RHOMED
LEFLUNOMIDE · by MEDERA
Composition
: Tab 10 mg/20 mg/100 mg: Leflunomide 10 mg/20 mg/100 mg.
Indications & Dosage
Moderate to severe active rheumatoid arthritis, Active psoriatic arthritis: Adult: Initially 100 mg once daily for 3 days then reduced to 10-20 mg once daily; if dose not tolerated or ALT level elevations; reduce dose to 10 mg/day. If elevations persist or ALT level is higher further, discontinue. Children: Not recommended.
Contraindications
Severe immunodeficiency, bone marrow dysfunction, blood dyscrasias, serious infections, hepatic impairment, moderate to severe renal insufficiency, severe hypoproteinaemia, ulcerative stomatitis. Contraception must be used by men and women during and for 2 years after use or until plasma levels fall below 0.02 mg/I.
Precautions
Anaemia, history of tuberculosis, impaired bone-marrow function, leucopenia, thrombocytopenia, risk of hepatotoxicity; monitor complete blood count & ALT before treatment and every 2 weeks for 6 months, then every 8 weeks; withdraw and washout if elevated and continue to monitor liver enzymes until normal. A washout procedure must be performed if toxicity or severe infection develops, or when switching to another disease-modifying antirheumatic drugs (DMARD) or for a desired preg-nancy.
Interactions
Other DMARDs, alcohol, hepatotoxic, or haematotoxic drugs, methotrexate, drugs metabolised by CYP2C9 (not NSAIDs), live vaccines, cholestyramine, activated charcoal.
Pregnancy
Contraindicated in pregnancy
Lactation
Contraindicated or not recommended
Side Effects
Abdominal pain, alopecia, anorexia, asthenia, diarrhoea, dizziness, dry skin, headache, increased blood pressure, leucopenia, nausea, oral mucosal disorders, paraesthesia, pruritus, rash, tenosynovitis, vomiting, anaemia, anxiety, hyperlipidaemia, hypokalaemia, hypophosphataemia, taste disturbance, tendon rupture, thrombocytopenia. Rare: Severe hepatotoxicity, hepatitis, eosinophilia, interstitial lung disease, jaundice, pancytopenia, severe infection, bone-marrow toxicity, hypouricaemia, malignancy, reduced sperm count, renal failure, pancreatitis