mitotane

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

What is mitotane?

Mitotane is a cancer medication 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.

What is the most important information I should know about mitotane?

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.

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

What should I discuss with my healthcare provider before taking mitotane?

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:

  • recent infection, surgery, or trauma;

  • liver disease; or

  • if you take a blood thinner (warfarin, Coumadin, Jantoven).

FDA pregnancy category D. 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 avoid pregnancy during your treatment with 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 to make sure you get the best results. 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 (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up 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.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Mitotane side effects

Get emergency medical help if you have any of these 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;

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

  • any bleeding that will not stop.

Common side effects may include:

  • nausea, vomiting, loss of appetite;

  • diarrhea;

  • drowsiness;

  • depressed mood, weakness, lack of energy;

  • dizziness, spinning sensation; or

  • mild skin rash.

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/day orally in 3 to 4 divided doses.
Maintenance dose: 9 to 10 g/day orally in 3 to 4 divided doses.
May increase up to 16 g/day if tolerated. Highest doses used have been 18 to 19 g/day.

What other drugs will affect mitotane?

Other drugs may interact with mitotane, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about mitotane.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2014-01-14, 4:23:06 PM.

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