FARXIGA is indicated:
  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • to reduce the risk of hospitalization for heart failure death in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

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NOW APPROVED

FARXIGA, the SGLT2i with the broadest* indication to reduce the risk of hospitalization for heart failure1-4

*Hospitalization for heart failure indication is not limited by diabetic nephropathy or the presence of macroalbuminuria.

SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes.

FOR TODAY

Add FARXIGA today for your patients like David with type 2 diabetes on metformin

FOR TOMORROW

To help lower A1C and help prevent hospitalization for heart failure tomorrow1

T2D initiates a silent cascade of damage leading to heart failure5

Diabetes may change the heart's structure, which is irreversible, making prevention of heart failure essential6,7

Diabetic cardiomyopathy
Heart Failure

Heart failure is one of the earliest and most frequent complications of T2D8,9

68% of patients with T2D had evidence of LVD within 5 years of T2D diagnosis10,*

33% greater chance of hospitalization for HF in patients with T2D compared to those without T2D11,†

While glucose is important in managing T2D...
controlling glucose alone has not been shown to reduce the risk of heart failure in patients with T2D12,‡

*Prospective, multicenter study evaluating clinical and echocardiographic characteristics of individuals with type 2 diabetes (n=386) who were determined to be free from cardiac disease. Mean duration of diabetes was 5 years; mean A1C was 7.1%. LVD comprised of the combined asymptomatic left ventricular systolic and/or diastolic dysfunction.10

Based on a 4-year analysis of 45,227 patients from the international REACH registry.11

Heart failure resulting in hospitalization or death.12

HF=heart failure; LVD=left ventricular dysfunction; T2D=type 2 diabetes.

IN ADULTS WITH TYPE 2 DIABETES

DECLARE: Design and Results

DECLARE: the largest CVOT with an SGLT2i to study hospitalization for heart failure risk reduction in both primary and secondary prevention patients1-4,13

Primary and Secondary Reduction of CV Risk Factors

*Patients included were ≥40 years of age.14

Primary prevention defined as multiple CV risk factors (age ≥55 years in men or ≥60 years in women and at least 1 of the following: dyslipidemia, hypertension, or current tobacco use) and without a history of a CV event at baseline.1

Secondary prevention defined as established CV disease (clinically evident ischemic heart disease, ischemic cerebrovascular disease, or peripheral arterial disease).14

DECLARE included patients like David with multiple CV risk factors, needing prevention of hHF

David with Multiple CV Risk Factors

DECLARE was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the effect of FARXIGA 10 mg compared with placebo on CV outcomes in adults with T2D and multiple CV risk factors or established CV disease.1

CV=cardiovascular; CVOT=cardiovascular outcomes trial; DECLARE=Dapagliflozin Effect on Cardiovascular Events; hHF=hospitalization for heart failure; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes.

IN ADULTS WITH TYPE 2 DIABETES AND ESTABLISHED CV DISEASE OR MULTIPLE CV RISK FACTORS

FARXIGA, the SGLT2i with the broadest* indication to reduce the risk of hospitalization for heart failure1-4

Hospitalization for HF1,15
(Component of primary endpoint)
Hospitalization for Heart Failure

27%

Relative risk reduction in the overall population, with FARXIGA

0.8% Absolute Risk Reduction
  • FARXIGA met the primary safety endpoint vs placebo for the composite of CV death, MI, or ischemic stroke (MACE); (HR, 0.93; 95% CI, 0.84-1.03) P<0.001 (noninferiority)14

*Hospitalization for heart failure indication is not limited by diabetic nephropathy or the presence of macroalbuminuria.

CI=confidence interval; CV=cardiovascular; HF=heart failure; HR=hazard ratio; MACE=major adverse cardiovascular events; MI=myocardial infarction; SGLT2i=sodium-glucose cotransporter 2 inhibitor.

IN ADULTS WITH TYPE 2 DIABETES

Reduction in risk of hospitalization for heart failure in prespecified subgroups of primary and secondary prevention patients16

PRIMARY PREVENTION16

(Multiple CV Risk Factors)

Primary Prevention of Multiple CV Risk Factors

SECONDARY PREVENTION16

(Established CV Disease)

Secondary Prevention of Established CV Disease

CI=confidence interval; CV=cardiovascular; hHF=hospitalization for heart failure; HR=hazard ratio.

DOSING INFORMATION
  • To improve glycemic control in patients with T2D, the recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily
  • To reduce the risk of hospitalization for heart failure in patients with T2D, the recommended dose of FARXIGA is 10 mg once daily
IN ADULTS WITH TYPE 2 DIABETES

FARXIGA: Well-established safety profile

Safety data from the DECLARE study14

Select adverse events of interest, n (%) FARXIGA (n=8574) Placebo (n=8569)
Amputation 123 (1.4) 113 (1.3)
Acute kidney injury 125 (1.5) 175 (2.0)
Fracture 457 (5.3) 440 (5.1)
Major hypoglycemia 58 (0.7) 83 (1.0)
Symptoms of volume depletion 213 (2.5) 207 (2.4)
Urinary tract infection 127 (1.5) 133 (1.6)
Genital infection* 76 (0.9) 9 (0.1)
Diabetic ketoacidosis 27 (0.3) 12 (0.1)
Fournier’s gangrene 1 (0.01) 5 (0.06)

*Leading to discontinuation of the trial regimen or considered to be serious adverse events.

    Warnings and Precautions

  • Acute Kidney Injury: FARXIGA causes intravascular volume contraction and can cause acute kidney injury. Reports of acute kidney injury requiring hospitalization and dialysis have occurred with FARXIGA. If acute kidney injury occurs, discontinue and promptly treat
  • Increases in serum creatinine and decreases in eGFR may be observed with initiation of FARXIGA. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses
  • Before initiating FARXIGA, evaluate renal function and monitor periodically. FARXIGA is not recommended when the eGFR is <45 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
  • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Rare but serious, life-threatening cases have been reported in patients receiving SGLT2 inhibitors including FARXIGA. Cases have been reported in females and males. Serious outcomes have included hospitalization, surgeries, and death. Assess patients presenting with pain or tenderness, erythema, swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue FARXIGA

Additional pooled safety data across clinical studies1

Adverse reactions in 12 placebo-controlled studies reported in ≥2% of patients treated with FARXIGA†,‡ FARXIGA 10 mg (n=1193) Placebo (n=1393)
Female genital mycotic infections§ 6.9% 1.5%
Nasopharyngitis 6.3% 6.2%
Urinary tract infections|| 4.3% 3.7%
Back pain 4.2% 3.2%
Increased urination 3.8% 1.7%
Male genital mycotic infections# 2.7% 0.3%
Nausea 2.5% 2.4%
Influenza 2.3% 2.3%
Dyslipidemia 2.5% 1.5%
Constipation 1.9% 1.5%
Discomfort with urination 2.1% 0.7%
Pain in extremity 1.7% 1.4%

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

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

§Genital 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 10 mg=598, placebo=677).

||Urinary 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.

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

#Genital 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 10 mg=595, placebo=716).

**In a pool of 21 phase 2b/3 trials, there were 5936 patients in the FARXIGA group and 3403 patients in the placebo group.17

††In a pool of 13 phase 2b/3 trials, there were 2360 patients in the FARXIGA 10 mg group and 2295 patients in the placebo group.18

  • In a pool of 21 phase 2b/3 trials, renal serious adverse events (renal impairment or failure) occurred in 0.2% of patients treated with FARXIGA and in 0.1% of patients in the placebo group17,**
  • In a pool of 13 phase 2b/3 trials, major hypoglycemia occurred in 0.1% of patients treated with FARXIGA 10 mg and in 0.1% of patients in the placebo group18,††
  • Warnings and Precautions

  • Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections. Monitor and treat appropriately
  • 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%)

Multiple guidelines emphasize the importance of managing heart failure risk in adults with T2D, and support early use of SGLT2i7,19,20

Recommendations on assessing CV risk and earlier SGLT2i use to manage risk

Association Inclusion of HF Use of SGLT2i
ADA Heart Icon Checked Radio Icon
ACC/AHA Heart Icon Checked Radio Icon
AHA/HFSA Heart Icon Checked Radio Icon
ACC formally endorses the ADA 2019 Standards of Medical Care in Diabetes, which includes HF as an important type of CVD in diabetes19

Guidelines recommend SGLT2i use after metformin, ahead of DPP4 inhibitors and SUs because of proven outcomes.19,20

ACC=American College of Cardiology; ADA=American Diabetes Association; AHA=American Heart Association; CV=cardiovascular; CVD=cardiovascular disease; DPP4=dipeptidyl peptidase-4; HF=heart failure; HFSA=Heart Failure Society of America; SGLT2i=sodium-glucose cotransporter 2 inhibitor; SU=sulfonylurea; T2D=type 2 diabetes.

IN ADULTS WITH TYPE 2 DIABETES AND ESTABLISHED CV DISEASE OR MULTIPLE CV RISK FACTORS

NOW APPROVED

FARXIGA, the SGLT2i with the broadest* indication to reduce the risk of hospitalization for heart failure1-4

Prevent Heart Failure for Today and Tomorrow
FOR TODAY

Add FARXIGA today for your patients like David with type 2 diabetes on metformin

FOR TOMORROW

To help lower A1C and help prevent hospitalization for heart failure tomorrow1

HF is one of the earliest and most frequent complications of T2D8,9
In patients from the DECLARE study with T2D
27% RRR in hHF in overall study population1,15

(HR 0.73; 95% CI, 0.61-0.88)
0.8% ARR


36% RRR in hHF in the prevention subgroup15,16

(HR 0.64; 95% CI, 0.46-0.88)
0.7% ARR

How you manage type 2 diabetes matters

*Hospitalization for heart failure indication is not limited by diabetic nephropathy or the presence of macroalbuminuria.

Primary prevention defined as multiple CV risk factors (age ≥55 years in men or ≥60 years in women with at least 1 of the following: dyslipidemia, hypertension, or current tobacco use) and without a history of a CV event at baseline.1

ARR=absolute risk reduction; HF=heart failure; hHF=hospitalization for heart failure; RRR=relative risk reduction; T2D=type 2 diabetes.

FARXIGA is indicated:
  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Access to affordable medications is necessary for patients with T2D at risk of hospitalization for heart failure

ACCESS:

FARXIGA is covered without prior authorization for the majority of your patients§

AFFORDABILITY:

$0 per month for most commercial patients||

FARXIGA Savings Card

"Patients" means covered lives (commercial, employer, federal programs, FEHBP, municipal plan, PBM, union) at tiers 1-3 preferred in the nation, as calculated by Fingertip Formulary® as of February 22, 2019.

§"Covered Without Prior Authorization" means that additional information is not required to be provided to the health plan in order for FARXIGA to be covered. Step edits may apply.

||As low as $0 for as long as you prescribe any available dose of FARXIGA.

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: FARXIGA causes intravascular volume contraction and can cause acute kidney injury. Reports of acute kidney injury requiring hospitalization and dialysis have occurred with FARXIGA. If acute kidney injury occurs, discontinue and promptly treat
  • Increases in serum creatinine and decreases in eGFR may be observed with initiation of FARXIGA. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses

    Before initiating FARXIGA, evaluate renal function and monitor periodically. FARXIGA is not recommended when the eGFR is <45 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
  • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Rare but serious, life-threatening cases have been reported in patients receiving SGLT2 inhibitors including FARXIGA. Cases have been reported in females and males. Serious outcomes have included hospitalization, surgeries, and death. Assess patients presenting with pain or tenderness, erythema, swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue FARXIGA
  • Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections. Monitor and treat appropriately

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

INDICATIONS AND LIMITATIONS OF USE FOR FARXIGA

FARXIGA is indicated:

  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Dosing

To improve glycemic control in patients with T2D, the recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.

To reduce the risk of hospitalization for heart failure in patients with T2D, the recommended dose of FARXIGA is 10 mg once daily.

Please read US Full Prescribing Information and Medication Guide for FARXIGA.

You may report side effects related to AstraZeneca products by clicking here.

References:

  1. FARXIGA® (dapagliflozin) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. Invokana® (canagliflozin) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2019.
  3. Jardiance® (empagliflozin) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2018.
  4. Steglatro (ertugliflozin) [prescribing information]. Whitehouse Station, NJ: Merck & Co, Inc; 2018.
  5. Marwick TH, Ritchie R, Shaw JE, Kaye D. Implications of underlying mechanisms for the recognition and management of diabetic cardiomyopathy. J Am Coll Cardiol. 2018;71(3):339-351.
  6. Yancy CW, Jessup M, Bozkurt B, et al: Writing Committee Members. 2013 ACCF/AHA guideline for the management of heart failure. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128(16):e240-e327.
  7. Dunlay SM, Givertz MM, Aguilar D, et al. Type 2 diabetes mellitus and heart failure: a scientific statement from the American Heart Association and the Heart Failure Society of America: this statement does not represent an update of the 2017 ACC/AHA/HFSA heart failure guideline update. Circulation. 2019;140(7):e294-e324.
  8. Shah AD, Langenberg C, Rapsomaniki E, et al. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1.9 million people. Lancet Diabetes Endocrinol. 2015;3(2):105-113.
  9. Bergenstal RM, Bailey CJ, Kendall DM. Type 2 diabetes: assessing the relative risks and benefits of glucose lowering medications. Am J Med. 2010;123(4):374.e9-374.e18.
  10. Faden G, Faganello G, De Feo S, et al. The increasing detection of asymptomatic left ventricular dysfunction in patients with type 2 diabetes mellitus with overt cardiac disease: data from the SHORTWAVE study. Diabetes Res Clin Pract. 2013;101(3):309-316.
  11. Cavender MA, Steg PG, Smith SC Jr, et al. Impact of diabetes mellitus on hospitalization for heart failure, cardiovascular events, and death: outcomes at 4 years from the reduction of atherothrombosis for continued health (REACH) registry. Circulation. 2015;132(10):923-931.
  12. Turnbull FM, Abraira C, Anderson RJ, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia. 2009;52(11):2288-2298.
  13. Cannon CP, McGuire DK, Pratley R, et al. Design and baseline characteristics of the evaluation of ertugliflozin efficacy and safety cardiovascular outcomes trial (VERTIS-CV). Am Heart J. 2018;206:11-23.
  14. Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019;380(4):347-357.
  15. Data on File, REF-62129; AstraZeneca Pharmaceuticals LP.
  16. Supplementary appendix to: Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019;380(4):347-357.
  17. Ptaszynska A, Mansfield T, Johnsson E, et al. Long-term renal safety with dapagliflozin treatment. Poster presented at: the 74th Scientific Sessions of the American Diabetes Association (ADA); June 13-17, 2014; San Francisco, CA.
  18. Jabbour S, Seufert J, Scheen A, et al. Dapagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of safety data from phase IIb/III clinical trials. Diabetes Obes Metab. 2018;20(3):620-628.
  19. American Diabetes Association. Cardiovascular disease and risk management: standards of medical care in diabetes—2019. Diabetes Care. 2019;42(suppl 1):S1-S193.
  20. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;74(10):1376-1414.

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