Brand Names: Lysodren

Generic Name: mitotane (Pronunciation: MYE toe tane)

• What is mitotane (Lysodren)?
• What are the possible side effects of mitotane (Lysodren)?
• What is the most important information I should know about mitotane (Lysodren)?
• What should I discuss with my healthcare provider before taking mitotane (Lysodren)?
• How should I take mitotane (Lysodren)?
• What happens if I miss a dose (Lysodren)?
• What happens if I overdose (Lysodren)?
• What should I avoid while taking mitotane (Lysodren)?
• What other drugs will affect mitotane (Lysodren)?
• Where can I get more information?

What is mitotane (Lysodren)?

Mitotane is a cancer medication. That interferes with the growth of cancer cells and slows their growth and spread in the body.

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

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

Lysodren 500 mg

round, white, imprinted with BL L1

What are the possible side effects of mitotane (Lysodren)?

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 a serious side effect such as:

• feeling like you might pass out;
• fast or pounding heartbeats;
• warmth, redness, or tingly feeling under your skin;
• sweating, cold or clammy skin;
• high fever, chills, uncontrolled shaking;
• blurred or double vision;
• confusion, problems with speech, balance, or walking;
• pain or burning when you urinate;
• blood in your urine; or
• unexpected weight loss.

Less serious side effects may include:

• dizziness, spinning sensation;
• drowsiness, tired feeling;
• depressed mood;
• mild skin rash;
• nausea, vomiting, diarrhea; or
• loss of appetite.

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.

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

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.

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

Before taking mitotane, tell your doctor if you have liver disease, or if you have had a recent infection, surgery, or trauma.

Always wear rubber gloves when handling mitotane tablets. The medicine from a crushed or broken tablet can be dangerous if it gets on your skin.

You may need to take steroid medication along with mitotane to best treat your condition. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

If you have any type of infection, serious injury or medical emergency, you may need to stop taking this medication for a short time. Your doctor will determine when you can start taking mitotane again.

Carry an ID card or wear a medical alert bracelet stating that you are taking mitotane, in case of an emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are using mitotane.

You must remain under the care of a doctor while taking mitotane. Do not miss any scheduled appointments.

It may take up to several months of using mitotane before your symptoms improve. Talk with your doctor if your symptoms do not improve or if they get worse.