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Summary
- INVOKANA is available as 100 mg or 300 mg film-coated tablets for oral administration. The Food and Drug Administration recommended starting dose of INVOKANA is 100 mg once daily, taken before the first meal of the day. In patients tolerating INVOKANA 100 mg once daily who have an estimated glomerular filtration rate (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. In patients with volume depletion, correcting this condition prior to initiation of INVOKANA is recommended.1
- Nine phase 3, randomized, double-blind, parallel-group, placebo- and active-controlled studies evaluated the safety and efficacy of INVOKANA, which included core and extension study periods. In most phase 3 studies, INVOKANA was started at a daily dose of 100 or 300 mg.2-12 In a 52-week phase 3, active-controlled study, patients were randomly assigned to receive either INVOKANA 300 mg or sitagliptin 100 mg daily.13
- The bioequivalence of canagliflozin 3x 100 mg to 1x 300 mg tablet was not conducted in the phase 3 development program. Both tablets are weight multiples of each other.14
CLINICAL STUDIES
- The safety and efficacy of INVOKANA was evaluated in nine phase 3, randomized, double-blind, parallel-group, placebo- and active-controlled studies, which included core and extension study periods. In most phase 3 studies, INVOKANA was administered at a starting dose of 100 or 300 mg once daily.2-12 In one phase 3, active-controlled, 52-week study, patients were randomized to INVOKANA 300 mg or sitagliptin 100 mg once daily.13
- Bioequivalence of canagliflozin 3x 100 mg to 1x 300 mg tablet was not conducted in the phase 3 development program. The 100 mg and 300 mg tablets are compressed from a common granulation, and they have exactly the same formulation and are weight multiples of each other.14
LITERATURE SEARCH
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 12 September 2024.
| 1 | Data on File. Canagliflozin Company Core Data Sheet. Janssen Research & Development, LLC. EDMS-ERI-30791109; 2020. |
| 2 | Stenlöf K, Cefalu WT, Kim KA, et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15(4):372-382. |
| 3 | Cefalu WT, Leiter LA, Yoon KH, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013;382(9896):941-950. |
| 4 | Wilding JP, Charpentier G, Hollander P, et al. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial. Int J Clin Pract. 2013;67(12):1267-1282. |
| 5 | Yale JF, Bakris G, Cariou B, et al. Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2013;15(5):463-473. |
| 6 | Bode B, Stenlöf K, Sullivan D, et al. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013;41(2):72-84. |
| 7 | Forst T, Guthrie R, Goldenberg R, et al. Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes on background metformin and pioglitazone. Diabetes Obes Metab. 2014;16(5):467-477. |
| 8 | Lavalle-González FJ, Januszewicz A, Davidson J, et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56(12):2582-2592. |
| 9 | Stenlöf K, Cefalu WT, Kim KA, et al. Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise: findings from the 52-week CANTATA-M study. Curr Med Res Opin. 2014;30(2):163-175. |
| 10 | Yale JF, Bakris G, Cariou B, et al. Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes mellitus and chronic kidney disease. Diabetes Obes Metab. 2014;16(10):1016-1027. |
| 11 | Leiter LA, Yoon KH, Arias P, et al. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015;38(3):355-364. |
| 12 | Neal B, Perkovic V, Mahaffey K, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(7):644-657. |
| 13 | Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013;36(9):2508-2515. |
| 14 | Center for Drug Evaluation and Research (CDER). INVOKANA (canagliflozin) Tablets - Clinical Pharmacology and Biopharmaceutics Review(s). Food and Drug Administration (FDA); 2012. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000ClinPharmR.pdf. Accessed September 12, 2024. |
