Ariva 10mg

Description

Ariva 10mg Tablets contain leflunomide, a disease-modifying antirheumatic drug (DMARD) used in Pakistan to manage rheumatoid arthritis by slowing disease progression and reducing joint inflammation. Bosch Pharmaceuticals produces it for systemic anti-rheumatic therapy, targeting autoimmune joint damage common in middle-aged patients from genetic or environmental factors in areas like Punjab or Sindh. Available in packs of 30 tablets, it’s prescription-only, priced around Rs. 405-450 per pack, and monitored under DRAP guidelines for long-term use.

How It Functions

Leflunomide inhibits dihydroorotate dehydrogenase (DHODH), an enzyme in pyrimidine synthesis, reducing activated T-cell proliferation and autoimmune inflammation in joints. Its active metabolite, teriflunomide, persists long-term, providing sustained effects. Chemically, it’s N-(4-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. Peak plasma levels occur in 6-12 hours, with a half-life of 14-18 days, allowing once-daily dosing and gradual onset over weeks.

Dosage Information

Adults: Loading dose of 100mg daily for 3 days, followed by 10-20mg once daily for rheumatoid arthritis. For the 10mg strength, one tablet daily maintenance after loading; adjust based on response and tolerance, up to 20mg if needed. Swallow whole with water, with or without food. Not for children; elderly may start at lower doses. Monitor blood tests monthly initially; discontinue with washout procedure (cholestyramine) if stopping for pregnancy or toxicity.

Side Effects

• Very Common (>1 in 10): High blood pressure, diarrhea, nausea, hair loss.
• Common (up to 1 in 10): Stomach pain, mouth sores, elevated liver enzymes, leucopenia (low white blood cells), tenosynovitis (tendon inflammation), headache, dizziness, weakness, abnormal sensations (paraesthesia), weight loss, rash, dry skin.
• Rare: Severe liver toxicity, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, severe infections, pustular psoriasis.

Drug Interactions

Leflunomide may interact with:

• Methotrexate: Increases liver toxicity risk.
• Warfarin or vitamin K antagonists: Enhances bleeding risk.
• CYP2C9 substrates (e.g., tolbutamide, phenytoin): Alters levels, raising toxicity.
• Rifampin: Reduces leflunomide efficacy.
• Live vaccines (e.g., BCG, yellow fever): Increases infection risk.
• Immunosuppressants (e.g., azathioprine): Additive bone marrow suppression.
• NSAIDs or aspirin: May heighten gastrointestinal or liver effects.

Indications

Approved for treating active rheumatoid arthritis in adults, reducing joint pain, swelling, and damage from autoimmune inflammation.

When Not to Use

Avoid in:

• Hypersensitivity to leflunomide or excipients.
• Severe immunodeficiency, bone marrow dysfunction, or blood disorders (e.g., anemia, low platelets).
• Moderate to severe liver or kidney insufficiency.
• Active infections or ulcerative stomatitis (mouth ulcers).
• Pregnancy or planning pregnancy (category X; teratogenic).
• Breastfeeding without washout.

Precautions

• Monitor ALT liver enzymes before starting, every 2 weeks for 6 months, then every 8 weeks; perform complete blood count periodically.
• Check blood pressure regularly; report infections, unusual bleeding, or bruising immediately.
• Use contraception for both men and women during treatment and up to 2 years after, or until blood levels are undetectable via washout (cholestyramine 8g three times daily for 11 days).
• Hypoproteinemia (low blood protein) requires caution; adjust dose in renal impairment.
• Elderly patients: Higher risk of toxicity; start low and monitor closely.
• Avoid alcohol to prevent liver strain, common in Pakistani social settings.

Warnings

• Hepatotoxicity: Life-threatening liver damage possible; discontinue if ALT >3x upper limit, with washout procedure.
• Bone marrow suppression: Risk of pancytopenia; stop if severe leucopenia or thrombocytopenia occurs.
• Severe skin reactions: Stevens-Johnson syndrome or epidermal necrolysis may be fatal; seek immediate care for rash or blisters.
• Infections: Increased susceptibility to serious infections; vaccinate before starting, avoid live vaccines.
• Pregnancy: Contraindicated; causes fetal harm—confirm negative test before use and use effective birth control.
• Hypertension: May elevate blood pressure; monitor and treat as needed.

Additional Notes

• Pregnancy Category: X—contraindicated due to teratogenic risks; requires washout if pregnancy occurs.
• Breastfeeding: Contraindicated; passes into milk and may harm infant—use washout if needed.
• Availability: Common in urban pharmacies like those in Rawalpindi; generics like Arava available, with DRAP oversight for imports.
• Stability: Stable at room temperature; discard if discolored.
• Reporting: Note batch for adverse events; report to DRAP for pharmacovigilance.

Doctor Review

Dr. Fatima Khan, a rheumatologist in Lahore, highlights Ariva’s role in slowing rheumatoid arthritis progression for patients unresponsive to methotrexate, easing joint pain in daily activities. DRAP guidelines back its DMARD status, but Dr. Khan urges monthly liver and blood tests to catch early toxicity, especially in those with hepatitis risks prevalent in Pakistan.

Disclaimer

This is general product information, not a prescription or medical advice. Consult your doctor or pharmacist for personal guidance.