Pharmacy Diabetes

SGLT-Formulation-Dapagliflozin

Dapagliflozin

  • Each film-coated tablet of Forxiga contains 10 mg of dapagliflozin.

  • Glycaemic management
    Forxiga is indicated in adults with type 2 diabetes mellitus:
    - As monotherapy as an adjunct to healthy eating and physical activity in individuals for whom metformin is otherwise indicated but was not tolerated.
    - As initial combination therapy with metformin, as an adjunct to healthy eating and physical activity, to improve glycaemic management when healthy eating and physical activity have not been successful to provide optimal glycaemic management and it is assumed response to metformin monotherapy will not be adequate (for example, high initial haemoglobinA1c [HbA1c] levels);
    - In combination with other anti-hyperglycaemic agents to improve glycaemic management, when these together with healthy eating and physical activity, do not provide optimal glycaemic management.
  • Prevention of hospitalisation for heart failure:
    Forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure.
  • Heart failure:
    Forxiga is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy.

For the latest PBS indications for dapaglifozin please see

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

  • Type 2 diabetes - The recommended daily dose of Forxiga is 10 mg once daily at any time of the day without regard to meals.
  • Heart failure - The recommended daily dose of Forxiga is 10 mg once daily at any time of the day without regard to meals. Forxiga should be used in conjunction with standard of care therapy.
  • Renal Impairment - Assess renal function prior to initiation of dapagliflozin and periodically thereafter. Note: Diabetes MedsCheck with referral for annual cycle of care to appropriate health care providers for review. No dose adjustment is required for individuals with eGFR≥ 45 mL/min/1.73 m. Forxiga should not be used once eGFR is <45ml/min/1.73 m. Treatment of heart failure - No dosage adjustment is required based on renal function.
  • Hepatic impairment - No dose is required for Forxiga with mild or moderate hepatic impairment. Forxiga should not be used in severe hepatic impairment.

  • No dose adjustment is required in the elderly.

  • Hypersensitivity to dapagliflozin or any active ingredient
  • Type 1 diabetes
  • Diabetic ketoacidosis
  • For the treatment of diabetes:
  • Forxiga should not be used in patients with eGFR < 45 mL/min/1.73m to improve glycaemic management since the efficacy of Forxiga is dependent on renal function.

  • Ketoacidosis in individuals with diabetes - There have been reports of ketoacidosis, including DKA (Diabetic ketoacidosis), with dapagliflozin and other sodium-glucose cotransporter 2 (SGLT2) inhibitors. Those treated with Forxiga 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, Forxiga should be ceased, and prompt treatment initiated. Restarting SGLT2 inhibitor treatment in those with previous DKA while on a SGLT2 inhibitor is not recommended.
  • Surgery - Forxiga 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 Forxiga maybe restarted once oral intake is normal.
  • 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, including. dapagliflozin. Serious outcomes have included hospitalisation, multiple surgeries, and death. Those treated with Forxiga who present with pain or tenderness, erythema, swelling in the genital or perineal area, fever, malaise should be evaluated for necrotising fasciitis. If suspected, Forxiga should be discontinued, and treatment should begin.
    Note: Diabetes MedsCheck with education on side effect profile and referral to healthcare team where required.
  • 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 appropriate health care team members.

  • Volume depletion - Forxiga 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.
    Note: Diabetes MedsCheck with education on side effect profile and referral for blood pressure monitoring in pharmacy. Referral to health care team if blood pressure is unstable.
  • Hypoglycaemia - Dapagliflozin 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 appropriate allied health care for further education on managing hypoglycaemia.
  • Genital infections:
    Note: Diabetes MedsCheck with education on side effect profile.
  • Necrotising fasciitis of the perineum (Fournier's gangrene)
    Note: Diabetes MedsCheck with education on side effect profile and 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 dapagliflozin. Monitoring of renal function is recommended as follows:
    - Prior to initiation of Forxiga and at least yearly thereafter.
    - Prior to initiation of concomitant medicines that may reduce renal function and periodically thereafter.
    - For renal function approaching eGFR45 mL/min/1.73 m at least 2 to 4 times per year. If renal function falls below eGFR< 45 mL/min/1.73 m, treatment with Forxiga should be discontinued.
    Note: Diabetes MedsCheck with education on side effect profile with referral to appropriate health care professional for annual cycle of care.

Dapagliflozin was rapidly and well absorbed after oral administration, irrespective of food. Maximum dapagliflozin plasma concentrations are usually attained within 2 hours (if administered in the fasted state), with the absolute oral bioavailability of 78%.

Dapagliflozin is approximately91%protein bound. And nor affected by health conditions such as renal or hepatic impairment.

Dapagliflozin is extensively metabolized to an inactive metabolite that does not contribute to its glucose lowering effect.

Dapagliflozin and related metabolites are primarily eliminated via urinary excretion. The mean plasma terminal half-life (t) for dapagliflozin was 12.9 hours following a single oral dose of Forxiga 10 mg to healthy subjects.

For more detailed information on this product please consult the product information.

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2012-PI-02861-1