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U.S. FDA Approves INVOKANA™ (Canagliflozin) For The Treatment Of Adults With Type 2 Diabetes

In studies of INVOKANA™ as monotherapy or in combination with agents not associated with hypoglycemia (such as metformin or metformin and pioglitazone), the incidence of hypoglycemic episodes were less than 5 percent across the groups (INVOKANA™ 100 mg [3.8 percent], INVOKANA™ 300 mg [4.3 percent], and placebo [2.2 percent]). There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA™ or any other antidiabetic medication. Additional data are being collected to further characterize the cardiovascular profile of INVOKANA™.

The Phase 3 studies for INVOKANA™ were presented at the American Diabetes Association ( ADA) Annual Scientific Sessions in June 2012, at the European Association for the Study of Diabetes ( EASD) Annual Meeting in October 2012, and at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension ( CODHy) in November 2012.

Janssen and its affiliates have rights to INVOKANA™ through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand, and parts of Asia.

About Type 2 Diabetes

The U.S. Centers for Disease Control and Prevention estimates that nearly 26 million Americans have diabetes, 90 to 95 percent of which is type 2 diabetes. Type 2 diabetes is a chronic condition that affects the body's ability to metabolize sugar, or glucose, and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin. 1 U.S. national data from 2007 to 2010 show that nearly half of adults with type 2 diabetes were not achieving recommended levels of glucose control. 2

Approximately 60 percent of patients with type 2 diabetes in the United States are obese, while another 30 percent are overweight. In most people at risk for type 2 diabetes, obesity causes the body to resist the action of insulin, and if the pancreatic beta cell cannot produce enough insulin, hyperglycemia and type 2 diabetes ensue. If left uncontrolled, type 2 diabetes can lead to serious complications; improved glycemic control has been demonstrated to reduce the onset and progression of these complications. 1

INDICATION STATEMENT

WHAT IS INVOKANA™?
  • INVOKANA™ is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
  • INVOKANA™ is not for people with type 1 diabetes.
  • INVOKANA™ is not for people with diabetic ketoacidosis (increased ketones in blood or urine).
  • It is not known if INVOKANA™ is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT INVOKANA™?INVOKANA™ can cause important side effects, including:
  • Dehydration. INVOKANA™ can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension).

You may be at higher risk of dehydration if you:
    • have low blood pressure
    • take medicines to lower your blood pressure, including diuretics (water pill)
    • are on low sodium (salt) diet
    • have kidney problems
    • are 65 years of age or older
  • Vaginal yeast infection. Women who take INVOKANA™ may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
    • vaginal odor
    • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
    • vaginal itching
  • Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA™ may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
    • redness, itching, or swelling of the penis
    • rash of the penis
    • foul smelling discharge from the penis
    • pain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

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