When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to mitotane, or if you are pregnant.

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.
• Tablet: Swallow whole. Do not crush, break, or chew it.
• Wash your hands immediately if you accidently touch a broken or crushed tablet.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions.
• 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 a 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. Use an effective form of birth control during treatment and for as long as your doctor says to after treatment.
• 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.
• Tell your doctor if you are breastfeeding, or if you have liver disease. Tell your doctor if you have surgery planned.
• This medicine may cause severe adrenal problems if you have a serious injury, infection, or illness of any kind. Call your doctor right away if you are sick or injured.
• 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.
• 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
• Changes in skin color, dark freckles
• Depression, nausea, vomiting, unusual weakness or tiredness, dizziness, fainting
• Fever, chills, cough, sore throat, body aches

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