Mitotane (Lysodren®)

This medication has toxic effects on a certain part of adrenal cortical cells, causing these cells to die. This also lowers how much cortisol your body makes and changes how steroids are metabolized (processed) in your body. You may need to take a steroid (such as hydrocortisone) by mouth to make up for this loss. Your oncology team will monitor you for this side effect. The exact mechanism of action is unknown.

How to Take Mitotane

Mitotane comes as a tablet to take by mouth. It is usually taken three to four times a day. Take mitotane at around the same times every day. The pill should be swallowed whole with a glass of water. Do not crush, chew or break. Mitotane should be taken with meals that have fat-rich foods, such as milk, chocolate, and oil.

Your care provider will determine your dose, which may change based on the levels in your blood and the side effects you may have. If you miss a dose, take the next dose as scheduled. Do not take two doses to make up for a missed dose. You may be need to take a steroid while you are taking mitotane.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include: anti-epileptics, rifabutin, rifampicin, griseofulvin, St. John’s wort, sunitinib, spironolactone, itraconzole, nimodipine, ranolazine, rivaroxaban, tofacitinib, aripiprazole, corticosteroids, linagliptin, quetiapine, among others. This medication can affect the level in your blood of warfarin or other anticoagulants that are used to treat and prevent blood clots. Be sure to tell your healthcare provider about all medications and supplements you take.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.

Where do I get this medication?

Mitotane is available through retail and mail order pharmacies. Your oncology team will work with your prescription drug plan to find an in-network pharmacy for distribution of this medication.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.

Possible Side Effects of Mitotane

There are a number of things you can do to manage the side effects of mitotane. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Adrenal Changes

This medication can cause adrenal insufficiency or can make existing adrenal insufficiency worse in some patients. Tell your provider if you have any history of adrenal disease. 

If you have any type of severe trauma (like an accident or fall), have an infection, or experience shock while taking mitotane, the medication will need to be stopped. Your body will not respond as it should because of the effect of mitotane on your adrenal glands. Steroids will be given until your adrenal gland works normally again. Tell your care team right away if you suffer any type of injury, have signs of infection (such as fever, chills, cough) or illness, or signs of shock after a traumatic event (such as cold, sweaty skin, shortness of breath, or a fast heartbeat). 

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Decrease in Appetite or Taste Changes

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your oncology care team about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce or dressings. Use seasonings like basil, oregano or rosemary to add flavor. Bacon, ham and onion can add flavor to vegetables.

Diarrhea

Your oncology team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses on non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Rash

Some patients may develop a rash, scaly skin, or red itchy bumps. Use an alcohol free moisturizer on your skin and lips; avoid moisturizers with perfumes or scents. Your oncology care team can recommend a topical medication if itching is bothersome. If your skin does crack or bleed, be sure to keep the area clean to avoid infection. Be sure to notify your oncology care team of any rash that develops, as this can be a reaction. They can give you more tips on caring for your skin.

Less common, but important side effects can include:

• Central Nervous System Toxicity: Prolonged use (greater than 2 years) of mitotane can lead to neurotoxic side effects including brain damage and functional impairment. The levels of mitotane in your blood will be closely monitored to prevent these problems and your neurological status will be closely monitored.
• Ovarian Macrocysts: These cysts have been reported in premenopausal women taking mitotoane. Report any gynecologic symptoms, like vaginal bleeding and/or pelvic pain, to your care team.
• Liver Toxicity: This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.
• Low White Blood Cell Count (Leukopenia or Neutropenia): White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your care team know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
  • Tips to preventing infection:
    • Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
    • Avoid large crowds and people who are sick (i.e.: those who have a cold, fever, or cough or live with someone with these symptoms).
    • When working in your yard, wear protective clothing including long pants and gloves.
    • Do not handle pet waste.
    • Keep all cuts or scratches clean.
    • Shower or bathe daily and perform frequent mouth care.
    • Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
    • Ask your oncology care team before scheduling dental appointments or procedures.
    • Ask your oncology care team before you, or someone you live with has any vaccinations.
• Low Red Blood Cell Count (Anemia): Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low, you may receive a blood transfusion.
• Low Platelet Count (Thrombocytopenia): Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.
  • Do not use a razor (an electric razor is fine).
  • Avoid contact sports and activities that can result in injury or bleeding.
  • Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding use of these agents and all over the counter medications/supplements while on therapy.
  • Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and until mitotane is not able to be found in your blood. This medication can make hormonal contraceptives not work as well. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breast feed while receiving this medication and until mitotane is not detectable in your blood.