JARDIANCE® (Empagliflozin)

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Impact of diabetes on the effects of SGLT2 inhibitors on kidney outcomes⁵

In addition to the established cardiovascular benefits of SGLT2 inhibitors, randomised data support their use for modifying risk of kidney disease progression and acute kidney injury, not only in patients with type 2 diabetes at high cardiovascular risk, but also in patients with chronic kidney disease or heart failure irrespective of diabetes status, primary kidney disease, or kidney function of patients included in the respective SGLT2 inhibitor clinical trials.⁵

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The only dedicated SGLT2i trial in CKD including patients across the full UACR spectrum.**^2-4

JARIDANCE reduced risk of kidney disease progression^† or CV death in a broad patient population* vs placebo.²

Adverse reactions from reported placebo-controlled studies and post-marketing experience with JARDIANCE®.

JARDIANCE® (empagliflozin) is simple to initiate at 10 mg dosing across all indications.¹

Helpful resources supporting you every step of the way.

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JARDIANCE® (empagliflozin) mechanism of action

SGLT2 inhibitors have multiple effects on metabolism and fluid balance in the Cardio-Renal-Metabolic (CRM) interconnected system.¹

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Helpful resources supporting you every step of the way

JARDIANCE® (empagliflozin) chronic kidney disease digital patient booklet

Answering frequently asked questions about CKD and JARDIANCE.

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JARDIANCE® (empagliflozin) initiation and management guide

Key considerations when initiating or managing your patient with chronic kidney disease on JARDIANCE.

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Licensed indications for use

Chronic Kidney Disease

JARDIANCE® is indicated in adults for the treatment of chronic kidney disease.¹

Type 2 diabetes

JARDIANCE® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

as monotherapy when metformin is considered inappropriate due to intolerance
in addition to other medicinal products for the treatment of diabetes¹

According to the 5.1 section of the SmPC, both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.¹

Heart failure

JARDIANCE® is indicated in adults for the treatment of symptomatic chronic heart failure.¹

Adverse reactions

JARDIANCE (empagliflozin) adverse reactions reported from placebo-controlled trials and post-marketing experience across all indications, as stated in the SmPC

Very common (≥1/10): Hypoglycaemia (when used with sulfonylurea or insulin), volume depletion
Common (≥1/100 to <1/10): UTIs, GTIs, thirst, constipation, pruritus, rash, increased urination, serum lipids increase
Uncommon (≥1/1000 to <1/100): Ketoacidosis, urticaria, angioedema, dysuria, blood creatinine increased/glomerular filtration rate decreased, haematocrit increased
Rare (≥10,000 to <1,1000): Necrotising fasciitis of the perineum (Fournier’s gangrene)
Very rare (<1/10,000): Tubulointerstitial nephritis

Please consult the SmPC for further details regarding adverse events, monitoring requirements and interactions prior to prescribing JARDIANCE.

* EMPA-KIDNEY included patients with a wide range of underlying causes of CKD, many with co-morbidities across the spectrum of cardiovascular, kidney, or metabolic conditions. EMPA-KIDNEY included adult patients with an eGFR ≥20 to <45mL/min/1.73m² or an eGFR ≥45 to <90mL/min/1.73m² with a UACR ≥200mg/g, at risk of CKD progression.

^† Kidney disease progression defined as: adults with kidney function loss (sustained reduction of ≥40% eGFR decline, sustained eGFR <10mL/min/1.73m²), end stage kidney disease (initiation of chronic dialysis or kidney transplant), or renal death.

** Full UACR spectrum defined by KDIGO categories A1 to A3.

Abbreviations

BI: Boehringer Ingelheim; CHF: chronic heart failure; CKD: chronic kidney failure; CV: cardiovascular; eGFR: estimated glomerular filtration rate; KA: ketoacidosis; SGLT2: sodium-glucose co-transporter-2; SmPC: summary of product characteristics; T2D: type 2 diabetes mellitus; UACR: urine albumin-creatinine ratio; UTI: urinary tract infection.

References

JARDIANCE® (empagliflozin) Summary of Product Characteristics (SmPC). Available at: http://www.medicines.org.uk/emc/medicine/28973.
Herrington WG, et al. N Engl J Med. 2023;388(2):117-127. (EMPA-KIDNEY results and the publication’s Supplementary Appendix).
Heerspink H, et al. N Engl J Med. 2020;383:1436-1446.
Perkovic V, et al. N Engl J Med. 2019;380:2295-2306.
Impact of Diabetes on the Effects of Sodium Glucose Co-Transporter-2 Inhibitors on Kidney Outcomes: Collaborative Meta-Analysis of Large Placebo-Controlled Trials. Lancet 2022;400:1788-1801.
National Institute for Health and Care Excellence (NICE) 2023. Empagliflozin for treating chronic kidney disease. Technology Appraisal Guidance TA942. Available from: https://www.nice.org.uk/guidance/ta942.

PC-GB-108939 V3

June 2024

JARDIANCE® (Empagliflozin)