Arava: Targeted Symptom Control in Rheumatoid Arthritis
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Synonyms | |||
Arava (leflunomide) is a disease-modifying antirheumatic drug (DMARD) specifically engineered for the management of active rheumatoid arthritis in adults. It functions by selectively inhibiting pyrimidine synthesis in rapidly dividing cells, such as activated lymphocytes, which play a central role in the autoimmune inflammatory processes underlying rheumatoid arthritis. This mechanism offers a targeted approach to reduce joint damage, alleviate pain, and improve physical function, providing a foundational treatment option for long-term disease management. Clinical evidence supports its efficacy in slowing radiographic progression and maintaining remission, making it a cornerstone therapy in rheumatological practice.
Features
- Active pharmaceutical ingredient: Leflunomide
- Available in 10 mg and 20 mg oral tablets
- Selective inhibition of dihydroorotate dehydrogenase (DHODH)
- Long half-life active metabolite (teriflunomide) enabling once-daily dosing
- Manufactured under current Good Manufacturing Practice (cGMP) standards
Benefits
- Reduces joint swelling, tenderness, and pain associated with active rheumatoid arthritis
- Slows the progression of structural joint damage as evidenced by radiographic findings
- Improves physical function and quality of life scores in clinical assessments
- Provides a convenient once-daily oral dosing regimen supporting treatment adherence
- Offers an alternative mechanism of action for patients with inadequate response to other DMARDs
- Demonstrates long-term efficacy in maintaining clinical response and remission
Common use
Arava is indicated for the treatment of adults with active rheumatoid arthritis. It is used to reduce signs and symptoms, inhibit structural damage as evidenced by erosion and joint space narrowing on X-ray, and improve physical function. It may be used as monotherapy or in combination with other non-biologic DMARDs, though concomitant use with other hepatotoxic or immunosuppressive agents requires careful risk-benefit assessment. Clinical use typically follows failure of or intolerance to first-line therapies such as methotrexate.
Dosage and direction
The recommended dosing regimen involves an initial loading dose of 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, the maintenance dose may be decreased to 10 mg daily. Administration should occur at approximately the same time each day, with or without food. Tablets should be swallowed whole with water and not crushed or chewed. Dose adjustments may be necessary in patients with renal impairment or those experiencing certain adverse reactions.
Precautions
Patients should be monitored regularly for hepatotoxicity with serum transaminase and albumin levels at baseline and at least monthly during initial treatment. Complete blood counts should be performed periodically due to risk of hematologic toxicity. Blood pressure should be monitored as hypertension may occur or worsen. Women of childbearing potential must use reliable contraception during treatment and during drug elimination procedures afterward due to teratogenic risk. Vaccination with live vaccines should be avoided during and following treatment. Skin reactions ranging from rash to serious disorders such as Stevens-Johnson syndrome have been reported and require prompt evaluation.
Contraindications
Arava is contraindicated in patients with known hypersensitivity to leflunomide, teriflunomide, or any component of the formulation. It must not be used in patients with severe hepatic impairment. Contraindication applies to pregnant women or women of childbearing potential not using reliable contraception. Concomitant use with other hepatotoxic drugs (e.g., methotrexate) requires extreme caution. Patients with severe immunodeficiency, bone marrow dysplasia, or severe uncontrolled infection should not receive this medication. The drug is contraindicated in patients with severe hypoproteinemia or pre-existing blood dyscrasias.
Possible side effects
Common adverse reactions (≥1%) include diarrhea, elevated liver enzymes, alopecia, rash, hypertension, and respiratory infection. Less frequent but serious side effects may include severe liver injury, bone marrow suppression, peripheral neuropathy, Stevens-Johnson syndrome, and interstitial lung disease. Gastrointestinal disturbances such as nausea, abdominal pain, and mouth ulcers may occur. Some patients experience weight loss, headache, or dizziness. Allergic reactions including anaphylaxis have been reported. Persistent fever, unusual bruising, or signs of infection should prompt immediate medical attention.
Drug interaction
Arava demonstrates significant interactions with several medication classes. Concomitant use with other hepatotoxic drugs (including methotrexate, azathioprine, and long-term acetaminophen) increases risk of liver injury. Rifampin may increase teriflunomide levels. Warfarin requires close INR monitoring as leflunomide may enhance its anticoagulant effect. Live vaccines are contraindicated during therapy. Bile acid sequestrants (cholestyramine) and activated charcoal accelerate elimination of teriflunomide. Concurrent use with other immunosuppressants may increase risk of serious infections.
Missed dose
If a dose is missed, it should be taken as soon as remembered on the same day. If remembered the next day, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose. Consistent daily administration is important for maintaining therapeutic drug levels due to the long half-life of the active metabolite. Healthcare providers should be consulted if multiple doses are missed or if uncertainty exists about proper dosing.
Overdose
In case of suspected overdose, symptoms may include elevated liver enzymes, hematological abnormalities, or gastrointestinal distress. There is no specific antidote for leflunomide overdose. Management involves immediate gastric lavage or administration of activated charcoal if ingestion occurred within recent hours. Cholestyramine (8 g three times daily for 11 days) or activated charcoal may be administered to enhance drug elimination. Supportive care should include monitoring of hepatic and hematologic parameters. Dialysis is not effective for removal due to high protein binding. Poison control center consultation is recommended.
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container with the lid tightly closed to protect from moisture and light. Do not store in bathroom or other areas with high humidity. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly dispose of any unused medication through take-back programs or according to local regulations.
Disclaimer
This information provides a summary of Arava (leflunomide) and does not include all possible uses, directions, precautions, or adverse effects. This information is not medical advice and does not replace consultation with a qualified healthcare professional. Patients must consult their physician for personalized medical advice regarding their condition and treatment options. The manufacturer’s prescribing information should be consulted for complete details before initiating therapy.
Reviews
Clinical studies demonstrate that approximately 50-60% of patients achieve ACR20 response with leflunomide therapy, with significant improvements in pain scores and physical function assessments. Rheumatologists report satisfactory efficacy profiles particularly in patients with moderate to severe disease activity. Patient-reported outcomes indicate meaningful improvements in quality of life measures, though some note gastrointestinal side effects as treatment-limiting factors. Long-term extension studies show sustained efficacy over 24 months of treatment with acceptable safety profiles when appropriate monitoring is implemented. Comparative studies indicate similar efficacy to methotrexate with different side effect profiles.