INDICATIONS AND USAGE
DUEXIS® (ibuprofen and famotidine), a 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
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- DUEXIS is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Bleeding, Ulceration, and Perforation
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
- DUEXIS is contraindicated in patients:
- With a known hypersensitivity to ibuprofen or famotidine or any components of the drug product or known hypersensitivity to other H2-receptor antagonists
- Who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Fatal anaphylactic reactions to NSAIDs have been reported in such patients
- In the setting of coronary artery bypass graft (CABG) surgery
WARNINGS AND PRECAUTIONS
- Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
- There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as DUEXIS, increases the risk of serious GI events.
- Elevation of one or more liver tests may occur during therapy with NSAIDs. DUEXIS should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop.
- Hypertension can occur with NSAID treatment. Monitor blood pressure closely with DUEXIS treatment.
- Avoid use of DUEXIS in patients with severe heart failure unless benefits are expected to outweigh the risk.
- Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
- Long-term administration of NSAIDs can result in renal papillary necrosis, other renal injury and renal toxicity. Use DUEXIS with caution in patients at greatest risk of this reaction.
- DUEXIS is not recommended in patients with creatinine clearance <50 mL/min.
- Anaphylactic reactions may occur in patients with or without known hypersensitivity to DUEXIS and in patients with aspirin-sensitive asthma.
- DUEXIS can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue use at first appearance of skin rash or any other sign of hypersensitivity.
- Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
- Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen, which is a component of DUEXIS.
- See full Prescribing Information for a list of clinically important drug interactions.
- The most common adverse reactions in the pivotal trials (>1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain, and headache.
USE IN SPECIFIC POPULATIONS
- DUEXIS should not be used in pregnant or lactating women. Consider withdrawal of NSAIDs, including DUEXIS, in women who have difficulties conceiving or who are undergoing investigation of infertility.
- Safety and efficacy of DUEXIS in pediatric patients has not been established.
For further information on DUEXIS, please see the Medication Guide and full Prescribing Information, including boxed warning, at www.DUEXIS.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.