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Exjade(R) Benefits Chronically Transfused Patients by Significantly Reducing Toxic Iron That Can Damage Key Organs, According to Landmark Trial
Date:12/8/2008

dilated fundoscopy) are recommended before the start of EXJADE treatment and thereafter at regular intervals (every 12 months). If disturbances are noted, consider dose reduction or interruption.

Gastrointestinal (GI) irritation may occur during Exjade treatment. Upper GI ulceration and hemorrhage have been reported in patients, including children and adolescents, receiving Exjade. Physicians and patients should remain alert for signs and symptoms of GI ulceration and hemorrhage and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. Use caution when administering Exjade in combination with drugs that have ulcerogenic or hemorrhagic potential, such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates, or anticoagulants.

The most frequently occurring adverse reactions with a suspected relationship to EXJADE were diarrhea, vomiting, nausea, abdominal pain, skin rash, and increases in serum creatinine. Maintenance of adequate hydration for patients experiencing diarrhea or vomiting is recommended. Gastrointestinal symptoms, increases in serum creatinine, and skin rash were dose related. These commonly reported adverse events were predominantly mild to moderate in severity with serious adverse events reported in 9.1% of patients in the EXJADE arm and 8.6% of patients in the deferoxamine arm.

For full prescribing information, please visit www.us.exjade.com

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "potentially," "can," "risk," "will," "may," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Exjade or regarding potential future revenues from Exjade. You should not place undue reliance on these statemen
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SOURCE Novartis Pharmaceuticals Corporation
Copyright©2008 PR Newswire.
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