Mitotane (MYE-toe-tane)

Treats cancer of the adrenal glands.

Brand Name(s):

Lysodren

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole. Do not crush, chew, or split it. Do not take tablets that are broken or crushed.
• Wear gloves when handling tablets. Do not touch the broken or crushed tablet. If you touch it, wash your hands with soap and water.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Some medicines can affect how mitotane works. Tell your doctor if you are also using midazolam, spironolactone, birth control pills, or blood thinner (including warfarin).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment with this medicine. Use an effective form of birth control that does not contain hormones (including condoms, diaphragms, and spermicide) during treatment and for as long as your doctor says to after treatment.
• Do not breastfeed during treatment and after you stop taking this medicine. Talk to your doctor if you have concerns.
• Tell your doctor if you have kidney disease, liver disease, adrenal problem, serious injury, infection, illness of any kind, or ovarian cysts. Tell your doctor if you have surgery planned.
• This medicine may cause the following problems:
  • Adrenal problems
  • Nerve problems (including sedation, lethargy, vertigo)
  • Cysts in the ovaries in premenopausal women (have menstrual cycles)
  • Liver problems
• This medicine may cause prolonged bleeding. Make sure any doctor or dentist who treats you knows that you are using this medicine.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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 do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Bloating, pelvic pain, vaginal bleeding
• Changes in skin color, dark freckles
• Dark urine or pale stools, loss of appetite, stomach pain, yellow skin or eyes
• Depression, nausea, vomiting, unusual weakness or tiredness, dizziness, fainting
• Fever, chills, cough, sore throat, body aches
• Soreness or swelling of the breasts in males
• Unusual bleeding or bruising

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

• Diarrhea, loss of appetite
• Feeling of constant movement of yourself or your surroundings
• Sleepiness

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