Mitotane (By mouth)

Introduction

Mitotane (MYE-toe-tane)

Treats cancer of the adrenal glands (adrenal cortical carcinoma).

Brand Name(s)

Lysodren

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Swallow the tablet whole. Do not crush, break, or chew it. If contact with broken or crushed tablets occurs, wash your hands immediately.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a blood thinner such as warfarin (Coumadin®).
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease.
• Your doctor may want you to carry an identification card or wear a bracelet stating that you are taking this medicine.
• Check with your doctor right away if you get a serious injury, infection, or illness of any kind. This medicine may weaken your body's defenses against infection or inflammation.
• Adrenal insufficiency may develop in patients using this medicine. Check with your doctor right away if you have more than one of the following symptoms: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.
• This medicine may make you dizzy, drowsy, or less alert than they are normally. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may cause some people to have changes in their behavior or memory, or to become depressed. This usually occurs in people who take this medicine for more than 2 years. If you or your caregiver notice any changes in behavior while you are taking this medicine, talk to your doctor right away.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in your urine, problems with urinating.
• Changes in skin color, dark freckles.
• Cold feeling, weakness, tiredness, nausea, or vomiting.
• Fast, slow, or uneven heartbeat.
• Fever, chills, and body aches.
• Lightheadedness, dizziness, or fainting.
• Problems with vision.
• Weight loss.

If you notice these less serious side effects, talk with your doctor:

• Depression.
• Diarrhea, loss of appetite, indigestion, or stomach pain.
• Feeling of constant movement of self or surroundings.
• Mild skin rash.
• Sleepiness or unusual drowsiness.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088