LUNAVA

What it is

Lunava is a leflunomide medicine available in 10 mg, 20 mg and 100 mg tablets.

Approved indications

— Treatment of active rheumatoid arthritis.

Dosing overview

Leflunomide therapy for rheumatoid arthritis is started with a loading dose of 100 mg once daily for three days. The recommended maintenance dose for rheumatoid arthritis is leflunomide 20 mg once daily. If dosing at 20 mg/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 leflunomide, however, there may be further improvement in the condition after four to six months of treatment.

Key safety warnings

A complete blood cell count including differential white blood cell count and platelets should be performed in all patients before the start of leflunomide treatment and monthly for the first six months, followed by every six to eight weeks thereafter. If used with concomitant methotrexate and/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 six months of treatment. Although confounding factors were present in many cases, a causal relationship to leflunomide cannot be excluded. ALT and AST must be checked before the start of leflunomide treatment and monitored at monthly or more frequent intervals for at least the first six months and then, if stable, every six to eight weeks thereafter. In addition, if leflunomide and methotrexate are given concomitantly, ALT, AST and serum albumin testing must be performed monthly. Pancytopenia is a rare event, which has been reported with leflunomide, with a fatal outcome in isolated cases. These events have been reported most frequently in cases of recent, concomitant or subsequent use of potentially myelotoxic/haematotoxic agents, such as methotrexate. 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. Peripheral neuropathy has been reported rarely in patients receiving leflunomide. Most patients recovered after discontinuation of leflunomide, but some patients had persistent symptoms. Cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and symptoms (DRESS) have been reported in patients treated with leflunomide. If a patient taking leflunomide develops any of these skin conditions, therapy should be stopped and washout procedures should be initiated immediately.

Contraindications

Leflunomide must not be given to patients with hypersensitivity to leflunomide, teriflunomide or to any of the excipients in the tablets. Leflunomide must not be given to patients with severe immunodeficiency states, e.g. acquired immunodeficiency syndrome (AIDS). Leflunomide must not be given to patients with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes other than rheumatoid arthritis. Leflunomide must not be given to patients with severe, uncontrolled infections. Leflunomide must not be given to patients with impairment of liver function. Leflunomide must not be given to pregnant women. Leflunomide must not be given to women of childbearing potential who are not using reliable contraception during treatment with leflunomide 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. Leflunomide must not be given to women who are breastfeeding. Leflunomide must not be given to patients with severe hypoproteinaemia. Leflunomide must not be given to patients who have or have had Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme.

Regulatory history

Lunava leflunomide tablets in strengths of 10 mg, 20 mg and 100 mg were first listed on the ARTG on 25 March 2011.