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IMPORTANT SAFETY INFORMATION ABOUT FARXIGA

Contraindications

  • Prior serious hypersensitivity reaction to...Read More FARXIGA
  • Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

Warnings and Precautions

  • Hypotension: FARXIGA causes intravascular volume contraction, and symptomatic hypotension can occur. Assess and correct volume status before initiating FARXIGA in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for hypotension
  • Ketoacidosis has been reported in patients with type 1 and type 2 diabetes receiving FARXIGA. Some cases were fatal. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue FARXIGA, evaluate and treat promptly. Before initiating FARXIGA, consider risk factors for ketoacidosis. Patients on FARXIGA may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis
  • Acute Kidney Injury and Impairment in Renal Function: FARXIGA causes intravascular volume contraction and renal impairment, with reports of acute kidney injury requiring hospitalization and dialysis. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat.
  • FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Before initiating FARXIGA, evaluate renal function and monitor periodically. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2

  • Urosepsis and Pyelonephritis: SGLT2 inhibitors increase the risk for urinary tract infections [UTIs] and serious UTIs have been reported with FARXIGA. Evaluate for signs and symptoms of UTIs and treat promptly
  • Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA
  • Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections. Monitor and treat appropriately
  • Increases in Low-Density Lipoprotein Cholesterol (LDL-C) occur with FARXIGA. Monitor LDL-C and treat per standard of care
  • Bladder cancer: An imbalance in bladder cancers was observed in clinical trials. There were too few cases to determine whether the emergence of these events is related to FARXIGA, and insufficient data to determine whether FARXIGA has an effect on pre-existing bladder tumors. FARXIGA should not be used in patients with active bladder cancer. Use with caution in patients with a history of bladder cancer
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA

Adverse Reactions

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%).

Use in Specific Populations

  • Pregnancy: Advise females of potential risk to a fetus especially during the second and third trimesters
  • Lactation: FARXIGA is not recommended when breastfeeding

INDICATION AND LIMITATIONS OF USE

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.

Expand

FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor 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.

DO YOU HAVE PATIENTS WITH TYPE 2 DIABETES WHO:

a1c_icon_mobile mobile

Continue to need improvement in A1C?

AND, WHO COULD ALSO BENEFIT FROM

weight and systolic BP reductions?

FARXIGA is not indicated for weight loss or the treatment of hypertension.

KEEP IN MIND THAT THE CURRENT AACE ALGORITHM RECOMMENDS

SGLT2i TREATMENT

ABOVE DPP-4i IN THE HIERARCHY1

Before choosing a therapy for your patient, individualize treatment considerations

  • Patients must be followed regularly and closely to ensure that glycemic goals are met and maintained, regardless of the treatment selected1
  • THERAPEUTIC GOAL
  • A1C EFFICACY
  • MECHANISM OF ACTION
  • RISK OF HYPOGLYCEMIA
  • EFFECT ON WEIGHT
  • SAFETY AND TOLERABILITY

FARXIGA is not indicated for weight loss.

FARXIGA IS THE #1 PRESCRIBED SGLT2i

IN THE WORLD2

IF YOU HAVE PATIENTS NOT AT A1C GOAL AND WHO COULD BENEFIT FROM WEIGHT AND SYSTOLIC BP REDUCTIONS, YOU SHOULD

MEET DIANA

DIANA’S NUMBERS HAVE HER PHYSICIAN CONCERNED...

Age

47 years

A1C

9.1%

BMI

31.4kg/m2

BP

127/81mm Hg

FARXIGA is not indicated for weight loss or the treatment of hypertension.

FOR YOUR PATIENTS LIKE DIANA,

CONSIDER FARXIGA

FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

FARXIGA IS AN SGLT2 INHIBITOR

Which means that FARXIGA provides a mechanism of action that removes glucose and the associated calories via renal excretion.3,4

  • FARXIGA causes intravascular volume contraction and renal impairment, with reports of acute kidney injury requiring hospitalization and dialysis. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat. FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Before initiating FARXIGA, evaluate renal function and monitor periodically. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2

In a pharmacodynamic study, use of FARXIGA resulted in excretion of approximately 70 grams of glucose in the urine per day at Week 12.4

That’s about

280

calories/day4,5

FARXIGA is not indicated for weight loss.

FOR ADULTS WITH TYPE 2 DIABETES, IN ADDITION TO DIET AND EXERCISE

FARXIGA MAY MAKE IT POSSIBLE TO:

Reduce A1C, with additional weight* and systolic blood pressure benefits4

FARXIGA is not indicated for weight loss or the treatment of hypertension.

*Up to 7-lb weight reduction was reported in clinical trials.

SBP reductions when added to metformin.

LET’S LOOK AT

CLINICAL STUDIES WITH FARXIGA…

Proven efficacy

as initial and add-on therapy

IN ADULTS WITH TYPE 2 DIABETES, IN ADDITION TO DIET AND EXERCISE

PRIMARY END POINT: A1C REDUCTION

when FARXIGA is used as initial therapy or with metformin XR at 24 weeks

PRIMARY END POINT: Mean A1C reduction in treatment-naive patients4,6,a

A1C reduction in patients with Type 2 diabetes when FARXIGA is used as initial therapy or with metformin XR at 24 weeks A1C reduction in patients with Type 2 diabetes when FARXIGA is used as initial therapy or with metformin XR at 24 weeks A1C reduction in patients with Type 2 diabetes when FARXIGA is used as initial therapy or with metformin XR at 24 weeks

FARXIGA 5 mg + metformin XR demonstrated a 2.1% reduction in A1C from baseline (n=194; BL=9.2%)b

bP<0.0001 vs FARXIGA 5 mg or metformin XR.

In a separate monotherapy study, FARXIGA 5 mg reduced A1C by -0.8% (BL=7.8%).

FARXIGA 5 mg + metformin XR demonstrated a 2.1% reduction in A1C from baseline (n=194; BL=9.2%)b

bP<0.0001 vs FARXIGA 5 mg or metformin XR.

In a separate monotherapy study, FARXIGA 5 mg reduced A1C by -0.8% (BL=7.8%).

Values are last observation carried forward and represent adjusted mean change from baseline.

aThe median metformin XR dose was 2000 mg per day.

bP<0.0001 vs FARXIGA 5 mg or metformin XR.

BL=baseline.

IN ADULTS WITH TYPE 2 DIABETES, IN ADDITION TO DIET AND EXERCISE

SECONDARY END POINT: SIGNIFICANT WEIGHT REDUCTION

when FARXIGA is used as initial therapy or with metformin XR at 24 weeks

SECONDARY END POINT: Mean weight reduction in treatment-naive patients4,6,c

Significant weight reduction when FARXIGA is used as initial therapy or with metformin XR at 24 weeks Significant weight reduction when FARXIGA is used as initial therapy or with metformin XR at 24 weeks Significant weight reduction when FARXIGA is used as initial therapy or with metformin XR at 24 weeks

FARXIGA 5 mg + metformin XR demonstrated a 6.0 lb weight reduction from baseline (n=194; BL=185.6 lb)d

dP<0.0001 vs metformin XR.

FARXIGA is not indicated for weight loss.

FARXIGA 5 mg + metformin XR demonstrated a 6.0 lb weight reduction from baseline (n=194; BL=185.6 lb)d

dP<0.0001 vs metformin XR.

FARXIGA is not indicated for weight loss.

Values are last observation carried forward and represent adjusted mean change from baseline.

cThe median metformin XR dose was 2000 mg per day.

dP<0.0001 vs metformin XR.

BL=baseline.

IN ADULTS WITH TYPE 2 DIABETES, IN ADDITION TO DIET AND EXERCISE

SIGNIFICANT SYSTOLIC BP REDUCTION

when added-on to metformin at 1 year vs glipizide + metformin

SECONDARY END POINT: Mean change from baseline in systolic BP relative to glipizide + metformin4,7

Significant mean change from baseline in systolic BP with FARXIGA + metformin relative to glipizide + metformin at 52 weeks Significant mean change from baseline in systolic BP with FARXIGA + metformin relative to glipizide + metformin at 52 weeks Significant mean change from baseline in systolic BP with FARXIGA + metformin relative to glipizide + metformin at 52 weeks

PRIMARY END POINT: 0.5% MEAN REDUCTION IN A1C from baseline (n=400; BL=7.7%) with FARXIGA + metformin was noninferior to glipizide + metformin at 52 weeks (0.5%; n=401; BL=7.7%)4,7,e

fP<0.0001 vs glipizide + metformin XR.

FARXIGA is not indicated for the treatment of hypertension.

PRIMARY END POINT: 0.5% MEAN REDUCTION IN A1C from baseline (n=400; BL=7.7%) with FARXIGA + metformin was noninferior to glipizide + metformin at 52 weeks (0.5%; n=401; BL=7.7%)4,7,e

fP<0.0001 vs glipizide + metformin XR.

FARXIGA is not indicated for the treatment of hypertension.

Values are last observation carried forward.

ePatients on metformin =1500 mg per day were randomized following a 2-week placebo lead-in period to glipizide 5 mg or dapagliflozin 2.5 mg and were up-titrated over 18 weeks to optimal glycemic effect (FPG <110 mg/dL, <6.1 mmol/L) or to the highest dose level (up to glipizide 20 mg and FARXIGA 10 mg) as tolerated by patients. At the end of the titration period, 87% of patients treated with FARXIGA had been titrated to the maximum study dose (10 mg) vs 73% treated with glipizide (20 mg). Dapagliflozin 2.5 mg is not an FDA-approved dose.

fP<0.0001 vs glipizide + metformin XR.

BL=baseline.

POOLED SAFETY ANALYSISVOLUME DEPLETION/GMIRATES OF HYPOGLYCEMIAHYPERSENSITIVITY REACTIONS

  • 1
  • POOLED SAFETY ANALYSIS
  • VOLUME DEPLETION/GMI
  • RATES OF HYPOGLYCEMIA
  • HYPERSENSITIVITY REACTIONS
  • 1

POOLED SAFETY ANALYSISVOLUME DEPLETION/GMIRATES OF HYPOGLYCEMIAHYPERSENSITIVITY REACTIONS

  • POOLED SAFETY ANALYSIS
  • VOLUME DEPLETION/GMI
  • RATES OF HYPOGLYCEMIA
  • HYPERSENSITIVITY REACTIONS

Adverse reactions in 12 placebo-controlled studies reported in =2% of patients treated with FARXIGA4,g,h

  • FARXIGA 5 mg (N=1145)
  • FARXIGA 10 mg (N=1193)
  • Placebo (N=1393)

Female genital mycotic infectionsi

  • 8.4%
  • 6.9%
  • 1.5%

Nasopharyngitis

  • 6.6%
  • 6.3%
  • 6.2%

Urinary tract infectionsj

  • 5.7%
  • 4.3%
  • 3.7%

Back pain

  • 3.1%
  • 4.2%
  • 3.2%

Increased urinationk

  • 2.9%
  • 3.8%
  • 1.7%

Male genital mycotic infectionsl

  • 2.8%
  • 2.7%
  • 0.3%

Nausea

  • 2.8%
  • 2.5%
  • 2.4%

Influenza

  • 2.7%
  • 2.3%
  • 2.3%

Dyslipidemia

  • 2.1%
  • 2.5%
  • 1.5%

Constipation

  • 2.2%
  • 1.9%
  • 1.5%

Discomfort with urination

  • 1.6%
  • 2.1%
  • 0.7%

Pain in extremity

  • 2.0%
  • 1.7%
  • 1.4%

gAdverse events were evaluated with FARXIGA 5 mg and 10 mg in 12 placebo-controlled studies ranging from 12 to 24 weeks.

hFARXIGA was studied as monotherapy in 4 studies, and in 8 studies as add-on to background antidiabetic therapy or as combination with metformin.

iGenital mycotic infections include the following adverse reactions, listed in order of frequency reported for females: vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis, fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial (N for females: FARXIGA 5 mg=581, FARXIGA 10 mg=598, placebo=677).

jUrinary tract infections include the following adverse reactions, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection, and prostatitis.

kIncreased urination includes the following adverse reactions, listed in order of frequency reported: pollakiuria, polyuria, and urine output increased.

lGenital mycotic infections include the following adverse reactions, listed in order of frequency reported for males: balanitis, fungal genital infection, balanitis candida, genital candidiasis, genital infection male, penile infection, balanoposthitis, balanoposthitis infective, genital infection, posthitis (N for males: FARXIGA 5 mg=564, FARXIGA 10 mg=595, placebo=716).

Volume depletion4

  • Volume depletion includes reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension
  • In a pool of 12 short-term, placebo-controlled studies, these rates were 0.6% with FARXIGA 5 mg, 0.8% with FARXIGA 10 mg, and 0.4% with placebo
  • In a pool of 13 short-term, placebo-controlled studies, these rates were 1.1% with FARXIGA 10 mg vs 0.7% with placebo

Genital mycotic infections4

  • Genital mycotic infections (GMI) were reported in 5.7% of patients with FARXIGA 5 mg, 4.8% with FARXIGA 10 mg, and 0.9% with placebo, in the 12-study placebo-controlled pool
  • Discontinuation from study due to GMI occurred in 0% of placebo-treated patients and 0.2% of patients treated with FARXIGA 10 mg
  • Rates of GMI were higher among patients with a history of GMI than in those without

Incidence of majorm and minorn hypoglycemia in controlled clinical studies4

  • FARXIGA 5 mg

  • FARXIGA 10 mg

  • Placebo

Monotherapym (24 weeks)

  • Major [n (%)]
  • Major [n (%)]
  • Minor [n (%)]
  • FARXIGA 5 mg n=64
  • 0
  • 0
  • FARXIGA 10 mg n=70
  • 0
  • 0
  • Placebo n=75
  • 0
  • 0

Add-on to metforminm (24 weeks)

  • Major [n (%)]
  • Major [n (%)]
  • Minor [n (%)]
  • FARXIGA 5 mg n=137
  • 0
  • 2 (1.5%)
  • FARXIGA 10 mg n=135
  • 0
  • 1 (0.7%)
  • Placebo n=137
  • 0
  • 0

Active control add-on to metformin vs glipizide (52 weeks)

  • Major [n (%)]
  • Major [n (%)]
  • Minor [n (%)]
  • FARXIGA 5 mg -
  • -
  • -
  • FARXIGA 10 mg n=406
  • 0
  • 7 (1.7%)
  • Placebo n=408
  • 3 (0.7%)
  • 147 (36.0%)

Add-on to glimepiridem (24 weeks)

  • Major [n (%)]
  • Major [n (%)]
  • Minor [n (%)]
  • FARXIGA 5 mg n=145
  • 0
  • 8 (5.5%)
  • FARXIGA 10 mg n=151
  • 0
  • 9 (6.0%)
  • Placebo n=146
  • 0
  • 3 (2.1%)

Add-on to pioglitazonem (24 weeks)

  • Major [n (%)]
  • Major [n (%)]
  • Minor [n (%)]
  • FARXIGA 5 mg n=141
  • 0
  • 3 (2.1%)
  • FARXIGA 10 mg n=140
  • 0
  • 0
  • Placebo n=139
  • 0
  • 0

Add-on to DPP-4 inhibitor (24 weeks)

  • Major [n (%)]
  • Major [n (%)]
  • Minor [n (%)]
  • FARXIGA 5 mg -
  • -
  • -
  • FARXIGA 10 mg n=225
  • 1 (0.4%)
  • 4 (1.8%)
  • Placebo n=226
  • 0
  • 3 (1.3%)

Add-on to insulin with or without other OADs (24 weeks)

  • Major [n (%)]
  • Major [n (%)]
  • Minor [n (%)]
  • FARXIGA 5 mg n=212
  • 1 (0.5%)
  • 92 (43.4%)
  • FARXIGA 10 mg n=196
  • 1 (0.5%)
  • 79 (40.3%)
  • Placebo n=197
  • 1 (0.5%)
  • 67 (34.0%)

OAD=oral antidiabetic.

mMajor episodes of hypoglycemia were defined as symptomatic episodes requiring external (third-party) assistance due to severe impairment in consciousness or behavior with a capillary or plasma glucose value <54 mg/dL and prompt recovery after glucose or glucagon administration.

nMinor episodes of hypoglycemia were defined as either a symptomatic episode with a capillary or plasma glucose measurement <63 mg/dL, regardless of need for external assistance or an asymptomatic capillary or plasma glucose measurement <63 mg/dL that does not qualify as a major episode.

Hypersensitivity reactions4

  • Hypersensitivity reactions (eg, angioedema, urticaria, hypersensitivity) were reported with FARXIGA treatment
  • Across the clinical program, serious anaphylactic reactions and severe cutaneous adverse reactions and angioedema were reported in 0.2% of comparator-treated patients and 0.3% of FARXIGA-treated patients

REMEMBER DIANA?

For your type 2 diabetes patients like her, who may need A1C reduction and could benefit from weight reduction or systolic blood pressure reduction…

IN ADDITION TO DIET AND EXERCISE,

CONSIDER FARXIGA

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.

Study Design

FARXIGA 5 mg + metformin XR initial combination:

A 24-week, phase 3, multicenter, randomized, double-blind, parallel-group clinical study to evaluate the efficacy and safety of FARXIGA 5 mg in combination with metformin XR in treatment-naive adults (aged 18-77 years) with type 2 diabetes who had inadequate glycemic control (A1C =7.5% and =12.0%). A total of 603 adult patients were randomized to 1 of 3 treatment groups: FARXIGA 5 mg + metformin XR, FARXIGA 5 mg + placebo, or metformin XR + placebo. The metformin XR dose was up-titrated weekly in 500-mg increments, as tolerated, up to a maximum of 2000 mg daily. Patients had a C-peptide concentration of =0.33 nmol/L and a body mass index (BMI) of =45 kg/m2. The primary end point of the study was change in A1C from baseline at Week 24. Mean metformin XR dose was 1773.5 mg in the combination group and 1843.6 mg in the metformin XR monotherapy group.4,6

Head-to-head FARXIGA + metformin immediate-release vs glipizide + metformin immediate-release:

A 52-week, phase 3, multicenter, randomized, double-blind, parallel-group noninferiority study to evaluate the efficacy and safety of FARXIGA compared with glipizide in adults with type 2 diabetes who had inadequate glycemic control (A1C >6.5% and =10.0%) with metformin. Patients had a BMI of =45 kg/m2. Patients with systolic blood pressure =180 mm Hg and/or diastolic blood pressure =110 mm Hg were excluded. A total of 816 adult patients stabilized on 1500 to 2500 mg of metformin per day were randomized to 1 of 2 treatment groups: FARXIGA up-titrated to a maximum dose of 10 mg (87% of patients) or glipizide up-titrated to a maximum dose of 20 mg (73% of patients). Up-titration occurred over 18 weeks, after which doses were kept constant unless down-titration was required to prevent hypoglycemia. The primary end point of the study was change in A1C from baseline at Week 52. Trial extensions at the end of 52 weeks and 104 weeks were performed. At the end of 208 weeks, 39.7% and 34.6% of patients in the dapagliflozin and glipizide groups, respectively, completed the study.4,7,8

Footnotes

Not actual patient. Actor portrayal.
Not actual patient. Actor portrayal.
Not actual patient. Actor portrayal.
BACK TO TOP

Important Safety Information For Farxiga

Contraindications

  • Prior serious hypersensitivity reaction to FARXIGA
  • Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

Warnings and Precautions

  • Hypotension: FARXIGA causes intravascular volume contraction, and symptomatic hypotension can occur. Assess and correct volume status before initiating FARXIGA in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for hypotension
  • Ketoacidosis has been reported in patients with type 1 and type 2 diabetes receiving FARXIGA. Some cases were fatal. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue FARXIGA, evaluate and treat promptly. Before initiating FARXIGA, consider risk factors for ketoacidosis. Patients on FARXIGA may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis
  • Acute Kidney Injury and Impairment in Renal Function: FARXIGA causes intravascular volume contraction and renal impairment, with reports of acute kidney injury requiring hospitalization and dialysis. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat.
  • FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Before initiating FARXIGA, evaluate renal function and monitor periodically. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2
  • Urosepsis and Pyelonephritis: SGLT2 inhibitors increase the risk for urinary tract infections [UTIs] and serious UTIs have been reported with FARXIGA. Evaluate for signs and symptoms of UTIs and treat promptly
  • Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA
  • Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections. Monitor and treat appropriately
  • Increases in Low-Density Lipoprotein Cholesterol (LDL-C) occur with FARXIGA. Monitor LDL-C and treat per standard of care
  • Bladder cancer: An imbalance in bladder cancers was observed in clinical trials. There were too few cases to determine whether the emergence of these events is related to FARXIGA, and insufficient data to determine whether FARXIGA has an effect on pre-existing bladder tumors. FARXIGA should not be used in patients with active bladder cancer. Use with caution in patients with a history of bladder cancer
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA

Adverse Reactions

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%).

Use in Specific Populations

  • Pregnancy: Advise females of potential risk to a fetus especially during the second and third trimesters
  • Lactation: FARXIGA is not recommended when breastfeeding

INDICATION AND LIMITATIONS OF USE

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.

References:

Reference:

  1. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  2. Data on File, REF-8609, AstraZeneca Pharmaceuticals LP.
  3. Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011;34(9):2015-2022.
  4. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  5. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  6. Wong ND, Patao C, Wong K, Malik S, Franklin SS, Iloeje U. Trends in control of cardiovascular risk factors among US adults with type 2 diabetes from 1999 to 2010: comparison by prevalent cardiovascular disease status. Diab Vasc Dis Res. 2013;10(6):505-513.
  7. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of diabetes and its burden in the United States, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed September 28, 2015.
  8. Centers for Disease Control and Prevention. Age-adjusted percentage of adults aged 18 years or older with diagnosed diabetes who were overweight, United States, 1994–2010. http://www.cdc.gov/diabetes/statistics/comp/fig7_overweight.htm. Accessed September 18, 2015.
  9. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  10. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  11. Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;66(5):446-456.
  12. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  13. Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;66(5):446-456.
  14. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  15. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise. Diabetes Care. 2010;33(10):2217-2224.
  16. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  17. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9733):2223-2233.
  18. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
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