Mitotane

By Medically reviewed by hellodoktor

Generic Name: Mitotane Brand Name(s): Generics only. No brands available.

Uses

What is Mitotane used for?

Mitotane is used to treat cancer of the adrenal glands. It works by slowing the growth of or killing adrenal gland cells and also decreases the amount of hormones made by the adrenal gland.

How should I take Mitotane?

Take this medication by mouth with or without food as directed by your doctor, usually 3 or 4 times daily. The dosage is based on your medical condition and response to treatment.

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 use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Learn how to safely handle and dispose of this medication and its container.

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.

How do I store Mitotane?

Mitotane is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Mitotane in the bathroom or the freezer. There may be different brands of Mitotane that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Mitotane down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Mitotane?

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: liver disease.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using mitotane. Mitotane may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control while using this medication and for some time after stopping treatment. Your doctor will do blood tests to decide when you can stop using birth control. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may harm a nursing infant. Breast-feeding is not recommended while using this drug and for some time after stopping this drug. Your doctor will do blood tests to see when you can start breast-feeding. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Mitotane during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Mitotane. Mitotane is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Mitotane?

Dizziness, drowsiness, nausea/vomiting, diarrhea, loss of appetite, or weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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: unusual/rapid weight loss, mental/mood changes (such as depression, confusion), vision changes (such as blurred vision, double vision), change in skin color, fainting, easy bleeding/bruising, bloody urine, signs of an ovarian cyst (such as unusual vaginal bleeding, pelvic pain).

Mitotane can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rash that could be a sign of a severe reaction. Get medical help right away if you develop any 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Mitotane?

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include naldemedine, ranolazine, certain products used to treat hepatitis C (such as asunaprevir, daclatasvir, ombitasvir/paritaprevir/ritonavir), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Mitotane may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Mitotane?

Mitotane may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Mitotane?

Mitotane may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Mitotane.

What is the dose of Mitotane for an adult?

Usual Adult Dose for Adrenal Cortical Carcinoma

-Initial Dose: 2 to 6 g orally per day in 3 to 4 divided doses

-Maintenance Dose: 9 to 10 g orally per day in 3 to 4 divided doses

-Maximum Dose: May increase up to 16 g orally per day, if tolerated, in 3 to 4 divided doses; the highest doses used in studies were 18 to 19 g per day.

-Duration of Therapy: Treatment should be continued as long as clinical benefits are observed.

Comments:

-Increase total daily dose incrementally.

-Treatment should be instituted in the hospital until a stable dosage regimen is achieved.

-Data suggests continuous treatment with the maximum possible dosage is the best approach; patients who have been treated intermittently (i.e., therapy restarted when severe symptoms have reappeared) often do not respond after the third or fourth such course.

Use: Treatment of inoperable adrenal cortical carcinoma of both functional and nonfunctional types

Liver Dose Adjustments

Use with caution in patients with liver disease.

Dose Adjustments

Severe Side Effects Occur During Treatment:

-Reduce dose until the maximum tolerated dose is achieved; if the patient can tolerate higher doses and improved clinical response appears possible, increase dose until adverse reactions interfere.

Dialysis

Data not available; however, this drug is not likely to be dialyzable because of its lipophilic nature.

Other Comments

Administration Advice:

-Drug tablets should not be crushed.

-If contact with crushed and/or broken tablets occurs, the affected area should be immediately washed.

Storage requirements:

-Handling and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.

-Impervious gloves should be worn when handling bottles containing this drug to minimize the risk of dermal exposure.

General:

-Clinical benefits/effectiveness may include maintenance of clinical status; slowing of metastatic lesion growth; tumor mass reduction; pain reduction, weakness or anorexia; reduction of symptoms and signs due to excessive steroid production.

-If no clinical benefits are observed after 3 months at the maximum tolerated dose (MTD), the case would be considered a clinical failure; however, 10% of patients who showed a measurable response required more than 3 months at the MTD.

-Early diagnosis and prompt treatment institution improve the probability of a positive clinical response.

-No proven antidotes have been established for overdosage with this drug. Prolonged observation for toxicity is required due to this drug’s long half-life.

Monitoring:

-Endocrine: Signs/symptoms of adrenal insufficiency; free cortisol and corticotropin (ACTH) levels (if steroid replacement therapy needed)

-Hematological: Red blood cell, white blood cell, and platelet counts (during treatment)

-Hepatic: Liver function tests (periodically, especially during the first months of treatment or during dose increases)

-Nervous System: Behavioral and neurological assessments (regular intervals, especially when plasma levels of this drug exceed 20 mg/L)

-Toxicity: Plasma levels of drug (during treatment to avoid toxic levels; after treatment discontinuation to determine when contraception use can be stopped)

Patient Advice:

-Talk with your doctor if you have a fever, infection, surgery, or are hurt while taking this drug as you may need extra doses of oral steroids to help your body deal with these stresses.

-This drug may cause harm to an unborn baby; talk to your doctor about birth control that you should use during treatment and how long you need to use this birth control after you stop taking this drug.

-Rise slowly from a sitting or lying down position and use care when climbing stairs to lower the chances of feeling dizzy or passing out while taking this drug.

-If any area of your body comes into contact with broken or crushed tablets, wash that area right away and contact your doctor.

-You should not take extra doses or 2 doses at the same time; talk to your doctor about how to handle missed doses.

-This drug may cause side effects such as drowsiness and confusion that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.

-Caregivers should wear disposable gloves when handling this drug.

-Pregnant women should not touch or have any contact with this drug.

What is the dose of Mitotane for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Mitotane available?

Mitotane is available in the following dosage forms and strengths:

  • Oral tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Mitotane, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: March 29, 2018 | Last Modified: September 12, 2019

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