INDICATIONS AND USAGE

CELEBREX is a nonsteroidal anti-inflammatory drug indicated for:

• Osteoarthritis (OA) (1.1)
• Rheumatoid Arthritis (RA) (1.2)
• Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
• Ankylosing Spondylitis (AS) (1.4)
• Acute Pain (AP) (1.5)
• Primary Dysmenorrhea (PD) (1.6)
• Familial Adenomatous Polyposis (FAP)-adjunct to usual care) (1.7)

DOSAGE AND ADMINISTRATION

Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient. (1, 5.1, 5.4)

• OA: 200 mg once daily or 100 mg twice daily (2.1, 14.1)
• RA: 100 to 200 mg twice daily (2.2, 14.2)
• JRA: 50 mg twice daily in patients 10–25 kg. 100 mg twice daily in patients more than 25 kg (2.3, 14.3)
• AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit (2.4, 14.4)
• AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed (2.5, 14.5)
• FAP: 400 mg twice daily with food, as an adjunct to usual care (2.6, 14.6)

Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B).

Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers, (2.7, 8.4, 8.8, 12.3).

DOSAGE FORMS AND STRENGTHS

Capsules: 50 mg, 100 mg, 200 mg and 400 mg (3)

CONTRAINDICATIONS

• Known hypersensitivity to celecoxib or sulfonamides (4)
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4, 5.7, 5.8, 5.13)
• Use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1)

WARNINGS AND PRECAUTIONS

• Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk (5.1, 14.7, 17.2).
• Serious gastrointestinal (GI) adverse events, which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at high risk for GI events, especially the elderly. CELEBREX should be used with caution in these patients (5.4, 8.5, 14.7, 17.3).
• Elevated liver enzymes and, rarely, severe hepatic reactions. Discontinue use of CELEBREX immediately if abnormal liver enzymes persist or worsen (5.5, 17.4).
• New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment with CELEBREX (5.2, 7.4, 17.2).
• Fluid retention and edema. CELEBREX should be used with caution in patients with fluid retention or heart failure (5.3, 17.6).
• Renal papillary necrosis and other renal injury with long term use. Use CELEBREX with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists (5.6, 7.4, 8.7, 17.6).
• Anaphylactoid reactions. Do not use CELEBREX in patients with the aspirin triad (5.7, 10, 17.7).
• Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning even without known prior sulfa allergy. Discontinue CELEBREX at first appearance of rash or skin reactions (5.8, 17.5).

ADVERSE REACTIONS

Most common adverse reactions in arthritis trials (>2% and >placebo): abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

• Concomitant use of CELEBREX and warfarin may result in increased risk of bleeding complications. (7.1)
• Concomitant use of CELEBREX increases lithium plasma levels. (7.2)
• Concomitant use of CELEBREX may reduce the antihypertensive effect of ACE Inhibitors and angiotensin II antaonists (7.4)
• Use caution with drugs known to inhibit P450 2C9 or metabolized by 2D6 due to the potential for increased plasma levels (2.7, 8.4, 8.8, 12.3)

USE IN SPECIFIC POPULATIONS

• Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation (5.9, 8.1, 17.8)