JARDIANCE® (Empagliflozin)
The content on this website is in relation to adult patients
Safety Profile
Adverse reactions from reported placebo-controlled studies and post-marketing experience with JARDIANCE® (empagliflozin)1
Please consult the SmPC for further details regarding adverse events, monitoring requirements, contraindications and interactions prior to initiating.
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| System organ class | Very common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1,000 to <1/100) | Rare (≥1/10,000 to <1/1,000) | Very rare (<1/10,000) |
|---|---|---|---|---|---|
| Infections and infestations | Vaginal moniliasis, vulvovaginitis,
balanitis and other genital infection* Urinary tract infection (including pyelonephritis and urosepsis)* | Necrotising fasciitis of the
perineum (Fournier’s gangrene)** | |||
| Metabolism and nutrition disorders | Hypoglycaemia (when used with sulphonylurea or insulin)* | Thirst | Ketoacidosis** | ||
| Gastrointestinal disorders | Constipation | ||||
| Skin and subcutaneous tissue disorders | Pruritus (generalised) Rash | Urticaria Angioedema | |||
| Vascular disorders | Volume depletion* | ||||
| Renal and urinary disorders | Increased urination* | Dysuria | Tubulointerstitial nephritis | ||
| Investigations | Serum lipids increased* | Blood creatinine increased/ Glomerular
filtration rate decreased* Haematocrit increased* |
- *See in section 4.8 of the SmPC for additional information.
- **See below and section 4.4 of SmpC for further details.
Indications
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 diabetes 1
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
Chronic kidney disease
JARDIANCE® is indicated in adults for the treatment of chronic kidney disease.1
Indications
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 diabetes 1
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
Chronic kidney disease
JARDIANCE® is indicated in adults for the treatment of chronic kidney disease.1
Further safety information across all indications
Empagliflozin is not recommended in severe hepatic impairment, breastfeeding, type 1 diabetes, and is contraindicated in patients with hypersensitivity to the active ingredient or any of its excipients. Empagliflozin should be avoided in pregnancy.
Ketoacidosis
- Rare cases of ketoacidosis, including life-threatening and fatal cases, have been reported in patients with diabetes mellitus treated with SGLT2 inhibitors, including JARDIANCE1
- Symptomatic or unwell patients should be assessed for ketoacidosis immediately, regardless of blood glucose level. JARDIANCE should be discontinued immediately if ketoacidosis is suspected or diagnosed. Restarting SGLT2 inhibitor treatment after ketoacidosis is not recommended unless another clear precipitating factor is identified and resolved1
- Suspend JARDIANCE for major surgical procedures or acute serious medical illnesses; Restart when ketone values are normal and the patient’s condition has stabilised1
- SGLT2 inhibitors should be used with caution in patients who may have a higher risk of ketoacidosis, e.g. those with a low beta-cell function reserve, those with restricted food intake, severe dehydration or reduced insulin doses, or those with increased insulin doses due acute medical illness, surgery or alcohol abuse1
- Refer to Section 4.4 of the SmPC for more details
Hypoglycaemia
- No increase in major hypoglycaemia was observed with empagliflozin compared to placebo as monotherapy or add-on to metformin1
- JARDIANCE® (empagliflozin) has an increased risk of hypoglycaemia when added to SU or insulin and is cited as very common in SmPC1
- Consider lowering the dose of SU or insulin to reduce the risk of hypoglycaemia1
Genital infections & UTIs
- Genital infections (e.g. thrush) were mild or moderate in intensity1 and rarely led to discontinuation2
- Temporary interruption of JARDIANCE should be considered in patients with complicated UTIs1
Dehydration
- JARDIANCE® (empagliflozin) may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension1
- Monitor your patients' volume status and adjust diuretics as appropriate. Consider temporary interruption of JARDIANCE until fluid loss is corrected.1
Necrotising fasciitis of the perineum (Fournier's gangrene)
- Fournier’s gangrene has been reported in T2D patients taking SGLT2 inhibitors as a rare (≥1/10 000 to <1/1 000) but serious event that requires urgent medical intervention and treatment.
- Advise your patients to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise.
- Discontinue JARDIANCE if Fournier’s gangrene is suspected.
- See section 4.4 of SmPC for further details.
KA: ketoacidosis; SGLT2: sodium-glucose co-transporter-2 inhibitors; SU: sulphonylurea; T2D: type 2 diabetes mellitus; UTI: urinary tract infection.
Learn more
Clinical trial
Efficacy
CV death was an exploratory endpoint in the EMPA-REG OUTCOME® study in patients with T2D and established cardiovascular disease.
JARDIANCE Initiation & Management guide for T2D, CHF and CKD
Abbreviations
CHF: chronic heart failure; CKD: chronic kidney failure; CV: cardiovascular; CVD: cardiovascular disease; T2D: type 2 diabetes mellitus.
References
- JARDIANCE® (empagliflozin) Summary of Product Characteristics (SmPC). Available at: http://www.medicines.org.uk/emc/medicine/28973.
- Kohler S, et al. 2017;34(7):1707-1726.
- Zinman B, et al. N Engl J Med. 2015;373:2117–2128.
- Inzucchi SE, et al. Circulation. 2018;138:1904–1907.
- Fitchett D, et al. J Am Coll Cardiol. 2018;71:364–367.
- Verma S, et al. Diabetes. 2020:69(Suppl 1):28-OR.
PC-GB-108852 V2
March 2024