2.1 Recommended Dosage
Individualize the starting dose of INVOKAMET (canagliflozin and metformin hydrochloride) based on the patient's current regimen:
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In patients on metformin, switch to INVOKAMET containing canagliflozin 50 mg with a similar total daily dose of metformin;
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In patients on canagliflozin, switch to INVOKAMET containing metformin 500 mg with a similar total daily dose of canagliflozin;
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In patients already treated with canagliflozin and metformin, switch to INVOKAMET containing the same total daily doses of each component.
Take INVOKAMET twice daily with meals, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin [see Dosage Forms and Strengths (3)].
In patients with volume depletion not previously treated with canagliflozin, correct this condition before initiating INVOKAMET [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), (8.6), and Patient Counseling Information (17)].
Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin 2000 mg and canagliflozin 300 mg in patients with an eGFR of 60 mL/min/1.73 m2 or greater [see Dosage and Administration (2.2)].
2.2 Recommended Dosage for Patients with Renal Impairment
Assess renal function before initiating INVOKAMET and periodically thereafter.
Do not initiate or continue INVOKAMET in patients with serum creatinine levels greater than or equal to 1.5 mg/dL for males or 1.4 mg/dL for females. In patients who meet these serum creatinine levels, do not initiate or continue INVOKAMET if eGFR is persistently less than 45 mL/min/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.3)].
No dose adjustment of INVOKAMET is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater).
Limit the dose of INVOKAMET to canagliflozin 50 mg twice daily in patients with moderate renal impairment with an eGFR of 45 to less than 60 mL/min/1.73 m2.
2.3 Concomitant Use with UDP-Glucuronosyl Transferase (UGT) Enzyme Inducers
If an inducer of UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) is co-administered with INVOKAMET, consider increasing the dose to canagliflozin 150 mg twice daily in patients currently tolerating 50 mg twice daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control [see Drug Interactions (7.2)].
Consider another antihyperglycemic agent in patients with an eGFR of 45 to less than 60 mL/min/1.73 m2 receiving concurrent therapy with a UGT inducer.
