WHAT ARE THE POSSIBLE SIDE EFFECTS OF INVOKANA™?
INVOKANA™ may cause serious side effects, including:
See "What is the most important information I should know about INVOKANA™?"
•a high amount of potassium in your blood (hyperkalemia)
•low blood sugar (hypoglycemia). If you take INVOKANA™ with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA™.
Signs and symptoms of low blood sugar may include:
•shaking or feeling jittery
•serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA™ and call your doctor right away or go to the nearest hospital emergency room. See "Who should not take INVOKANA™?". Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
The most common side effects of INVOKANA™ include:
•vaginal yeast infections and yeast infections of the penis (See "What is the most important information I should know about INVOKANA™?")
•urinary tract infection
•changes in urination, including urgent need to urinate more often, in larger amounts, or at night
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of INVOKANA™. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please see full Prescribing Information (http://www.janssenpharmaceuticalsinc.com/assets/invokana_prescribing_info.pdf) and Medication Guide
( http://www.janssenpharmaceuticalsinc.com/assets/invokana_med_guide.pdf ).
Trademarks are those of their respective owners.
About Janssen Pharmaceuticals, Inc.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Pharmaceuticals, Inc. is dedicated to addressing and resolving the major unmet medical needs of our time. Driven by our commitment to patients, healthcare professionals, and caregivers, we strive to develop sustainable and integrated healthcare solutions by working in partnership with all stakeholders on the basis of trust and transparency. Our daily work is guided by meeting goals of excellence in quality, innovation, safety, and efficacy in order to advance patient care.
Our company provides medicines for an array of illnesses and disorders in several therapeutic areas. Other innovative therapies that Janssen Pharmaceuticals, Inc. offers include ACIPHEX® (rabeprazole sodium), ELMIRON® (pentosan polysulfate sodium), INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension, NUCYNTA® ER (tapentadol extended-release tablets), RISPERDAL® CONSTA® (risperidone) Long-Acting Injection and XARELTO® (rivaroxaban). The full prescribing information for INVEGA® SUSTENNA®, NUCYNTA® ER and RISPERDAL® CONSTA® and XARELTO®, including boxed warnings, are available here
(http://www.invegasustenna.com/important-product-information ), here (http://www.nucynta.com/sites/default/files/pdf/nucyntaer-pi.pdf#zoom=100
), here (http://www.risperdalconsta.com/sites/default/files/RisperdalConstaPI.pdf#zoom=100
), and here (http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf#zoom=100
For more information on Janssen Pharmaceuticals, Inc., visit us at http://www.janssenpharmaceuticalsinc.com or follow us on Twitter at
http://www.twitter.com/JanssenUS and on YouTube at http://www.Youtube.com/JanssenUS .
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at
http;//www.sec.gov , http://www.jnj.com or on request from Johnson & Johnson. Neither Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
*Dr. Aguilar was not associated with the INVOKANA™ clinical trials and was not compensated for any media work. He has been a paid consultant to Janssen Pharmaceuticals, Inc.
1 Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. Available at: http://www.diabetes.org/in-my-community/local-offices/miami-florida/assets/files/national-diabetes-fact-sheet.pdf . Accessed January 28, 2013.
2 Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988–2010. Diabetes Care. 2013 Feb 15. Epub ahead of print.
SOURCE Janssen Pharmaceuticals, Inc.
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