Mitotane

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

Mitotane may also be used for reasons not mentioned in this medication guide.

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.

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 decide when you can start taking mitotane again. Do not change your doses or medication schedule without advice from your doctor.

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

Tell your doctor if you have ever had:

• a recent infection, surgery, or injury;
• 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.

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 right away if you have:

• blurred or double vision;
• confusion, problems with speech, balance, or walking;
• a light-headed feeling, like you might faint;
• 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.

Usual Adult Dose for Adrenal Cortical Carcinoma:

Initial dose: 2 to 6 g orally per day, in 3 to 4 divided dosesComments:-Increase the dose incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated.Use: For the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma.

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

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

• 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.

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, 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 the medicines you are currently taking and any medicine you begin or stop using.