How does this medication work? What will it do for me?

Mitotane belongs to the group of cancer-fighting medicines known as antineoplastics. It is used to treat certain kinds of cancer that affect the adrenal cortex (the part of the body responsible for making steroid hormones like cortisol). Mitotane reduces the amount of adrenocorticoid hormones produced by the adrenal cortex and affects how steroids are broken down in the body.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each one-half inch, biconvex, round, compressed white tablet, bisected on one side and impressed with "BL" over "L1" on the other side, contains 500 mg of mitotane. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, microcrystalline cellulose, and polyethylene glycol.

How should I use this medication?

The dose of mitotane depends on response to the medication and the amount of medication that can be tolerated. Usually, the starting dose is 2 g to 6 g of mitotane daily in 3 or 4 equally divided doses, with or without food. Your doctor may increase the dose, depending on response, until adverse side effects appear. Usually, this medication is started in the hospital until a stable dose is reached.

The tablets should be swallowed whole with a glass of water. Do not crush or chew the tablets. Take this medication with a meal that contains foods high in fat, such as milk, chocolate, or oil.

This medication should not be handled by people other than the person taking it or their caregivers. Pregnant women should not handle mitotane. If you come into contact with broken tablets, wash your hands thoroughly with soap and water right away.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication away from moisture, heat, and direct light; and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to mitotane or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • body aches
  • decreased appetite
  • diarrhea
  • dizziness
  • nausea
  • spinning sensation
  • tiredness or drowsiness
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • breast development (men)
  • confusion
  • dizziness or light headedness when rising from a lying or sitting position
  • flushing
  • increased blood pressure
  • lethargy
  • memory problems
  • muscle weakness
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • skin rash
  • swelling of the ankles, hands, abdomen, or face
  • symptoms of bladder inflammation (e.g., pain, discomfort, or burning when urinating; blood in the urine)
  • symptoms of decreased adrenal function (e.g., tiredness, weakness, nausea, vomiting, low blood pressure)
  • symptoms of decreased testosterone production (men) (e.g., decreased interest or ability in sexual activity, decreased fertility)
  • symptoms of hypothyroidism (e.g., dry skin, constipation, weight gain, fatigue, aches, pains, stiffness, intolerance to cold, depression, memory problems)
  • symptoms of ovarian cysts (e.g., bloating, lower abdominal or pelvic pain, lower back pain, vaginal bleeding)
  • unexplained bruising
  • vision changes (e.g., blurred vision, double vision, clouding of the lens, vision loss, halos around light, central spot in vision)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of allergic reaction (swelling of the mouth, face, or tongue or difficulty breathing)
  • signs of taking too much medication (e.g., dizziness, memory, speech attention or balance problems)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Drowsiness/reduced alertness: Mitotane may cause sedation, lethargy, or dizziness. You should exercise caution when driving, operating machinery, or performing other tasks requiring mental alertness.

Liver disease: Decreased liver function or liver disease may cause this medication to build up in your body, causing side effects. If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Risk of adrenal insufficiency: Mitotane's effect on the adrenal gland may result in the need for steroid replacement therapy during times when your body is under significant stress (e.g., during surgery, trauma, or severe illness).

Pregnancy: The safety of mitotane during pregnancy has not been established. This medication should not be used during pregnancy unless the benefits outweigh the risks.

Breast-feeding: Mitotane passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. This medication should not be used during breast-feeding unless the benefits outweigh the risks.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 18 years.

What other drugs could interact with this medication?

There may be an interaction between mitotane and any of the following:

  • abiraterone
  • amiodarone
  • anti-cancer medications (e.g., brentuximab, docetaxel, doxorubicin, etoposide, irinotecan, vincristine)
  • antipsychotics (e.g., aripiprazole, clozapine, haloperidol, quetiapine)
  • apixaban
  • apremilast
  • atorvastatin
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • benzodiazepines (e.g., alprazolam, clonazepam, diazepam)
  • bisoprolol
  • buprenorphine
  • buspirone
  • calcitriol
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • carbamazepine
  • clarithromycin
  • clindamycin
  • cobicistat
  • corticosteroids (e.g., beclomethasone, dexamethasone, prednisone)
  • cyclosporine
  • dapsone
  • darifenacin
  • disopyramide
  • domperidone
  • dronedarone
  • elagolix
  • elexacaftor, tezacaftor, and ivacaftor
  • eliglustat
  • enzalutamide
  • eplerenone
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • everolimus
  • exemestane
  • fesoterodine
  • flibanserin
  • "gliptin" diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
  • hepatitis medications (e.g., elbasvir and grazoprevir, glecaprevir and pibrentasvir, velpatasvir)
  • HIV integrase inhibitors (e.g., bictegravir, elvitegravir)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., doravirine, efavirenz, etravirine, nevirapine, rilpivirine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • ivabradine
  • lemborexant
  • lidocaine
  • lumacaftor and ivacaftor
  • macitentan
  • maraviroc
  • mefloquine
  • methadone
  • mifepristone
  • mirabegron
  • mirtazapine
  • naloxegol
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tramadol)
  • ondansetron
  • oxcarbazepine
  • perampanel
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • praziquantel
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • propafenone
  • protein kinase inhibitors (e.g., dabrafenib, dasatinib, idelalisib, imatinib, nilotinib, pazopanib)
  • quinidine
  • quinine
  • rifabutin
  • riociguat
  • rivaroxaban
  • roflumilast
  • romidepsin
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, escitalopram, fluoxetine, paroxetine, sertraline)
  • sirolimus
  • solifenacin
  • spironolactone
  • tacrolimus
  • tamoxifen
  • ticlopidine
  • ticagrelor
  • tolvaptan
  • trazodone
  • trimethoprim
  • warfarin
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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