Drug Action
Reversibly inhibits sodium-glucose co- transporter 2 (SGLT2) in the renal proximal convoluted tubule to reduce glucose reabsorption and increase urinary glucose excretion.
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Individual generic drug information
Extracted information for Empagliflozin only.
Reversibly inhibits sodium-glucose co- transporter 2 (SGLT2) in the renal proximal convoluted tubule to reduce glucose reabsorption and increase urinary glucose excretion.
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Type 2 diabetes mellitus as monotherapy (if metformin inappropriate) | Type 2 diabetes mellitus in combination with insulin or other antidiabetic drugs (if existing treatment fails to achieve adequate glycaemic control) ▶BY MOUTH ▶Adult 18–84 years: 10 mg once daily, increased to 25 mg once daily if necessary and if tolerated ▶Adult 85 years and over: Initiation not recommended
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DUE TO INTERACTIONS ▶Dose of concomitant insulin or drugs that stimulate insulin secretion may need to be reduced.
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Diabetic ketoacidosis
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Complicated urinary tract infections—consider temporarily interrupting treatment. elderly (risk of volume depletion). heart failure (limited experience). hypotension. risk of volume depletion CAUTIONS, FURTHER INFORMATION ▶Volume depletion Manufacturer advises correct hypovolaemia before starting treatment. Consider interrupting treatment if volume depletion occurs.
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NICE decisions ▶Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes (May 2016) NICE TA390 Empagliflozin (Jardiance ®) as monotherapy is recommended as an option for treating type 2 diabetes in adults for whom metformin is contra-indicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control, only if a dipeptidyl peptidase- 4 (DPP-4) inhibitor would otherwise be prescribed, and a sulfonylurea or pioglitazone is not appropriate. Patients currently receiving empagliflozin whose disease does not meet the above criteria should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta390 ▶Empagliflozin in combination therapy for treating type 2 diabetes (March 2015) NICE TA336 Empagliflozin (Jardiance ®) in a dual therapy regimen in combination with metformin is an option for the treatment of type 2 diabetes, only if: . a sulfonylurea is contra-indicated or not tolerated, or . the patient is at significant risk of hypoglycaemia or its consequences. Empagliflozin in a triple therapy regimen is an option for the treatment of type 2 diabetes in combination with: . metformin and a sulfonylurea, or . metformin and a thiazolidinedione. Empagliflozin in combination with insulin with or without other antidiabetic drugs is an option for the treatment of type 2 diabetes. Patients currently receiving empagliflozin whose disease does not meet the above criteria should have the option to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta336
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Extracted information for Empagliflozin only.
MHRA/CHM ADVICE (UPDATED APRIL 2016): RISK OF DIABETIC KETOACIDOSIS WITH SODIUM-GLUCOSE CO-TRANSPORTER 2 (SGLT2) INHIBITORS (CANAGLIFLOZIN, DAPAGLIFLOZIN OR EMPAGLIFLOZIN) A review by the European Medicines Agency has concluded that serious, life-threatening, and fatal cases of diabetic ketoacidosis (DKA) have been reported rarely in patients taking an SGLT2 inhibitor. In several cases, the presentation of DKA was atypical with patients having only moderately elevated blood glucose levels, and some of them occurred during off-label use. To minimise the risk of such effects when treating patients with a SGLT2 inhibitor, the European Medicines Agency has issued the following advice: . inform patients of the signs and symptoms of DKA, (including rapid weight loss, nausea or vomiting, abdominal pain, fast and deep breathing, sleepiness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat), and advise them to seek immediate medical advice if they develop any of these . test for raised ketones in patients with signs and symptoms of DKA, even if plasma glucose levels are near-normal . use empagliflozin with caution in patients with risk factors for DKA, (including a low beta cell reserve, conditions leading to restricted food intake or severe dehydration, sudden reduction in insulin, increased insulin requirements due to acute illness, surgery or alcohol abuse), and discuss these risk factors with patients . discontinue treatment if DKA is suspected or diagnosed . do not restart treatment with any SGLT2 inhibitor in patients who experienced DKA during use, unless another cause for DKA was identified and resolved . interrupt SGLT2 inhibitor treatment in patients who are hospitalised for major surgery or acute serious illnesses; treatment may be restarted once the patient’s condition has stabilised MHRA/CHM ADVICE: SGLT2 INHIBITORS: MONITOR KETONES IN BLOOD DURING TREATMENT INTERRUPTION FOR SURGICAL PROCEDURES OR ACUTE SERIOUS MEDICAL ILLNESS (MARCH 2020) New recommendations have been issued following a European review of peri-operative diabetic ketoacidosis in patients taking SGLT2 inhibitors. Healthcare professionals are advised to monitor ketone levels during SGLT2 inhibitor treatment interruption in patients who have been hospitalised for major surgery or acute serious illness—measurement of blood ketone levels is preferred to urine. Treatment may be restarted once ketone levels are normal and the patient’s condition has stabilised. MHRA/CHM ADVICE: SGLT2 INHIBITORS: REPORTS OF FOURNIER’S GANGRENE (NECROTISING FASCIITIS OF THE GENITALIA OR PERINEUM) (FEBRUARY 2019) Fournier’s gangrene, a rare but serious and potentially life-threatening infection, has been associated with the use of sodium-glucose co-transporter 2 (SGLT2) inhibitors. If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and urgently start treatment (including antibiotics and surgical debridement). Patients should be advised to seek urgent medical attention if they experience severe pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise—urogenital infection or perineal abscess may precede necrotising fasciitis.
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→Appendix 1: empagliflozin
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▶Common or very common Balanoposthitis. hypoglycaemia (in combination with insulin or sulfonylurea). increased risk of infection. skin reactions. thirst. urinary disorders. urosepsis ▶Uncommon Hypovolaemia ▶Rare or very rare Diabetic ketoacidosis (discontinue immediately) ▶Frequency not known Angioedema. Fournier’s gangrene (discontinue and initiate treatment promptly)
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Manufacturer advises avoid—toxicity in animal studies.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises avoid in severe impairment—no information available.
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Avoid initiation if eGFR below 60 mL/minute/1.73 m2. Avoid if eGFR is persistently below 45 mL/minute/1.73 m2. Dose adjustments Reduce dose to 10 mg once daily if eGFR falls persistently below 60 mL/minute/1.73 m2.
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Determine renal function before treatment and before initiation of concomitant drugs that may reduce renal function, then at least annually thereafter.
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Extracted information for Empagliflozin only.
There can be variation in the licensing of Endocrine system different medicines containing the same drug. Tablet ▶Jardiance (Boehringer Ingelheim Ltd) Empagliflozin 10 mg Jardiance 10mg tablets | 28 tablet P £36.59 DT = £36.59 Empagliflozin 25 mg Jardiance 25mg tablets | 28 tablet P £36.59 DT = £36.59
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Extracted information for Empagliflozin only.
Patients should be informed of the signs and symptoms of diabetic ketoacidosis, see MHRA advice.
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Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
10 mg once daily, increased to 25 mg
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 766
First line only; read the complete Indications and dose section above.
Initiation not recommended
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 766