Prior to Initiation of XIGDUO XR

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Assess renal function before initiating XIGDUO XR therapy and periodically thereafter [see Warnings and Precautions (5.1, 5.3)].

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​Assess volume status and, if necessary, correct volume depletion prior to initiation of XIGDUO XR [see Warnings and Precautions (5.3)​ and Use in Specific Populations (8.5​, 8.6)​].

Recommended Administration

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Take XIGDUO XR orally once daily in the morning with food.

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Swallow XIGDUO XR tablets whole and never crush, cut, or chew.

​2.3 Recommended Dosage

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Individualize the starting dose of XIGDUO XR based upon the patient’s current regimen. Patients taking an evening dose of metformin extended-release should skip their last dose before starting XIGDUO XR.

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To improve glycemic control in patients not already taking dapagliflozin, the recommended starting dose for dapagliflozin is 5 mg once daily.

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​For indications related to heart failure and chronic kidney disease the recommended dose for dapagliflozin is 10 mg once daily.

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Dosing may be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 10 mg dapagliflozin and 2,000 mg metformin hydrochloride (HCl) extended-release.

Patients with Renal Impairment

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No dose adjustment for XIGDUO XR is needed in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2.

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Initiation of XIGDUO XR is not recommended in patients with an eGFR between 30 and 45 mL/min/1.73 m2. Assess the benefit and risk of continuing therapy if eGFR falls persistently below this level.

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Dapagliflozin is likely to be ineffective to improve glycemic control in patients with eGFR less than 45 mL/min/1.73 m2.

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Metformin initiation is not recommended for patients with eGFR less than 45 mL/min/1.73 m2.

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XIGDUO XR is contraindicated in patients with an eGFR below 30 mL/min/1.73 m2, end-stage renal disease, or on dialysis due to the metformin component [see Contraindications (4), Warnings and Precautions (5.1, 5.2), and Use in Specific Populations (8.6)].

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue XIGDUO XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart XIGDUO XR if renal function is stable [see Warnings and Precautions (5.1)].