disorders: Increased urination, dysuria. Reproductive system and breast disorders: Vulvovaginal pruritus. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis. Potentially Fatal: Rarely, diabetic ketoacidosis, necrotising fasciitis of the perineum (Fournier's gangrene).
Monitoring Parameters
Correct volume depletion prior to treatment initiation. Obtain renal function at baseline and periodically during treatment. Monitor blood glucose; HbA1c (at least twice yearly in patients with stable glycaemic control; quarterly in patients not meeting treatment goals or with therapy change); volume status (e.g. blood pressure, electrolytes, haematocrit). Monitor for signs and symptoms of genital mycotic infections and UTI, necrotising fasciitis (e.g. fever and malaise along with genital or perianal pain, tenderness, erythema, swelling); lower limb and feet sores, ulcers or infection; ketoacidosis (e.g. nausea, vomiting, abdominal pain, shortness of breath), and hypersensitivity reactions.
Drug Interactions
Increased risk of hypoglycaemia with insulin and insulin secretagogues (e.g. sulfonylureas). Increased risk of dehydration and hypotension with diuretics. May decrease serum lithium concentrations.
Lab Interference
May interfere with 1,5-anhydroglucitol (1,5-AG) assay. May lead to a false-positive result for urine glucose test.
Action
Description: Mechanism of Action: Ertugliflozin selectively and reversibly inhibits sodium-glucose co-transporter 2 (SGLT2) in the proximal renal tubules, reducing the reabsorption of filtered glucose and lowering the renal threshold for glucose. This action promotes the urinary excretion of glucose, thereby reducing plasma glucose concentrations. Pharmacokinetics: Absorption: Bioavailability: Approx 100%. Time to peak plasma concentration: 1 hour (fasting); 2 hours (with high-fat, high-calorie meal). Distribution: Plasma protein binding: 93.6%. Metabolism: Extensively metabolised via O-glucuronidation by UGT1A9 and UGT2B7 into inactive metabolites; to a lesser extent by CYP enzymes. Excretion: Via urine (50.2%; 1.5% as unchanged drug); faeces (40.9%; 33.8% as unchanged drug) Elimination half-life: 16.6 hours.
Chemical Structure
Ertugliflozin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 44814423, Ertugliflozin. https://pubchem.ncbi.nlm.nih.gov/compound/Ertugliflozin. Accessed Mar. 27, 2025.
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