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 (CV) thrombotic events, including myocardial infarction (MI) 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 ibuprofen at 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.
- Avoid use of DUEXIS in patients with a recent MI unless benefits are expected to outweigh the risk of recurrent CV thrombotic events. If DUEXIS is used in patients with a recent MI, monitor paitents for signs of cardiac ischemia.
- Dicontinue DUEXIS if active and clinically significant bleeding from any source occurs.
- 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.
- Monitor renel function in patients with renal or hepatic impairment, heart failure, dehydration, or hyovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh the risk of worsening renal function.
- 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.
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as DUEXIS. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue DUEXIS and evaluate the patient immediately.
- Limit use of NSAIDs, including DUEXIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
- Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
See full Prescribing Information for a list of clinically important drug interactions.
- The most common adverse reactions in the clinical trials (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain, and headache.
USE IN SPECIFIC POPULATIONS
- Use of NSAIDs, including DUEXIS, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios.
Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy.
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.