Pharmacy Diabetes

sglt-Empagliflozin

Empagliflozin

  • Jardiance 10 mg film-coated tablets contains 10 mg empagliflozin.
  • Jardiance 25 mg film-coated tablets contains 25 mg empagliflozin.

  • Glycaemic management as a treatment for type 2 diabetes
    - As monotherapy as an adjunct to healthy eating and physical activity in individuals where metformin is otherwise indicated but was not tolerated.

    - As add-on combination therapy. In combination with other glucose lowering medicinal products including insulin, when these, together with healthy eating and healthy eating, do not provide adequate glycaemic management.

  • Prevention of cardiovascular death.
    - Jardiance is indicated in individuals with type 2 diabetes and established cardiovascular disease to reduce the risk of cardiovascular death. To prevent cardiovascular deaths, Jardiance should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

For the latest PBS indications for empagliflozin please see

https://www.pbs.gov.au/pbs/search?analyse=false&term=EMPAGLIFLOZIN&search-type=medicines

  • The recommended starting dose of Jardiance is 10 mg once daily, without regard to food. If further glycaemic management is required, dose should be increased to 25mg once a day.
  • Renal impairment - Renal function should be accessed prior to initiation of empagliflozin and periodically thereafter.
    No dose adjustment is required for individuals with eGFR≥ 45 mL/min/1.73 m.
    Jardiance is contraindicated with persistent eGFR< 45 mL/min/1.73 m
    Note: Diabetes MedsCheck, annual cycle of care referral to appropriate health care professionals to ensure people with diabetes are aware of their renal function and what to do if this drops)
  • Hepatic impairment - No dose adjustment is required.

  • No dosage adjustment is required.

  • Hypersensitivity to dapagliflozin or any active ingredient
  • Type 1 diabetes
  • Diabetic ketoacidosis
  • Jardiance is contraindicated with persistent eGFR< 45 mL/min/1.73 m

  • Ketoacidosis in individuals with diabetes - There have been reports of ketoacidosis, including DKA (Diabetic ketoacidosis), with empagliplozin and other sodium-glucose cotransporter 2 (SGLT2) inhibitors. Those treated with Jardiance who present with signs and symptoms consistent with ketoacidosis (including nausea, vomiting, abdominal pain, malaise, and shortness of breath, should be assessed for ketoacidosis (even if blood glucose levels are within the healthy range). If ketoacidosis is suspected, Jardiance should be ceased, and prompt treatment initiated. Restarting SGLT2 inhibitor treatment in those with previous DKA while on a SGLT2 inhibitor is not recommended.
    Note: Diabetes MedsCheck with referral to healthcare team especially credentialled diabetes educator for counselling on monitoring of ketones and what to do should ketones present in elevated numbers.
  • Surgery - Jardiance should be ceased prior to major surgery. Those scheduled for non-urgent surgery who have not ceased dapagliflozin should be assessed and consideration should be given to postponing the procedure. Treatment with Jardiance maybe restarted once oral intake is normal.
    Note: Diabetes MedsCheck with education on sick day management with referral to health cate team.
  • Necrotising fasciitis of the perineum (Fournier's gangrene) - A rare, but serious and potentially life-threatening necrotising infection, have been reported in female and male patients with diabetes mellitus treated with SGLT2 inhibitors. Serious outcomes have included hospitalisation, multiple surgeries, and death. Those treated with SGLT2 inhibitors who present with pain or tenderness, erythema, swelling in the genital or perineal area, fever, malaise should be evaluated for necrotising fasciitis. If suspected, GLT2 inhibitors should be discontinued, and treatment should begin.
    Note: Diabetes MedsCheck with education on side effects profile and what to do if symptoms develop. Referral to healthcare team.
  • Lower limb amputations - An increase in cases of lower limb amputation (primarily of the toe) has been observed in a long-term clinical study with some SGLT2 inhibitors. It is important to regularly examine feet and counsel on routine preventative footcare.
    Note: Diabetes MedsCheck with education on side effect profile and referral to healthcare team.

  • Volume depletion - Jardiance induces osmotic diuresis (by its mechanism of action) which may lead to the modest decrease in blood pressure. This may be of concern for those individuals with a history of hypotension, dehydration, or gastrointestinal illness or those on diuretic therapy. (Diabetes Medscheck, Side effect profile, counselling, referral for blood pressure monitoring in pharmacy with referral back to appropriate health care professional if blood pressure is unstable)
  • Hypoglycaemia - Jardiance does not cause hypoglycaemia on its own. However, when used in conjunction with sulfonylureas or insulin hypoglycaemia can occur.
    Note: Diabetes MedsCheck with education on side effect profile and referral to healthcare team for counselling on managing hypoglycaemia.
  • Genital infections
    Note: Diabetes MedsCheck with education on side effect profile.
  • Necrotising fasciitis of the perineum (Fournier's gangrene) Diabetes MedsCheck, Side effect profile, counselling, referral to appropriate health care professional if occurs)
  • Urinary tract infections
    Note: Diabetes MedsCheck with education on side effect profile.
  • Renal-related adverse reactions (acute kidney injury, renal impairment, acute prerenal failure) may occur with treated with Jardiance. Monitoring of renal function is recommended as follows: - Prior to initiation of Jardiance and at least yearly thereafter. - Prior to initiation of concomitant medicines that may reduce renal function and periodically thereafter. - If renal function falls below eGFR< 45 mL/min/1.73 m, treatment with Jardiance should be discontinued.
    Note: Diabetes MedsCheck with education on side effect profile and referral to health care team for annual cycle of care.

After oral administration, empagliflozin was rapidly absorbed and reached mean peak in 1.5 hours.

The apparent steady-state volume of distribution was estimated to be 73.8 L.

No major metabolites of empagliflozin were detected in human plasma

The terminal elimination half-life of empagliflozin was estimated to be 12.4 h.

For more detailed information on this product please consult the product information
https://www.tga.gov.au/sites/default/files/auspar-empagliflozin-171026-pi.pdf