FARXIGA is the FIRST and ONLY FDA-approved SGLT2i for patients with HFrEF with and without type 2 diabetes.1-4
As proven in the DAPA-HF trial, FARXIGA may reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF).
Now may be the time to consider FARXIGA as part of your standard of care for patients with HFrEF with heart failure exacerbations* or those recently hospitalized for heart failure.1
The landmark DAPA-HF trial is the largest SGLT2i study to date for patients with HFrEF1,5,†
DAPA-HF enrolled 4744 patients with HFrEF on guideline-directed medical therapy (GDMT)1,5
ELIGIBILITY CRITERIA
- ≥18 years of age
- Diagnosis of symptomatic HFrEF (NYHA class II-IV)
- LVEF ≤40%
- Elevated NT-proBNP ≥600 pg/mL (or ≥400 pg/mL if hospitalized for heart failure within the past 12 months)
- eGFR ≥30 mL/min/1.73 m2
Baseline medications in DAPA-HF reflected broad use of GDMT1,5
- Patients were well-treated on standard of care, including beta-blockers, diuretics, RAASi therapy (ACEIs, ARBs, ARNI), and MRAs
Primary end point1,5:
- Time to first occurrence of any of the components of the composite of cardiovascular death, hospitalization for heart failure, or urgent visit for heart failure
*In the chronic setting.
†As of August 21, 2020.
ACEI=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor blocker; ARNI=angiotensin receptor-neprilysin inhibitor; DAPA-HF=Dapagliflozin And Prevention of Adverse outcomes in Heart Failure; eGFR=estimated glomerular filtration rate; FDA=US Food and Drug Administration; HFrEF=heart failure with reduced ejection fraction; LVEF=left ventricular ejection fraction; MRA=mineralocorticoid receptor antagonist; NT-proBNP=N-terminal pro B-type natriuretic peptide; NYHA=New York Heart Association; RAASi=renin-angiotensin aldosterone system inhibitor; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes.
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,*
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)
Patients without T2D (n=2605)
Patients with T2D (n=2139)
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.
Secondary outcomes: All-cause mortality across DAPA-HF study population1
*Data represented as event rates over a median follow-up of 18.2 months.1
ARR=absolute risk reduction; DAPA-HF=Dapagliflozin And Prevention of Adverse outcomes in Heart Failure; HR=hazard ratio; RRR=relative risk reduction; SoC=standard of care.
Reference:
- 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.
Results for the primary composite end point were consistent across subgroups, including patients with and without T2D1
T2D=type 2 diabetes.
Reference:
- 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.
Safety profile of FARXIGA in DAPA-HF across patients with and without T2D6
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 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
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
RECOMMENDED DOSE
FARXIGA tablet shown is not actual size.
ONCE-DAILY
AM DOSING
NO
TITRATION
COMPLEMENTS EXISTING
HEART FAILURE THERAPY
- 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
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.
eGFR=estimated glomerular filtration rate; HFrEF=heart failure with reduced ejection fraction; SGLT2=sodium-glucose cotransporter 2; T2D=type 2 diabetes.
IN PATIENTS WITH HFrEF
Help save lives now by reducing CV death or hospitalization for heart failure1
Novel pathway complements existing therapies1
Well-established safety profile1
Covered without prior authorization for the majority of Commercial and Medicare Part D patients nationwide11,*
Make FARXIGA part of your standard of care now for your patients with HFrEF with heart failure exacerbations† or a recent heart failure hospitalization
FARXIGA Delivers Savings Your Eligible Patients Can Count On
*As low as $0 for as long as your doctor prescribes any available dose of FARXIGA.
†Data on File. US-8797; AstraZeneca Pharmaceuticals LP.
*As low as $0 for as long as your doctor prescribes any available dose of FARXIGA.
†Data on File. US-8797; AstraZeneca Pharmaceuticals LP.
*“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.
†In the chronic setting.
CV=cardiovascular; HFrEF=heart failure with reduced ejection fraction.
ISI
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:
- FARXIGA® (dapagliflozin) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.
- Invokana® (canagliflozin) [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2020.
- Jardiance® (empagliflozin) [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2020.
- Steglatro™ (ertugliflozin) [package insert]. Whitehouse Station, NJ: Merck & Co, Inc; 2020.
- 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.
- 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.
- Data on File, REF-74540; AstraZeneca Pharmaceuticals LP.
- 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.
- 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.
- 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.
- Formulary data are provided by Fingertip Formulary® and are current as of September 2020.