Mitotane

Mitotane is a prescription medication used to treat cancer of the adrenal gland that can not be treated with surgery. Mitotane belongs to a group of drugs called antineoplastic agents. These work by slowing growth or reducing the size of the tumor.

Mitotane comes as a tablet to take by mouth. It is usually taken three to four times a day. Take mitotane at around the same times every day.

Common side effects of mitotane include loss of appetite, nausea or vomiting, and diarrhea. Mitotane can also cause dizziness or drowsiness. Do not drive or operate machinery until you know how this medication affects you.

Mitotane is a prescription medication used to treat cancer of the adrenal gland that can not be treated with surgery.

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

Mitotane may be found in some form under the following brand names:

• Lysodren

Common side effects of mitotane include the following:

• loss of appetite
• nausea
• vomiting
• diarrhea
• depression
• lack of energy
• unusual drowsiness
• feeling that the room is spinning
• changes in vision
• rash or changes in skin color

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• antidepressants ('mood elevators')
• medications for anxiety, mental illness, or seizures
• sedatives, sleeping pills, or tranquilizers
• spironolactone (Aldactone)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

• abdominal or side pain
• confusion
• fast heartbeat
• high fever or shaking chills
• excessive sweating

Do not take this medication if you are allergic to mitotane or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before taking mitotane,

• tell your doctor and pharmacist if you are allergic to mitotane, or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking mitotane, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking mitotane.
• 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Mitotane can cause fetal (unborn baby) harm when administered to a pregnant woman. Abnormal pregnancy outcomes such as preterm births and early pregnancy loss have been reported.

It is recommended to use effective contraception during treatment and for a certain period after discontinuation of treatment.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Mitotane has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from mitotane, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Mitotane comes as a tablet to take by mouth. It is usually taken three to four times a day. 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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended treatment schedule is to start the patient at 2 grams to 6 grams per day in divided doses, either 3 or 4 times a day. Doses are usually increased incrementally to 9 grams to 10 grams per day.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at room temperature.
• 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.

Mitotane should be administered under the supervision of a qualified physician experienced in the uses of cancer chemotherapeutic agents. Mitotane should be temporarily discontinued immediately following shock or severe trauma since adrenal suppression is its prime action. Exogenous steroids should be administered in such circumstances, since the depressed adrenal may not immediately start to secrete steroids.