Mitotane (Lysodren)

Mitotane is a chemotherapy drug. It’s pronounced my-toe-tane. It is also known as Lysodren. You might have it as a treatment for a rare type of adrenal gland cancer called adrenal cortical cancer (ACC). It is for cancer that:

• can’t be removed with surgery (unresectable)
• has come back after treatment (relapsed)
• has spread to another part of the body (metastatic cancer)

You might have mitotane on its own or with other chemotherapy drugs.

How does mitotane work?

It is not completely clear how mitotane works. As well as destroying cancer cells, doctors think it stops cells in the adrenal gland from working properly. It may reduce the amount of steroid hormones being made by the adrenal gland, and may also affect the breakdown of these hormones. This helps to improve symptoms caused by the excess hormones.

How do you have mitotane?

You take mitotane as tablets that you swallow with a glass of water during a meal. You take them with food that contains fat such as milk, chocolate or vegetable oils.

Speak to your pharmacist if you have problems swallowing the tablets.

Whether you have a full or an empty stomach can affect how much of a drug gets into your bloodstream.

You should take the right dose, no more or less.

Talk to your healthcare team before you stop taking a cancer drug or if you miss a dose.

How do you take mitotane?

You usually take mitotane 2 to 3 times a day. You start on a low amount (dose) of mitotane. Your doctor then gradually increases the dose until you have the correct level in your blood.

You take mitotane for as long as it is working and the side effects aren’t too bad.

Tests

You have blood tests before and during your treatment. They check your levels of blood cells and other substances in the blood. They also check how well your liver and kidneys are working.

You have regular blood tests to check the level of mitotane in your blood. At first you have these tests frequently, they become less frequent once the levels are stable.

What are the side effects of mitotane?

Side effects can vary from person to person. They also depend on what other treatments you're having. 

When to contact your team

Your doctor, nurse or pharmacist will go through the possible side effects. They will monitor you during treatment and check how you are at your appointments. Contact your advice line as soon as possible if:

• you have severe side effects 

• your side effects aren’t getting any better

• your side effects are getting worse

Early treatment can help manage side effects better. 

We haven't listed all the side effects here. Remember it is very unlikely that you will have all of these side effects. But you might have some of them at the same time.

Common side effects

These side effects happen in more than 10 in 100 people (more than 10%). You might have one or more of them. They include:

Low levels of the cortisol hormone

Cortisol is one of the steroid hormones. It is made in the adrenal glands , which sit on top of the kidneys . Cortisol is also known as the stress hormone as it helps your body react quickly to stressful situations.

Mitotane lowers the amount of cortisol your adrenal glands make. You usually have steroid tablets alongside this treatment to help with your cortisol levels.

Loss of appetite

You might lose your appetite for various reasons while having cancer treatment. Sickness, taste changes or tiredness can put you off food and drinks.

Feeling or being sick

Feeling or being sick is usually well controlled with anti sickness medicines. It might help to avoid fatty or fried foods, eat small meals and snacks and take regular sips of water. Relaxation techniques might also help.

It is important to take anti sickness medicines as prescribed even if you don’t feel sick. It is easier to prevent sickness rather than treat it once it has started.

Diarrhoea

Contact your advice line if you have diarrhoea. For example, in one day you have 2 or more loose bowel movements than usual. If you have a stoma , you might have more output than normal. Your doctor may give you anti diarrhoea medicine to take home with you after treatment.

Try to eat small meals and snacks regularly. It’s best to try to have a healthy balanced diet if you can. You don’t necessarily need to stop eating foods that contain fibre. But if your diet is normally very high in fibre, it might help to cut back on high fibre foods such as beans, nuts, seeds, dried fruit, bran and raw vegetables. 

Drink plenty to try and replace the fluid lost. Aim for 8 to 10 glasses per day.

Tiredness and weakness (fatigue)

You might feel very tired and as though you lack energy.

Various things can help you to reduce tiredness and cope with it, for example exercise. Some research has shown that taking gentle exercise can give you more energy. It is important to balance exercise with resting.

Feeling drowsy

This drug may make you feel drowsy or dizzy. Don’t drive or operate machinery if you have this.

After stopping mitotane you shouldn’t drive or operate heavy machinery until the drug can no longer be picked up in your blood.

Tummy (abdominal) pain

Tell your treatment team if you have this. They can check the cause and give you medicine to help. 

Bleeding longer than usual

If you have an area that is bleeding, you might notice it takes longer to stop than usual. The reason for why this happens is not known. It’s important to let your healthcare team know straight away if you are bleeding.

Abnormal sensation

This includes numbness, tingling or a prickly feeling on your skin. It’s often temporary and can improve after you finish treatment. Tell your doctor if you're finding it difficult to walk or complete fiddly tasks such as doing up buttons. 

Skin rash

Skin problems include a skin rash, redness, dry skin and itching. This usually goes back to normal when your treatment finishes. Your nurse will tell you what products you can use on your skin to help.

Increased risk of getting an infection

Increased risk of getting an infection is due to a drop in white blood cells. Symptoms include a change in temperature, aching muscles, headaches, feeling cold and shivery and generally unwell. You might have other symptoms depending on where the infection is.

Infections can sometimes be life threatening. You should contact your advice line urgently if you think you have an infection. 

Muscle weakness

Mitotane can cause muscle weakness in any part of your body. This commonly affects your eyes, eyelids, swallowing, facial expressions and speaking.

Let your healthcare team know if you notice any changes.

Breast swelling in men (gynaecomastia)

Seeing your body change can be quite upsetting. Talk to your doctor or nurse about this.

Confusion

You or the people around you may notice that you feel confused. Tell your doctor or nurse if this happens.

Liver changes

You might have liver changes that are usually mild and unlikely to cause symptoms, they are usually picked up on blood tests. These changes usually go back to normal when treatment finishes.

Less commonly mitotane can cause inflammation of the liver. Symptoms can include yellowing of the skin and whites of the eyes. You might also pass dark coloured wee.

You have regular blood tests to check for any changes in the way your liver is working. But if you notice any of these symptoms contact your advice line.

High fat levels in the blood

You will have regular blood tests to monitor this. 

Sore mouth

Mouth sores and ulcers can be painful. It helps to keep your mouth and teeth clean, drink plenty of fluids, avoid acidic foods such as oranges, lemons and grapefruits and chew gum to keep the mouth moist. Tell your doctor or nurse if you have ulcers.

Dizziness and loss of balance (vertigo)

You might feel dizzy and you may feel as though the room is spinning. This is vertigo. Let your doctor or nurse know if this happens.

Difficulty coordinating movements

You might have difficulty coordinating your movements. This might affect your speech so you may slur your words, when walking you might be unsteady or frequently trip, or you might have trouble picking up things or carrying out fiddly tasks such as doing up buttons.

Let your healthcare team know if you have any problems with your movement.

Occasional side effects

These side effects happen in between 1 and 10 out of every 100 people (between 1 and 10%). You might have one or more of them. They include:

• headaches
• memory problems or difficulty concentrating - you have regular checks to help spot any changess
• breathlessness and looking pale due to low levels of red blood cells in the blood (anaemia)
• low levels of platelets in the blood - symptoms might include bruising easily, bleeding gums or nosebleeds
• injury to the nerves in your body, symptoms might include sensitivity to touch, weakness in your legs or arms, swallowing problems, or you might be unsteady when walking

Other side effects

There isn't enough information to work out how often these side effects might happen. You might have one or more of them. They include:

• taste changes
• high or low blood pressure
• cysts on your ovary – you might have tummy pain or pass blood
• eye problems such as blurred or double vision, loss of sight, you may have halos or wavy lines which affect your eyesight – let your healthcare team know if you notice any changes with your eyesight

Coping with side effects

We have more information about side effects and tips on how to cope with them.

What else do I need to know?

Other medicines, foods and drink

Cancer drugs can interact with medicines, herbal products, and some food and drinks. We are unable to list all the possible interactions that may happen. An example is grapefruit or grapefruit juice which can increase the side effects of certain drugs.

Tell your healthcare team about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies. Also let them know about any other medical conditions or allergies you may have.

Pregnancy and contraception

This treatment might harm a baby developing in the womb. It is important not to become pregnant or father a child while you're having treatment and for as long as mitotane is picked up in your blood afterwards. Talk to your doctor or nurse about effective contraception before starting treatment.

Loss of fertility

It is not known whether this treatment affects fertility in people. Talk to your doctor before starting treatment if you think you may want to have a baby in the future.

Breastfeeding

Don’t breastfeed during this treatment because the drug may come through into your breast milk.

Treatment for other conditions 

If you are having tests or treatment for anything else, always mention your cancer treatment. For example, if you are visiting your dentist.

Immunisations

Don’t have immunisations with live vaccines while you’re having treatment and for up to 12 months afterwards. The length of time depends on the treatment you are having. Ask your doctor or pharmacist how long you should avoid live vaccinations.

In the UK, live vaccines include rubella, mumps, measles, BCG, yellow fever and one of the shingles vaccines called Zostavax.

You can have:

• other vaccines, but they might not give you as much protection as usual
• the flu vaccine (as an injection)
• the coronavirus (COVID-19) vaccine - talk to your doctor or pharmacist about the best time to have it in relation to your cancer treatment

Members of your household who are aged 5 years or over are also able to have the COVID-19 vaccine. This is to help lower your risk of getting COVID-19 while having cancer treatment and until your immune system recovers from treatment.

Contact with others who have had immunisations - You can be in contact with other people who have had live vaccines as injections. Avoid close contact with people who have recently had live vaccines taken by mouth (oral vaccines) such as the oral typhoid vaccine. Sometimes people who have had the live shingles vaccine can get a shingles type rash. If this happens they should keep the area covered.

If your immune system is severely weakened, you should avoid contact with children who have had the flu vaccine as a nasal spray as this is a live vaccine. This is for 2 weeks following their vaccination.

Babies have the live rotavirus vaccine. The virus is in the baby’s poo for about 2 weeks and could make you ill if your immunity is low. Get someone else to change their nappies during this time if you can. If this isn't possible, wash your hands well after changing their nappy.

More information about this treatment

For further information about this treatment and possible side effects go to the electronic Medicines Compendium (eMC) website. You can find the patient information leaflet on this website.

You can report any side effect you have to the Medicines Health and Regulatory Authority (MHRA) as part of their Yellow Card Scheme.