CELAXIB

What it is

CELAXIB is a medicine containing celecoxib. It is available in 100 mg and 200 mg capsule strengths. The capsules are hard capsules; 100 mg capsules are opaque and white with two blue bands marked "100" on the body, and 200 mg capsules are opaque and white with two gold bands marked "200" on the body.

Approved indications

— Symptomatic treatment of osteoarthritis, rheumatoid arthritis and 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. Patients on long-term treatment should be reviewed regularly, such as every three months, with regards to efficacy, risk factors and ongoing need for treatment.

Key safety warnings

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, and celecoxib is a COX-2 inhibitor. The risk of serious cardiovascular thrombotic events may increase with duration of use, and patients with cardiovascular disease or cardiovascular risk factors may be at greater absolute risk due to their increased rate at baseline. To minimise the potential risk for an adverse cardiovascular event, the lowest effective dose should be used for the shortest duration possible. Serious gastrointestinal toxicity such as bleeding, ulceration, and upper and lower gastrointestinal perforation has infrequently been observed in patients treated with celecoxib, although celecoxib exhibited a low incidence of gastroduodenal ulceration and serious clinically significant gastrointestinal events within clinical trials. Upper gastrointestinal ulcers, gross bleeding or perforation caused by NSAIDs appear to occur in approximately 1% of patients treated for 3–6 months, and in about 2–4% of patients treated for one year. Patients most at risk of developing gastrointestinal complications with NSAIDs are elderly patients; patients with cardiovascular disease; patients using concomitant antiplatelet drugs such as aspirin or corticosteroids; patients who consume alcohol; or patients with a prior history of gastrointestinal disease, and celecoxib should be prescribed with extreme caution in these patients. Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and fixed drug eruption have been reported very rarely in association with the use of celecoxib. Patients appear to be at highest risk for these events early in the course of therapy, with onset occurring in the majority of cases within the first month of treatment, and celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Contraindications

CELAXIB is contraindicated in patients with known hypersensitivity to celecoxib or any of the excipients contained in the capsules. Celecoxib should not be given to patients who have demonstrated allergic-type reactions to sulfonamides or 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. Celecoxib should not be used with other non-steroidal anti-inflammatory drugs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions. Celecoxib is contraindicated for the peri-operative treatment of pain in patients undergoing coronary artery bypass graft (CABG) surgery. CELAXIB is also contraindicated in patients with unstable ischaemic heart disease of thrombus aetiology or documented myocardial infarction or stroke within 3 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

CELAXIB celecoxib 200 mg and 100 mg capsule blister packs were first listed on the ARTG on 23 February 2018. A CELAXIB RELIEF variant (celecoxib 200 mg capsule blister pack) was subsequently registered on 4 October 2024.