ry tract infection, and increased urination.
Inform female patients of child bearing age that the use of INVOKANA during pregnancy has not been studied in humans, and that INVOKANA should only be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Instruct patients to report pregnancies to their physicians as soon as possible.
Inform nursing mothers to discontinue INVOKANA or nursing, taking into account the importance of drug to the mother.
Laboratory Tests
Due to its mechanism of action, patients taking INVOKANA will test positive for glucose in their urine.
Hypotension
Inform patients that symptomatic hypotension may occur with INVOKANA and advise them to contact their doctor if they experience such symptoms [see Warnings and Precautions (5.1)]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.
Genital Mycotic Infections in Females (e.g., Vulvovaginitis)
Inform female patients that vaginal yeast infection may occur and provide them with information on the signs and symptoms of vaginal yeast infection. Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.5)].
Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis)
Inform male patients that yeast infection of penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with prior history. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.5)].
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions such as urticaria and rash have been reported with INVOKANA. Advise patients to report immediately any signs or symptoms suggesting allergic reaction or angioedema, and to take no more drug until they have consulted prescribing physicians.
Urinary Tract Infections
Inform patients of the potential for urinary tract infections. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur.
Active ingredient made in Belgium
Finished product manufactured by:
Janssen Ortho, LLC
Gurabo, PR 00778
tured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
Licensed from Mitsubishi Tanabe Pharma Corporation
© 2013 Janssen Pharmaceuticals, Inc.
MEDICATION GUIDE
INVOKANA™ (in-vo-KAHN-uh)
(canagliflozin)
Tablets
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
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