IMPORTANT SAFETY INFORMATION AND INDICATION
Important Safety Information and Indications
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 the treatment and may increase with duration of use
- CELEBREX 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
Use CELEBREX at the lowest dose for the shortest duration possible to minimize risk of CV, GI and hepatic adverse events.
- Known hypersensitivity to celecoxib or any components of the drug product or sulfonamides
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- In the setting of CABG surgery
Warnings and Precautions
Post-MI Patients: Avoid the use of CELEBREX in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If CELEBREX is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Hypertension: NSAIDs, including CELEBREX, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: Avoid the use of CELEBREX in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If CELEBREX is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury and may cause a dose-dependent reduction in prostaglandin formation, which may precipitate overt renal decompensation. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CELEBREX in patients with advanced renal disease unless benefits are expected to outweigh the risk of worsening renal function. If CELEBREX is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.
Anaphylactic Reactions: Celecoxib has been associated with anaphylactic reactions in patients with and without known hypersensitivity to celecoxib and in patients with aspirin-sensitive asthma. CELEBREX is a sulfonamide and both NSAIDs and sulfonamides may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
Exacerbation of Asthma Related to Aspirin Sensitivity: CELEBREX is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Serious Skin Reactions: Serious skin reactions have occurred following treatment with CELEBREX, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). These serious events may occur without warning and can be fatal. Discontinue CELEBREX at first appearance of skin rash or other signs of hypersensitivity.
Premature Closure of Fetal Ductus Arteriosus: Celecoxib may cause premature closure of the ductus arteriosus. Avoid use of NSAIDs, including CELEBREX, in pregnant women starting at 30 weeks of gestation (third trimester).
Hematologic Toxicity: Anemia has occurred in NSAID treatment patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including CELEBREX, may increase the risk of bleeding events. Monitor patients for signs of bleeding.
Disseminated Intravascular Coagulation (DIC): Because of the risk of disseminated intravascular coagulation with use of CELEBREX in pediatric patients with systemic onset JRA, monitor patients for signs and symptoms of abnormal clotting or bleeding, and inform patients and their caregivers to report symptoms as soon as possible.
Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking CELEBREX with drugs that interfere with hemostasis. Concomitant use of CELEBREX and oral corticosteroids, antiplatelet drugs (such as aspirin), anticoagulants, or selective serotonin reuptake inhibitors (SSRIs), is not recommended.
ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with CELEBREX may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
ACE Inhibitors and ARBs: Concomitant use with CELEBREX in the elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
Digoxin: Concomitant use with CELEBREX can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.
Use in Specific Populations
Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation.
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of CELEBREX in women who have difficulties conceiving.
Adverse Reactions: The most common adverse reactions in arthritis trials (>2% and > placebo) are: abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash.
Please see Full Prescribing Information, including BOXED WARNING, and Medication Guide.
CELEBREX is indicated for the management of the signs and symptoms of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients 2 years and older, and ankylosing spondylitis; for the management of acute pain in adults, and for the management of primary dysmenorrhea.