Important Safety Information
- CELEBREX may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All nonsteroidal anti-inflammatory drugs (NSAIDs) may have a similar risk. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.
- CELEBREX is contraindicated for the treatment of perioperative pain in coronary artery bypass graft (CABG) surgery.
- NSAIDs, including CELEBREX, cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events.
CELEBREX is contraindicated in patients with active gastrointestinal bleeding; in patients who have demonstrated allergic-type reactions to sulfonamides; or in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
As with all NSAIDs, CELEBREX can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Blood pressure should be monitored closely with all NSAIDs.
Fluid retention and edema have been observed in some patients taking NSAIDs, including CELEBREX. NSAIDs should be used with caution in patients with fluid retention or heart failure.
NSAIDs, including CELEBREX, may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors and angiotensin II antagonists, and in some patients can reduce the natriuretic effect of furosemide and thiazides.
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, may result in deterioration of renal function, including possible acute renal failure. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
CELEBREX can be used with low-dose aspirin. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.
Concomitant administration of aspirin with CELEBREX increases the rate of GI ulceration or other complications, compared with use of CELEBREX alone.
Treatment with NSAIDs, including CELEBREX, is not recommended in those patients with advanced renal disease. In addition, NSAIDs may cause renal toxicity.
Serious skin reactions such as exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis have been reported in patients receiving CELEBREX. These reactions can be fatal. They can occur without warning and in patients without prior known sulfa allergy. CELEBREX should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Rare cases of anaphylactic reactions and angioedema have been reported in patients receiving CELEBREX. Patients should seek immediate emergency assistance if they have swelling of the face or throat or have difficulty breathing.
CELEBREX should be avoided in late pregnancy.
NSAIDs, including CELEBREX, should be used with caution in pediatric patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation.
CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults; the treatment of primary dysmenorrhea; and for relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older.
In a randomized, double-blind study of patients undergoing TKA,
CELEBREX helped significantly reduce knee pain, as measured by VAS1Data shown above reflect week 6 snapshot after continuous CELEBREX use for 6 weeks after elective primary TKA
In a prospective, randomized study in patients undergoing arthroscopic meniscectomy,
CELEBREX helped significantly reduce postsurgical knee pain at 90° flexion2,3
See data about CELEBREX and the Oxford Knee Score, an overall measure of knee pain and function
In the same study,
CELEBREX helped improve Oxford Knee Score,* an overall measure of pain and function, at week 61,2
In a prospective, randomized study in patients with ankle sprain,
CELEBREX offered acute pain relief comparable to the maximum therapeutic dose of Rx ibuprofen in patients with ankle sprain4
In a prospective, randomized study in patients with ankle sprain,
CELEBREX provided 3-day-faster return to function* vs placebo in patients with acute pain4
*Secondary end point: median time to return to normal function/activity or improvement by at least 2 grades (on a scale of 1-5) in the patient’s assessment of normal function/activity.In the same study, at day 11, the proportion of patients that achieved normal walking/activity without pain was comparable between those treated with CELEBREX (42%) and Rx ibuprofen (45%)4
Schroer et al was a randomized, double-blind, placebo-controlled study in patients undergoing elective unilateral total knee arthroplasty (TKA) to evaluate any rehabilitation benefits of CELEBREX therapy for 6 weeks after the TKA (N=107). CELEBREX 400 mg was given to each patient before surgery and daily throughout their hospitalization with as needed morphine through a patient-controlled analgesia system on the night of surgery. All patients were placed on oral narcotics the morning after surgery. At hospital discharge, patients were randomized to either CELEBREX 200 mg BID or placebo for 6 weeks. All patients had a prescription for oral narcotics as needed. Primary end point was narcotic use (total pill count), and secondary measures included knee pain during activity and at rest, as measured by a visual analog scale (VAS), and Oxford Knee Score.
Ekman et al (2006) was a 36-hour, randomized, parallel-group, double-blind, placebo-controlled study to compare total opioid analgesic use at 24 hours after arthroscopic meniscectomy of the knee (primary end point). Patients received CELEBREX 400 mg administered approximately 1 hour before surgery and CELEBREX 200 mg administered at the first request for pain medication after surgery, or placebo. Postsurgery patients were allowed to take 1 to 2 hydrocodone/acetaminophen (APAP) tablets every 4 to 6 hours as rescue medication. Secondary end points included patients' assessment of pain at rest and at 90° flexion using a 0- to 100-mm visual analog scale (VAS). Improvement in patients' assessment of pain at 90° flexion at 8, 10, and 12 hours confirmed in a replicate study. CELEBREX significantly reduced postsurgical knee pain at rest at 10 and 12 hours in the same 2 studies.
Ekman et al (2002) was a 10-day, multicenter, double-blind, randomized, parallel-group, placebo-controlled trial to evaluate the efficacy and tolerability of CELEBREX, ibuprofen, or placebo in the treatment of moderate-to-severe acute pain (at least 45 mm on a 100-mm VAS) in 445 adult patients with grade 1 or grade 2 ankle sprain. Patients were randomized to CELEBREX 200 mg BID, ibuprofen 800 mg TID, or placebo. The first dose of study medication was taken as soon as possible after randomization and within 48 hours of injury. Treatment with rest, ice, compression, and elevation (RICE) and physical therapy was permitted; analgesia other than the study medication was not. The study was powered to detect differences between CELEBREX and placebo and to establish noninferiority vs ibuprofen. Primary end points (evaluated on day 4) were pain rating using the patient's assessment of ankle pain on a visual analog scale (VAS) and severity based on the patient's global assessment of ankle injury. Secondary end points included: pain rating using the patient's assessment of ankle pain on a VAS on days 8 and 11; severity based on the patient's global assessment of ankle injury on days 8 and 11; median time to return to normal function/activity or to improve by at least 2 grades.
*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 , or write: CELEBREX $4 Co-pay Card, 14001 Weston Parkway, Suite 103, Cary, NC 27513.
†Generic prescription celecoxib patients with commercial insurance pay an average co-pay of $23.21 as of January 2015.6
1. Schroer WC, Diesfeld PJ, LeMarr AR, Reedy ME. Benefits of prolonged postoperative cyclooxygenase-2 inhibitor administration on total knee arthroplasty recovery: a double-blind, placebo-controlled study. J Arthroplasty. 2011;26(6 suppl):2-7.
2. Ekman EF, Wahba M, Ancona F. Analgesic efficacy of perioperative celecoxib in ambulatory arthroscopic knee surgery: a double-blind, placebo-controlled study. Arthroscopy. 2006;22(6):635-642.
3. Data on file. Pfizer Inc, New York, NY.
4. Ekman EF, Fiechtner JJ, Levy S, Fort JG. Efficacy of celecoxib versus ibuprofen in the treatment of acute pain: a multicenter, double-blind, randomized controlled trial in acute ankle sprain. Am J Orthop. 2002;31(8):445-451.
5. IMS PayerTrak data, January 2015.