Mitotane causes your body to decrease its ability to quickly respond to stress (shock, severe injury, or infection). Mitotane may need to be stopped if you experience an injury, infection, or other stress. Your doctor may also prescribe another medication (corticosteroid).
Tell your doctor if you experience unusual weakness, tiredness, dizziness, fainting, loss of appetite, nausea, vomiting, diarrhea, or signs of an infection (e.g., persistent sore throat, fever).Who should not take mitotane?
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.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used alone or with other medications to treat other forms of Cushing's syndrome not caused by adrenal cancer (e.g., non-pituitary tumor).
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 and may harm an unborn baby, 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.
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 right away if you have any serious side effects, including: severe dizziness, flushing, fast/pounding heartbeat, shakiness (tremors), unusual/rapid weight loss, change in skin color/thickness, 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, get medical help right away 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.
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.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
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 right away 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.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Use reliable forms of birth control (such as condoms, birth control pills) during and after treatment with mitotane. Your doctor will use blood tests to decide when you can stop using birth control. If you become pregnant or think you may be pregnant, tell your doctor right away.
This medication passes into breast milk and may harm a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: "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).
Mitotane can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include suvorexant, certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir), among others.
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.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (e.g., complete blood count, blood pressure, cortisol, electrolytes, liver tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
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.
Store at room temperature 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.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2015. Copyright(c) 2015 First Databank, Inc.
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