ATARIS

What it is

ATARIS contains leflunomide as the active ingredient. Each tablet contains 10 mg or 20 mg of leflunomide. Leflunomide is an isoxazole immunomodulatory agent which in the body is rapidly metabolised to A771726, the active form. It has immunomodulating and immunosuppressive characteristics, acts as an anti-proliferative agent and displays weak anti-inflammatory properties.

Approved indications —

Active Rheumatoid Arthritis. — Active Psoriatic Arthritis. ATARIS is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

Dosing overview

Doses higher than 20 mg per day are not recommended. If dosing at 20 mg per day is not well tolerated, the dose may be decreased to 10 mg daily. An improvement in the patient's rheumatoid condition may begin as early as four weeks after starting therapy with ATARIS, however, there may be further improvement in the condition after four to six months of treatment.

Key safety warnings

Pancytopenia is a rare event reported with leflunomide, with fatal outcomes in isolated cases. These events have been reported most frequently in cases of recent, concomitant or subsequent use of potentially myelotoxic or haematotoxic agents, such as methotrexate. A complete blood cell count including differential white blood cell count and platelets should be performed before starting treatment and monthly for the first 6 months, followed by 6–8 weeks thereafter. If used with concomitant methotrexate or other potential immunosuppressives, chronic monitoring should be monthly. Very rare cases of severe liver injury, with fatal outcome in isolated cases, have been reported during treatment with leflunomide. Most of the cases occurred within the first 6 months of treatment. Alanine aminotransferase and aspartate aminotransferase must be checked before starting treatment and monitored at monthly or more frequent intervals for at least the first 6 months and then, if stable, every 6 to 8 weeks thereafter. If leflunomide and methotrexate are given concomitantly, alanine aminotransferase, aspartate aminotransferase and serum albumin testing must be performed monthly. Cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and symptoms have been reported in patients treated with leflunomide. If a patient taking ATARIS develops any of these skin conditions, therapy should be stopped and washout procedures should be initiated immediately. Interstitial lung disease has been reported rarely during treatment with leflunomide. The risk of its occurrence is increased in patients with a history of interstitial lung disease. Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy. New onset or worsening pulmonary symptoms, such as cough and dyspnoea, with or without associated fever, may be a reason for further investigation.

Contraindications

ATARIS is contraindicated in patients with hypersensitivity to leflunomide, teriflunomide or to any of the excipients in the tablets; patients with severe immunodeficiency states such as AIDS; patients with significantly impaired bone marrow function or significant anaemia, leukopenia or thrombocytopenia due to causes other than rheumatoid arthritis or psoriatic arthritis; patients with severe, uncontrolled infections; patients with impairment of liver function; pregnant women; women of childbearing potential who are not using reliable contraception during treatment with ATARIS and for a certain period of time thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/L unless undergoing washout treatment; women who are breast-feeding; patients with severe hypoproteinaemia; and patients who have or have had Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme.

PBS listing

No PBS listing information is provided in the available source documents.

Regulatory history

ATARIS 10 mg and ATARIS 20 mg tablets were first listed on the ARTG on 25 March 2011.