Lysodren (Mitotane)

You may receive your first few doses of LYSODREN 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 LYSODREN 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 LYSODREN, 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 LYSODREN 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 LYSODREN, 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 LYSODREN.

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

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help.

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.

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 need to stop taking LYSODREN 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 LYSODREN, 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 LYSODREN.

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

To make sure LYSODREN 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).

Do not use LYSODREN 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 LYSODREN. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

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

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.

Other drugs may interact with LYSODREN, 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.