Arava

What is it?

A disease modifying, antirheumatic drug (DMARD) comprising leflunomide, which has an effect on the immune system, preventing proliferation of T-lymphocytes and interfering with the inflammatory disease process. It is rapid acting and begins to have a noticeable effect in about one month but can have serious side effects. Available in three strengths: white tablets containing 10mg leflunomide, marked ZBN; triangular, yellow tablets containing 20mg leflunomide, marked ZBO; white tablets containing 100mg leflunomide, marked ZBP. All tablets are film-coated.

Medical Uses

Rheumatoid arthritis in active phase.

Dosage

Adults; initial, loading dose is 100mg once each day for three days; thereafter, 10 to 20mg once daily.

Special Care

To be used only as directed by specialist and with supervision and monitoring. There is a risk of liver toxicity and tests for liver function are necessary before, during and after treatment. If toxicity occurs, a special, wash out procedure must be followed which is Also, necessary if therapy with an alternative DMARD is required or if the patient is a woman who wishes to conceive. Blood pressure must be regularly monitored.

Avoid Use

Children and young people aged less than 18 years, pregnant or breastfeeding women. Treated patients must use contraception during and after drug has been withdrawn, for a possible period of 2 years. Also, avoid use in patients with serious immunodeficiency, blood and bone marrow disorders, liver or kidney impairment, inflammation and ulceration of the mouth, other severe infections, low protein levels in blood.

Possible Drug and Food Interactions

Other DMARDs, live vaccines, activated charcoal, methotrexate, colestyramine, alcohol, drugs which may have toxic effects on the blood or liver, drugs (other than NSAIDs) metabolised by CYP2C9.

Known Side Effects

Gastrointestinal upset, mouth disorders, abdominal pain, elevated blood pressure, effects on blood, tenosyndvitis (inflammation of tendon sheaths), headache, weight loss, allergic responses, weakness and debility, dizziness. Rarely, liver toxicity which can prove fatal, Stevens- Johnson syndrome, other skin effects. all adverse side effects must be reported to the CSM.