FARXIGA is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.

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

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IN PATIENTS WITH HFrEF WITH AND WITHOUT T2D

FARXIGA reduced the risk of CV death or hospitalization for heart failure1,6,*

Primary end point was a composite of CV death or hospitalization for heart failure1,5,*

Primary Composite end point of CV death or hospitalization for heart failure Primary Composite end point of CV death or hospitalization for heart failure

Results for the primary composite end point were consistent across subgroups, including patients with and without T2D1

Composite end point of CV death or hospitalization for heart failure1,6,7,*,‡

Patients without T2D (n=2605)

Patients with T2D (n=2139)

FARXIGA Results for the Primary Composite End Point

Patients without T2D (n=2605)

FARXIGA Results for the Primary Composite End Point

Patients with T2D (n=2139)

FARXIGA Results for the Primary Composite End Point

No other SGLT2i is indicated to reduce CV death in patients with HFrEF with and without T2D—only FARXIGA1-4

*Also includes urgent visits for heart failure.1

Data represented as event rates over a median follow-up of 18.2 months.5

P interaction 0.80 for patients with and without T2D.6

ARR=absolute risk reduction; CV=cardiovascular; HFrEF=heart failure with reduced ejection fraction; HR=hazard ratio; NNT=number needed to treat; RRR=relative risk reduction; SGLT2i=sodium-glucose cotransporter 2 inhibitor; SoC=standard of care; T2D=type 2 diabetes.

Safety profile of FARXIGA in DAPA-HF across patients with and without T2D6

Safety Profile of FARXIGA in DAPA-HF

Patients without T2D

FARXIGA 10 mg
(n=1295)

Placebo
(n=1305)

Select safety outcomes*

AE leading to treatment discontinuation

5.3%

4.5%

Volume depletion

7.3%

6.1%

Renal AE

4.8%

6.0%

Fracture

2.1%

1.9%

Amputation

0.1%

0.2%

Severe hypoglycemia

0.0%

0.0%

Diabetic ketoacidosis

0.0%

0.0%

Patients with T2D

FARXIGA 10 mg
(n=1073)

Placebo
(n=1063)

Select safety outcomes*

AE leading to treatment discontinuation

4.0%

5.4%

Volume depletion

7.8%

7.8%

Renal AE

8.5%

8.7%

Fracture

2.1%

2.4%

Amputation

1.1%

0.8%

Severe hypoglycemia

0.4%

0.4%

Diabetic ketoacidosis

0.3%

0.0%

  • In patients without T2D

    - Severe hypoglycemia was not increased for FARXIGA compared to placebo6

    - FARXIGA did not negatively impact A1C (mean A1C of 5.74 at baseline and 5.79 at 24 months)7

  • In the overall study population*

    - Low rates of serious AEs related to volume depletion were reported for FARXIGA (1.2%) and placebo (1.7%)5

    - Low rates of serious AEs were reported for FARXIGA for hypotension (0.3%) and hyperkalemia (0.1%)8

*The safety population included patients receiving 1 dose of trial medication: FARXIGA n=2368 and placebo n=2368.6

Severe hypoglycemia defined as hypoglycemia requiring the assistance of another person to actively administer carbohydrates, glucagon, or take other corrective action.6

Warnings and Precautions

  • 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
  • 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 with diabetes mellitus 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

FARXIGA has a well-established safety profile1

Pooled results across 12 placebo-controlled studies

FARXIGA Safety Profile

FARXIGA 10 mg
(n=1193)

Placebo
(n=1393)

Adverse reactions in placebo-controlled studies of glycemic control reported in ≥2% of patients treated with FARXIGA

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%

Discomfort with urination

2.1%

0.7%

  • In a pool of 21 phase 2b/3 trials, serious renal AEs (renal impairment or failure) occurred in 0.2% of patients treated with FARXIGA and in 0.1% of patients in the placebo group9,‖
  • In a pool of 13 phase 2b/3 trials, severe hypoglycemia occurred in 0.1% of patients treated with FARXIGA 10 mg and in 0.1% of patients in the placebo group10,¶
  • 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%)

AEs 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.1

§n for females: FARXIGA 10 mg=598, placebo=677; n for males: FARXIGA 10 mg=595, placebo=716.1

In a pool of 21 phase 2b/3 trials, there were 5936 patients in the FARXIGA group and 3403 patients in the placebo group.9

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.10

A1C=glycated hemoglobin; AE=adverse event; DAPA-HF=Dapagliflozin And Prevention of Adverse outcomes in Heart Failure; eGFR=estimated glomerular filtration rate; SGLT2=sodium-glucose cotransporter 2; T2D=type 2 diabetes.

FARXIGA offers a novel pathway that complements your current therapies for HFrEF

FARXIGA may influence several physiological functions that can improve heart failure outcomes1

Physiological Functions Chart Physiological Functions Chart

FARXIGA reduces reabsorption of glucose and sodium by inhibiting SGLT2 in the proximal renal tubule, resulting in increased delivery of sodium to the distal tubule1

HFrEF=heart failure with reduced ejection fraction; SGLT2=sodium-glucose cotransporter 2.

IN PATIENTS WITH HFrEF WITH AND WITHOUT T2D

Make FARXIGA part of your standard of care for treating your patients with HFrEF

To reduce the risk of cardiovascular death or hospitalization for heart failure1

10 MG

FARXIGA 10 mg Tablet

RECOMMENDED DOSE

FARXIGA tablet shown is not actual size.

ONCE-DAILY
AM DOSING

Calendar Icon

NO
TITRATION

No Titration Icon

COMPLEMENTS EXISTING
HEART FAILURE THERAPY

Plus Pills Icon
  • The label for FARXIGA does not suggest a dose adjustment when used with diuretics. However, before FARXIGA is initiated, the volume status for patients should be assessed and corrected1
  • 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

eGFR=estimated glomerular filtration rate; HFrEF=heart failure with reduced ejection fraction; SGLT2=sodium-glucose cotransporter 2; T2D=type 2 diabetes.

Because risk never rests

FARXIGA—The FIRST and ONLY FDA-approved SGLT2i for patients with HFrEF with and without T2D1-4

Make FARXIGA part of your heart failure standard of care

  • Helped save lives by reducing CV death or hospitalization for heart failure* in patients with HFrEF1
  • Novel pathway complements existing therapies1
  • Well-established safety profile1

For your patients with HFrEF with:

  • Heart failure exacerbations1,†
  • A recent heart failure hospitalization1
Guide to Manage Heart Failure

FOR YOUR PATIENTS:

A Guide to Helping You Manage Heart Failure

FARXIGA Delivers Coverage and Savings Your Patients Can Count On

  • FARXIGA is covered without prior authorization for the majority of your patients
  • Your commercially insured patients may be eligible§ for the FARXIGA Savings Card
FARXIGA Savings Card

*Also includes urgent visits for heart failure.1

In the chronic setting.

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.

§Savings subject to monthly limit. Subject to eligibility. Restrictions apply. Not available for government-insured patients.

CV=cardiovascular; FDA=US Food and Drug Administration; HFrEF=heart failure with reduced ejection fraction; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes.

ISI

Important Safety Information For Farxiga

INDICATIONS AND LIMITATIONS OF USE

Contraindications

  • Prior serious hypersensitivity reaction to FARXIGA
  • Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) being treated for glycemic control without established CV disease or multiple CV risk factors
  • Patients on dialysis

Warnings and Precautions

  • 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
  • Ketoacidosis in Diabetes Mellitus 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
  • 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 with diabetes mellitus 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:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors
  • 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.

DOSING

  • To reduce the risk of CV death and hospitalization for heart failure in patients with HFrEF, the recommended dose of FARXIGA is 10 mg orally once daily
  • To reduce the risk of hospitalization for heart failure in patients with T2D and established CV disease or multiple CV risk factors, the recommended dose of FARXIGA is 10 mg orally once daily
  • To improve glycemic control in patients with T2D, the recommended starting dose of FARXIGA is 5 mg orally 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

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:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors
  • 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.

References:

Reference:

  1. FARXIGA® (dapagliflozin) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.
  2. Invokana® (canagliflozin) [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2020.
  3. Jardiance® (empagliflozin) [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2020.
  4. Steglatro (ertugliflozin) [package insert]. Whitehouse Station, NJ: Merck & Co, Inc; 2020.
  5. McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995-2008.
  6. Petrie MC, Verma S, Docherty KF, et al. Effect of dapagliflozin on worsening heart failure and cardiovascular death in patients with heart failure with and without diabetes. JAMA. 2020;323(14):1353-1368.
  7. Data on File, REF-74540; AstraZeneca Pharmaceuticals LP.
  8. Supplement to: McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995-2008.
  9. Ptaszynska A, Mansfield T, Johnsson E, Parikh SJ, Yavin Y, List JF. Long-term renal safety with dapagliflozin treatment. Poster presented at: 74th Annual Scientific Sessions of the American Diabetes Association; June 13-17, 2014; San Francisco, CA. Poster 1036-P.
  10. Jabbour S, Seufert J, Scheen A, Bailey CJ, Karup C, Langkilde AM. 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.

Important Safety Information For Farxiga

INDICATIONS AND LIMITATIONS OF USE

Contraindications

  • Prior serious hypersensitivity reaction to FARXIGA
  • Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) being treated for glycemic control without established CV disease or multiple CV risk factors
  • Patients on dialysis

FARXIGA is indicated:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors
  • 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 (CV) disease or multiple CV risk factors
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors
  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors