Lysodren (Mitotane) 500mg 100 Tablets | Esteve China Mainland | GLT

Generic Information: Lysodren / 利舒仁 (Mitotane) — China Mainland Version

This is the China Mainland presentation of mitotane, sold under the Chinese brand name 利舒仁 with the international name Lysodren on the carton. It is the same 500 mg scored tablet as the global original, but its China journey is worth knowing: the National Medical Products Administration (NMPA) approved it on 8 September 2023, and it went on sale across the mainland on 7 January 2025 — with Peking Union Medical College Hospital writing the first mainland prescription within 48 hours. The marketing authorization holder recorded in China's reimbursement filings is Esteve Pharmaceuticals S.A., the Spanish company that acquired HRA Pharma Rare Diseases in 2024 and now holds the global Lysodren rights.

What Is Lysodren (Mitotane) Used For?

The Chinese indication mirrors the global label: symptomatic treatment of advanced (unresectable, metastatic or recurrent) adrenocortical carcinoma. ACC is one of the most malignant and rare endocrine tumors — incidence about 0.5–2 per million, five-year survival near 30% — and surgery is the only chance of cure. For patients whose disease cannot be fully resected or has returned, mitotane is the standard of care, and the NMPA approval records it as the only drug approved in China for ACC, as well as the only ACC-specific drug approved globally, with orphan-drug status in the US, EU and China.

How Does Lysodren (Mitotane) Work?

Mitotane is a selective adrenal cytotoxic agent: it alters mitochondrial structure and inhibits sterol O-acyltransferase 1 (SOAT1) to directly kill adrenocortical cells, while separately suppressing the adrenal's steroid production. The second effect is clinically crucial for functional tumors, because it lowers the cortisol and other hormones responsible for the Cushing's syndrome and metabolic derangements that often kill ACC patients before the tumor mass itself does. Chinese clinicians describe it as controlling both the tumor and the hormone storm, which is why it is used across functional and nonfunctional disease.

Indications of Lysodren (China Label)

The Chinese label covers symptomatic treatment of advanced adrenocortical carcinoma — unresectable, metastatic or recurrent. The mainland approval was granted after a global development history that began with FDA approval in 1970 and EMA orphan designation; China's filing leaned on that accumulated evidence and on domestic urgent-need pathways. Patients who previously had to import the drug through temporary compassionate-use channels now have a legitimate mainland supply, a change that transformed access for the roughly ten thousand ACC patients estimated across China.

Dosage and Administration

Treatment begins at 2 g to 3 g per day for adults, then the dose is increased gradually — typically every two weeks — until the plasma mitotane level reaches the therapeutic window of 14–20 mg/L. For patients whose symptoms demand rapid control of Cushing's syndrome, a higher starting dose of 4–6 g per day may be used, with faster weekly escalation; starting above 6 g per day is not recommended. The medicine is taken in divided doses with food, swallowed whole, and because it is fat-soluble and long-acting, levels must be monitored regularly and for weeks after any change or stop. Treatment should be overseen by a physician experienced with the drug.

Side Effects of Lysodren (利舒仁)

The mainland package profile matches the international one: gastrointestinal upset (anorexia, nausea, vomiting, diarrhea) and central nervous system effects (dizziness, vertigo, sedation, depression) lead the list, the latter in about 40% of patients. The boxed warning concerns adrenal crisis during shock, severe trauma or infection, when the drug is temporarily stopped and exogenous steroids are given. Monitoring covers liver function, blood counts, lipid and thyroid panels, and pelvic ultrasound in premenopausal women. Because mitotane strongly induces CYP3A4 and can harm a fetus, drug interactions are reviewed carefully and effective nonhormonal contraception is required.

Storage Instructions

Store at room temperature, sealed and protected from light, in the original carton. No refrigeration. This is a cytotoxic medicine — keep it out of children's reach and return unused tablets to a pharmacy rather than discarding them in household waste.

Why Choose Lysodren (利舒仁) from GLT?

The China Mainland presentation matters to two groups of buyers. For patients inside China, it is the domestically approved product with Chinese labeling and the 利舒仁 brand they can reconcile against the NMPA record; for patients outside China, it is the same originator molecule in a cost-effective regulated-market package. GLT supplies sealed mainland cartons with batch documentation and pre-shipment photographs, serves individual families and institutional tenders, and answers personally on WhatsApp +86 15234153837 and [email protected]. If mainland stock is tight we will say so and quote the US original or the Lao generics side by side.

How to Order Lysodren (Mitotane)

Message WhatsApp +86 15234153837 or email [email protected] with the quantity you need. GLT returns a formal quotation with shipping and payment options, usually within one working day, and dispatches sealed stock with complete export paperwork on confirmation. Recurring supply can be scheduled so treatment never lapses.

FAQ

When was mitotane approved in mainland China? The NMPA approved it on 8 September 2023, and it went on sale across the mainland on 7 January 2025.

Who holds the marketing authorization in China? The reimbursement filing records Esteve Pharmaceuticals S.A., the Spanish company that acquired HRA Pharma Rare Diseases in 2024 and now holds the global Lysodren rights.

Is the China version the same medicine as the US one? Yes — the identical 500 mg mitotane tablet; only the carton language, the 利舒仁 brand and the marketing authorization holder differ.

Why does dosing start lower in China than in the US label? The Chinese label starts at 2–3 g/day and the US label at 2–6 g/day, but both titrate to the same 14–20 mg/L target window — the difference is a starting-dose convention, not a different drug.

Can you supply Lao generics too? Yes — MITODX, LuciMito and Mytanne are listed on our site; we quote them alongside the originals.