What are the presentations of Farxiga (dapagliflozin)?

From the Guidelines

Farxiga (dapagliflozin) is available in two tablet strengths: 5 mg and 10 mg for oral administration, with the recommended dose being 10 mg once daily, as indicated by the most recent evidence 1. The tablets are yellow, biconvex, round, and film-coated, with "5" or "10" engraved on one side depending on the strength.

• Farxiga is typically packaged in bottles or blister packs containing 30 tablets for a one-month supply.
• The medication works as an SGLT2 inhibitor, reducing blood glucose by preventing kidney reabsorption of glucose, causing it to be excreted in urine.
• Farxiga is indicated for adults with type 2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease, as supported by studies such as DAPA-HF 1 and EMPEROR-Reduced 1.
• Patients should be advised about potential side effects including genital mycotic infections, urinary tract infections, and volume depletion, particularly when initiating therapy, as noted in the evidence 1.
• The benefits of Farxiga in reducing the risk of worsening heart failure and cardiovascular death have been consistently demonstrated across multiple trials, including EMPA-REG OUTCOME, CANVAS, DECLARE-TIMI 58, and CREDENCE, with the most recent meta-analysis confirming these findings 1.

From the FDA Drug Label

Table 18: DAPAGLIFLOZIN TABLETS Presentations Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Package Size NDC Code 5 mg yellow, biconvex, round “5” engraved on one side and “1427” engraved on the other side Bottles of 30 66993-456-30 10 mg yellow, biconvex, diamond-shaped “10” engraved on one side and “1428” engraved on the other side Bottles of 30 66993-457-30

Dapagliflozin presentations are available in two strengths:

• 5 mg: yellow, biconvex, round tablets with “5” engraved on one side and “1427” engraved on the other side, available in bottles of 30.
• 10 mg: yellow, biconvex, diamond-shaped tablets with “10” engraved on one side and “1428” engraved on the other side, available in bottles of 30 2.

From the Research

Farxiga Presentations

• Farxiga, also known as empagliflozin, is a sodium-glucose co-transporter-2 (SGLT2) inhibitor used in the treatment of type 2 diabetes mellitus (T2DM) and heart failure 3, 4, 5.
• The medication has been shown to have a favorable effect on non-glycemic outcomes, including modest reductions in body weight and blood pressure, as well as cardioprotective and renoprotective properties 4, 5.
• Empagliflozin has been compared to other SGLT2 inhibitors, such as canagliflozin and dapagliflozin, in terms of its efficacy in reducing hospitalization for heart failure and cardiovascular death in patients with T2DM and established cardiovascular disease 6, 7.
• Studies have demonstrated that empagliflozin is generally well-tolerated and has a low inherent risk of hypoglycemia, making it a valuable treatment option for patients with T2DM 4, 5.
• The cost-effectiveness of empagliflozin has also been evaluated, with results suggesting that it is a cost-effective treatment option compared to canagliflozin, dapagliflozin, and standard of care in patients with T2DM and established cardiovascular disease 7.

Clinical Evidence

• The EMPA-REG OUTCOME trial demonstrated that empagliflozin reduced major adverse cardiovascular events (MACE) by 14%, cardiovascular death by 38%, and hospitalization for heart failure (HHF) by 35% compared to placebo 4, 5, 7.
• The CANVAS Program and DECLARE-TIMI 58 trial also evaluated the efficacy of canagliflozin and dapagliflozin, respectively, in reducing MACE and HHF in patients with T2DM and established cardiovascular disease 7.
• A comparison of the three SGLT2 inhibitors (empagliflozin, canagliflozin, and dapagliflozin) in patients with decompensated heart failure and T2DM found that they had similar effects on glycosuria, body weight, and blood pressure, but differed in their effects on neurohumoral responses 6.

Treatment Options

• Empagliflozin is approved for use in adults with T2DM and established cardiovascular disease to reduce the risk of cardiovascular death 4, 7.
• The medication can be used as monotherapy or in combination with other antidiabetic agents to improve glycemic control in patients with T2DM 4.
• Empagliflozin has been shown to be a valuable treatment option for patients with T2DM and heart failure, and its use is worthy of consideration in patients at high cardiovascular risk 4, 5.