Important Safety Information
Prescribing Information
Medication Guide
For US Healthcare Professionals

Why Lysodren®

Learn why Lysodren® is prescribed to treat ACC and how it works

How Does It Work?

Lysodren® is used when surgery cannot remove the tumor.1

Lysodren® has 2 main actions 2:

1

It ACTS against tumors

destroying cancer cells

2

It controls hormones

improving symptoms caused by the excess hormones

In other words, Lysodren® helps to stop tumors from growing while reducing hormone levels, in certain patients.*

Lysodren® needs time to build up in your body before it starts working effectively. Even if your dose is not changed for a while, the level in your blood can continue to rise over time. If it gets too high, you may be asked to stop taking it for a few days and restart at a lower dose.3

*The precise way Lysodren® works is not completely understood.

When Is It Prescribed?4

Lysodren® Results (efficacy outcomes)

In a clinical study of 127 patients diagnosed with ACC5:

stat
Overall survival (OS) averaged 18.5 months (1.3 to 220 months) after starting Lysodren®
stat
In total, 50 patients (40.9%) experienced clinical benefit (disease control greater than 180 days)
stat
28 patients (22.0%) experienced a long-term benefit of greater than 12 months
  1. Chemotherapy for Adrenal Cancer. American Cancer Society. January 2, 2018. Accessed April 2, 2024. https://www.cancer.org/cancer/types/adrenal-cancer/treating/chemotherapy.html
  2. Waszut U, Szyszka P, Dworakowska D. Understanding mitotane mode of action. J Physiol Pharmacol. 2017;68(1):13-26.
  3. Lysodren®. US Prescribing information. ESTEVE.
  4. Mitotane (Lysodren). Cancer Research UK. Accessed April 9, 2024. https://www.cancerresearchuk.org/about-cancer/treatment/drugs/mitotane-lysodren
  5. Megerle F, Herrmann W, Schloetelburg W, et al. Mitotane monotherapy in patients with advanced adrenocortical carcinoma. J Clin Endocrinol Metab. 2018;103(4):1686-1695. doi:10.1210/jc.2017-02591
INDICATION AND IMPORTANT SAFETY INFORMATION FOR LYSODREN©
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Warning/Adrenal crisis in the setting of shock, severe trauma or infection: Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs.

What is LYSODREN®?

LYSODREN is a prescription medicine used to treat people with cancer of the adrenal glands (adrenocortical carcinoma) that is either functional (where the tumor produces excess steroid hormones) or non-functional (where the tumor does not produce hormones) and the cancer cannot be removed by surgery.

IMPORTANT SAFETY INFORMATION INCLUDING WARNINGS

What is the most important information I should know about LYSODREN®?

LYSODREN can cause serious side effects including:

Adrenal Insufficiency and Adrenal Crisis.

  • Adrenal Insufficiency. LYSODREN can cause your adrenal glands to stop making enough corticosteroid hormones (adrenal insufficiency) or make this problem worse in people with cancer of the adrenal glands (adrenocortical carcinoma). Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with LYSODREN if you develop adrenal insufficiency during treatment.
  • Adrenal Crisis. LYSODREN can cause your adrenal glands to suddenly stop making enough corticosteroid hormones (adrenal crisis). You are at increased risk for developing adrenal crisis if you experience shock, severe injury, or infection during treatment with LYSODREN. Adrenal crisis may lead to death. Tell your healthcare provider right away if you get an injury, infection, or other illness during treatment with LYSODREN. Your healthcare provider will temporarily stop LYSODREN if shock, severe injury, or infections happen during treatment. Tell your healthcare provider if you have any planned surgery.

Your healthcare provider will check your levels of corticosteroid hormones during treatment and may give you corticosteroid medicine if you develop adrenal gland problems. Tell your healthcare provider right away if you develop any signs or symptoms of adrenal gland problems, including:

  • severe weakness
  • confusion
  • pain in the lower back and legs
  • stomach (abdominal) pain
  • nausea, vomiting, or diarrhea
  • feeling lightheaded or dizzy
  • passing out
  • feeling very tired
  • decreased appetite
  • weight loss
  • areas of darkened skin
  • craving salt
  • low blood sugar
  • feeling irritable or depressed
  • hair loss

What should I tell my doctor before taking LYSODREN®?

  • have an injury, infection or illness
  • plan to have surgery. Tell your healthcare providers you are taking LYSODREN. You may need to stop taking LYSODREN before any surgery and dental procedures.
  • have cysts on your ovaries
  • have liver or kidney problems
  • have bleeding problems
  • are pregnant or plan to become pregnant. LYSODREN can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. LYSODREN can pass into your breast milk and may harm your baby

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYSODREN with certain other medicines may affect the way LYSODREN and the other medicines work and may increase your risk of side effects.
This is especially important if you take:

  • Spironolactone
  • Hormonal birth control
  • Warfarin
  • Drugs that are broken down by the liver enzyme CYP3A such as midazolam, acetaminophen, codeine, etc.

What are the most common side effects of LYSODREN®?

The most common side effects of LYSODREN include:

  • Loss of appetite
  • GI upset (nausea, vomiting, diarrhea)
  • Depression
  • Dizziness or lightheadedness
  • Rash
  • Increased fat in the blood (elevated triglycerides or cholesterol)
  • Changes in hormone levels

These are not all of the possible side effects of LYSODREN. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-844-LYSODREN (1-844-597-6373) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full US Prescribing Information, including boxed warning, for LYSODREN® (mitotane), tablets.

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Last updated: October 2025; 0097-10/2026@ESTEVE

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