in the United States
"With the launch of DUEXIS, patients who suffer from the pain and inflammation of rheumatoid arthritis and osteoarthritis, and who also may be at risk for developing upper gastrointestinal ulcers from NSAID use, have a new and potentially important treatment option," said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. "Beginning today, our sales representatives are introducing DUEXIS to physicians across the United States. We expect broad managed care access to DUEXIS and plan to ensure it is available to patients at a reasonable out of pocket cost."
About DUEXIS
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.
For more information about DUEXIS, including Full Prescribing information, please visit: www.DUEXIS.com
Recent Press Releases
May 10, 2012
Horizon Pharma Announces First Quarter 2012 Financial Results
May 07, 2012
Annals of the Rheumatic Diseases Publishes Pivotal Phase 3 Study Demonstrating Efficacy and Safety of RAYOS(R) (Delayed-Release Prednisone) in Combination With DMARD Therapy in Rheumatoid Arthritis Patients
May 02, 2012
Horizon Pharma to Present at the 11th Annual JMP Securities Research Conference
AGA Institute and Horizon Pharma Launch "Connect to Protect" Program to Educate Physicians and Consumers on Risks Associated with NSAID Use
Important DUEXIS® (ibuprofen and famotidine) Tablets Safety Information
Cardiovascular and Gastrointestinal Risks
· 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 pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.
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 (eg, 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 anaphylacoid 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.