Arava 20 mg film-coated tablets – leflunomide for active rheumatoid and psoriatic arthritis

Arava is a medicine containing the active substance leflunomide and belongs to the group of selective immunosuppressants. As a disease-modifying antirheumatic drug (DMARD) it reduces joint inflammation, swelling, pain and stiffness.

It is used in adults with active rheumatoid arthritis and active psoriatic arthritis. In Serbia it is authorised in the 20 mg strength (bottle of 30 film-coated tablets). Treatment is prescribed and monitored by a specialist, with regular blood counts, liver enzyme tests and blood pressure checks; improvement is usually felt after 4–6 weeks and may continue for 4–6 months.

What is Arava (leflunomide) used for and how should it be taken correctly?

Key facts about the medicine

What is Arava used for?

• active rheumatoid arthritis in adults – as a disease-modifying antirheumatic drug
• active psoriatic arthritis in adults

Previous or concurrent treatment with other medicines that burden the liver or blood (e.g. methotrexate) may increase the risk of serious side effects, so the doctor carefully weighs benefits and risks.

How is it taken and dosed?

• Start of treatment: loading dose of 100 mg once daily for 3 days (omitting the loading dose may reduce side effects – the doctor decides).
• Rheumatoid arthritis: maintenance dose 10–20 mg once daily depending on disease activity.
• Psoriatic arthritis: maintenance dose 20 mg once daily.
• Swallow the tablets whole with plenty of liquid, with or without food. Treatment is usually long-term.
• Monitoring: ALT and full blood count before starting, every 2 weeks for the first 6 months, then every 8 weeks; regular blood pressure checks.

This is the general dosing from the package leaflet and Summary of Product Characteristics and not an individual recommendation.

Special patient groups

• Children and adolescents under 18: use is not recommended.
• Over 65 and mild kidney impairment: no dose adjustment is needed.
• Men wishing to father a child: reliable contraception during treatment; before conception – drug elimination procedure, laboratory confirmation and a further wait of at least 3 months.

Contraindications – when the medicine must not be used

• hypersensitivity to leflunomide, teriflunomide or the excipients (especially previous severe skin reactions, e.g. Stevens-Johnson syndrome)
• any impairment of liver function
• moderate to severe kidney impairment
• severe hypoproteinaemia
• immunodeficiency states (e.g. AIDS)
• bone marrow impairment or significant anaemia, leucopenia, neutropenia or thrombocytopenia
• serious infections
• pregnancy, suspected pregnancy and breastfeeding; women of childbearing potential without reliable contraception

Precautions and warnings

• Caution with previous interstitial lung disease and tuberculosis (or contact with an affected person) – the doctor may perform tests.
• The medicine can cause blood, liver, lung and peripheral nerve disorders, serious allergic reactions including DRESS, and increase the risk of serious infections.
• Blood pressure is checked regularly, as leflunomide can raise it.
• Unexplained chronic diarrhoea and skin ulcers should be reported to the doctor.
• Calcium tests may show falsely low values.
• Certain vaccines should not be given during treatment and for some time afterwards – ask your doctor.
• The medicine contains lactose.

Interactions with other medicines, alcohol and food

• Combination with other DMARDs and immunosuppressants is not recommended: antimalarials (chloroquine, hydroxychloroquine), gold preparations, D-penicillamine, azathioprine, methotrexate.
• Caution/monitoring is needed with warfarin and other oral anticoagulants, teriflunomide, repaglinide, pioglitazone, nateglinide, rosiglitazone, daunorubicin, doxorubicin, paclitaxel, topotecan, duloxetine, alosetron, theophylline, tizanidine, oral contraceptives (ethinylestradiol/levonorgestrel), cefaclor, penicillin G, ciprofloxacin, indometacin, ketoprofen, furosemide, zidovudine, statins (rosuvastatin, simvastatin, atorvastatin, pravastatin) and sulfasalazine.
• Colestyramine and activated charcoal reduce leflunomide absorption (used deliberately only for accelerated elimination as decided by the doctor).
• NSAIDs and corticosteroids can be continued with Arava.
• Food does not affect absorption; alcohol is not recommended (liver damage).

Pregnancy and breastfeeding

Arava must not be taken during pregnancy or breastfeeding. If you become pregnant during treatment or within two years after stopping, contact your doctor immediately for testing and accelerated elimination (colestyramine 8 g three times daily for 11 days or activated charcoal, as decided by the doctor). Before a planned pregnancy, laboratory confirmation that the drug has been eliminated and a further wait of at least one month are required.

Driving and using machines

Arava can cause dizziness that impairs concentration and reactions – in that case do not drive or use machines.

Possible side effects

• Common (up to 1 in 10): leucopenia, mild allergic reactions, loss of appetite and weight, tiredness, headache, dizziness, paraesthesia, mild rise in blood pressure, colitis, diarrhoea, nausea, vomiting, mouth inflammation or ulcers, abdominal pain, raised liver enzymes, increased hair loss, eczema, dry skin, rash, itching, tendinitis, raised creatine kinase, peripheral neuropathy.
• Uncommon (up to 1 in 100): anaemia, thrombocytopenia, low potassium, anxiety, taste disturbance, hives, tendon rupture, raised blood lipids, low phosphate.
• Rare (up to 1 in 1,000): eosinophilia, pancytopenia, severe rise in blood pressure, interstitial lung disease, hepatitis and jaundice, sepsis.
• Very rare: agranulocytosis, severe allergic reactions, vasculitis, pancreatitis, severe liver damage, Stevens-Johnson syndrome, toxic epidermal necrolysis.
• Frequency not known: kidney failure, pulmonary hypertension, reversible effect on male fertility, cutaneous lupus, psoriasis, DRESS, skin ulcer.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: contact your doctor immediately and bring the pack; for accelerated elimination the doctor may use colestyramine or activated charcoal.
• Missed dose: take it as soon as you remember unless it is almost time for the next dose; do not take a double dose.
• Stopping or switching to another DMARD is agreed with the specialist, because the drug remains in the body for a long time.

Related information

• How to lower high blood pressure without drugs – measures that complement treatment

For additional care and support with joint pain and stiffness, see also the Bones, joints and muscles category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: leflunomide 20 mg per film-coated tablet.
• Core: lactose monohydrate, maize starch, povidone K25, colloidal anhydrous silica, magnesium stearate, crospovidone.
• Coating: hypromellose, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172), talc.
• Pack: 100 mL HDPE bottle with a screw cap with integrated desiccant, 30 film-coated tablets, in a carton with a leaflet.
• Marketing authorisation holder: AMICUS SRB D.O.O., Milorada Jovanovića 9, Belgrade. Manufacturer: Opella Healthcare International SAS, Compiègne, France.

Storage

• Keep the bottle tightly closed.
• Keep out of the sight and reach of children; shelf life 3 years.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

When will Arava start to work?

Improvement is usually felt after about 4 weeks or longer, and in some patients only after 4–6 months of treatment.

How often are blood tests done?

According to the Summary of Product Characteristics: before starting, every two weeks during the first six months and then every eight weeks (liver enzyme ALT and full blood count).

Can I become pregnant after stopping treatment?

The drug can take up to two years to be eliminated. An accelerated elimination procedure (colestyramine or activated charcoal) shortens this to a few weeks; laboratory confirmation and a wait of at least one month are then needed.

May I drink alcohol with Arava?

It is not recommended, as alcohol increases the risk of liver damage.

Sources

• ALIMS – Summary of Product Characteristics Arava®, 20 mg, film-coated tablets (April 2023)
• ALIMS – Package leaflet Arava®, 20 mg, film-coated tablets (April 2023)

Sources checked on: 23 October 2026.