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FDA Approves Expanded Invokamet Indication
Janssen news release; 2016 May 24
The FDA has approved Invokamet, a combination therapy of canagliflozin and metformin, for first-line treatment of adults with type 2 diabetes.
Indications: Invokamet is a sodium-glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Dosage and administration: Recommended starting dose of canagliflozin is 50 mg twice daily and metformin 500 mg twice daily.
Efficacy and safety: The expanded indication was based largely on a 26-week, double-blind, active-controlled, multicenter phase 3 study that showed those who took the combination had significantly greater decreases in A1C.
Side effects/risks: Most common adverse reactions associated with canagliflozin are female genital mycotic infections, urinary tract infection, and increased urination. Most common adverse reactions associated with metformin are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.
Citation: U.S. FDA expands indication of Invokamet (canagliflozin/metformin HCl) to include first-line treatment of adults with type 2 diabetes [news release]. Raritan, NJ: Janssen Pharmaceuticals, Inc; May 24, 2016. http://www.prnewswire.com/news-releases/us-fda-expands-indication-of-invokamet-canagliflozinmetformin-hcl-to-include-first-line-treatment-of-adults-with-type-2-diabetes-300273797.html. Accessed May 25, 2016.
Invokamet [package insert]. Raritan, NJ: Janssen Pharmaceuticals, Inc 2016. https://www.invokamet.com/prescribing-information.pdf. Accessed May 25, 2016.
                        