Comprehensive medication guide to Lysodren including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
Commercial insurance patients can typically access the ESTEVE manufacturer copay program, limiting costs to $80/month or less. Lysodren is listed as Tier 5 on most Medicare Part D formularies; Medicare patients benefit from the $2,000 annual out-of-pocket cap effective 2025. Prior authorization is typically required by commercial plans.
Estimated Cash Pricing
Lysodren costs approximately $3,808 for 100 tablets (500 mg) at retail. At typical doses of 6–12 tablets per day, monthly retail costs range from $7,000 to over $14,000. No generic is available. Standard coupon programs like GoodRx do not apply; patients should call 1-844-597-6373 for manufacturer assistance.
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Lysodren is the brand name for mitotane, an oral adrenal cytotoxic agent. FDA-approved since 1970, it is the only drug approved by the FDA specifically for adrenocortical carcinoma (ACC) — a rare and aggressive cancer of the adrenal glands. Lysodren is manufactured by ESTEVE Pharmaceuticals S.A. and is available as 500 mg scored tablets.
ACC is an extremely rare cancer, occurring in approximately 0.72 per million people per year in the United States. Because Lysodren treats such a small patient population, it is distributed exclusively through a specialty pharmacy network (Direct Success Inc., 1-844-597-6373) and is not available at standard retail pharmacies. There is no FDA-approved generic version of Lysodren.
Lysodren is classified as a hazardous drug. Caregivers handling the tablets must wear disposable gloves. Treatment is typically initiated in a hospital setting, with careful plasma level monitoring required throughout the titration period.
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Lysodren (mitotane) works through two complementary mechanisms. First, it acts as an adrenal cytotoxin — it is metabolized inside adrenal cortex cells into reactive compounds that directly damage and destroy those cells, including cancer cells. This is its tumor-fighting mechanism. Second, it inhibits steroidogenesis — it blocks key enzymes (including StAR and CYP11A1) that the adrenal cortex uses to produce cortisol and other steroid hormones, reducing uncontrolled hormone production in functional ACC.
Mitotane is highly lipophilic — it dissolves in fat and accumulates extensively in adipose tissue throughout the body. This gives it an extremely long half-life of 18 to 159 days. Therapeutic plasma levels of 14–20 mg/L typically take 3 to 5 months of consistent dosing to achieve, as the drug gradually saturates fat stores before reaching steady state in the bloodstream. Levels above 20 mg/L are associated with serious CNS toxicity and must be avoided.
Mitotane is also a strong inducer of CYP3A4, a liver enzyme that metabolizes approximately 50% of all prescription drugs. This means Lysodren can significantly reduce the effectiveness of many co-administered medications — including hormonal contraceptives, warfarin, and numerous cancer drugs — requiring dose adjustments and careful drug interaction review.
500 mg — tablet
White, round, biconvex scored tablet. Starting dose: 2,000–6,000 mg/day in 3–4 divided doses. Target plasma level: 14–20 mg/L.
Lysodren is one of the most difficult prescription medications to access in the United States — not because of a traditional drug shortage, but because of its specialty-only distribution model. Retail pharmacies (CVS, Walgreens, Rite Aid, Walmart) cannot order Lysodren through standard wholesale channels. It is distributed exclusively through Direct Success Inc. (1-844-597-6373), a specialty pharmacy network.
Patients frequently report calling multiple pharmacies only to be told the drug is unavailable — not because of supply disruption, but because those pharmacies are simply not in the Lysodren distribution network. Access is further complicated by insurance prior authorization requirements (typically required by commercial plans), the very high retail cost with no generic alternative, and the limited number of oncologists familiar with the specialty pharmacy enrollment process.
If you're struggling to find a pharmacy that can fill your Lysodren prescription, medfinder can help. medfinder is a paid service that calls pharmacies in your area to find which ones can fill your prescription, then texts you the results — saving hours of frustrating calls.
Lysodren (mitotane) is not a controlled substance, so there are no DEA scheduling restrictions on which licensed prescribers can write for it. Any physician with a valid DEA number can legally prescribe Lysodren. However, given the complexity of ACC management — including therapeutic plasma level monitoring, hazardous drug protocols, steroid replacement, and extensive drug interactions — Lysodren is strongly recommended to be managed by a specialist.
Prescribers who typically manage Lysodren:
Medical oncologists specializing in rare cancers or endocrine malignancies
Endocrinologists with experience in adrenal disorders, Cushing's syndrome, or neuroendocrine tumors
Adrenal tumor specialists at NCI-designated comprehensive cancer centers
Telehealth availability: Because Lysodren is not a controlled substance, it can legally be prescribed via telemedicine. However, initial treatment requires hospital-based titration and regular in-person laboratory monitoring, so telehealth should supplement rather than replace in-person specialist care for ACC.
No. Lysodren (mitotane) is not a controlled substance and is not scheduled by the DEA under the Controlled Substances Act. There are no federal scheduling restrictions on who can prescribe it or how it can be dispensed.
While any licensed physician with a valid DEA number may legally prescribe Lysodren, its complexity — including therapeutic drug monitoring requirements, hazardous drug handling protocols, prior authorization processes, and specialty distribution — means it is almost always managed by oncologists or endocrinologists with experience treating adrenocortical carcinoma. Prescriptions must be routed through the specialty pharmacy network (Direct Success Inc.) rather than retail chains.
The most common side effects of Lysodren include:
Nausea, vomiting, diarrhea, and abdominal discomfort
Loss of appetite (anorexia)
Dizziness and lightheadedness
Depression, mental sluggishness, and fatigue
Rash
Elevated cholesterol and triglycerides
Decreased thyroid hormones (hypothyroidism)
Decreased testosterone (in males)
Serious side effects that require immediate medical attention:
Adrenal crisis: Life-threatening emergency — risk increases with illness, surgery, or injury (Boxed Warning)
Severe CNS toxicity: Profound sedation, vertigo, confusion, memory loss (associated with plasma levels > 20 mg/L)
Embryo-fetal toxicity: Lysodren can cause preterm birth and pregnancy loss; non-hormonal contraception required
Hepatotoxicity: Liver damage; monitor LFTs throughout treatment
Prolonged bleeding time: Important consideration before any surgical procedure
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Ketoconazole
Antifungal used off-label as a steroidogenesis inhibitor for cortisol control in ACC and Cushing's syndrome. Faster onset than mitotane; significant hepatotoxicity risk. Does not have mitotane's cytotoxic effects.
Metyrapone (Metopirone)
Steroidogenesis inhibitor that blocks 11-beta-hydroxylase. Used off-label for Cushing's syndrome; often combined with mitotane. Can cause hypertension, hypokalemia, and androgenic side effects.
Osilodrostat (Isturisa)
FDA-approved for Cushing's disease. Rapid onset steroidogenesis inhibitor; useful in ACC-related hypercortisolism when mitotane access is delayed or metyrapone is contraindicated.
EDP chemotherapy (etoposide + doxorubicin + cisplatin)
Used in combination with mitotane as first-line systemic therapy for advanced/metastatic ACC (EDP-M regimen, per FIRM-ACT trial). Does not replace mitotane but is given alongside it.
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Spironolactone
majorSpironolactone may block the action of mitotane. Concomitant use is contraindicated per prescribing information.
Warfarin
majorMitotane's strong CYP3A4 induction significantly alters warfarin metabolism and INR. Avoid concomitant use if possible; if used together, monitor INR very frequently and adjust doses accordingly.
Hormonal contraceptives
majorLysodren can render hormonal contraceptives (pills, patches, rings) unreliable. Non-hormonal contraception is required during treatment and until plasma levels are undetectable.
CYP3A4 substrates (broad class)
moderateMitotane is a strong CYP3A4 inducer. It significantly reduces plasma levels of hundreds of CYP3A4-metabolized drugs, potentially causing therapeutic failure. Review all medications before prescribing.
Corticosteroids (hydrocortisone)
moderatePatients on Lysodren require higher-than-normal steroid replacement doses because CYP3A4 induction speeds up cortisol/hydrocortisone metabolism. Dose adjustments are expected and necessary.
Ketoconazole
moderateKetoconazole is a strong CYP3A4 inhibitor, creating a pharmacokinetic interaction with mitotane. The combination is sometimes used clinically for cortisol control but requires careful management.
Lysodren (mitotane) is a truly unique medication — the only FDA-approved treatment for adrenocortical carcinoma, approved since 1970, with no generic alternative. Its dual role as an adrenal cytotoxin and steroidogenesis inhibitor makes it irreplaceable in ACC treatment. However, its specialty-only distribution, high cost, complex pharmacokinetics, and extensive drug interaction profile make it one of the most challenging medications to access and manage.
For patients and caregivers navigating Lysodren, the most important steps are: working with an experienced specialist, establishing care through the Direct Success specialty pharmacy network early, enrolling in the appropriate financial assistance program before the first dispense, and maintaining proactive refill management to prevent treatment gaps. Keep emergency hydrocortisone on hand at all times, and carry a medical alert card informing emergency providers of your adrenal insufficiency risk.
If you ever have difficulty locating a pharmacy that can fill your Lysodren prescription, medfinder is here to help. medfinder is a paid service that calls pharmacies near you to find which ones can fill your prescription, then sends results directly to your phone.
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