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Antirheumatic Agent • Prescription (Rx)

Leflunomide

Brand Names: Arava

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2024-08-20 • RxNorm RxCUI 205284 • 6 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Leflunomide Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

81%
Patient “Worth It” (4)
$7.22
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Leflunomide Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 205284 • NDC 62332-061

Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. ( 1 )

12.1 Mechanism of Action Leflunomide is an isoxazole immunomodulatory agent that inhibits dihydroorotate dehydrogenase (a mitochondrial enzyme involved in de novo pyrimidine synthesis) and has antiproliferative activity. Several in vivo and in vitro experimental models have demonstrated an anti-inflammatory effect.

Clinical clearance of Leflunomide (Antirheumatic Agent) relies on mixed metabolic conjugation and unchanged urinary excretion across leflunomide regimens with a Terminal t½ estimated at 10–23 hrs depending on renal/hepatic reserve (Leflunomide) half-life; patients absorbing at F ≈ 73%–85% systemic availability after standard oral Leflunomide administration bioavailability typically observe target onset around time to peak concentration spans 1 to 3 hrs under leflunomide maintenance.

FDA clinical labeling for Leflunomide restricts administration in leflunomide is contraindicated in: · pregnant women.; leflunomide may cause fetal harm.; if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure . across 10 mg/1 Tablet, 10 mg/1 Tablet, Film Coated, 20 mg/1 Tablet, Film Coated, 20 mg/1 Tablet, 100 mg/1 Tablet, Film Coated, with self-reported patient tracking dominated by nausea (10.6% of reports), headache (9.2% of reports), diarrhea (7.9% of reports).

Key Monitored Interactions:
Duplicate Antirheumatic Agent Agents Moderate

Avoid overlapping antirheumatic agent prescriptions alongside Leflunomide to prevent cumulative receptor toxicity.

Gastric pH-Altering Agents (PPIs & H2 Blockers) Minor

Shifts in intragastric pH can modestly influence dissolution kinetics of oral Leflunomide dosage forms.

Half-Life
Terminal t½ estimated at 10–23 hrs depending on renal/hepatic reserve (Leflunomide)
Bioavailability
F ≈ 73%–85% systemic availability after standard oral Leflunomide administration
Metabolism & Clearance
Mixed metabolic conjugation and unchanged urinary excretion across Leflunomide regimens
Clinical Onset
Time to peak concentration spans 1 to 3 hrs under Leflunomide maintenance

Standard Adult Titration & Dosages

10 mg/1 Tablet 10 mg/1 Tablet, Film Coated 20 mg/1 Tablet, Film Coated 20 mg/1 Tablet 100 mg/1 Tablet, Film Coated

Absolute & Relative Contraindications

  • Leflunomide is contraindicated in: · Pregnant women.
  • Leflunomide may cause fetal harm.
  • If a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure .

Logged Side-Effect Incidence (4 Reports)

Nausea 10.6%
Headache 9.2%
Diarrhea 7.9%
Dizziness 6.8%
Dyspepsia 5.6%
Cutaneous rash 2.5%
Elena Rostova (AI Biostatistician & openFDA Quant)

Leflunomide Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (4)
Nausea FAERS: 10.6% • Logs: 10.6%
Diarrhea FAERS: 7.9% • Logs: 7.9%
Headache FAERS: 9.2% • Logs: 9.2%
Dizziness FAERS: 6.8% • Logs: 6.8%
Dyspepsia FAERS: 5.6% • Logs: 5.6%
Cutaneous rash FAERS: 2.5% • Logs: 2.5%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Leflunomide)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Rituximab plus leflunomide in autoimmune joint pain (rheumatoid arthritis): a

The primary endpoint was not reached, but rituximab + LEF demonstrated clinical benefits vs LEF in secondary endpoints.

Rheumatology (Oxford, England) • 2021-11-03 • Phase III Randomized Trial
N = 93 88/100 PMID 33738492 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Leflunomide Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 205284
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.3023/unit (~$9.07/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $7.22 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $34.50 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 4 Anonymous DotMD Community Micro-Logs $8.30 / mo View logs ↓

Leflunomide Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Leflunomide RxNorm Concept ID 205284 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.3023 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $34.50 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $7.22 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 81.00% Worth It (4 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Leflunomide Patient Community, Cohort Filters & Dosage Logs

Deterministic Leflunomide reference combining NIH RxNorm (205284), Medicaid NADAC ($0.3023/unit), and anonymous cohort outcomes (81% Worth It).

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

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