Lysodren

(Mitotane)

The active ingredient in Lysodren is mitotane. Lysodren’s mechanism of action is not fully understood. It is thought to work by directly damaging cancer cells in the adrenal cortex. It also reduces the production of sex and steroid hormones (cortisol), helping to alleviate symptoms caused by excessive hormone production in tumor cells.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labelling, Instructions for Use, and Medication Guide before using Lysodren. However, the following is a synopsis of the general guidelines for the use of Lysodren:

• Lysodren is taken by mouth as tablets. They are usually taken with food to reduce stomach upset.
• Lysodren is typically given in 3 or 4 divided doses per day.
• Your healthcare provider will start treatment at a low dose and gradually increase it.
• Blood tests are required regularly to monitor mitotane levels, hormone levels, liver function, and blood cell counts.
• Do not stop or change your dose unless instructed by your healthcare provider.
• Because mitotane has a long half-life and builds up in the body, dose changes may take weeks to show full effects.

Some mild or common side effects of mitotane seen in clinical trials include:

• Nausea or vomiting.
• Diarrhea.
• Depression.
• Loss of appetite or weight loss.
• Dizziness or lightheadedness.
• Fatigue or weakness.
• Abdominal pain.
• Skin rash.
• Increased fat in the blood (triglycerides or cholesterol).

Some individuals may experience serious side effects while using Lysodren. These adverse reactions may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of adrenal insufficiency include extreme weakness, low blood pressure, confusion, fainting, lightheadedness, dizziness, nausea, or vomiting.
• Increased risk of ovarian cysts in premenopausal women. These cysts can appear on both sides of the ovaries and can cause symptoms such as bloating, pelvic pain, or vaginal bleeding.
• Central nervous system toxicity and neurological effects include confusion, trouble thinking, difficulty walking, or severe dizziness.
• Increased risk of infections because of low white blood cell counts.
• Low levels of platelets in the blood and symptoms such as bruising easily, bleeding gums, or nosebleeds.
• Serious liver problems indicated by yellowing of the skin or eyes, dark or brown urine, and stomach pain.
• Severe allergic reactions, including hives or swelling of the face or throat.

These are not all of the possible side effects of Lysodren. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Lysodren, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Adrenal insufficiency or low cortisol levels.
• Hepatic (liver) impairment or abnormal liver enzymes.
• Neurological conditions affecting the central nervous system.
• A history of hormone imbalance.
• Planned surgery or serious illness, which may require stress-dose corticosteroids.
• Patients taking Lysodren often require steroid hormone replacement because the drug suppresses normal adrenal hormone production.

Boxed Warning

Lysodren has a boxed warning for adrenal insufficiency and central nervous system toxicity. Mitotane can cause severe and potentially life-threatening adrenal suppression, requiring immediate corticosteroid replacement. It can also cause serious neurological toxicity, especially at high blood levels. Treatment should be managed by experienced healthcare professionals with close monitoring.

Lysodren is contraindicated in patients with known hypersensitivity to mitotane.

Lysodren works gradually, and it may take weeks or months to reach effective blood levels. Treatment response varies based on the type and stage of adrenocortical carcinoma.

When Lysodren is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Corticosteroids, which may require dose adjustment due to increased metabolism.
• Warfarin, as mitotane, may reduce its effectiveness by increasing enzyme activity.
• Spironolactone, which may interfere with adrenal hormone effects.
• Hormonal contraceptives, which may be less effective.
• Over-the-counter supplements that affect liver enzymes.

Lysodren is available as oral tablets.

Typical dosing based on source information includes:

Initial dosing often starts at 2 to 6 grams per day, divided into several doses.

The dose may be gradually increased up to 9 to 10 grams per day, depending on tolerance and blood levels.

Blood tests are used to guide dose adjustments.

The safety and effectiveness in pediatric patients have not been established.

If you miss a dose, take the next dose as scheduled. Do not take two doses to make up for a missed dose.

It should be stored at room temperature, away from the reach of children or pets.

Lysodren is manufactured by Bristol Myers Squibb.

No, Lysodren is not currently available as a generic medication.

Do not stop taking Lysodren without medical advice. Abrupt discontinuation may worsen adrenal insufficiency or cancer-related symptoms.

Lysodren can harm an unborn baby. Effective birth control is required during treatment and after stopping it for as long as mitotane plasma levels are detectable.

Mitotane may pass into breast milk and could cause serious harm to a nursing infant. Breastfeeding is not recommended during treatment.