Midostaurin, daunorubicin and cytarabine

Midostaurin, daunorubicin and cytarabine are cancer drugs. This combination is a treatment for acute myeloid leukaemia (AML).

What are midostaurin, daunorubicin and cytarabine?

Midostaurin is a type of targeted cancer drug and daunorubicin and cytarabine are chemotherapy drugs. Midostaurin is pronounced MY-doh-STAW-rin. You pronounce daunorubicin as DAW-noh-ROO-bih-sin and cytarabine as sye-TARE-a-been.

This combination of cancer drugs is a treatment for acute myeloid leukaemia (AML).

You have this combination for AML if your cancer has a change (mutation) in the FLT3 gene. Your doctor will check for this mutation before you can start this drug.

How do midostaurin, daunorubicin and cytarabine work?

Midostaurin is a type of cancer growth blocker called a tyrosine kinase inhibitor (TKI).

Tyrosine kinase inhibitors block chemical messengers (enzymes) called tyrosine kinases. Tyrosine kinases help to send growth signals in cells, so blocking them stops the cell from growing and dividing.

Daunorubicin and cytarabine destroy quickly dividing cells, such as cancer cells.

How do you have midostaurin, daunorubicin and cytarabine?

You have daunorubicin and cytarabine into your bloodstream (intravenously). You take midostaurin as capsules.

Into your bloodstream

You might have treatment through a long plastic tube that goes into a large vein in your chest. The tube stays in place throughout the course of treatment. This can be a:

• central line
• PICC line
• portacath

When taking midostaurin capsules you swallow them whole with a full glass of water. You take the capsules with food. You should not open, crush or chew the capsules. You usually take them twice a day, about 12 hours apart.

Taking capsules

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

You should take the right dose, not more or less.

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

How often do you have midostaurin, daunorubicin and cytarabine?

You have midostaurin, daunorubicin and cytarabine as cycles of treatment. This means that you have the drugs and then a rest to allow your body to recover.

Each cycle of treatment lasts 21 days (3 weeks), but you don't always start on day 22 with your next cycle. You wait until your blood counts have recovered. You have:

• up to 2 cycles to get rid of the leukaemia cells (induction treatment)
• up to 4 cycles to lower the risk of leukaemia coming back (consolidation treatment)

It might take around 5 to 6 months in total.

If there is no sign of your cancer (remission), you continue on midostaurin. This is called maintenance treatment. Maintenance treatment means you take midostaurin twice a day for up to 12 cycles of 28 days (4 weeks). So this can take up to 12 months.

Induction treatment (up to 2 cycles)

You have each cycle of treatment in the following way:

Consolidation treatment (up to 4 cycles)

You have each cycle of treatment in the following way:

Maintenance treatment (up to 12 cycles)

You take midostaurin as capsules twice a day, morning and evening, 12 hours apart. Each cycle is 28 days.

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.

What are the side effects of midostaurin, daunorubicin and cytarabine?

How often and how severe the side effects are 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:

Increased risk of infection

Increased risk of getting an infection

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

Bruising and bleeding

This is due to a

drop in the number of platelets in your blood

Blood tests might show that your blood takes longer to clot.

Allergic reaction

A reaction may happen during the infusion. Symptoms can include a skin rash, itching, swelling of the lips, face or throat, breathing difficulties, fever and chills. Your nurse will give you medicines beforehand to try to prevent a reaction.

Heart changes

You may have changes to how your heart works such as your heart rhythm. Tests such as a heart trace (ECG) might pick this up.

Difficulty sleeping

If you have difficulty sleeping, it can help to change a few things about how you try to sleep. Try to go to bed and get up at the same time each day and spend some time relaxing before you go to bed. Some light exercise each day may also help.

Headaches

Let your doctor or nurse know if you have headaches. They can give you painkillers such as paracetamol to help.

Blood pressure changes

Tell your doctor or nurse if you feel light headed or dizzy, this could be a sign that your blood pressure is low.

Less commonly, you might have high blood pressure causing blurred vision, nosebleeds, shortness of breath and headaches.

Breathlessness and looking pale

You might be

breathless and look pale

Feeling or being sick (nausea)

Feeling or being sick

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.

A sore mouth

You might get a sore mouth and mouth ulcers. It may be painful to swallow drinks or food. You will have mouth washes to keep your mouth healthy.

You can have painkillers to reduce the soreness. Take them half an hour before meals to make eating easier.

Piles (haemorrhoids)

Swollen veins near your anus (called piles or haemorrhoids) can be painful when you open your bowels. You can try a cream from your pharmacist or tell your doctor.

Less commonly, you might have discomfort in your back passage (anorectal area).

Skin changes

You might notice skin changes, such as dryness, itching, rashes or areas of skin which differ in appearance and are raised like bumps.

Tell your healthcare team if you have any rashes or problems with your skin and nails. They might be able to give you something to help like a cream or lotion.

Less commonly, you might have dry skin.

Sweating

This drug might cause you to sweat more than usual. But there are

ways to reduce sweating

Let your healthcare team know if you are sweating much more than normal.

Pain in different parts of the body

It is common to have pain in your throat, tummy (abdomen) and back or joints

Speak to your doctor or nurse about what painkillers you can take to help with this.

Less commonly, you might have pain in your bones, arms, legs or neck.

Rarely you might have muscle pain.

Liver changes

You might have

liver changes

Changes to the levels of minerals in your blood

You may have changes in levels of minerals and salts in your blood, such as low potassium and high sodium.

Low potassium can cause muscle weakness, muscle spasms or changes to your heart rhythm.

High sodium can cause muscle weakness, drowsiness, confusion, fits (convulsions) and feeling less awake.

You have regular blood tests during treatment to check this.

Less commonly you might have high levels of calcium in the blood causing nausea, vomiting, constipation, stomach pain, passing urine often, feeling thirsty, weakness and twitching of muscles.

High blood sugar levels

High blood sugar levels can cause headaches, feeling thirsty and blurred vision. You have regular tests to check your blood sugar levels. You may need to check your levels more often if you are diabetic.

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:

• high levels of uric acid in your blood which can lead to a build up of crystals in body tissues and cause inflamed joints
• fainting or passing out
• shaky hands (tremor)
• swollen eyelids
• heart problems such as a fast heart rate or a build up of fluid around the heart which can cause shortness of breath
• a build up of fluid around the lungs which can cause shortness of breath
• weight gain
• a blood clot in a tube (line) that goes into a vein

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 drinks

Cancer drugs can interact with some other medicines and herbal products. Tell your doctor or pharmacist about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies.

Alcohol

Midostaurin contains small amounts of alcohol. This is not harmful to most people but may be if you have alcohol problems.

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.

Contraception and pregnancy

This treatment may harm a baby developing in the womb. It is important not to become pregnant or get someone pregnant while you're having treatment and for at least 6 months afterwards.

Talk to your doctor or nurse about effective contraception before starting treatment. Let them know straight away if you or your partner falls pregnant while having treatment.

It is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives, such as the pill, should add a barrier method of contraception.

Breastfeeding

Don’t breastfeed during this treatment and for 6 months afterwards. The drug may come through in the breast milk.

Treatment for other conditions

Always tell other doctors, nurses, pharmacists or dentists that you’re having this treatment. For example, if you need treatment for anything else, including teeth problems.

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.