New Data From the Phase III DAPA-HF Trial Showed FARXIGA Reduced the Worsening of Heart Failure or Cardiovascular Death in HFrEF Patients With and Without Chronic Kidney Disease - Seite 2

AstraZeneca announced in August 2019 that the US Food and Drug Administration (FDA) granted Fast Track designation for the development of FARXIGA to delay the progression of renal failure and prevent CV and renal death in patients with CKD. The Phase III DAPA-CKD trial evaluates the effect of FARXIGA on renal outcomes and CV mortality in patients with CKD with and without T2D versus placebo, on top of standard of care. Additionally, in September 2019, the FDA granted Fast Track designation for FARXIGA to reduce the risk of CV death, or the worsening of HF in adults with HFrEF or HF with preserved ejection fraction (HFpEF) based on the Phase III DAPA-HF and DELIVER trials. FARXIGA is not approved to reduce the risk of HF in patients without T2D, or to reduce the risk of CV death or renal disease.

Indication and Limitations of Use for FARXIGA (dapagliflozin) tablets

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.

Important Safety Information for FARXIGA (dapagliflozin) tablets

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