Posted on April 28th, 2009 by

Class: Chemotherapy

Generic Name: Mitotane (MYE-toe-tane)
Trade Name: Lysodren®

How is this drug used? Mitotane is FDA approved for the treatment of inoperable adrenal cancer. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Mitotane inhibits functions of the adrenal gland; however, its mechanism of action remains largely unknown.

How is mitotane given (administered)? Mitotane is administered orally and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient. Patients may also receive steroids while being treated with mitotane, as natural steroid production may be inhibited with treatment.  Patients may start steroid replacement therapy at the start of treatment with mitotane.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with mitotane.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Endocrine and hormone function levels will also be monitored through blood tests.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.  Behavioral and neurologic assessments will be made if patients are treated with mitotane for over two years.

What are the most common side effects of treatment with mitotane?

• Nausea and vomiting
• Diarrhea
• Loss of appetite
• Central nervous system disturbances (dizziness, lethargy, weakness, sedation)
• Skin rash or redness

What are other less common side effects of treatment with mitotane?

• Visual abnormalities
• Blood in the urine
• Bleeding of the bladder
• High blood pressure
• Low blood pressure
• Protein in the urine
• Redness of the face and skin
• Generalized aching
• Fever

What are the possible late side effects of treatment with mitotane?

Patients treated with mitotane for over two years are at a slightly increased risk of developing brain damage and function impairment.

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Eat small meals frequently to help alleviate nausea.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should limit or avoid driving or operating heavy machinery while being treated with mitotane, as it may cause dizziness or sedation.
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should inform their physician if taking the blood thinner, warfarin, as they may require additional monitoring.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• If an oral dose is missed, do not double up on doses.  Patients should contact their physician in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.
• Patients should alert medical personnel (or wear identification) regarding mitotane therapy in the event of shock or trauma.
• Patients should use caution when driving or completing tasks that require mental alertness until effects of the drug are known

When should patients notify their physician?

• Confusion, dizziness
• Blood in the urine or painful urination
• Visual abnormalities, change in vision
• Fever or infection
• Severe nausea or vomiting
• Acute loss of appetite
• Muscle tremors or twitching

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2016 CancerConnect Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Tags: Chemotherapy, M

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