Safety and Tolerability

SAFETY AND TOLERABILITY OF JARDIANCE® (EMPAGLIFLOZIN) A SGLT2 INHIBITOR FOR THE TREATMENT OF TYPE 2 DIABETES MELLITUS1

Jardiance® is a sodium-glucose co-transporter 2 inhibitor that works independently of β-cell function and insulin resistance1.

A total of 13 076 patients with type 2 diabetes were treated in placebo controlled, double-blind clinical studies of 18 up to 24 weeks, to evaluate the safety of empagliflozin1.

The overall incidence of adverse events leading to discontinuation with Jardiance® was similar to placebo1.

JARDIANCE® SAFETY AND TOLERABILITY PROFILE

Jardiance

INCIDENCE OF URINARY TRACT AND GENITAL INFECTIONS WITH JARDIANCE® vs. PLACEBO2

The incidence of both genital and urinary tract infections was higher in female patients than male patients2.

The majority of patients who experienced a urinary tract infection or genital infection reported a single event which was characterised as mild2.

LOW INCIDENCE OF HYPOGLYCAEMIA WITH JARDIANCE®1,3,4

When Jardiance® was taken as monotherapy or in combination with metformin the incidences of hypoglycaemia were similar to that of the placebo3,4.

Insulin and insulin secretagogues are known to cause hypoglycaemia. The risk of hypoglycaemia is increased when Jardiance® is used in combination with insulin or insulin secretagogues (e.g. sulphonylurea)1.

OTHER SIDE-EFFECTS WITH JARDIANCE®1


System Organ ClassVery common
( ≥ 1 / 10)
Common
( ≥ 1 / 100, < 1 / 10 )
Uncommon
( ≥ 1 / 1000, < 1 / 100 )
Metabolism & nutrition disorders Weight loss
Increased serum lipid
 
Vascular disorders  Volume depletion (hypotension & dehydration)
Skin & subcutaneous tissue disorders Pruritis 
Renal & urinary disordersGlycosuriaIncreased urinationDysuria Ketonuria Fluid volume depletion Increased blood creatinine
Decreased glomerular filtration rate
Gastrointestinal disorders Thirst 
Investigations  Increased haematocrit Increased blood creatinine
Decreased glomerular filtration rate

CONTRAINDICATIONS TO JARDIANCE® USE1

  • Hypersensitivity to empagliflozin or any of the excipients of Jardiance1
  • Treatment of type 1 diabetes mellitus1
  • Treatment of ketoacidosis
  • Moderate and severe renal impairment (creatinine clearance < 60 mL / min), end state renal disease or dialysis
  • Pregnancy and lactation

JARDIANCE® INDICATIONS1

Jardiance® tablets are indicated for adults with type 2 diabetes mellitus:

  • As an adjunct to diet and exercise to improve glycaemic control in adults1,
  • In combination with glucose-lowering medicines, including metformin, athiazolidinedione, a Sulphonylurea, a DPP4 inhibitor, or insulin, when these togetherwith diet and exercise, do not provide adequate glycaemic control1.

REFERENCES:

  1. Jardiance® approved package insert. Date of publication 12 December 2017
  2. Kim g, Gerich J, Salsali A et al. Empagliflozin increases genital infections but not urinary tract infections (UTIs) in pooled data from four pivotal phase III trials. [Unpublished poster]. Poster 74-LB presented at 73rd Scientific Session of American Diabetes Association; June 21-25,2013; Chicago, IL
  3. Roden M, Weng J, Eilbracht J et al on behalf of the EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol 2013;1:208-219
  4. Häring H-U, Merker L, Seewaldt-Becker E et al. Empagliflozin as add-on to metformin for 24 weeks improves glycaemic control in patients with type 2 diabetes (T2DM). [Unpublished poster]. Poster 1092-P presented at American Diabetes Association (ADA) 73rd Scientific Sessions, 21 – 25 June 2013. Chicago, USA.

S4 JARDIANCE® 10 mg: Each film-coated tablet contains empagliflozin 10 mg. Reg. No. 48/21.2/1380.
S4 JARDIANCE® 25 mg: Each film-coated tablet contains empagliflozin 25 mg. Reg. No. 48/21.2/0411.
For full prescribing information refer to the package insert approved by the Medicines Regulatory Authority.
BI Ref. No. PC-ZA-100208. 03-2022