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Mitotane

Generic name: mitotane (MYE toe tane)
Brand name: Lysodren
Dosage forms: oral tablet (500 mg)
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com on Mar 12, 2021. Written by Cerner Multum.

What is mitotane?

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.

Warnings

You may need to take steroid medicine, or 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 mitotane again. 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

Tell your doctor if you have ever had:

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.

Do not breastfeed while using this medicine.

Follow your doctor's instructions about how long to avoid pregnancy and breastfeeding after your treatment ends. Mitotane can stay in your bloodstream long after you stop using it.

How should I take mitotane?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if mitotane is effective.

You may need to take steroid medicine, or 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. 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.

Store mitotane at room temperature away from moisture and heat.

Ask your pharmacist how to safely handle mitotane tablets. You may need to wear latex gloves when handling this medicine. Do not use a broken tablet.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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?

Avoid driving or hazardous activity until you know how mitotane will affect you. Your reactions could be impaired.

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

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.

Mitotane dosing information

Usual Adult Dose for Adrenal Cortical Carcinoma:

2 to 6 g orally daily in 3 to 4 divided doses; increase dose incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated

Comments:
-Initiate this drug in a 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 course.

Use: For the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma

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 affect 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.

Does Mitotane interact with my other drugs?

Enter other medications to view a detailed report.

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.