Mitotane is used to treat cancer of the adrenal gland (adrenal cortical carcinoma).

Mitotane may also be used for purposes not listed in this medication guide.

You may need to take steroid medicine, or stop taking mitotane for a short time if you have a serious injury or medical emergency. Your doctor will determine when you can start taking mitotane again. Do not change your doses or medication schedule without advice from your doctor.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if mitotane is effective.

You may need to take steroid medicine, or stop taking mitotane 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. Do not change your doses or medication schedule without advice from your doctor.

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

Store mitotane at room temperature away from moisture and heat.

Ask your pharmacist how to safely handle mitotane tablets. You may need to wear latex gloves when handling this medicine. Do not use a broken tablet.

Usual Adult Dose for Adrenal Cortical Carcinoma:

2 to 6 g orally daily in 3 to 4 divided doses; increase dose incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated

Comments:
-Initiate this drug in a hospital until a stable dosage regimen is achieved.
-Data suggests continuous treatment with the maximum possible dosage is the best approach; patients who have been treated intermittently (i.e., therapy restarted when severe symptoms have reappeared) often do not respond after the third or fourth course.

Use: For the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma

Tell your doctor if you have ever had:

• recent infection, surgery, or trauma;

• liver disease; or

• if you take a blood thinner (warfarin, Coumadin, Jantoven).

Do not use mitotane if you are pregnant. This medicine could harm the unborn baby or cause miscarriage or premature birth. Use effective birth control to prevent pregnancy while you are using mitotane.

Do not breastfeed while using this medicine.

Follow your doctor's instructions about how long to avoid pregnancy and breastfeeding after your treatment ends. Mitotane can stay in your bloodstream long after you stop using it.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Avoid driving or hazardous activity until you know how mitotane will affect you. Your reactions could be impaired.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mitotane may cause serious side effects. 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;

• pelvic pain, vaginal bleeding;

• easy bruising or bleeding (nosebleeds, bleeding gums); or

• any bleeding that will not stop.

Common side effects of mitotane may include:

• nausea, vomiting, loss of appetite;

• diarrhea;

• depressed mood;

• dizziness, spinning sensation; or

• 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 report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect mitotane, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests 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.

Wear or carry medical identification stating that you take mitotane to be sure you get proper treatment in an emergency.

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.