ARCOXIA

What it is

ARCOXIA is etoricoxib, a white to off-white powder. Each tablet of ARCOXIA for oral administration contains either 30, 60, 90 or 120 mg of etoricoxib. Etoricoxib is a member of a new class of agents called Coxibs and is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range.

Approved indications ARCOXIA is indicated for:

— Symptomatic treatment of the signs and symptoms of osteoarthritis — Treatment of acute gouty arthritis — Treatment of acute pain, including that related to primary dysmenorrhoea and minor dental procedures

Dosing overview

As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.

Key safety warnings

Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with an increased risk of serious thrombotic events (especially myocardial infarction and stroke), relative to placebo and some NSAIDs. Long term safety data beyond one year are not currently available for etoricoxib compared to placebo or NSAIDs other than diclofenac. Etoricoxib should be used with caution for patients with known cardiovascular disease, history of atherosclerotic cardiovascular disease or significant risk factors for cardiovascular events. Physicians and patients should remain alert for cardiovascular events, even in absence of previous symptoms, and should be informed about signs and symptoms of serious cardiovascular toxicity and the steps to take if they occur. Although the risk of upper gastrointestinal (GI) toxicity is not eliminated with ARCOXIA, the results of the MEDAL Program demonstrate that in patients treated with ARCOXIA, the risk of upper GI toxicity with ARCOXIA 60 mg or 90 mg once daily is significantly less than with diclofenac 150 mg daily. Upper GI ulcers and ulcer complications have occurred in patients treated with ARCOXIA. These events can occur at any time during use and without warning symptoms. There is a further increase in the risk of gastrointestinal adverse effects when etoricoxib is taken concomitantly with acetylsalicylic acid (even at low doses). A significant difference in gastrointestinal safety between selective COX-2 inhibitors plus acetylsalicylic acid versus NSAIDs plus acetylsalicylic acid has not been demonstrated in long-term clinical trials. Fluid retention, oedema and hypertension have been observed in patients taking ARCOXIA. All Non-steroidal Anti-inflammatory Drugs (NSAIDs), including etoricoxib, can be associated with new onset or recurrent congestive heart failure. Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Therefore, hypertension should be controlled before treatment with etoricoxib and special attention should be paid to blood pressure monitoring during treatment. Blood pressure should be monitored within two weeks after initiation of treatment and periodically thereafter. If blood pressure rises significantly, alternative treatment should be considered. 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 NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance. These serious events may occur without warning. Patients appear to be at highest risk for these reactions early in the course of therapy, with onset occurring in the majority of cases within the first month of treatment.

Contraindications

ARCOXIA is contraindicated in patients with hypersensitivity to any component of this product; a history of asthma, urticaria or other allergic reactions after taking aspirin or other NSAIDs; congestive heart failure (NYHA II-IV); hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled; established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty); severe hepatic dysfunction (serum albumin less than 25 g/l or Child-Pugh score of 10 or greater); active peptic ulceration or gastrointestinal bleeding; or estimated creatinine clearance less than 30 mL/min.

PBS listing

Information regarding PBS listing is not available in the provided source documents.

Regulatory history

ARCOXIA etoricoxib 120 mg and 60 mg tablet blister packs were first listed on the Australian Register of Therapeutic Goods on 11 October 2002. The 30 mg tablet blister pack was first listed on 11 April 2008, and the 90 mg tablet blister pack was first listed on 5 November 2013.