Important Safety Information
Important Safety Information
- Not for use in pediatrics (<18 years).
- No dosage adjustment is required in patients ≥65 years of age. FORXIGA should be used with caution in this population as a higher proportion of patients ≥65 years of age treated with FORXIGA had adverse reactions related to volume depletion and renal impairment or failure, compared to patients treated with placebo.
- Patients with an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2, end-stage renal disease (ESRD) or patients on dialysis.
Most serious warnings and precautions:
- Diabetic ketoacidosis: Clinical trial and post-market cases of diabetic ketoacidosis (DKA), a serious life-threatening condition requiring urgent hospitalization, have been reported in patients with type 2 diabetes mellitus (T2DM) treated with FORXIGA (dapagliflozin) and other sodium-glucose co-transporter 2 (SGLT2) inhibitors. A number of these cases have been atypical with blood glucose values below 13.9 mmol/L (250 mg/dL). Some cases of DKA have been fatal. If DKA is suspected, regardless of blood glucose level, patients should discontinue FORXIGA treatment and be assessed for DKA immediately. If DKA is diagnosed, FORXIGA should be discontinued immediately.
- FORXIGA should not be used for the treatment of DKA or in patients with a history of DKA.
- FORXIGA is not indicated, and should not be used, in patients with type 1 diabetes.
Other relevant warnings and precautions:
- DKA: Interruption of treatment with FORXIGA should be considered in type 2 diabetes patients who are hospitalized for major surgical procedures, serious infections or acute serious medical illness. Patients with conditions that can precipitate DKA while taking FORXIGA should be monitored closely. Caution should also be taken when reducing the insulin dose in patients requiring insulin.
- Use in patients at risk for volume depletion, hypotension and/or electrolyte imbalances.
- Risk of hypoglycemia when used in combination with insulin or insulin secretagogues.
- Dose-related LDL-C increases; monitor LDL-C levels.
- Increased mean hemoglobin/hematocrit and frequency of patients with abnormally elevated values of hemoglobin/hematocrit.
- Increased risk of genital mycotic infections and urinary tract infections (including urosepsis and pyelonephritis).
- Risk of necrotizing fasciitis of the perineum (Fournier’s gangrene).
- Not recommended in severe hepatic impairment.
- Renal function abnormalities and acute kidney injury, including acute renal failure. Patients with hypovolemia may be more susceptible to these changes.
- Renal function should be assessed prior to initiation of FORXIGA and regularly thereafter, with more frequent monitoring in patients whose eGFR decreases to <60 mL/min/1.73 m2.
- Not recommended in patients with an eGFR persistently <45 mL/min/1.73 m2 and severe renal impairment.
- Not for use in pregnant or nursing women.
- Patients taking FORXIGA will test positive for glucose in their urine.
For more information:
Please consult the Product Monograph at www.azinfo.ca/forxiga/pm367 for important information relating to adverse reactions, drug interactions and dosing. The Product Monograph is also available by calling 1-800-668-6000.