Important Safety Information
Prescribing Information
Medication Guide
For US Healthcare Professionals

Support & Resources

Find available resources and organizations that support patients with ACC and their caregivers

Personalized Support

Walgreens Specialty Pharmacy is the pharmacy for Lysodren® prescriptions
Have questions for the pharmacy?
Call 1-800-320-2112
(Available M-F 8 am – 8 pm, Sat. 8 am – 5 pm, EST)

Benefits of Walgreens Specialty Pharmacy Include

  • Checking your coverage and possible co-pays or other out-of-pocket costs
  • Ongoing support and pharmacist access
  • Connecting with patient care advocates to answer questions about your possible side effects, medications, and more
  • Check status of refill orders
  • Access to financial assistance programs available to eligible patients
  • Timely patient support from their dedicated care team

Financial Assistance

Financial assistance may be available to help with the cost of Lysodren® and reduce your out-of-pocket expenses. To see if your qualify, please call 1-844-LYSODREN (1-844-597-6373).

Use these handy resources for ongoing support throughout Lysodren® treatment.

Resources for Your Patients and Their Caregivers

Use these downloadable resources to help you during your treatment with Lysodren®.

download
Patient Guidebook:
Helpful guide for understanding ACC and treatment with Lysodren®, including dosage and appointment trackers
Download now
download

Pediatric ACC Brochure
A helpful guide for understanding ACC, designed specifically for pediatric patients or adult patient’s young family members.

Download now

Click below to learn more about NCCN (National Comprehensive Cancer Network) guidelines.

NCCN GUIDELINES

Patient Advocacy Organizations

Support is also available to patients and caregivers from the following organizations:

Let’s Cure ACC
Let’s Cure ACC >

Let’s Cure ACC provides resources, guides, and ways to connect with ACC patients and caregivers.

Adrenal Cure Collective 
Adrenal Cure Collective  >

Adrenal Cure Collective is a non-profit organization that aims to improve the treatment and research of adrenocortical carcinoma.

ACC Warriors
ACC Warriors >

ACC Warriors builds awareness around this rare disease, shares stories of “ACC Warriors,” and features fundraising events to help ACC families.

ACC Connections
ACC Connections >

ACC Connections features videos, content, and social media channels to help patients and caregivers access the care they need in their fight against ACC.

National Adrenal Diseases Foundation
National Adrenal Diseases Foundation >

National Adrenal Diseases Foundation presents access to educational resources, support for patients and caregivers, and research on adrenal diseases.

American Cancer Society
American Cancer Society >

American Cancer Society offers support and information for cancer patients, caregivers, and healthcare professionals.

PAN Foundation
PAN Foundation >

PAN Foundation helps patients with life-threating and rare diseases to fund their out-of-pocket costs with financial assistance for medications and treatments.

International Neuroendocrine Cancer Alliance
International Neuroendocrine Cancer Alliance >

International Neuroendocrine Cancer Alliance (INCA) works with global communities from around the world to support patient access, raise awareness, and promote research.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR LYSODREN©
READ MORE ⇧
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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