Lysodren (Mitotane) 500mg 100 Tablets | HRA Pharma US Original | GLT

Generic Information: Lysodren (Mitotane) — United States Original

Lysodren is the United States presentation of mitotane, the only medicine ever approved anywhere in the world specifically for adrenocortical carcinoma (ACC). First cleared by the US FDA in 1970 and marketed today by HRA Pharma Rare Diseases, it remains a genuinely unique drug: an adrenal cytotoxic agent that is, chemically, a relative of the insecticide DDT — o,p'-DDD. The US presentation GLT supplies is a bottle of 100 white, scored, biconvex 500 mg tablets, each impressed with "BL" over "L1" on the reverse side, the imprint that confirms genuine US stock.

What Is Lysodren (Mitotane) Used For?

Lysodren is indicated for patients with inoperable, functional or nonfunctional adrenocortical carcinoma. ACC is exceptionally rare — roughly one to two cases per million people per year — and aggressive, with a five-year survival around 30%. Because surgery is the only curative option and many patients present too late for it, mitotane is the standard systemic therapy for unresectable disease, and it is also used after surgery as adjuvant treatment to delay recurrence. It is the orphan drug that defines the field, listed as such by the FDA, the EMA and China's NMPA alike.

How Does Lysodren (Mitotane) Work?

Mitotane attacks the adrenal cortex on two fronts. Its cytotoxic effect — altering mitochondria and inhibiting sterol O-acyltransferase 1 (SOAT1) — directly destroys adrenocortical cells and, over time, can induce atrophy of the gland itself. In parallel it suppresses steroidogenesis, cutting the cortisol and other steroid hormones that functional ACC tumors pour out and that drive Cushing's syndrome in these patients. That dual action explains why the drug both shrinks disease and calms the metabolic storm of hormone excess, even when the tumor does not fully regress.

Indications of Lysodren (US Label)

The FDA label reads precisely: treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma. There are no contraindications listed — a reflection of how desperate the untreated disease is — but the label carries a boxed warning that patients face increased risk of adrenal crisis during shock, severe trauma or infection, requiring temporary drug discontinuation and exogenous steroid cover. Cushing's syndrome relief is a well-established off-label use, especially for rapid control of severe hypercortisolism before surgery or in patients with metastatic disease.

Dosage and Administration

Treatment starts at 2 g to 6 g per day (2000–6000 mg) in three or four divided doses taken with food, then the dose is titrated against blood levels to reach the therapeutic window of 14–20 mg/L. That is the entire art of this drug: it is lipophilic, accumulates in fat tissue, and has a half-life measured in weeks to months, so levels drift for a long time after any change. Levels above 20 mg/L sharply raise the risk of central nervous system toxicity, at which point the dose is typically cut by half or more. Blood counts, liver function and — in premenopausal women — pelvic ultrasound are checked before starting and during titration.

Side Effects of Lysodren

The most common reactions are gastrointestinal — anorexia, nausea, vomiting, diarrhea — together with central nervous system effects: dizziness, vertigo, sedation, lethargy and depression, reported in roughly 40% of patients. Serious monitoring items are adrenal insufficiency (steroid replacement is often required), hepatotoxicity, hematologic toxicity and prolonged bleeding time, which matters if surgery is planned. Because mitotane is a strong CYP3A4 inducer, it also undercuts the levels of many other drugs, including some anticoagulants and hormonal contraceptives — nonhormonal contraception is required, as the drug can harm a fetus. Hypercholesterolemia, hypothyroidism and reduced free testosterone in men are additional class effects to watch.

Storage Instructions

Store the bottle at room temperature, tightly closed and away from light and moisture, in the original packaging. Keep out of reach of children, and return unused tablets to a pharmacy for disposal — this is a cytotoxic agent and must not enter household waste or drains.

Why Choose Lysodren (US) from GLT?

Patients and institutions ask GLT for the US presentation for one reason above all: certainty. Genuine US Lysodren carries the "BL over L1" imprint and HRA Pharma Rare Diseases packaging that pharmacies and customs brokers recognize, with batch documentation and pre-shipment photographs on request. Because ACC is so rare, local supply is often absent or exhausted, and GLT exists to close exactly that gap — we source sealed US stock, serve families and hospital tenders alike, and answer every enquiry personally on WhatsApp +86 15234153837 or at [email protected]. We will also be straight with you: the US original sits at the top of the global price range, and we routinely quote the Chinese and Lao presentations side by side so the choice is made on facts.

How to Order Lysodren (Mitotane)

Send the required quantity to WhatsApp +86 15234153837 or [email protected]. GLT replies with a formal quotation, courier and payment options — usually within one working day — and dispatches sealed stock with complete export documentation on confirmation. Monthly and multi-month schedules can be arranged so therapy is never interrupted; institutional buyers can request CoA and batch images before payment.

FAQ

Why is mitotane so special among cancer drugs? It is the only drug ever approved specifically for adrenocortical carcinoma, and it doubles as an adrenal toxin and a steroid-suppressing agent — no other oncology drug works this way.

What does the "14–20 mg/L" target mean? Mitotane works best when its blood level stays in that therapeutic window; below it the drug is less effective, and above 20 mg/L the risk of neurological side effects climbs sharply. Levels are monitored and the dose adjusted to stay in range.

Is Lysodren used for Cushing's syndrome too? Yes, off-label — the same steroid-suppressing effect makes it useful for severe hypercortisolism, though the formal FDA indication is ACC.

How long does the drug stay in the body? A very long time — its half-life is measured in weeks to months because it stores in fat tissue, so levels must be watched for weeks even after stopping.

Can GLT supply the Chinese or Lao versions instead? Yes — the China Mainland Lysodren and the Lao generics MITODX, LuciMito and Mytanne are all listed on our site; ask for a side-by-side quotation.