Mitotane Tablets

What is this medication?

MITOTANE (MYE toe tane) treats adrenal gland cancer. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Lysodren

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Addison disease
• Bleeding disorder
• Cysts in or on your ovaries
• Infection
• Kidney disease
• Liver disease
• Low adrenal gland function
• Low blood cell levels (white cells, red cells, and platelets)
• Recent or having surgery
• Recent weight loss
• Severe injury to your body from trauma, such as a car accident or burn
• An unusual or allergic reaction to mitotane, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it with food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Handling this medication may be harmful. Wear gloves while touching the medication or bottle. Talk to your care team about how to handle this medication. Special instructions may apply.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

If you vomit after taking your dose, do not take another dose. Take your next dose at your usual time the next day.

What may interact with this medication?

Do not take this medication with any of the following:

• Artemether
• Certain antivirals for HIV or hepatitis, such as atazanavir, cobicistat, daclatasvir, darunavir, doravirine, elbasvir; grazoprevir, elvitegravir, fostemsavir, lenacapavir, lopinavir, nelfinavir, ritonavir, tipranavir
• Certain medications for fungal infections, such as isavuconazonium
• Lonafarnib
• Lorlatinib
• Lurasidone
• Mavacamten
• Pacritinib
• Praziquantel
• Ranolazine

This medication may also interact with the following:

• Estrogen and progestin hormones
• Spironolactone
• Warfarin

This medication may affect how other medications work. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work done while you are taking this medication.

Tell your care team right away if serious injury, infection, or another illness occurs while you are taking this medication. Tell them if you plan to have surgery. This medication can make it hard for your body to respond to stress. Your care team may reduce your dose or have you stop taking this medication until you recover.

Before having surgery or dental work, talk to your care team to make sure it is ok. This medication can increase the risk of bleeding. You may need to stop this medication before surgery. Talk to your care team if you have questions.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for as long as your care team tells you to after the last dose. You will need a negative pregnancy test before starting this medication. Estrogen and progestin hormones may not work as well while you are taking this medication. Contraception is recommended while taking this medication and for some time after the last dose. Your care team can help you find the option that works for you.

If you may be pregnant, do not handle broken or crushed tablets of this medication. If you are pregnant and come into contact with broken or crushed tablets, contact your care team.

Do not breastfeed while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Cyst in or on the ovary—unusual vaginal bleeding, pelvic pain
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Loss of appetite
• Stomach pain
• Unexpected breast tissue growth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature at 25 degrees C (77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.