Drug reference
Moderate to severe active rheumatoid arthritis (specialist use only) ▶BY MOUTH ▶Adult: Initially 100 mg once daily for 3 days, then reduced to 10–20 mg once daily Active psoriatic arthritis (specialist use only) ▶BY MOUTH ▶Adult: Initially 100 mg once daily for 3 days, then Musculoskeletal system reduced to 20 mg once daily
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Serious infection. severe hypoproteinaemia. severe immunodeficiency
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Anaemia (avoid if significant and due to causes other than rheumatoid arthritis). history of tuberculosis. impaired bone-marrow function (avoid if significant and due to causes other than rheumatoid arthritis). leucopenia (avoid if significant and due to causes other than rheumatoid arthritis). thrombocytopenia (avoid if significant and due to causes other than rheumatoid arthritis)
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Exclude pregnancy before treatment.
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→Appendix 1: leflunomide
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▶Common or very common Abdominal pain. accelerated hair loss. appetite decreased. asthenia. diarrhoea. dizziness. gastrointestinal disorders. headache. leucopenia. nausea. oral disorders. paraesthesia. peripheral neuropathy. skin reactions. tendon disorders. vomiting. weight decreased ▶Uncommon Anaemia. anxiety. electrolyte imbalance. hyperlipidaemia. taste altered. thrombocytopenia ▶Rare or very rare Agranulocytosis. eosinophilia. hepatic disorders. infection. pancreatitis. pancytopenia. respiratory disorders. sepsis. severe cutaneous adverse reactions (SCARs). vasculitis ▶Frequency not known Cutaneous lupus erythematosus. hypouricaemia. pulmonary hypertension. renal failure SIDE-EFFECTS, FURTHER INFORMATION Discontinue treatment and institute washout procedure in case of serious side-effect (consult product literature). Hepatotoxicity Potentially life-threatening hepatotoxicity reported usually in the first 6 months. Discontinue treatment (and institute washout procedure— consult product literature) or reduce dose according to liver-function abnormality; if liver-function abnormality persists after dose reduction, discontinue treatment and institute washout procedure.
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Effective contraception essential during treatment and for at least 2 years after treatment in women and at least 3 months after treatment in men (plasma concentration monitoring required; waiting time before conception may be reduced with washout procedure—consult product literature). The concentration of the active metabolite after washout should be less than 20 micrograms/litre (measured on 2 occasions 14 days apart) in men or women before conception—consult product literature.
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Avoid—active metabolite teratogenic in animal studies.
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Present in milk in animal studies— manufacturer advises avoid.
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Manufacturer advises avoid—active metabolite may accumulate.
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Manufacturer advises avoid in moderate or severe impairment—no information available.
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▶Monitor full blood count (including differential white cell count and platelet count) before treatment and every 2 weeks for 6 months then every 8 weeks. ▶Monitor liver function before treatment and every 2 weeks for first 6 months then every 8 weeks. ▶Monitor blood pressure.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 4 ▶Leflunomide (Non-proprietary) Leflunomide 10 mg Leflunomide 10mg tablets | 30 tablet P £46.00 DT = £5.00 Leflunomide 15 mg Leflunomide 15mg tablets | 30 tablet P £46.00 DT = £46.00 Leflunomide 20 mg Leflunomide 20mg tablets | 30 tablet P £61.36 DT = £5.18 ▶Arava (Sanofi) Leflunomide 10 mg Arava 10mg tablets | 30 tablet P £51.13 DT = £5.00 Leflunomide 20 mg Arava 20mg tablets | 30 tablet P £61.36 DT = £5.18 Leflunomide 100 mg Arava 100mg tablets | 3 tablet P £30.67
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Washout Procedure The active metabolite persists for a long period; to aid drug elimination in case of serious adverse effect, or before starting another disease-modifying antirheumatic drug, or before conception, stop treatment and give either colestyramine p. 210 or charcoal, activated Musculoskeletal system p. 1438. Procedure may be repeated as necessary.
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Initially 100 mg once daily for 3 days, then
First-line fragment. Read the complete Indications and Dose section above.
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Initially 100 mg once daily for 3 days, then
First-line fragment. Read the complete Indications and Dose section above.
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