Arava: Advanced DMARD Therapy for Rheumatoid Arthritis Relief
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Synonyms | |||
Arava (leflunomide) is a disease-modifying antirheumatic drug (DMARD) specifically engineered to target the underlying mechanisms of rheumatoid arthritis. By selectively inhibiting pyrimidine synthesis in activated lymphocytes, it reduces joint inflammation, slows radiographic progression, and helps preserve physical function. This oral therapy offers a convenient, once-daily dosing option for adults with moderate to severe active rheumatoid arthritis, providing long-term disease control and improved quality of life. Clinical studies demonstrate its efficacy both as monotherapy and in combination with other antirheumatic agents.
Features
- Active ingredient: Leflunomide 10mg, 20mg tablets
- Mechanism: Inhibits dihydroorotate dehydrogenase (DHODH), reducing autoimmune T-cell proliferation
- Formulation: Film-coated, scored tablets for dose adjustment
- Administration: Oral, once daily with or without food
- Bioavailability: >80%, with peak plasma concentration in 6–12 hours
- Half-life: Approximately 2 weeks due to active metabolite
- Metabolism: Hepatic, via CYP450 and non-enzymatic processes
- Excretion: Renal and fecal elimination
Benefits
- Reduces joint swelling, tenderness, and morning stiffness within 4–8 weeks of initiation
- Slows radiographic evidence of joint erosion and cartilage destruction
- Improves physical function scores and enables sustained remission in responsive patients
- Offers convenient once-daily dosing compared to some injectable alternatives
- May be used as monotherapy or combined with methotrexate for synergistic effect
- Demonstrates long-term efficacy with continuous treatment in clinical trials
Common use
Arava is primarily indicated for the treatment of adults with active rheumatoid arthritis to reduce signs and symptoms, inhibit structural damage evidenced by X-ray erosion, and improve physical function. It is often prescribed when patients have had an inadequate response to first-line DMARDs like methotrexate or cannot tolerate them. Some off-label uses include management of psoriatic arthritis and certain autoimmune conditions under specialist supervision, though robust evidence for these indications is limited.
Dosage and direction
The recommended loading dose is 100 mg once daily for 3 days, followed by a maintenance dose of 20 mg once daily. For patients who cannot tolerate the 20 mg dose, a reduction to 10 mg daily may be considered. Administration should occur at approximately the same time each day, with or without food. Tablets should be swallowed whole with water. Dose adjustments are necessary in patients with hepatic impairment or those taking concomitant medications that affect liver function. The long half-life necessitates careful monitoring during initiation and discontinuation.
Precautions
Before initiating Arava, conduct complete blood count (CBC), liver function tests (ALT/AST), and serum creatinine. Monitor blood pressure regularly due to potential hypertension risk. Use caution in patients with history of hepatic disease, immunodeficiency, or bone marrow dysfunction. Vaccination with live vaccines is not recommended during treatment. Women of childbearing potential must use reliable contraception due to teratogenic risk. Consider drug elimination procedure (cholestyramine washout) if rapid clearance is needed. Regular ophthalmologic examinations are advised for patients with diabetes or history of ocular inflammation.
Contraindications
Arava is contraindicated in patients with known hypersensitivity to leflunomide or any component of the formulation. It must not be used during pregnancy or in women not using reliable contraception. Severe hepatic impairment (Child-Pugh Class C) or pre-existing acute/chronic liver disease prohibits use. Concomitant administration with teriflunomide is contraindicated. Patients with severe immunodeficiency, bone marrow dysplasia, or significant anemia/leukopenia/thrombocytopenia should not receive this medication. Severe renal impairment (CrCl <30 mL/min) requires avoidance due to inadequate safety data.
Possible side effects
Common adverse reactions (≥5% incidence) include diarrhea, nausea, abdominal pain, headache, hypertension, alopecia, rash, and respiratory infections. Less frequent but clinically significant effects include elevated liver enzymes (10–15% of patients), weight loss, and mild allergic reactions. Serious side effects requiring immediate medical attention include hepatotoxicity (0.5%), severe skin reactions (Stevens-Johnson syndrome), peripheral neuropathy, interstitial lung disease, and pancytopenia. Most side effects are dose-dependent and may decrease with continued therapy or dose reduction.
Drug interaction
Arava interacts significantly with: rifampin (increases leflunomide levels), warfarin (potentiates anticoagulation), and live vaccines (diminished immune response). Concomitant use with other hepatotoxic drugs (methotrexate, azathioprine) increases liver injury risk. Cholestyramine and activated charcoal accelerate elimination by 40–50%. CYP2C9 substrates (phenytoin, tolbutamide) may require dose adjustment. NSAIDs and other RA medications generally show acceptable safety profiles in combination, though monitoring is advised.
Missed dose
If a dose is missed, take it as soon as remembered the same day. If missed entirely, skip the dose and resume the regular schedule the next day. Do not double the dose to make up for a missed administration. Given the long half-life of leflunomide, occasional missed doses are unlikely to significantly affect therapeutic efficacy, though consistent daily dosing is recommended for optimal disease control.
Overdose
Symptoms may include nausea, vomiting, abdominal pain, diarrhea, leukopenia, and elevated liver enzymes. In case of suspected overdose, initiate the recommended elimination procedure: administer cholestyramine 8 g orally three times daily for 24 hours (or 4 g three times daily for 11 days if rapid elimination is not critical). Plasma levels should be monitored; concentrations below 0.02 mg/L indicate adequate elimination. Supportive care including hydration and symptomatic treatment is essential. Hemodialysis is not effective due to high protein binding.
Storage
Store at controlled room temperature (20–25°C or 68–77°F) in the original container. Protect from light and moisture. Keep tightly closed and out of reach of children. Do not use after the expiration date printed on the packaging. Do not store in bathroom or other humid areas. Discard any tablets that appear discolored or damaged.
Disclaimer
This information is for educational purposes and does not replace professional medical advice. Always consult a qualified healthcare provider for diagnosis and treatment decisions. Individual response to Arava may vary based on clinical status, comorbidities, and concomitant medications. Full prescribing information including boxed warnings should be reviewed before initiation. Safety and efficacy in pediatric patients have not been established.
Reviews
Clinical trials demonstrate 50–60% of patients achieve ACR20 response within 6 months, with significant improvements in pain scores and functional status. Long-term extension studies show sustained efficacy over 5+ years of treatment. Patient-reported outcomes indicate improved quality of life measures, though gastrointestinal side effects lead to discontinuation in approximately 5–10% of users. Real-world evidence supports its position as an effective option after methotrexate failure, with particular benefit in slowing radiographic progression.