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Mitotane

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

Medically reviewed on November 13, 2017

What is mitotane?

Mitotane is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Mitotane is used to treat cancer of the adrenal gland (adrenal cortical carcinoma).

Mitotane may also be used for purposes not listed in this medication guide.

Important Information

You may need to stop taking mitotane for a short time if you have a serious injury or medical emergency. Your doctor will determine when you can start taking this medicine again. You may need to take steroid medication along with mitotane, especially if you have a serious injury or medical emergency. Do not change your doses or medication schedule without advice from your doctor.

You must remain under the care of a doctor while taking mitotane.

Before taking this medicine

You should not use this medicine if you are allergic to mitotane.

To make sure mitotane is safe for you, tell your doctor if you have:

Do not use mitotane if you are pregnant. This medicine could harm the unborn baby or cause miscarriage or premature birth. Use effective birth control to prevent pregnancy while you are using mitotane. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

Mitotane can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

How should I take mitotane?

You may receive your first few doses of mitotane in a hospital setting where you can be monitored in case the medication causes serious side effects.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Always wear rubber gloves when handling mitotane tablets. Do not crush or break a tablet and do not use a broken pill. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.

You may need to take steroid medication along with mitotane, especially if you have a serious injury or medical emergency. Do not change your doses or medication schedule without advice from your doctor.

You may need to stop taking mitotane for a short time if you have a serious injury or medical emergency. Your doctor will determine when you can start taking this medicine again.

While using mitotane, you may need frequent medical tests. Your nerve and muscle function may also need to be checked. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with mitotane.

You must remain under the care of a doctor while taking mitotane.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking mitotane?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Mitotane side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • blurred or double vision;

  • confusion, problems with speech, balance, or walking;

  • a light-headed feeling, like you might pass out;

  • pelvic pain, vaginal bleeding;

  • easy bruising or bleeding (nosebleeds, bleeding gums); or

  • any bleeding that will not stop.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Mitotane dosing information

Usual Adult Dose for Adrenal Cortical Carcinoma:

-Initial Dose: 2 to 6 g orally per day in 3 to 4 divided doses
-Maintenance Dose: 9 to 10 g orally per day in 3 to 4 divided doses
-Maximum Dose: May increase up to 16 g orally per day, if tolerated, in 3 to 4 divided doses; the highest doses used in studies were 18 to 19 g per day.
-Duration of Therapy: Treatment should be continued as long as clinical benefits are observed.

Comments:
-Increase total daily dose incrementally.
-Treatment should be instituted in the hospital until a stable dosage regimen is achieved.
-Data suggests continuous treatment with the maximum possible dosage is the best approach; patients who have been treated intermittently (i.e., therapy restarted when severe symptoms have reappeared) often do not respond after the third or fourth such course.

Use: Treatment of inoperable adrenal cortical carcinoma of both functional and nonfunctional types

What other drugs will affect mitotane?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with mitotane, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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