Mitotane

IMPORTANT WARNING:

Mitotane may cause a serious, life-threatening condition that can occur when not enough hormone (cortisol) is produced by the adrenal glands in your body. Tell your doctor if you have or develop a severe infection, illness, or injury, or if you are having surgery, including dental surgery. Your doctor will probably tell you not to take mitotane. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; weakness; lightheadedness; dizziness; decreased consciousness; feeling irritable or depressed; confusion; lower back or leg pain; nausea, vomiting, or diarrhea; stomach pain; weight loss; changes in skin color; hair loss; or craving for salt.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with mitotane and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of taking mitotane.

WHY is this medicine prescribed?

Mitotane is used to treat cancer of the adrenal gland that can not be treated with surgery. Mitotane is in a class of medications called antineoplastic agents. It works by slowing growth or reducing the size of the tumor.

Are there OTHER USES for this medicine?

Mitotane is also sometimes used to treat Cushing's syndrome (condition where the body produces too much of the hormone cortisol). Talk to your doctor about the risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Mitotane comes as a tablet to take by mouth. It is usually taken three to four times a day with a high-fat meal or snack. Ask your doctor for examples of foods that you can eat when you take mitotane. Take mitotane at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mitotane exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not open, chew, or crush them. Do not take tablets that are broken or crushed. If any of the tablets are broken or crushed, do not touch them with your bare hands. You should wear rubber or latex gloves when you handle broken or crushed tablets so that your skin does not come into contact with the medication. If the broken or crushed tablets touch your skin, wash the area well with soap and water right away. If you are a caregiver, you should wear rubber or latex gloves when handling mitotane tablets.

If you vomit after taking mitotane, do not take another dose. Continue your regular dosing schedule.

Your doctor will start you on a low dose of mitotane and gradually increase your dose depending on how well the medication works for you and the side effects you experience.

Your doctor may need to decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with mitotane.

Continue to take mitotane even if you feel well. Do not stop taking mitotane without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking mitotane,

• tell your doctor and pharmacist if you are allergic to mitotane, any other medications, or any of the ingredients in mitotane tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dose of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had ovarian cysts, bleeding problems, high cholesterol or triglycerides, or liver, kidney, or thyroid disease. Also, tell your doctor if you plan to lose weight or if you have recently lost weight.

• tell your doctor if you are pregnant or plan to become pregnant. You will need to take a pregnancy test before you start treatment. You should not become pregnant while you are taking mitotane. Mitotane may interfere with the action of hormonal contraceptives (birth control pills, patches, rings, implants, or injections), so you will need to use a reliable non-hormonal method of birth control such as a barrier method (device that blocks sperm from entering the uterus such as a condom or a diaphragm) to prevent pregnancy during your treatment and for as long as your doctor tells you to after your final dose. Ask your doctor to help you choose a method of birth control that will work for you. If you become pregnant while taking mitotane, call your doctor immediately. Mitotane may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking mitotane and for as long as your doctor tells you after your final dose.

• you should know that mitotane may make you dizzy or drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that mitotane may cause ovarian cysts in women who have not yet experienced menopause (change of life; end of monthly periods). Your doctor may tell you to have an ultrasound (a type of imaging to look at organs and structures inside the body) of your ovaries before and during your treatment with mitotane if you have not yet experienced menopause. If you experience any of the following symptoms, call your doctor immediately: abnormal vaginal bleeding or pelvic pain or discomfort.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Mitotane may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• changes in vision
• rash
• enlarged breasts in men

Some side effects can be serious. If you experience any of these symptoms those listed in the IMPORTANT WARNING and SPECIAL PRECAUTIONS sections, call your doctor immediately:

• yellowing of the skin or eyes, dark urine, loss of appetite, fatigue, nausea, vomiting, itching, or pain in the upper right part of the stomach
• unusual bleeding or bruising; red or black, tarry stools; vomiting blood or material that looks like coffee grounds; pink or brown urine; coughing up blood or blood clots; nose bleeds
• pale skin
• trouble breathing
• fever, sore throat, ongoing cough and congestion, or other signs of infection
• unusual drowsiness or sleepiness, lack of energy, difficulty thinking or concentrating, decreased coordination, memory loss, trouble talking, dizziness, or feeling of pins and needles in your hands and feet

Mitotane may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• extreme tiredness
• dizziness
• muscle weakness
• trouble walking

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests, such as blood tests before, during, and after your treatment to check your body's response to mitotane.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking mitotane.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.