DOLICOX

ETORICOXIB KRKA is indicated in adults and adolescents from 16 years of age for the symptomatic treatment of osteoarthritis.

The decision to prescribe a selective COX-2 inhibitor should be based on the assessment of all specific risks for each patient (see sections 4.3 and 4.4).

Pregnancy

There is no clinical data in pregnant women exposed to etoricoxib. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk for the pregnant woman is unknown. Like other drugs inhibiting prostaglandin synthesis, etoricoxib may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. Etoricoxib is contraindicated during pregnancy (see section 4.3). In case of pregnancy occurring during treatment, etoricoxib treatment must be discontinued.

Breastfeeding

The passage of etoricoxib into human breast milk is unknown. Etoricoxib is excreted in the milk of lactating rats. Women treated with etoricoxib should not breastfeed (see sections 4.3 and 5.3).

Fertility

The use of etoricoxib, like any drug known to inhibit COX-2, is not recommended in women planning pregnancy.

Patients experiencing dizziness, vertigo, or drowsiness during treatment with etoricoxib must refrain from driving or using machines.

Summary of the safety profile

In clinical studies, the safety of etoricoxib was evaluated in 7152 subjects, including 4614 patients with osteoarthritis, rheumatoid arthritis (RA), chronic low back pain or ankylosing spondylitis (approximately 600 patients with osteoarthritis or RA were treated for one year or longer).

In clinical studies, the adverse experience profile was similar in patients with osteoarthritis or RA treated with etoricoxib for one year or longer.

In a clinical study of the treatment of acute gouty arthritis, patients were treated with etoricoxib 120 mg once daily for 8 days. The adverse experience profile in this study was generally similar to that reported in the combined studies conducted in osteoarthritis, RA and chronic low back pain.

In a cardiovascular safety program from pooled data of three active comparator-controlled studies, 17 412 patients with osteoarthritis or RA were treated with etoricoxib (60 or 90 mg) for a mean duration of approximately 18 months. Safety data and details of this program are presented in section 5.1.

In clinical studies of acute post-operative dental pain including 614 patients treated with etoricoxib (90 mg or 120 mg), the adverse experience profile in these studies was generally similar to that reported in the combined osteoarthritis, RA and chronic low back pain studies.

Tabulated list of adverse reactions

The following adverse reactions have been reported with an incidence greater than placebo in clinical studies in patients with osteoarthritis, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg up to the recommended dose for up to 12 weeks; for up to 3 years and 1/2 in the MEDAL program studies; for up to 7 days in acute pain studies; or from post-marketing experience (see Table 1).

Table 1 :

*Frequency category defined for each adverse effect by the incidence reported in the clinical study database: Very common (≥ 1/10), Common (≥ 1/100, < 1/10), Uncommon (≥ 1/1 000, < 1/100), Rare (≥ 1/10 000, < 1/1 000), Very rare (< 1/10 000).

‡ This adverse effect has been identified in the context of pharmacovigilance. Its reported frequency has been estimated based on the highest frequency observed in the clinical study data combined by indication and authorised dose.

† The frequency category 'rare' has been defined in accordance with the Guideline on Summary of Product Characteristics (SmPC) (rev. 2, September 2009) based on an estimated upper bound of the 95% confidence interval for 0 events considering the number of patients treated with etoricoxib in the pooled phase III clinical trial data by dose and indication (n = 15 470).

ß 'Hypersensitivity' includes the terms 'allergy', 'drug allergy', 'drug hypersensitivity', 'hypersensitivity', 'hypersensitivity NOS', 'hypersensitivity reaction' and 'non-specific allergy'.

§ Based on analyses of long-term placebo and active comparator-controlled clinical trials, COX-2 inhibitors have been associated with an increased risk of serious arterial thrombotic events, including myocardial infarction and stroke. Based on existing data, the increase in the absolute risk of these events is not expected to exceed 1% per year (uncommon).

The following serious adverse effects have been reported in association with the use of NSAIDs and cannot be excluded for etoricoxib: nephrotoxicity, including interstitial nephritis and nephrotic syndrome.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reactions via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/ .