Gemtuzumab ozogamicin, daunorubicin and cytarabine

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

What are gemtuzumab ozogamicin, daunorubicin and cytarabine?

Gemtuzumab ozogamicin is a type of targeted cancer drug. Daunorubicin and cytarabine are chemotherapy drugs.

Gemtuzumab ozogamicn is pronounced gem-TOO-zoo-mab OH-zoh-ga-MIH-sin. Daunorubicin is pronounced 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 leukaemia cells produce too much of a protein called CD33.

How do gemtuzumab ozogamicin, daunorubicin and cytarabine work?

Gemtuzumab ozogamicin is a type of targeted cancer drug called a monoclonal antibody conjugate. This means it is a monoclonal antibody linked to a chemotherapy drug. It targets a protein called CD33 on the surface of leukaemia cells. The gemtuzumab sticks to all the CD33 proteins it finds. Then ozogamicin enters the cells and kills them.

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

How do you have gemtuzumab ozogamicin, daunorubicin and cytarabine?

You have gemtuzumab ozogamicin, daunorubicin and cytarabine as a drip into your bloodstream (intravenously).

You 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

How often do you have gemtuzumab ozogamicin, daunorubicin and cytarabine?

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

The length of each cycle is usually 28 days (4 weeks), but this depends on how well your blood counts recover.

You might have:

• up to 2 cycles to get rid of the leukaemia cells (induction treatment). You usually have a bone marrow test after your first cycle to check how well the treatment has worked
• 1 to 2 further cycles to lower the risk of leukaemia coming back (consolidation treatment)

Induction treatment (1st cycle)

You usually have the 1st cycle of induction treatment in the following way:

You then start your next cycle of induction treatment or move onto consolidation treatment. Your bone marrow test results will help your doctor decide which treatment you have next.

Induction treatment (2nd cycle)

You only have the 2nd cycle of induction treatment if you still have leukaemia cells. You have the 2nd cycle of induction treatment in the following way:

You have another bone marrow test before starting consolidation treatment.

Consolidation treatment (1st cycle)

You have the 1st cycle of consolidation treatment in the following way:

You may then start a 2nd cycle of consolidation treatment.

Consolidation treatment (2nd cycle)

You have the 2nd cycle of consolidation treatment in the following way:

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 gemtuzumab ozogamicin, 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

Breathlessness and looking pale

You might be

breathless and look pale

Shortness of breath

Tell your doctor or nurse if you have this.

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.

Liver changes

It’s common for your blood tests to show that your treatment could be affecting how well your liver works.

Less commonly this treatment can cause a condition called veno occlusive disease (VOD). This is when the blood vessels of the liver get blocked. The signs of this include:

• yellowing of the skin and whites of your eyes (jaundice)
• liver tenderness (under the ribs on the right side of the body)
• an enlarged liver
• weight gain due to a build up of fluid

You’ll have regular blood tests to check on your liver but let your healthcare team know straight away if you have any of the above signs.

Raised uric acid levels in the blood

High levels of uric acid in your blood can lead to a build up of crystals in body tissues and cause inflamed joints. You’ll have regular blood tests to check your levels. Drinking plenty of fluids helps to flush out the excess uric acid. You might also have medicines to control the uric acid levels.

Headaches

Tell your healthcare team if you keep getting headaches. They can give you painkillers to help.

Fast heartbeat

You may feel that your heart is beating very quickly. This can make you feel dizzy, breathless and tired.

Changes in blood pressure

During treatment, your blood pressure may be lower or higher than normal. Tell your nurse if you feel dizzy, faint, or if you have headaches, nosebleeds, blurred or double vision, or shortness of breath. Your blood pressure usually goes back to normal while you are on treatment or when treatment ends.

Feeling or being sick

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.

Diarrhoea or constipation

Tell your healthcare team if you have

diarrhoea or constipation

Tummy (abdominal) pain

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

Rarely, you might get inflammation of the lining of the tummy wall (peritonitis)

Sore mouth and throat

It may be

painful to swallow drinks or food

Skin rash

A rash can also be itchy. Tell your doctor or nurse if you have a skin rash. They can prescribe medicine to stop the itching and soothe your skin.

Less common skin changes include redness, blistering, itching, or raised red patches that might look like nettle rash (urticaria).

Rarely you might have flat or slightly raised brown patches, similar to freckles or age spots. Other rare conditions include red lumps on the ears, scalp, face and body.

High temperature or chills

You might get a high temperature. Or you might feel cold or start shivering (chills).

Swollen hands and feet

Swelling of hands and feet is due to fluid build up. This is called oedema. Let your doctor or nurse know if you have any swelling.

Tiredness and weakness

You might feel

very tired

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.

Loss of appetite

You might

lose your appetite

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:

• a reaction during the infusion – you might get a rash, shortness of breath, redness or swelling of the face and dizziness – tell your team straight away if this happens
• build up of fluid in the tummy (abdomen)
• eye changes such as bleeding in the white of the eye causing light sensitivity, burning, vision changes, tears and inflammation of the clear dome shape on the surface of the eye (cornea)
• indigestion, symptoms include heartburn, bloating and burping
• difficulty swallowing
• digestive system problems such as inflammation and ulcers of the back passage (anus) and food pipe (oesophagus). Rarely the wall of your intestine might get gas filled cysts (pneumatosis cystoides intestinalis ) or the tissue of the intestine might die
• inflammation of your blood vessels – symptoms can vary depending on which blood vessels are affected - general symptoms include feeling very tired, loss of appetite, weight loss, a high temperature, and aches and pains
• complete hair loss, but your hair usually grows back after treatment finishes
• kidney changes that might show up on a blood or wee (urine) tests. Some people might have problems not being able to pass urine (urinary retention). Let your nurse or doctor know if this happens to you
• changes to the levels of chemicals in the blood due to breakdown of cancer cells (tumour lysis syndrome) – you have regular blood tests to check for this
• failure of parts of the body such as the heart and kidneys

Rare side effects

These side effects happen in fewer than 1 in 100 people (less than 1%). You might have one or more of them. They include:

• inflammation of the layers of tissue that surrounds the heart (pericarditis), causing chest pain
• inflammation of the lungs (pneumonia), causing a cough or breathing problems
• muscle or joint pain
• changes to your heart rhythm - your doctor might ask you to have tests to check your heart, such as an electrocardiogram (ECG)

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:

• changes in the brain that are usually reversible, causing a sudden onset of symptoms including headaches, dizziness, confusion, fits (seizures) and changes to vision (reversible posterior leukoencephalopathy syndrome)
• a second cancer, such as leukaemia, some years after this treatment - your doctor will discuss this with you
• red or pink urine that is harmless and due to the colour of the chemotherapy - it lasts for one or two days
• inflammation of the bladder (cystitis) can cause pain and occasionally blood when passing wee (urine) – let your nurse or doctor know if you have any pain or see blood in your wee

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.

Loss of fertility

You may not be able to become pregnant or get someone pregnant after treatment with these drugs. Talk to your doctor before starting treatment if you think you may want to have a baby in the future.

Men might be able to store sperm before starting treatment. And women might be able to store eggs or ovarian tissue. But these services are not available in every hospital, so you would need to ask your doctor about this.

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.

Breastfeeding

It is not known whether these drugs come through into breast milk. Doctors usually advise that you don’t breastfeed during this treatment for 1 month afterwards.

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.