Generic name: canagliflozin 50mg, metformin hydrochloride 500mg
Dosage form: tablet, film coated
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- Individualize the starting dose of INVOKAMET (canagliflozin and metformin hydrochloride) based on the patient's current regimen:
In patients currently not treated with either canagliflozin or metformin, initiate therapy with INVOKAMET containing canagliflozin 50 mg and metformin 500 mg [see Clinical Studies (14.1)];
In patients on metformin, switch to INVOKAMET containing canagliflozin 50 mg and the same, or nearest appropriate, daily dose of metformin;
In patients on canagliflozin, switch to INVOKAMET containing metformin 500 mg with the same daily dose of canagliflozin;
In patients already treated with canagliflozin and metformin, switch to INVOKAMET containing the same daily dose of canagliflozin and the same, or nearest appropriate, daily dose of metformin.
- Take one INVOKAMET tablet twice daily with meals; in patients tolerating canagliflozin 50 mg twice daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control, INVOKAMET dose can be increased for the canagliflozin component to 150 mg twice daily, with gradual metformin dose escalation to reduce the gastrointestinal side effects due to metformin [see Dosage Forms and Strengths (3) and Clinical Studies (14.1)].
- 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)].
Recommended Dosage for Patients with Renal Impairment
- Assess renal function before initiating INVOKAMET and periodically thereafter.
- INVOKAMET is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.1, 5.4)].
- Limit the dose of the canagliflozin component to 50 mg twice daily in patients with moderate renal impairment with an eGFR of 45 to less than 60 mL/min/1.73 m2.
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 canagliflozin 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.
Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue INVOKAMET at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 45 and 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 INVOKAMET if renal function is stable [see Warnings and Precautions (5.1)].
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- Drug class: antidiabetic combinations
Other brands: Invokamet XR