Mitotane tablets

What is this medication?

MITOTANE (MYE toe tane) limits the activity of the adrenal gland. It is used to treat adrenal cancer that cannot be treated by surgery.

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:

• liver disease
• an unusual or allergic reaction to mitotane, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• artemether
• certain antivirals for HIV or hepatitis like atazanavir, cobicistat, daclatasvir, darunavir, doravirine, elbasvir; grazoprevir, elvitegravir, fostemsavir, lopinavir, nelfinavir, ritonavir, or tipranavir
• certain medicines for fungal infections like isavuconazonium, ketoconazole, itraconazole, or posaconazole
• lorlatinib
• lurasidone
• praziquantel
• ranolazine

This medicine may also interact with the following medications:

• warfarin

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?

Visit your doctor or health care professional for regular checks on your progress. You may need blood work done while you are taking this medicine. If you are going to need surgery, be sure to tell your doctor before the procedure is scheduled. Do not stop taking except on your doctor's advice.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Tell your doctor immediately if you get a serious injury, serious infection, or any serious illness requiring a hospital visit or emergency care, including trauma. Mitotane should be stopped until you recover.

Try to avoid people who are sick during your treatment. Do not have any vaccinations without your doctor's approval and avoid anyone who has recently had oral polio vaccine.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. The use of effective birth control is advised. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• breast enlargement in both males and females
• changes in vision
• confusion
• depressed mood
• drowsiness
• headache
• impaired concentration
• pelvic pain
• seizures
• signs and symptoms of infection like fever or chills; cough; sore throat
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; yellowing of the eyes or skin
• stomach pain
• trouble with walking or balance
• trouble speaking
• unusually weak or tired
• unusual vaginal bleeding

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

• diarrhea
• dizziness
• fatigue
• mild loss of appetite
• nausea, vomiting

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.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date. Talk to your health care provider about how to dispose of this medicine.

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.