What Is Lysodren? Uses, Dosage, and What You Need to Know in 2026

If you or someone you care about has been diagnosed with adrenocortical carcinoma (ACC) — cancer of the adrenal cortex — your doctor may have mentioned Lysodren. This medication has been used in cancer treatment since 1970, yet it remains relatively unknown because the disease it treats is so rare. This guide explains what Lysodren is, what it treats, how it's used, and what patients and caregivers need to know before starting treatment.

What Is Lysodren?

Lysodren is the brand name for mitotane, an oral adrenal cytotoxic agent. Its chemical name is (±)-1,1-dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl) ethane — also known as o,p'-DDD. It is chemically related to the insecticide DDT, which led to the discovery of its adrenal-damaging properties in the mid-20th century.

Lysodren has been FDA-approved since 1970 — making it one of the oldest cancer drugs still in widespread use. It is manufactured by ESTEVE Pharmaceuticals and available as 500 mg white, round, scored tablets for oral use. There is no FDA-approved generic version of Lysodren.

What Is Lysodren Used For?

Lysodren is FDA-approved for a single indication:

Adrenocortical carcinoma (ACC) — specifically, inoperable ACC that is either functional (producing excess steroid hormones) or non-functional (not producing excess hormones)

It is also used in adjuvant settings (after surgery) to reduce the risk of ACC recurrence, though this use is not officially FDA-labeled.

Off-label, Lysodren is sometimes used in the management of Cushing's syndrome (excess cortisol production), particularly when caused by ACC. It controls hormone production in 70–75% of patients with functional ACC.

What Is Adrenocortical Carcinoma?

Adrenocortical carcinoma is a rare and aggressive cancer of the outer layer (cortex) of the adrenal glands — two small glands that sit on top of each kidney. ACC is estimated to affect about 0.72 per million people per year in the United States, with a median diagnosis age in the fifth to sixth decade of life.

ACC is often diagnosed at an advanced stage. About 60% of ACCs are "functional," meaning the tumor produces excess steroid hormones — causing symptoms of Cushing's syndrome (weight gain, high blood pressure, diabetes, easy bruising), virilization (in women), or other hormonal effects. The remaining 40% are "non-functional" and discovered incidentally or due to tumor mass effects.

How Is Lysodren Taken?

Lysodren is taken orally (by mouth), in 3 to 4 divided doses per day. The recommended starting dose is 2,000 to 6,000 mg per day (4 to 12 tablets of 500 mg each).

Key dosing points:

Take with food — especially high-fat food. Lysodren is lipophilic (fat-loving) and absorption is enhanced by fatty meals. Take doses at consistent times relative to meals.

Target plasma level: 14–20 mg/L — your doctor will titrate the dose gradually to reach this level, which typically takes 3 to 5 months.

Toxic above 20 mg/L — levels above 20 mg/L are associated with severe CNS toxicity. Plasma levels must be checked every 2 weeks during dose titration.

Do not miss a dose — if you miss a dose, take the next one as scheduled. Do not double up.

Hazardous drug handling — caregivers must wear disposable gloves when handling Lysodren tablets. Crushed or broken tablets should not be touched with bare hands.

How Long Is Lysodren Treatment?

In most ACC patients, Lysodren treatment is long-term — often for years. Even after achieving therapeutic plasma levels, regular monitoring continues indefinitely. When treatment is discontinued, mitotane levels in the blood can remain detectable for a very long time (months to years) because the drug accumulates in fat tissue and is slowly released.

Because Lysodren essentially eliminates adrenal function, virtually all patients require lifelong adrenal steroid replacement therapy (typically hydrocortisone and fludrocortisone), even after stopping Lysodren.

Who Makes Lysodren and Where Can You Get It?

Lysodren is manufactured by ESTEVE Pharmaceuticals S.A. (Barcelona, Spain) and distributed in the United States exclusively through Direct Success Inc. (1-844-597-6373). It is available only through specialty pharmacies — not at retail chains like CVS or Walgreens.

How to Access Lysodren

Accessing Lysodren requires working through the specialty pharmacy network. Your oncologist's office should route the prescription directly to a specialty pharmacy. If you're having trouble finding a pharmacy that carries it, medfinder can help — it's a paid service that calls pharmacies near you to find which ones can fill your prescription, then sends you the results by text.

See: Why Is Lysodren So Hard to Find? [Explained for 2026].