What is the dosing of Farxiga (dapagliflozin) for renal benefits, is it only 10 milligrams?

From the Guidelines

For renal benefits, Farxiga (dapagliflozin) is dosed at 10 mg once daily, which is the only approved dose for chronic kidney disease, as supported by the most recent evidence from 1 and 1. This dosage has been shown to reduce the risk of kidney function decline, kidney failure, and cardiovascular death in patients with chronic kidney disease with or without type 2 diabetes. The medication works by inhibiting sodium-glucose cotransporter-2 (SGLT2) in the kidneys, which reduces glucose reabsorption and increases glucose excretion in urine. Key points to consider when prescribing Farxiga for renal benefits include:

• The medication should be taken in the morning with or without food.
• Patients should maintain adequate hydration while taking this medication and be aware of potential side effects such as genital mycotic infections and volume depletion.
• Kidney function should be assessed before starting treatment, and the medication is not recommended for patients with severe kidney impairment (eGFR less than 25 mL/min/1.73m²) or end-stage renal disease, as indicated in 1 and 1. Some important considerations for dosing adjustments based on kidney function are:
• For patients with an eGFR of 25 to <45 mL/min/1.73m², the dose of Farxiga is 10 mg once daily, as stated in 1.
• Initiation of Farxiga is not recommended in patients with an eGFR <25 mL/min/1.73m², but it may be continued in patients with heart failure and chronic kidney disease who are already on the medication, as noted in 1.

From the FDA Drug Label

To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression The recommended dosage of DAPAGLIFLOZIN TABLETS is 10 mg orally once daily in adults for the following indications: • To reduce the risk of sustained eGFR decline, end stage kidney disease (ESKD), cardiovascular (CV) death, and hospitalization for heart failure (hHF) in patients with chronic kidney disease at risk of progression

The recommended dosing for renal benefits of Farxiga (dapagliflozin) is 10 mg orally once daily.

• The dosage is the same for patients with an eGFR greater than or equal to 25 mL/min/1.73 m2 as for those with normal renal function.
• Patients with an eGFR less than 25 mL/min/1.73 m2 should not initiate treatment, but those already on the medication may continue at 10 mg orally once daily if their eGFR falls below 25 mL/min/1.73 m2 2.

From the Research

Dapagliflozin Dosing for Renal Benefits

• The dosing of dapagliflozin for renal benefits is typically 10 mg once daily, as seen in the DAPA-CKD trial 3.
• This trial demonstrated that dapagliflozin significantly reduced the risk of a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes in patients with chronic kidney disease 3.
• The study found that the effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes, suggesting a potential renoprotective effect of the drug 3.

Mechanism of Action

• Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor that has been shown to have antihyperglycemic, cardioprotective, and possibly renoprotective properties 4, 5.
• The mechanism of action of dapagliflozin on heart function in non-diabetic patients with decompensated heart failure remains to be explored 5.
• SGLT2 inhibitors, including dapagliflozin, have been found to exert renal protection by suppressing inflammation and fibrosis, in addition to modulation of hemodynamic and metabolic activities 6.

Clinical Trials and Studies

• The DAPA-CKD trial was a randomized controlled trial that demonstrated the efficacy of dapagliflozin in reducing the risk of renal and cardiovascular outcomes in patients with chronic kidney disease 3.
• Other studies have also shown that dapagliflozin improves glycemic control, lowers blood pressure, and reduces body weight, all of which may contribute to its renoprotective effects 4, 7.
• Further research is needed to fully understand the benefits and mechanisms of action of dapagliflozin in patients with renal disease 6, 7.