f -0.57% (95% CI: -0.71; -0.44) for INVOKANA 100 mg and -0.70% (95% CI: -0.84; -0.57) for INVOKANA 300 mg. Statistically significant (p<0.001 for both doses) reductions from baseline in fasting plasma glucose (FPG) and body weight were also observed in this study relative to placebo [see Use in Specific Populations (8.5)].
Moderate Renal Impairment
A total of 269 patients with type 2 diabetes and a baseline eGFR of 30 mL/min/1.73 m2 to less than 50 mL/min/1.73 m2 inadequately controlled on current diabetes therapy participated in a 26-week, double-blind, placebo-controlled clinical study to eva luate the efficacy and safety of INVOKANA in combination with current diabetes treatment (diet or antihyperglycemic agent therapy, with 95% of patients on insulin and/or sulfonylurea). The mean age was 68 years, 61% of patients were men, and the mean baseline eGFR was 39 mL/min/1.73 m2. Patients were randomized to the addition of INVOKANA 100 mg, INVOKANA 300 mg, or placebo, administered once daily.
At the end of treatment, INVOKANA 100 mg and INVOKANA 300 mg daily provided greater reductions in HbA1C relative to placebo (-0.30% [95% CI: -0.53; -0.07] and -0.40%, [95% CI: -0.64; -0.17], respectively) [see Warnings and Precautions (5.2), Adverse Reactions (6.1), and Use in Specific Populations (8.6)].
16 HOW SUPPLIED/STORAGE AND HANDLINGINVOKANA (canagliflozin) tablets are available in the strengths and packages listed below:
100 mg tablets are yellow, capsule-shaped, film-coated tablets with "CFZ" on one side and " 100" on the other side.
NDC 50458-140-30 Bottle of 30
NDC 50458-140-90 Bottle of 90
NDC 50458-140-50 Bottle of 500
NDC 50458-140-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)
300 mg tablets are white, capsule-shaped, film-coated tablets with "CFZ" on one side and " 300" on the other side.
NDC 50458-141-30 Bottle of 30
NDC 50458-141-90 Bottle of 90
NDC 50458-141-50 Bottle of 500
NDC 50458-141-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)
Storage and Handling
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).
17 PATIENT COUNSELING INFORMATIONSee FDA-approved patient labeling (Medication Guide).
Instructions
Instruct patients to read the Medication Guide before starting INVOKANA (canagliflozin) therapy and to reread it each time the prescription is renewed.
Inform patients of the potential risks and benefits of INVOKANA and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.
Instruct patients to take INVOKANA only as prescribed. If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of INVOKANA at the same time.
Inform patients that the most common adverse reactions associated with INVOKANA are genital mycotic infection, urina |
