CELEXI

What it is

Celexi is celecoxib , a hard capsule formulation . Celexi is available in 100 mg and 200 mg capsule strengths .

Approved indications

— Symptomatic treatment of osteoarthritis — Symptomatic treatment of rheumatoid arthritis — Symptomatic treatment of ankylosing spondylitis — Treatment of primary dysmenorrhoea in adults — Short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury

Dosing overview

The shortest duration possible and the lowest effective daily dose should be used, as the cardiovascular risks of celecoxib may increase with dose and duration of exposure . Doses can be given without regard to timing of meals .

Key safety warnings

**Cardiovascular and thrombotic events.** COX-2 inhibitors have been associated with an increased risk of serious cardiovascular and thrombotic adverse events, myocardial infarction, and stroke, which can be fatal . This risk may increase with duration of use; the relative increase appears similar in those with or without known cardiovascular disease or risk factors, however patients with cardiovascular disease or risk factors may be at greater risk in terms of absolute incidence due to their increased baseline rate . To minimise potential risk for an adverse cardiovascular event, the lowest effective dose should be used for the shortest duration possible .

**Gastrointestinal toxicity.** Infrequently, serious gastrointestinal toxicity such as bleeding, ulceration, and upper and lower gastrointestinal perforation has been observed in patients treated with celecoxib . Only one in five patients who develop a serious upper gastrointestinal adverse event on NSAID therapy is symptomatic; upper gastrointestinal ulcers, gross bleeding or perforation appear to occur in approximately one per cent of patients treated for three to six months, and in about two to four per cent treated for one year . Patients most at risk include elderly patients, patients with cardiovascular disease, patients using concomitant antiplatelet drugs or corticosteroids, patients who consume alcohol, or patients with prior gastrointestinal disease; celecoxib should be prescribed with extreme caution in these patients .

**Serious skin reactions.** Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely . Patients appear to be at highest risk early in the course of therapy, with onset occurring in the majority of cases within the first month of treatment .

**Renal effects.** Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury; renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion, and administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and secondarily in renal blood flow .

Contraindications

Known hypersensitivity to celecoxib or any of the excipients contained in the Celexi capsules . Demonstrated allergic-type reactions to sulfonamides . Celexi should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs, including other COX-2 specific inhibitors . Celexi is contraindicated for the peri-operative treatment of pain in patients undergoing coronary artery bypass graft surgery . Celexi is contraindicated in patients with unstable ischaemic heart disease of thrombus aetiology or documented myocardial infarction or stroke within three months; patients with active peptic ulceration or gastrointestinal bleeding; patients with estimated creatinine clearance less than 30 mL/min; patients with congestive heart failure (NYHA II–IV); and patients with severe hepatic impairment (Child-Pugh score ≥10) .

Regulatory history

Celexi 100 mg capsule and 200 mg capsule formulations were first registered on the ARTG on 10 January 2014 in the regular evaluation licence category .