Monograph Details
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Musculoskeletal Disorders
> Arthritis/rheumatic disorders
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ARAVA |
| Manufacturer |
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Sanofi Aventis |
| Legal Classification |
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Rx
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| Pharmacological Class |
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DMARD (pyrimidine synthesis inhibitor). |
| Generic Name |
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Leflunomide 10mg, 20mg, 100mg; tabs. |
| Indications |
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Active rheumatoid arthritis to reduce signs/symptoms, inhibit structural damage, and improve physical function. May be used with aspirin, NSAIDs, and/or low-dose corticosteroids. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: Loading dose: 100mg daily for three days; maintenance 20mg daily. If not well tolerated, and/or if ALT elevations >2xULN occur, may reduce to 10mg daily; monitor closely. If ALT elevations >2 but ≤3xULN persist despite dose reduction or if ALT elevations >3xULN, discontinue and give cholestyramine and activated charcoal as needed. Max 20mg/day. |
| Contraindications |
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Women of childbearing potential who are not using reliable contraception. Hepatic impairment or (+) hepatitis B or C serologies: not recommended. Pregnancy (Cat.X). Nursing mothers: not recommended. |
| Precautions |
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Monitor liver function (esp. ALT) and blood (WBCs, platelets, HCT) at baseline, then monthly for 1st six months; then every 6–8 weeks, if stable. Monitor monthly with methotrexate, other immunosuppressants. Obtain (–) pregnancy test before starting therapy; use reliable contraception. All women of childbearing potential and men wishing to father a child should use cholestyramine or activated charcoal to eliminate drug after therapy (see protocol in labeling). Renal impairment. Severe immunodeficiency, bone marrow dysplasia, severe uncontrolled infections. Delay giving live vaccines. |
| Interactions |
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May increase levels of diclofenac, ibuprofen, tolbutamide. Caution with rifampin, and with other hepatotoxic drugs. |
| Adverse Reactions |
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Diarrhea, elevated liver enzymes, alopecia, rash, respiratory infections, hypertension, headache, GI upset; rare: hepatotoxicity, sepsis, interstitial lung disease, immunosuppression. |
| How Supplied |
Tabs 10mg, 20mg—30
100mg—blister pack (1 x 3) |
| Additional Resources |
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• Related Prescribing Note |
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