Brand Lysodren

Mitotane is used to treat cancer of the adrenal glands. The adrenal glands produce hormones, which are needed by the body to deal with stress, fight infection, and maintain normal functions such as blood pressure. Certain cancers cause the adrenal glands to produce too much cortisol and other hormones, causing a certain serious condition (Cushing's syndrome). Too much of these hormones can cause many problems such as blood pressure changes, weight changes, muscle/bone weakness, thinning skin, and diabetes. Mitotane works by killing or slowing the growth of adrenal gland cells and also reverses the side effects caused by too much hormone production.

Take this medication by mouth with or without food, usually 3 or 4 times daily or as directed by your doctor. This medication is often started in the hospital, where your doctor can follow you closely as your dose is adjusted to the best dose for you. Dosage is based on your medical condition and response to therapy (e.g., cortisol levels). Usually, you will need to take replacement corticosteroids (e.g., hydrocortisone) every day while you are taking this drug and for some time after stopping mitotane. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. It may take up to several months to receive the full benefit from this drug. Inform your doctor if your condition persists or worsens. Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. Learn proper technique for safe handling and disposal of this medicine and its container. Consult your pharmacist.

Before taking mitotane, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infection (especially viral infections such as chickenpox, herpes), blood pressure problems, liver disease. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. This medication can make it difficult to control your blood pressure. To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. If you have been using this product, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids (e.g., hydrocortisone), especially if your body is stressed due to a major infection, surgery or injury. Tell your doctor immediately if a stress situation (e.g., trauma, surgery, serious infection) is occurring or any of the following side effects occur: unusual weakness, sudden weight loss, dizziness. This advice applies during and up to 8 months after stopping mitotane treatment. Carry an emergency card or bracelet with this information. Consult your doctor or pharmacist for more details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known if this drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), corticosteroids (e.g., dexamethasone, prednisone), "water pills"/diuretics (e.g., furosemide, spironolactone), drugs removed from your body by certain liver enzymes (such as barbiturates, phenytoin). Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely. This product can affect the results of certain lab tests (including thyroid function tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Dizziness, drowsiness, nausea, diarrhea, loss of appetite, headache, or unusual weakness may occur. If these effects persist or worsen, notify your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness, flushing, fast/pounding heartbeat, shakiness (tremors), unusual/rapid weight loss, change in skin color/thickness. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, breast tenderness/enlargement (males), unwanted facial/body hair (females), mental/mood changes (e.g., depression, irritability, difficulty concentrating, confusion), speech problems, numbness/tingling of hands/feet, unsteadiness, pink urine, vision problems. This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat. Mitotane can commonly cause a rash that usually goes away. However, you may not be able to tell it apart from a rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop a rash. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.