Pronunciation:

MYE-toe-tane

Brand Names:

• Lysodren

Dosage Forms:

• Tablet

Warnings:

Patients treated with mitotane are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue mitotane and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs .

Classifications:

Therapeutic—

Adrenocortical Suppressant

Uses of This Medicine:

Mitotane is used to treat cancer of the adrenal glands (adrenocortical carcinoma) that cannot be removed by surgery. 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:

Allergies—

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.

Children—

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.

Older adults—

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 caution and an adjustment in the dose for patients receiving mitotane.

Breast-feeding—

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.

Other medicines—

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.

• Atazanavir
• Bacillus of Calmette and Guerin Vaccine, Live
• Daclatasvir
• Dasabuvir
• Delamanid
• Dengue Tetravalent Vaccine, Live
• Doravirine
• Elbasvir
• Fostemsavir
• Grazoprevir
• Isavuconazonium Sulfate
• Lenacapavir
• Lonafarnib
• Lorlatinib
• Lurasidone
• Mavacamten
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Nirmatrelvir
• Pacritinib
• Praziquantel
• Ritonavir
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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.

• Abemaciclib
• Abiraterone Acetate
• Abiraterone Acetate, Micronized
• Acalabrutinib
• Acoramidis
• Adagrasib
• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Alfentanil
• Alpelisib
• Amiodarone
• Apremilast
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Astemizole
• Atogepant
• Avacopan
• Avapritinib
• Axitinib
• Bedaquiline
• Belumosudil
• Benzhydrocodone
• Bictegravir
• Bortezomib
• Bosutinib
• Brigatinib
• Buprenorphine
• Cabozantinib
• Cannabidiol
• Capivasertib
• Capmatinib
• Cariprazine
• Ceritinib
• Cholera Vaccine
• Cisapride
• Clarithromycin
• Clindamycin
• Clozapine
• Cobimetinib
• Codeine
• Colchicine
• Conivaptan
• Copanlisib
• Crinecerfont
• Crizotinib
• Cyclosporine
• Daridorexant
• Dasatinib
• Deflazacort
• Desogestrel
• Deutivacaftor
• Dexamethasone
• Dienogest
• Dihydrocodeine
• Dihydroergotamine
• Diltiazem
• Docetaxel
• Dofetilide
• Dronedarone
• Drospirenone
• Duvelisib
• Ebola Zaire Vaccine, Live
• Elacestrant
• Elexacaftor
• Eliglustat
• Encorafenib
• Ensartinib
• Entrectinib
• Eravacycline
• Erdafitinib
• Ergotamine
• Erlotinib
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Everolimus
• Exemestane
• Fedratinib
• Fenfluramine
• Fentanyl
• Fexinidazole
• Finerenone
• Flibanserin
• Fosaprepitant
• Fosnetupitant
• Fostamatinib
• Fruquintinib
• Gepirone
• Gestodene
• Glasdegib
• Hemin
• Hydrocodone
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Imatinib
• Infigratinib
• Influenza Virus Vaccine, Live
• Irinotecan
• Irinotecan Liposome
• Istradefylline
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ixazomib
• Ketoconazole
• Larotrectinib
• Lazertinib
• Lefamulin
• Lemborexant
• Leniolisib
• Levoketoconazole
• Levomethadyl
• Levonorgestrel
• Linagliptin
• Lomitapide
• Lumateperone
• Lurbinectedin
• Macimorelin
• Macitentan
• Manidipine
• Maraviroc
• Maribavir
• Mavorixafor
• Medroxyprogesterone
• Meperidine
• Mestranol
• Methadone
• Midostaurin
• Mirtazapine
• Mitapivat
• Mobocertinib
• Naloxegol
• Neratinib
• Netupitant
• Nilotinib
• Nirogacestat
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olanzapine
• Olaparib
• Oliceridine
• Olutasidenib
• Omaveloxolone
• Osimertinib
• Oxcarbazepine
• Oxycodone
• Paclitaxel
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Pazopanib
• Pemigatinib
• Pentazocine
• Perampanel
• Pexidartinib
• Pimavanserin
• Pimozide
• Pirtobrutinib
• Pitolisant
• Ponatinib
• Pralsetinib
• Pretomanid
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Regorafenib
• Repotrectinib
• Revumenib
• Ribociclib
• Rimegepant
• Ripretinib
• Risperidone
• Ritlecitinib
• Romidepsin
• Rotavirus Vaccine, Live
• Ruxolitinib
• Samidorphan
• Segesterone
• Selpercatinib
• Selumetinib
• Sildenafil
• Sirolimus
• Sirolimus Protein-Bound
• Sonidegib
• Sotorasib
• Sparsentan
• Spironolactone
• Stiripentol
• Sufentanil
• Sunitinib
• Suzetrigine
• Tacrolimus
• Tadalafil
• Tamoxifen
• Tasimelteon
• Tazemetostat
• Temsirolimus
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tivozanib
• Tofacitinib
• Tolvaptan
• Tramadol
• Tretinoin
• Tucatinib
• Ubrogepant
• Ulipristal
• Upadacitinib
• Valbenazine
• Vandetanib
• Vanzacaftor
• Velpatasvir
• Vemurafenib
• Venetoclax
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voclosporin
• Vonoprazan
• Vorapaxar
• Vortioxetine
• Voxelotor
• Voxilaprevir
• Warfarin
• Zanubrutinib
• Zolpidem
• Zuranolone

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.

• Midazolam

Other interactions—

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:

• Adrenal problems or
• Illness or
• Infection or
• Injury or
• Ovarian cyst or
• Shock or
• Surgery or
• Trauma—Use with caution. May increase risk for more serious side effects.

• Kidney disease, mild to moderate or
• Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe or
• Liver disease, severe—Use is not recommended in patients with these conditions.

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 this medicine 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.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food (eg, high-fat meal or snack).

Swallow the tablet whole. Do not crush, chew, or split it. Do not take tablets that are broken or crushed.

Wear gloves when handling tablets. Do not touch the broken or crushed tablet. If you touch it, wash your hands with soap and water.

Dosing—

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 3 or 4 divided doses per day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.

Storage—

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 your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment with this medicine. Use an effective form of birth control that does not contain hormones (eg, condoms, diaphragms, and spermicide) to keep from getting pregnant during treatment and for as long as this medicine is detected in your blood. If you think you have become pregnant while using the medicine, tell your doctor right away.

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.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have dizziness or lightheadedness, drowsiness, feeling of constant movement of self or surroundings, sensation of spinning, sleepiness, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness. These may be symptoms of nerve problems.

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 cysts in the ovaries in premenopausal women (have menstrual cycles). Tell your doctor if you have bloating, sudden or severe pelvic pain, or vaginal bleeding.

This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, general tiredness or weakness, light-colored stools, nausea and vomiting, upper right stomach pain, or yellow eyes and skin.

This medicine can temporarily lower the number of white blood cells in your blood, which will increase the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause prolonged bleeding. Make sure any doctor or dentist who treats you knows that you are using this medicine.

This medicine may cause changes in hormone levels. Check with your doctor right away if you have swelling of the breasts or breast soreness in males.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

Darkening of the skin

diarrhea

dizziness or lightheadedness

drowsiness

loss of appetite

mental depression

nausea or vomiting

skin rash

unusual tiredness or weakness

Less common

Blood in the urine

blurred vision

double vision

Incidence not known

Bloating

chills

cloudy urine

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

feeling of warmth

fever

frequent urination

headache

pelvic cramping, discomfort, pain, or heaviness

nervousness

painful urination

pounding in the ears

redness of the face, neck, arms, and occasionally, upper chest

slow or fast heartbeat

swelling of the breasts or breast soreness in both females and males

vaginal bleeding

vision changes

white area over the eye

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:

More common

Feeling of constant movement of self or surroundings

indigestion

passing of gas

sensation of spinning

sleepiness

Less common

Aching muscles

flushing or redness of the skin

muscle twitching

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.