INVOKANA
By Janssen Pharmaceuticals, Inc. | Last revised: 31 March 2013
INVOKANA- canagliflozin tablet, film coated
Janssen Pharmaceuticals, Inc.
1 INDICATIONS AND USAGEINVOKANA™ (canagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].
Limitation of Use
INVOKANA is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
2 DOSAGE AND ADMINISTRATION2.1 Recommended DosageThe recommended starting dose of INVOKANA (canagliflozin) is 100 mg once daily, taken before the first meal of the day. In patients tolerating INVOKANA 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control, the dose can be increased to 300 mg once daily [see Warnings and Precautions (5.2), Clinical Pharmacology (12.2), and Patient Counseling Information (17)].
In patients with volume depletion, correcting this condition prior to initiation of INVOKANA is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5 and 8.6), and Patient Counseling Information (17)].
2.2 Patients with Renal ImpairmentNo dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater).
The dose of INVOKANA is limited to 100 mg once daily in patients with moderate renal impairment with an eGFR of 45 to less than 60 mL/min/1.73 m2.
INVOKANA should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2.
Assessment of renal function is recommended prior to initiation of INVOKANA therapy and periodically thereafter. INVOKANA should be discontinued when eGFR is persistently less than 45 mL/min/1.73 m2 [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].
2.3 Concomitant Use with UDP-Glucuronosyl Transferase (UGT) Enzyme InducersIf an inducer of UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) is co-administered with INVOKANA, consider increasing the dosage to 300 mg once daily in patients currently tolerating INVOKANA 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control [see Drug Interactions (7.1)].
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.
3 DOSAGE FORMS AND STRENGTHS◦INVOKANA 100 mg tablets are yellow, capsule-shaped, film-coated tablets with "CFZ" on one side and "100" on the other side.
◦INVOKANA 300 mg tablets are white, capsule-shaped, film-coated tablets with "CFZ" on one side and "300" on the other side.
4 CONTRAINDICATIONS◦History of a serious hypersensitivity reaction to INVOKANA [see Warnings and Precautions (5.6)].
◦Severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end stage renal disease or patients on dialysis [see Warnings and Precautions (5.2), and Use in Specific Populations (8.6)].
5 WARNINGS AND PRECAUTIONS5.1 HypotensionINVOKANA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating INVOKANA [see Adverse Reactions (6.1)] particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensin-aldosterone syst