Important Safety Information and Indications

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.

Contraindications

  • 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.

Drug Interactions

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 analgesic dose of aspirin is not generally 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.

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.

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.

Please see Full Prescribing Information including BOXED WARNING and Medication Guide.

Indications

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.

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Indications and Dosing

  • CELEBREX should be used at the lowest effective dose for the shortest duration consistent with treatment goals for the individual patient
  • CELEBREX can be administered without regard to timing of meals
  • CELEBREX is available in 4 strengths: 50 mg, 100 mg, 200 mg, and 400 mg capsules
Download a 1-page dosing reference for CELEBREX.

Osteoarthritis (OA)

CELEBREX is indicated for the management of the signs and symptoms of OA.

200 mg once daily or 100 mg twice per day

Rheumatoid Arthritis (RA)

CELEBREX is indicated for the management of the signs and symptoms of RA.

100 mg to 200 mg twice per day

Acute Pain in Adults

CELEBREX is indicated for the management of acute pain in adults.

Day 1: 400-mg initial dose + 200 mg if needed
Days >1: 200 mg twice per day as needed

Ankylosing Spondylitis

CELEBREX is indicated for the management of signs and symptoms of ankylosing spondylitis.

Starting dose 200 mg in single (once per day) or divided (twice per day) doses
If no effect
after 6 weeks
A trial of 400 mg daily may be worthwhile
If no effect after 6 weeks on 400 mg daily A response is not likely and an alternate treatment should be considered

Primary Dysmenorrhea

CELEBREX is indicated for the management of primary dysmenorrhea.

Day 1: 400-mg initial dose + 200 mg if needed
Days >1: 200 mg twice per day as needed

Juvenile Rheumatoid Arthritis (JRA)

CELEBREX is indicated for the management of the signs and symptoms of JRA in pediatric patients ≥2 years.

Patients 10 kg to 25 kg (22 lb to 55 lb): 50 mg twice per day
Patients >25 kg (>55 lb): 100 mg twice per day

NSAIDs, including CELEBREX, should be used with caution in pediatric patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation.

Special Populations

Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B).
Initiate treatment with half of the lowest recommended dose in adult patients who are known or suspected to be poor CYP2C9 metabolizers

Consider using alternative treatments in JRA patients who are known or suspected to be poor CYP2C9 metabolizers

*Eligibility required. Terms and conditions apply. Card will be accepted only at participating pharmacies. Card is not health insurance. No membership fee. Savings of up to $125 per fill for a maximum savings of up to $1,750 per year. For more information, visit www.Celebrex.com, call 1-855-612-1956, or write: CELEBREX Savings Card, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.