PROVEN IN PATIENTS WITH CKD AT RISK OF PROGRESSION, WITH OR WITHOUT T2D

NOW APPROVED: The first therapy in 20 years to help delay the worsening of CKD1

Protect life: FARXIGA helps protect your patients with CKD at risk of progression against worsening kidney function, ESKD, CV death, and hospitalization for heart failure—so they can live life.1

Efficacy

IN PATIENTS WITH CKD AT RISK OF PROGRESSION, WITH OR WITHOUT T2D

FARXIGA helps protect against CKD progression, dialysis, and CV death1,2

DAPA-CKD primary composite end point2,*

DAPA-CKD Primary Composite End Point
DAPA-CKD Primary Composite End Point

*Sustained ≥50% eGFR decline, ESKD, CV or renal death.2

Consistent results of the primary composite end point regardless of T2D diagnosis2

Results Regardless of T2D Diagnosis
Results Regardless of T2D Diagnosis

Over the median follow-up of 2.4 years.2

Consistent results of the primary composite end point were demonstrated in a broad range of patients with CKD, irrespective of age, race, gender, causes of CKD, T2D diagnosis, baseline eGFR, and UACR levels2

FARXIGA significantly reduced the incidence of all-cause mortality2

DAPA-CKD secondary end point: All-cause mortality

DAPA-CKD Secondary End Point
DAPA-CKD Secondary End Point

Safety

FARXIGA has an expansive, established safety profile2-7

DAPA-CKD: Select AEs in patients with CKD1-3,6,7

  • No occurrences of severe hypoglycemic events* or diabetic ketoacidosis were observed in patients without T2D2
  • No increase in SAEs of hyperkalemia was observed in patients with or without T2D1,6
DAPA-CKD Safety Chart
DAPA-CKD Safety Chart

DAPA-CKD Safety Chart

*Severe hypoglycemia defined as symptoms of severe impairment in consciousness or behavior, need of external assistance, intervention to treat hypoglycemia, and prompt recovery from acute symptoms after the intervention.3

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
  • 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

Pooled safety data across 12 placebo-controlled clinical studies of glycemic control in patients with T2D1

Adverse reactions reported in ≥2% of patients treated with FARXIGA

Pooled Safety Data of Clinical Studies of Glycemic Control in Patients with T2D
Pooled Safety Data of Clinical Studies of Glycemic Control in Patients with T2D
  • Additional common AEs seen in >2% of patients taking FARXIGA included back pain, dyslipidemia, nasopharyngitis, nausea, and influenza1

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


Study Design

The DAPA-CKD study was stopped early due to overwhelming efficacy2,3

DAPA-CKD Study Design
DAPA-CKD Study Design

*ESKD defined as the need for maintenance dialysis (peritoneal or hemodialysis) for at least 28 days, renal transplantation, or sustained eGFR <15 mL/min/1.73 m2 for at least 28 days.2


ACEI=angiotensin-converting enzyme inhibitor; AE=adverse event; ARB=angiotensin II receptor blocker; ARR=absolute risk reduction; CKD=chronic kidney disease; CV=cardiovascular; DAPA-CKD=Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease; eCVD=established cardiovascular disease; eGFR=estimated glomerular filtration rate; ESKD=end-stage kidney disease; HFrEF=heart failure with reduced ejection fraction; HR=hazard ratio; NNT=number needed to treat; RRR=relative risk reduction; SAE=serious adverse event; SGLT2=sodium-glucose cotransporter 2; SoC=standard of care; T2D=type 2 diabetes; UACR=urinary albumin-to-creatinine ratio.

IMPORTANT SAFETY INFORMATION FOR FARXIGA