Adult: As monotherapy (if metformin is inappropriate due to intolerance) or in combination with insulin or other antidiabetic agents in addition to diet and exercise to improve glycaemic control: Initially, 10 mg once daily in the morning, may be increased to 25 mg once daily if necessary and tolerated. Max: 25 mg daily. Elderly: ≥85 years Not recommended.
Oral Heart failure
Adult: Risk reduction of CV mortality and hospitalisation: 10 mg once daily in the morning. Elderly: ≥85 years Not recommended.
Oral Cardiovascular risk reduction
Adult: Risk reduction of CV mortality in patients with type 2 diabetes mellitus and established CV disease, in conjunction with other measures to decrease CV risk in line with current standard of care: Initially, 10 mg once daily in the morning, may be increased to 25 mg once daily if necessary and tolerated. Max: 25 mg daily. Elderly: ≥85 years Not recommended.
Renal Impairment
Type 2 diabetes mellitus; Cardiovascular risk reduction:
eGFR <60 mL/min/1.73 m2: Do not initiate therapy or reduce to 10 mg once daily in patients already taking empagliflozin; eGFR <30 mL/min/1.73 m2, ESRD, patient on dialysis: Contraindicated.
Heart failure:
In patients with or without type 2 diabetes mellitus: eGFR ≥20 mL/min/1.73 m2: 10 mg once daily; eGFR <20 mL/min/1.73 m2: Not recommended.
Hepatic Impairment
Severe: Not recommended.
Administration
May be taken with or without food.
Contraindications
Severe renal impairment (eGFR <30 mL/min/1.73 m2) when used for type 2 diabetes mellitus and CV risk reduction; ESRD and patients on dialysis. Lactation.
Special Precautions
Patient with CV disease, history of hypotension, risk factors for acute kidney injury (e.g. hypovolaemia, chronic kidney insufficiency), risk factors that may predispose to ketoacidosis (e.g. low β-cell function reserve, pancreatic disorders suggesting insulin deficiency such as history of pancreatitis or pancreatic surgery, dose reduction of insulin, caloric restriction, alcohol abuse, acute febrile illness, severe dehydration); history of genitourinary fungal infections, risk factors for amputation (e.g. prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers). Uncircumcised males. Not indicated for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis. Consider temporary treatment discontinuation at least 3 days prior to surgery. Renal and severe hepatic impairment. Elderly. Pregnancy.
Adverse Reactions
Significant: Bone fractures, lower limb amputation (mainly of the toe); genitourinary fungal infections (e.g. vulvovaginal mycotic infection, vulvovaginal candidiasis, vulvovaginitis, candida balanitis, balanoposthitis), complicated UTI (including urosepsis and pyelonephritis); acute kidney injury, including acute interstitial nephritis, acute renal failure, increased serum creatinine, and decreased eGFR; hypovolaemia, including symptomatic hypotension, syncope, and dehydration; hepatic injury, hypersensitivity reactions (e.g. angioedema, asthma, rash, urticaria), increased haematocrit. Gastrointestinal disorders: Nausea, constipation. Investigations: Increased serum lipids. Metabolism and nutrition disorders: Thirst. Musculoskeletal and connective tissue disorders: Arthralgia. Renal and urinary disorders: Increased urination, dysuria. Skin and subcutaneous tissue disorders: Generalised pruritus. Potentially Fatal: Rarely, diabetic ketoacidosis, necrotising fasciitis of the perineum (Fournier's gangrene).
Adhere to the routine preventive foot care advised by your doctor.
Monitoring Parameters
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, haematocrit, electrolytes). Obtain renal function at baseline and periodically during therapy. Assess for signs of diabetic ketoacidosis, volume depletion, UTI, and genital mycotic infections. Confirm diagnosis of ketoacidosis by directly measuring blood ketones and arterial pH.
Drug Interactions
Increased risk of hypoglycaemia with insulin and insulin secretagogues (e.g. sulfonylureas); when combined with empagliflozin, a lower dose of insulin or insulin secretagogue may be required. May increase the risk of volume depletion, dehydration, and hypotension with diuretics (e.g. thiazide, loop diuretics).
Lab Interference
May cause a positive result for urine glucose tests. May interfere with 1,5-anhydroglucitol (1,5-AG) assay.
Action
Description: Mechanism of Action: Empagliflozin is a potent, selective, and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2), the main site of filtered glucose reabsorption in the renal proximal convoluted tubules. Inhibition of SGLT2 reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose resulting in increased urinary glucose excretion, thereby decreasing plasma glucose concentration. Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Time to peak plasma concentration: Approx 1.5 hours. Distribution: Volume of distribution: 73.8 L. Plasma protein binding: Approx 86%. Metabolism: Metabolised primarily via glucuronidation by uridine diphosphate glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9 to minor metabolites. Excretion: Via urine (54.4%; 50% as unchanged drug); faeces (41.2%, mainly as unchanged drug). Apparent terminal elimination half-life: 12.4 hours.
Chemical Structure
Empagliflozin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 11949646, Empagliflozin. https://pubchem.ncbi.nlm.nih.gov/compound/11949646. Accessed Aug. 25, 2022.
A10BK03 - empagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
References
Anon. Empagliflozin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/07/2022.Boehringer Ingelheim (N.Z.) Limited. Jardiance 10 mg and 25 mg Film Coated Tablets data sheet 19 November 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 07/07/2022.Buckingham R (ed). Empagliflozin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/07/2022.FDA Approves Treatment for Wider Range of Patients with Heart Failure. U.S. FDA. https://www.fda.gov. Accessed 07/07/2022.Jardiance 10 mg and 25 mg Film-coated Tablets (Boehringer Ingelheim [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/07/2022.Jardiance 10 mg Film-coated Tablets (Boehringer Ingelheim International GmbH). MHRA. https://products.mhra.gov.uk. Accessed 07/07/2022.Jardiance Tablet, Film Coated (Boehringer Ingelheim Pharmaceuticals, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/07/2022.Joint Formulary Committee. Empagliflozin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/07/2022.
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