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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 10 mg Initial Combination Therapy With Metformin XR*
Primary end point: Mean reduction in A1C levels at 24 weeks1,2,a
aThe median metformin XR dose was 2000 mg per day.
bP<0.0001 vs FARXIGA 10 mg or metformin XR.
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 at 24 weeks1,2,c
cThe median metformin XR dose was 2000 mg per day.
dP<0.0001 vs metformin XR monotherapy.
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.
*Recommended starting dose of FARXIGA is 5 mg once daily. In patients tolerating 5 mg who require additional glycemic control, the dose can be increased to 10 mg once daily.
†Weight reduction was a secondary end point.
FARXIGA 10 mg Initial Combination Therapy With Metformin XR
Randomized, double-blind, active-controlled, multicenter, 24-week, phase 3 trial
Evaluate the efficacy and safety of FARXIGA plus metformin XR in treatment-naïve adult patients whose type 2 diabetes cannot be controlled with diet and exercise alone.
Change in A1C from baseline at Week 24
24 weeks
Patients were 18 to 77 years of age with type 2 diabetes who had inadequate glycemic control (A1C ≥7.5% and ≤12.0%) and had a C-peptide ≥1.0 ng/mL and a body mass index (BMI) ≤45 kg/m2.
FARXIGA in combination and as monotherapy was dosed at 10 mg. The metformin XR dose was up-titrated weekly in 500-mg increments, as tolerated, up to a maximum of 2000 mg daily. Mean metformin XR dose was 1928.6 mg in the combination group and 1949.7 mg for the metformin XR monotherapy group.
FARXIGA tablet shown is not actual size.
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: