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Mitotane

Generic Name: mitotane (MYE-toe-tane)
Brand Name: Lysodren

Mitotane may reduce the amount of natural steroid in the body. This may decrease your ability to recover from physical stress such as illness, injury, or surgery. Tell your doctor or dentist that you take mitotane before you receive any medical or dental care, emergency care, or surgery. Tell your doctor right away if you become ill or have an injury while you use mitotane. You may need to stop taking mitotane for a period of time. You may need to take a corticosteroid (eg, prednisone) until your body can make enough on its own. Check with your doctor for more information.


Mitotane is used for:

Treating adrenal cortical cancer that cannot be treated with surgery.

Mitotane is an adrenal cytotoxic agent. Exactly how mitotane works is not known. It may work by slowing adrenal gland function.

Do NOT use mitotane if:

  • you are allergic to any ingredient in mitotane
  • you have suffered severe trauma or shock

Contact your doctor or health care provider right away if any of these apply to you.

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Before using mitotane:

Some medical conditions may interact with mitotane. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems
  • if you will be having surgery

Some MEDICINES MAY INTERACT with mitotane. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because their effectiveness may be decreased by mitotane

This may not be a complete list of all interactions that may occur. Ask your health care provider if mitotane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use mitotane:

Use mitotane as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take mitotane by mouth with or without food.
  • Mitotane may be started in a hospital setting until an individualized dose is determined.
  • If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
  • Swallow mitotane whole. Do not break, crush, or chew before swallowing.
  • To minimize the risk of skin exposure always wear gloves when handling bottles containing mitotane.
  • Be sure you know how to properly handle and dispose of mitotane. Ask your doctor or pharmacist if you are unsure.
  • If you miss a dose of mitotane, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use mitotane.

Important safety information:

  • Mitotane may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use mitotane with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Tell your doctor or dentist that you take mitotane before you receive any medical or dental care, emergency care, or surgery.
  • If you may become pregnant, you must use an effective form of birth control while you take mitotane and for a period of time after stopping it. If you have questions about effective birth control, talk with your doctor.
  • Lab tests, such as adrenal function tests and neurological and behavioral tests, may be performed while you use mitotane. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Mitotane should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Mitotane may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using mitotane while you are pregnant. Mitotane is found in breast milk. Do not breast-feed while taking mitotane.

Possible side effects of mitotane:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; lack of energy; loss of appetite; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; blurred vision, double vision, or other vision changes; confusion; depression; fainting; fever, chills, or persistent sore throat; severe or persistent dizziness, drowsiness, headache, light-headedness, or tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of mitotane:

Store mitotane at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep mitotane out of the reach of children and away from pets.

General information:

  • If you have any questions about mitotane, please talk with your doctor, pharmacist, or other health care provider.
  • Mitotane is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take mitotane or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about mitotane. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to mitotane. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using mitotane.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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