RAYOS is contraindicated in patients who have known hypersensitivity to prednisone or to any of the excipients. Rare instances of anaphylaxis have occurred in patients receiving corticosteroids.
Important information about RAYOS
Do not use RAYOS if you are allergic to prednisone.
Long-term use of RAYOS can affect how your body responds to stress. Symptoms can include weight gain, severe fatigue, weak muscles and high blood sugar.
RAYOS can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had.
RAYOS can cause high blood pressure, salt and water retention and low blood potassium.
There is an increased risk of developing holes in the stomach or intestines if you have certain stomach and intestinal disorders.
Behavior and mood changes can occur, including intense excitement or happiness, sleeplessness, mood swings, personality changes or severe depression.
Long-term use of RAYOS can cause decreases in bone density.
RAYOS can cause cataracts, eye infections and glaucoma.
Do not receive a "live" vaccine while taking RAYOS. The vaccine may not work as well during this time and may not fully protect you from disease.
Taking RAYOS during the first trimester of pregnancy can harm an unborn baby.
Long-term use of RAYOS can slow growth and development in children.
The most common side effects with RAYOS are water retention, high blood sugar, high blood pressure, unusual behavior and mood changes, increased appetite and weight gain.
Please see full prescribing information for RAYOS at www.RAYOSrx.com.
About Horizon Pharma
Horizon Pharma, Inc. is a specialty pharmaceutical company that has developed and is commercializing DUEXIS and RAYOS/LODOTRA, both of which target unmet therapeutic needs in arthritis, pain and inflammatory diseases. The Company's strategy is to develop, acquire, in-license and/or co-promote additional innovative medicines where it can execute a targeted commercial approach in specific therapeutic areas while taking advantage of its commercial strengths and the infrastructure the Company has put in place.
About Skyepharma PLC
Skyepharma uses its multiple drug delivery technologies and expertise to create pharmaceutical products. The Group receives revenues from 13 approved products in the areas of inhalation, oral, topical and injectable delivery as well as generating income from the development of further products and technology licenses. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.Skyepharma.com.
This press release contains forward-looking statements, including statements regarding the issuance of a patent based on the notice of allowance from the U.S. Patent and Trademark Office and the ability to protect the innovation and commercial potential of RAYOS. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include risks regarding whether the administrative processes required for the issuance of a patent as indicated in the notice of allowance will be completed in a timely matter or at all, whether the patent, if issued as indicated in the notice of allowance, will provide sufficient protection and market exclusivity for RAYOS, whether any patents issued to Horizon may be challenged, invalidated, infringed or circumvented by third parties and other factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release, and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.
Robert J. De Vaere
Executive Vice President, Chief Financial Officer
Burns McClellan, Inc.
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