Xigduo XR Dosage

Testing Prior to Initiation of XIGDUO XR

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Assess renal function before initiating XIGDUO XR and then as clinically indicated [see Warnings and Precautions (5.1, 5.3)].

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Assess volume status. In patients with volume depletion, correct this condition before initiating 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.

Recommended Dosage

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

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​To improve glycemic control in patients aged 10 years and older not already taking dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily.

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For indications in adults related to heart failure and chronic kidney disease, the recommended dosage 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 dosage of 10 mg dapagliflozin and 2,000 mg metformin HCl extended-release.

Recommended Dosage in Patients with Renal Impairment

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No dosage 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 HCl 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 HCl 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 an eGFR less than 60 mL/min/1.73 m2, 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)].

​2.6 Temporary Interruption for Surgery

​Withhold XIGDUO XR for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume XIGDUO XR when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].