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In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Please read US Full Prescribing Information and Medication Guide for FARXIGA.
You may report side effects related to AstraZeneca products by clicking here.
AN SGLT2 INHIBITOR TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS
FARXIGA as Add-On Therapy to Metformin
Primary end point: Mean reduction in A1C levels with FARXIGA + metformin at 24 weeks1,2
aP<0.0001 vs placebo + metformin.
BL=baseline.
Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.
A secondary end point: Mean weight reduction with FARXIGA + metformin at 24 weeks1,2
bP<0.0001 vs placebo + metformin.
BL=baseline.
Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.
FARXIGA is not indicated for weight loss.
*Weight reduction was a secondary end point.
Other end point: Significant mean changes from baseline in systolic BP with FARXIGA + metformin relative to placebo + metformin at 24 weeks1,2
cP<0.05 vs placebo + metformin.
BL=baseline.
Values are last observation (including data after rescue) carried forward.
FARXIGA is not indicated for the treatment of hypertension.
†Blood pressure reduction was another end point.
Volume Depletion: FARXIGA can cause intravascular volume depletion which may manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including FARXIGA. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating FARXIGA in these patients, assess volume status and renal function. After initiating therapy, monitor for signs and symptoms of hypotension and renal function.
FARXIGA as Add-On Therapy to Metformin
Randomized, double-blind, placebo-controlled, multicenter, 24-week, phase 3 trial
‡Dapagliflozin 2.5 mg is not an FDA-approved dose; thus, data from this treatment group are not presented.
Evaluate the efficacy and safety of FARXIGA in adult patients with type 2 diabetes who have inadequate glycemic control with metformin.
24 weeks
Patients were 18 to 77 years of age with type 2 diabetes who had an A1C of ≥7.0% and ≤10.0%, BMI ≤45 kg/m2, fasting C-peptide ≥1.0 ng/mL, and were given a stable dose of metformin (≥1500 mg/day) for ≥8 weeks prior to enrollment. Patients with systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg were excluded.
Patients on metformin at a dose of at least 1500 mg per day were randomized after completing a 2-week, single-blind, placebo lead-in period. Following the lead-in period, eligible patients were randomized to dapagliflozin 2.5 mg,§ FARXIGA 5 mg, FARXIGA 10 mg, or placebo in addition to their current dose of metformin.
§Dapagliflozin 2.5 mg is not an FDA-approved dose.
FARXIGA tablets shown are not actual sizes.
Change in A1C from baseline at Week 24
In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
FARXIGA is indicated:
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Please read US Full Prescribing Information and Medication Guide for FARXIGA.
You may report side effects related to AstraZeneca products by clicking here.
FARXIGA is indicated:
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
References:
Reference:
Most common (≥5%) and occurring more frequently than comparator in clinical trials: nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia (5.1%)
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Please read US Full Prescribing Information and Medication Guide for BYDUREON, including Boxed WARNING.
References:
FARXIGA is indicated: