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Mitotane

(mye-toe-tane)

Trade/other name(s): Lysodren

Why would this drug be used?

Mitotane is used to help treat cancer of the adrenal cortex that cannot be fully removed by surgery.

How does this drug work?

Mitotane is part of a general group of drugs known as hormone antagonists. It reduces the amount of hormone produced by the adrenal cortex, which helps the symptoms of adrenal cortical cancer and may slow the growth of the cancer.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any medical conditions such as kidney disease, liver disease (including hepatitis), heart disease, congestive heart failure, diabetes, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you are planning surgery or any medical procedure. This drug can cause problems with bleeding and may also affect your body’s response to surgery or other physical stress (see “Precautions”).
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug has not been tested on pregnant women, and there may be an increased risk of harm to the fetus if a woman takes this drug during pregnancy.
  • If you are breast-feeding. This drug has been detected in breast milk, and could harm the baby.
  • If you take any blood pressure medicines or have a problem with fainting. This drug may lower your blood pressure, which could be dangerous if it is already affected by other medicines.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Mitotane may reduce the action of the blood thinner warfarin (Coumadin), requiring that the dose be adjusted. If you are on Coumadin and stop taking Mitotane, talk with your doctor because your warfarin dose may need to be adjusted again.

This drug may make you drowsy. This can add to the effects of other medicines or substances that make you sleepy or less alert, such as:

  • Antihistamines
  • Anti-anxiety drugs (tranquilizers or sedatives)
  • Sleeping pills
  • Muscle relaxers
  • Barbiturates
  • Anti-seizure medicines
  • Opioid pain medicines
  • Anesthetics
  • Antidepressants such as amitriptyline, desipramine, doxepin, imipramine, nortriptyline
  • Anti-psychotic drugs
  • Certain anti-nausea medicines
  • Alcohol

Check with your doctor, nurse, or pharmacist about other medicines, vitamins, herbs, and supplements can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Mitotane comes in pill form, and doses are usually given 3 or 4 times a day. Some doctors start with a lower dose and gradually increase to a higher one. The drug is more effective when the higher dose is used, so your doctor may continue to raise your dose until you start having trouble with side effects or you are taking a total of 18 to 20 tablets per day (6 tablets 3 times a day, or 5 tablets 4 times a day.) Treatment is continued as long as it helps you. Don’t allow others to touch crushed or broken pills. If there is skin contact, wash thoroughly right away.

Take this drug exactly as your doctor tells you to. If you do not understand the instructions, your doctor or nurse can explain them to you.

Keep the medicine in a tightly closed container, away from children and pets.

Precautions

Mitotane may make the adrenal cortex's hormone output too low. You may notice weakness, poor appetite, nausea, vomiting, diarrhea, exhaustion, irritability, dizziness, or fainting. These symptoms are serious and can progress to coma and even death. Call your doctor or nurse right away. You may need cortisone-like drugs to replace the lost hormones. Some doctors start replacement hormones at the same time the mitotane is started rather than wait to see if you have problems.

Because of its effects on the adrenal cortex, mitotane lowers your body's ability to respond to stress, such as surgery, illness, or severe injury. If your stress level increases, or if you become sick, run a fever, or hurt yourself, contact your doctor right away. You may need to stop the mitotane and take extra cortisone-like medicines to keep from going into shock.

Sometimes the low level of adrenal hormone can become permanent and does not improve after mitotane is stopped. In that case, lifelong treatment with cortisone-like medicines may be required.

Mitotane can make you sleepy. Until you know how mitotane affects you, be careful with driving, operating machinery, or other tasks that require alertness.

Be sure that any doctors or dentists who are planning surgery or emergency treatment on you know that you are on this medicine. Some doctors recommend that anyone taking mitotane should have a medical alert bracelet or necklace warning that adrenal output is suppressed.

Long term use of high doses of mitotane can affect brain function and may lead to brain damage. Your doctor may check you for this problem while you’re on the drug. It may improve after the drug is stopped.It is very important that you keep taking this medicine even if you feel well. Talk with your doctor before stopping this drug.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • Diarrhea*
  • Sleepiness
  • Nausea
  • Vomiting
  • Tiredness
  • Poor appetite*
  • Depression
  • Skin rash (often goes away while still on the medicine)

Less common

  • Trouble with eyesight, such as blurred or double vision
  • Dizziness*
  • Vertigo (feeling that you’re moving when you’re not, or the room is moving)
  • Permanent adrenal hormone deficiency (even after drug is stopped)*

Less common

  • Breast development in men
  • Problems with low thyroid hormone levels
  • Shortness of breath
  • Wheezing
  • Blood or protein in the urine
  • Fever
  • High or low blood pressure
  • Flushing
  • Severe adrenal hormone deficiency with nausea, vomiting, fatigue, dizziness, fainting, coma, and death*

*See "Precautions" section for more detailed information.

Other side effects not listed above can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved before 1984 (FDA cannot verify dates of drugs approved before 1984.)

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 12/19/2013
Last Revised: 12/19/2013