JARDIANCE® (Empagliflozin)

The content on this website is in relation to adult patients

 

Safety Profile

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 classVery 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 disordersHypoglycaemia
(when used with sulphonylurea or insulin)*		ThirstKetoacidosis**  
Gastrointestinal disorders Constipation   
Skin and subcutaneous tissue disorders Pruritus (generalised)
Rash		Urticaria
Angioedema		  
Vascular disordersVolume depletion*    
Renal and urinary disorders Increased urination*Dysuria Tubulointerstitial nephritis
Investigations Serum lipids increased*Blood creatinine increased/ Glomerular filteration 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.
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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.

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

  • Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in patients treated with JARDIANCE® (empagliflozin) (10 mg: 4.0%, 25 mg: 3.9%) compared to placebo (1.0%). These infections were reported more frequently in females treated with JARDIANCE® (empagliflozin) compared to placebo, and the difference in frequency was less pronounced in males. The genital tract infections were mild or moderate in intensity.1

Urinary tract infections

  • The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with JARDIANCE® (empagliflozin) 25 mg and placebo (7.0% and 7.2%) and higher in JARDIANCE® (empagliflozin) 10 mg (8.8%). Similar to placebo, urinary tract infection was reported more frequently for JARDIANCE® (empagliflozin) in patients with a history of chronic or recurrent urinary tract infections. The intensity (mild, moderate, severe) of urinary tract infection was similar in patients treated with JARDIANCE® (empagliflozin) and placebo. Urinary tract infection was reported more frequently in females treated with JARDIANCE® (empagliflozin) compared to placebo; there was no difference in males. Temporary interruption of JARDIANCE® (empagliflozin) should be considered in patients with complicated urinary tract infections.1

Volume depletion

  • The overall frequency of volume depletion was similar in patients treated with JARDIANCE® (empagliflozin) (10 mg: 0.6%, 25 mg: 0.4%) and placebo (0.3%). The frequency of volume depletion events was increased in patients 75 years and older treated with JARDIANCE® (empagliflozin) 10 mg (2.3%) or JARDIANCE® (empagliflozin) 25 mg (4.3%) compared to placebo (2.1%).1
  • Based on the mode of action of SGLT2 inhibitors, osmotic diuresis accompanying glucosuria may lead to a modest decrease in blood pressure. Therefore, caution should be exercised in patients for whom a JARDIANCE‑induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti‑hypertensive therapy with a history of hypotension or patients aged 75 years and older.

Increased urination

  • Increased urination was observed at higher frequencies in patients treated with JARDIANCE® (empagliflozin 10 mg: 3.5%, empagliflozin 25 mg: 3.3%) compared to placebo (1.4%). Increased urination was mostly mild or moderate in intensity.1

Ketoacidosis

  • Rare cases of ketoacidosis, including life-threatening and fatal cases, have been reported in patients with diabetes mellitus treated with SGLT2 inhibitors, and uncommon (≥1/1,000 to <1/100) with JARDIANCE. In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14mmol/l (250mg/dl). It is not known if ketoacidosis is more likely to occur with higher doses of JARDIANCE.
  • In patients where ketoacidosis is suspected or diagnosed, treatment with JARDIANCE should be discontinued immediately.

Elderly

  • The effect of JARDIANCE on urinary glucose excretion is associated with osmotic diuresis, which could affect the hydration status. Patients aged 75 years and older may be at an increased risk of volume depletion. Therefore, special attention should be given to their volume intake in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).

Necrotising fasciitis of the perineum (Fournier’s gangrene)

  • Cases of necrotising fasciitis of the perineum, (also known as Fournier’s gangrene), have been reported in female and male patients with diabetes mellitus taking SGLT2 inhibitors. This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
  • Patients should be advised 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.

ACE inhibitors: angiotensin-converting enzyme inhibitor; SGLT2: sodium-glucose cotransporter 2; SU: sulphonylurea; UTI: urinary tract infection.

JARDIANCE® (empagliflozin) 25 mg is not licensed for use in patients with heart failure.

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JARDIANCE® (empagliflozin) clinical studies

Clinical studies

JARDIANCE efficacy data vs placebo from pre-specified analysis of the primary outcome (composite of first HHF or CV death) of EMPEROR-Preserved trial in the older patients with chronic heart failure that you see and treat in the clinical practice.6
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JARDIANCE® (empagliflozin) efficacy trials

JARDIANCE® efficacy data across the LVEF spectrum

JARDIANCE demonstrated superiority in reducing the risk of CV death or HHF composite in patients on top of standard of care (HFrEF) or background therapy (HFpEF) vs placebo.7,8
This was the primary composite outcome from the EMPEROR-Reduced and EMPEROR-Preserved Trials.7,8
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Initiation guide

JARDIANCE Initiation & Management guide for T2D, CHF and CKD

Key considerations when initiating or managing your patient with symptomatic chronic heart failure on JARDIANCE
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Abbreviations

CHF: chronic heart failure; CKD: chronic kidney failure; CV: cardiovascular; HHF: hospitalisation for heart failure; HFpEF: heart failure with preserved ejection fraction; HFrEF: heart failure with reduced ejection fraction; LVEF: left ventricular ejection fraction; T2D: type 2 diabetes mellitus.

References

References
  1. JARDIANCE® (empagliflozin) Summary of Product Characteristics (SmPC). Available at: http://www.medicines.org.uk/emc/medicine/28973.
  2. Kohler S, Zeller C, Iliev H, Kaspers S. Adv Ther. 2017;34(7):1707–1.
  3. Verma S, Leiter LA, Sharma A, et al. Diabetes. 2020:69(Supplement 1):1–7.
  4. Haring HU, Merker L, Seewaldt-Becker E et al. Diabetes Care 2014;37(6):1650–1659.
  5. Data on file. Boehringer Ingelheim.
  6. Böhm M et al. J Am Coll Cardiol. 2022;80(1):1–18.
  7. Packer M et al. N Engl J Med. 2020;383(15):1413–1424.
  8. Anker SD et al. N Engl J Med. 2021;385(16):1451–1461.

PC-GB-108860 V2

March 2024

Reporting adverse events

Adverse events should be reported. Reporting form and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone).

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