Farxiga Dosage

Prior to Initiation of FARXIGA

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Assess renal function prior to initiation of FARXIGA therapy and then as clinically indicated [see Warnings and Precautions (5.2)].

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Assess volume status. In patients with volume depletion, correct this condition before initiating FARXIGA [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5, 8.6)].

​2.2 Recommended Dosage for Glycemic Control in Adults and Pediatric Patients Aged 10 Years and Older with Type 2 Diabetes Mellitus

​In adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, the recommended starting dosage of FARXIGA is 5 mg orally once daily to improve glycemic control. For additional glycemic control, the dosage can be increased to 10 mg orally once daily.

​For Adult and Pediatric Patients with Type 2 Diabetes Mellitus and Renal Impairment:

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The recommended dosage for FARXIGA in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2 is the same as the recommended dosage in patients with normal renal function.

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FARXIGA is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. FARXIGA is likely to be ineffective to improve glycemic control in this setting based upon its mechanism of action.

Recommended Dosage for Other Indications in Adults

The recommended dosage of FARXIGA is 10 mg orally once daily in adults for the following indications:

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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.

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To reduce the risk of CV death, hHF, and urgent heart failure visit in patients with heart failure.

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To reduce the risk of hHF in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.

For Adults with Renal Impairment Receiving FARXIGA for Indications Other than Glycemic Control:

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The recommended dosage of FARXIGA in patients with an eGFR greater than or equal to 25 mL/min/1.73 m2 is the same as the recommended dosage in patients with normal renal function.

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Initiation with FARXIGA is not recommended in patients with an eGFR less than 25 mL/min/1.73 m2.

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If the eGFR falls below 25 mL/min/1.73 m2 while receiving treatment with FARXIGA, patients may continue FARXIGA 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF.

​2.4 Temporary Interruption for Surgery

​Withhold FARXIGA for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume FARXIGA when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].