APX-CELECOXIB

What it is

APX-CELECOXIB is celecoxib, available in 100 mg and 200 mg capsules. The capsules are hard gelatin formulations, with 100 mg capsules being opaque white with two blue bands marked "100" on the body, and 200 mg capsules being opaque 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

As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. 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. This risk may increase with duration of use. APX-CELECOXIB should be used with caution in patients with significant established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, as well as patients at high risk of cardiovascular disease including those with significant and multiple risk factors such as diabetes, hypertension, hypercholesterolaemia, cardiac failure and smokers. To minimise the potential risk for an adverse cardiovascular event, the lowest effective dose should be used for the shortest duration possible. Infrequently, serious gastrointestinal toxicity such as bleeding, ulceration, and upper and lower gastrointestinal perforation has been observed in patients treated with celecoxib. Patients most at risk of developing gastrointestinal complications 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 such as ulceration, gastrointestinal bleeding or inflammatory conditions. APX-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, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib, as has fixed drug eruption which may present as a more severe variant known as generalised bullous fixed drug eruption. Patients appear to be at highest risk for these events early in the course of therapy, with onset in the majority of cases within the first month of treatment, and APX-CELECOXIB should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. APX-CELECOXIB can lead to the onset of new hypertension or worsening of pre-existing hypertension and should be used with caution in patients with hypertension, with blood pressure monitored closely during initiation and throughout the course of therapy.

Contraindications

APX-CELECOXIB is contraindicated in patients with known hypersensitivity to celecoxib or any of the excipients, and in those with demonstrated allergic-type reactions to sulfonamides. It 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. APX-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. APX-CELECOXIB is contraindicated for the peri-operative treatment of pain in patients undergoing coronary artery bypass graft surgery. APX-CELECOXIB is contraindicated in patients with unstable ischaemic heart disease of thrombus aetiology or documented myocardial infarction or stroke within 3 months, those with active peptic ulceration or gastrointestinal bleeding, those with estimated creatinine clearance less than 30 mL/min, those with congestive heart failure (NYHA II-IV), and those with severe hepatic impairment (Child-Pugh score ≥10).

Regulatory history

APX-CELECOXIB (celecoxib 200 mg and 100 mg capsules) was first registered on the ARTG on 4 May 2020 under licence category RE.