DUEXIS, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.
Important safety information
Risk of Serious Cardiovascular and Gastrointestinal Events
See full Prescribing Information for complete boxed warning (according to the U.S.
Ibuprofen, a component of DUEXIS, may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a component of DUEXIS, increase the risk of serious gastrointestinal adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.
DUEXIS should not be given to patients who have experienced asthma, urticaria or allergic reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylaxis with NSAIDs has been reported in such patients. DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery. DUEXIS is contraindicated in patients in late stages of pregnancy as premature closure of the ductus arteriosus in the fetus may occur. DUEXIS should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. Cross sensitivity with other H2-receptor antagonists has been observed.
When active and clinically significant bleeding from any source occurs in patients receiving DUEXIS, the treatment should be withdrawn.
NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Monitor blood pressure closely during treatment with DUEXIS.
Fluid retention and edema have been observed in some patients taking NSAIDs. DUEXIS should be used with caution in patients with fluid retention or heart failure.
Long-term administration of NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, has resulted in renal papillary necrosis and other renal injury. Use DUEXIS with caution in patients at risk (e.g., the elderly; those with renal impairment, heart failure or liver impairment and those taking diuretics or ACE inhibitors).
Hepatic injury ranging from transaminase elevations to liver failure can occur. If clinical signs and symptoms consistent with liver disease develop, if abnormal liver tests persist or worsen or if systemic manifestations occur, DUEXIS should be discontinued immediately.
Anaphylaxis may occur in patients with the aspirin triad or in patients without prior exposure to DUEXIS. If an anaphylactoid reaction occurs, DUEXIS should be discontinued immediately.
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be fatal, can occur. Discontinue DUEXIS if rash or other signs of local skin reaction occur.
Nursing mothers should use DUEXIS with caution, as it is not known if ibuprofen is excreted in human milk, and famotidine is excreted in human milk.
The most common adverse reactions (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain and headache.
For further information on DUEXIS, please see full Prescribing Information at www.DUEXIS.com.
This press release contains forward-looking statements, including statements regarding a potentially streamlined review process for Horizon's MAA for DUEXIS and the timing for a decision on the updated MAA. 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, but are not limited to, risks regarding Valeant's ability to comply with on-going regulatory requirements with respect to the
Robert J. De VaereExecutive Vice President and Chief Financial Officer Email Contact Media Julie NormartInvigorate PR 415-946-1087 Email Contact Investors Kathy Galante Burns McClellan, Inc.212-213-0006 Email Contact
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