The dosage of antihyperglycaemic therapy with XIGDUO XR should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended dose of dapagliflozin 10 mg and metformin extended-release 2000 mg.
XIGDUO XR should generally be administered once daily with the evening meal. The following tablet strengths are available: XIGDUO XR 10/500 (dapagliflozin 10 mg/metformin HCl extended-release 500 mg), XIGDUO XR 10/1000 (dapagliflozin 10 mg/metformin HCl extended-release 1000 mg), XIGDUO XR 5/1000 (dapagliflozin 5 mg/metformin HCl extended-release 1000 mg).
Initial therapy: If therapy with a combination tablet containing dapagliflozin and metformin is considered appropriate, the recommended dose of dapagliflozin is 10 mg once daily. The recommended starting dose of metformin extended-release is 500 mg once daily, which can be titrated to 2000 mg once daily. The maximum dose of XIGDUO XR is dapagliflozin 10 mg/metformin extended-release 2000 mg taken as two 5 mg/1000 mg tablets once daily.
Add on combination therapy: In patients treated with metformin, the dose of XIGDUO XR should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Following a switch from metformin immediate-release to metformin extended-release, glycaemic control should be monitored closely and dosage adjustments made accordingly.
When dapagliflozin is used as an add-on therapy with insulin or an insulin secretagogue, a lower dose of insulin or an insulin secretagogue may be considered to reduce the risk of hypoglycaemia.
No studies have been performed specifically examining the safety and efficacy of XIGDUO XR in patients previously treated with other antihyperglycaemic agents and switched to XIGDUO XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycaemic control can occur.
If no adequate strength of Xigduo XR is available, individual mono-components should be used instead of the fixed dose combination.
Patients should be informed that XIGDUO XR tablets must be swallowed whole and never crushed, cut, or chewed. Occasionally, the inactive ingredients of XIGDUO XR will be eliminated in the faeces as a soft, hydrated mass that may resemble the original tablet.
Renal Impairment: An eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with eGFR <60 ml/min.
If no adequate strength of XIGDUO XR is available, individual mono components should be used instead of the fixed dose combination. (See Table 11.)
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Hepatic Impairment: Since impaired hepatic function has been associated with some cases of lactic acidosis in patients taking metformin, XIGDUO XR should not be used in patients with clinical or laboratory evidence of hepatic impairment (see Use in hepatic impairment under Precautions).
Paediatric and Adolescent: Safety and effectiveness of XIGDUO XR in paediatric and adolescent patients have not been established.
Use in the Elderly: Because metformin is eliminated by the kidney, and because elderly patients are more likely to have decreased renal function, XIGDUO XR should be used with caution as age increases.