Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands
ARCOXIA is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
ARCOXIA is indicated in adults and adolescents 16 years of age and older for the short-term treatment of moderate pain associated with dental surgery.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks (see sections 4.3, 4.4).
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. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
For acute pain conditions, etoricoxib should be used only for the acute symptomatic period.
The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, etoricoxib was given for 8 days.
The recommended dose is 90 mg once daily, limited to a maximum of 3 days. Some patients may require other postoperative analgesia in addition to ARCOXIA during the three day treatment period.
Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore:
The dose for OA should not exceed 60 mg daily.
The dose for RA and ankylosing spondylitis should not exceed 90 mg daily.
The dose for acute gout should not exceed 120 mg daily, limited to a maximum of 8 days treatment.
The dose for postoperative acute dental surgery pain should not exceed 90 mg daily, limited to a maximum of 3 days.
No dosage adjustment is necessary for elderly patients. As with other drugs, caution should be exercised in elderly patients (see section 4.4).
Regardless of indication, in patients with mild hepatic dysfunction (Child-Pugh score 5-6) a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 30 mg once daily should not be exceeded.
Clinical experience is limited particularly in patients with moderate hepatic dysfunction and caution is advised. There is no clinical experience in patients with severe hepatic dysfunction (Child-Pugh score ≥10); therefore, its use is contra-indicated in these patients (see sections 4.3, 4.4 and 5.2).
No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2). The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated (see sections 4.3 and 4.4).
Etoricoxib is contra-indicated in children and adolescents under 16 years of age (see section 4.3).
ARCOXIA is administered orally and may be taken with or without food. The onset of the effect of the medicinal product may be faster when ARCOXIA is administered without food. This should be considered when rapid symptomatic relief is needed.
In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases. The most frequently observed adverse experiences were consistent with the safety profile for etoricoxib (e.g. gastrointestinal events, cardiorenal events).
In the event of overdose, it is reasonable to employ the usual supportive measures, e.g. remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required.
Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.
Shelf life: 3 years.
Bottles: Keep the container tightly closed in order to protect from moisture.
Blisters: Store in the original package in order to protect from moisture.
30 mg: Aluminium/aluminium blisters in packs containing 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets.
60 mg: Aluminium/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets.
90 and 120 mg: Aluminium/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets.
60, 90 and 120 mg: Aluminium/aluminium blisters (unit doses) in packs of 5, 50 or 100 tablets.
White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two 1-gram desiccant containers or 90 tablets and one 1-gram desiccant container.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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