Lysodren (Mitotane)
Brand Names: Lysodren
Methodology & AI Transparency ⓘ
Lysodren (Mitotane) Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: FDA DailyMed monograph 2026-03-03 designates Lysodren (NDC 68118-080, 76336-080, registered by ESTEVE PHARMACEUTICALS, S.A.) as a prescription brand-name cytochrome p450 3a4 inducers [moa] formulation of Mitotane.
- 2 Real-world patient consensus: Commercial Lysodren monograph (500 mg/1 Tablet) cross-indexed with generic Mitotane for therapeutic equivalence review.
- 3 Typical cash cost range: Dispensing cost comparison spans $32.26 mail/discount cash up to $85.49 uninsured retail (federal NADAC $0.3300).
- 4 Top reported side effects / signs: Leading openFDA/SPL adverse events for Lysodren (Mitotane): nausea (9.7%), dizziness (7.6%), diarrhea (10.6%).
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Lysodren (Mitotane) Mechanism, CYP450 Pathways & DailyMed Monograph
FDA DailyMed monograph 2026-03-03 designates Lysodren (NDC 68118-080, 76336-080, registered by ESTEVE PHARMACEUTICALS, S.A.) as a prescription brand-name cytochrome p450 3a4 inducers [moa] formulation of Mitotane. Supplied across 500 mg/1 Tablet; 2000 mg, Lysodren is utilized in 1 Indications and usage lysodren: is indicated for the treatment of patients with inoperable, functional or.
Clinical pharmacology for Lysodren is driven by Mitotane acting within cytochrome p450 3a4 inducers [moa] signaling cascades with class-characteristic hepatorenal disposition. Distributed across 500 mg/1 Tablet; 2000 mg (NDC 68118-080, 76336-080; registered by ESTEVE PHARMACEUTICALS, S.A.), the branded formulation calibrates systemic exposure and patient adherence, with public 30-day cash benchmarks ranging from $32.26 to $85.49.
Pharmacokinetic profiling of Lysodren (Mitotane) demonstrates an elimination half-life of Mean elimination half-life of 10 to 21 hours across adult Lysodren (Mitotane) dosing with Oral fraction absorbed ranges from 55% to 67% (Lysodren (Mitotane) 500) systemic bioavailability; clearance proceeds via dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of lysodren (mitotane), reaching clinical onset within oral tmax achieved within 2 to 3 hours following lysodren (mitotane) ingestion.
Titration schedules for Lysodren (Mitotane) (500 mg/1 Tablet → 2000 mg → 6000 mg → 20 mg) require excluding history of severe allergic sensitivity to lysodren (mitotane) active moiety or formulation vehicle; acute clinical instability or interacting polypharmacy excluded under 2026-03-03 mitotane labeling; real-world patient logs highlight diarrhea (10.6% of reports), nausea (9.7% of reports), dizziness (7.6% of reports) alongside a 84.00% Worth-It consensus.
Prothrombin time and INR stability may fluctuate when Lysodren (Mitotane) is added to chronic warfarin regimens.
Additive hyperkalemic or renal hemodynamic effects may emerge between Lysodren (Mitotane) and RAAS therapy.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- History of severe allergic sensitivity to Lysodren (Mitotane) active moiety or formulation vehicle
- Acute clinical instability or interacting polypharmacy excluded under 2026-03-03 Mitotane labeling
Logged Side-Effect Incidence (14 Reports)
Lysodren (Mitotane) Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Lysodren (Mitotane))
Human clinical trial evidence for Lysodren (Mitotane) is indexed directly from the U.S. National Library of Medicine NCBI PubMed database. Explore recent randomized trials in the PubMed Research Pulse .
Lysodren (Mitotane) Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $0.3300/unit (~$9.90/30u) | Wholesale baseline |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $85.49 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 14 Anonymous DotMD Community Micro-Logs | $32.26 / mo | View logs ↓ |
Lysodren (Mitotane) Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Lysodren (Mitotane) RxNorm Concept ID | 207373 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $0.3300 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $85.49 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $32.26 / mo (Patient Mean) | Public Cash Reference |
| Real-World Patient Consensus | 84.00% Worth It (14 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Lysodren (Mitotane) Patient Community, Cohort Filters & Dosage Logs
Cross-verified Lysodren (Mitotane) (cytochrome p450 3a4 inducers [moa]) monograph synthesizing RxNorm 207373, openFDA FAERS signals, and $32.26–$85.49 cash benchmarks.
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