Mitotane (Oral route)
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 .
Uses of This Medicine:
Mitotane is used to treat some types of cancer in the adrenal glands. This medicine acts on a part of the body called the adrenal cortex. Mitotane reduces the amount of steroids (cortisone-like hormones) that are produced by the adrenal cortex. These hormones are important for various functions of the body, including growth. However, too much of these hormones can cause problems.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of mitotane in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mitotane in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving mitotane.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Rotavirus Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abiraterone Acetate
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Ado-Trastuzumab Emtansine
- Bacillus of Calmette and Guerin Vaccine, Live
- Brentuximab Vedotin
- Eslicarbazepine Acetate
- Ethinyl Estradiol
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Typhoid Vaccine
- Ulipristal Acetate
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Injury, serious or
- Shock or
- Trauma, severe—Should not be used in patients with these conditions.
- Liver disease—The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take mitotane only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Do not stop taking this medicine without first checking with your doctor. To do so may increase the chance of unwanted effects.
Swallow the tablet whole. Do not crush, break, or chew it. If contact with broken or crushed tablets occurs, wash your hands immediately.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For cancer of the adrenal glands:
- Adults—At first, 2 to 6 grams (g) per day, given in divided doses three or four times a day. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For cancer of the adrenal glands:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.
Your doctor may want you to carry an identification card or wear a bracelet stating that you are taking this medicine.
Check with your doctor right away if you get a serious injury, infection, or illness of any kind. This medicine may weaken your body's defenses against infection or inflammation.
Adrenal insufficiency may develop in patients using this medicine. Check with your doctor right away if you have more than one of the following symptoms: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; tricyclic antidepressants (medicine for depression); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
This medicine may cause some people to have changes in their behavior or memory, or to become depressed. This usually occurs in people who take this medicine for more than 2 years. If you or your caregiver notice any changes in behavior while you are taking this medicine, talk to your doctor right away.
Side Effects of This Medicine:
- More common
- Darkening of the skin
- dizziness or lightheadedness
- loss of appetite
- mental depression
- nausea or vomiting
- skin rash
- unusual tiredness or weakness
- Less common
- Blood in the urine
- blurred vision
- double vision
- Shortness of breath
- Incidence not known
- cloudy urine
- cold sweats
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- feeling of warmth
- frequent urination
- lower abdominal cramping
- painful urination
- pounding in the ears
- redness of the face, neck, arms, and occasionally, upper chest
- slow or fast heartbeat
- vision changes
- white area over the eye
- More common
- Feeling of constant movement of self or surroundings
- passing of gas
- sensation of spinning
- stomach pain, fullness, or discomfort
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- Less common
- Aching muscles
- flushing or redness of the skin
- muscle twitching
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014