Gemtuzumab ozogamicin, daunorubicin and cytarabine

Gemtuzumab ozogamicin, daunorubicin and cytarabine is a cancer drug combination. It is a treatment for some people with acute myeloid leukaemia.

What are gemtuzumab ozogamicin, daunorubicin and cytarabine?

Gemtuzumab ozogamicin, daunorubicin and cytarabine are cancer drugs. How to pronounce the drug names are in brackets.

• gemtuzumab ozogamicin (gem-too-zoo-mab oh-zoh-ga-mih-sin)

• daunorubicin (daw-noh-roo-bih-sin)

• cytarabine (sye-tare-a-been)

You have this combination for acute myeloid leukaemia (AML) if your leukaemia cells produce too much of a protein called CD33. Your doctor will check for this protein before you start treatment. If too much of the protein is present, your AML is called CD33 positive.

Read more about acute myeloid leukaemia

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.

Read more about monoclonal antibody drugs

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

If you don't have a central line

You might have treatment through a thin short tube (a cannula) that goes into a vein in your arm. You have a new cannula each time you have treatment.

Risk of tissue damage

When you are having this treatment through a cannula it could damage the tissue if it leaks out of the vein. This is called extravasation. This can happen anywhere along the vein that the drug is going into. It doesn’t happen very often. Tell your nurse straight away if you notice any changes such as swelling, redness, pain, burning, or a stinging feeling.

Your nurse will stop the drug treatment. And they will treat the area to relieve symptoms and reduce tissue damage. Contact your healthcare team if you develop any of these symptoms when you are at home.

Read more about having medicine into your bloodstream

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:

Day 1

• You have gemtuzumab ozogamicin as a drip into your bloodstream (intravenously) over 2 hours.

• You have daunorubicin as a drip into your bloodstream over 30 minutes.

• You have cytarabine as an injection into your vein, twice a day, 12 hours apart, or as a drip into your bloodstream over 22 hours.

Days 2 to 3

• You have daunorubicin as a drip into your bloodstream over 30 minutes.

• You have cytarabine as an injection into your vein, twice a day, 12 hours apart, or as a drip into your bloodstream over 22 hours.

Day 4

• You have gemtuzumab ozogamicin as a drip into your bloodstream over 2 hours.

• You have cytarabine as an injection into your vein, twice a day, 12 hours apart, or as a drip into your bloodstream over 22 hours.

Days 5 to 6

• You have cytarabine as an injection into your, twice a day, 12 hours apart, or as a drip into your bloodstream over 22 hours.

Day 7

• You have gemtuzumab ozogamicin as a drip into your bloodstream over 2 hours.

• You have cytarabine as an injection into your vein, twice a day, 12 hours apart, or as a drip into your bloodstream over 22 hours.

Day 8

• Your nurse disconnects your cytarabine drip.

Day 9 to 28

• You have no treatment.

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:

Days 1 to 2

• You have daunorubicin as a drip into your bloodstream over 30 minutes.

• You have cytarabine as a drip into your bloodstream over 2 to 3 hours, twice a day, 12 hours apart.

Day 3

• You have cytarabine as a drip into your bloodstream over 2 to 3 hours, twice a day, 12 hours apart.

Day 4 to 28

• You have no treatment.

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:

Day 1

• You have gemtuzumab ozogamicin as a drip into your bloodstream over 2 hours.

• You have daunorubicin as a drip into your bloodstream over 30 minutes.

• You have cytarabine as a drip into your bloodstream over 2 to 3 hours, twice a day, 12 hours apart.

Day 2 to 4

• You have cytarabine as a drip into your bloodstream over 2 to 3 hours, twice a day, 12 hours apart.

Day 5 to 28

• You have no treatment.

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:

Day 1

• You have gemtuzumab ozogamicin as a drip into your bloodstream (infusion) over 2 hours.

• You have daunorubicin as a drip into your bloodstream over 30 minutes.

• You have cytarabine as a drip into your bloodstream over 2 to 3 hours, twice a day, 12 hours apart.

Day 2

• You have daunorubicin as a drip into your bloodstream over 30 minutes.

• You have cytarabine as a drip into your bloodstream over 2 to 3 hours, twice a day, 12 hours apart.

Day 3 to 4

• You have cytarabine as a drip into your bloodstream over 2 to 3 hours, twice a day, 12 hours apart.

Day 5 to 28

• You have no treatment.

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 also have heart tests such as an ECG before your first cycle of treatment.

What are the side effects of gemtuzumab ozogamicin, daunorubicin and cytarabine?

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. Talk to your healthcare team if you have any new symptoms that you think might be a side effect of your treatment.

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 is due to a drop in white blood cells. Symptoms include a change in temperature, aching muscles, cough, headaches, feeling cold and shivery, pain or a burning feeling when peeing, or generally feeling 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. 

Bruising and bleeding

This is due to a drop in the number of platelets in your blood. These blood cells help the blood to clot when we cut ourselves. You may have nosebleeds or bleeding gums after brushing your teeth. Or you may have lots of tiny red spots or bruises on your arms or legs. This is known as petechiae.

Bleeding may also happen in the brain tissue, which can cause a change in mental status, the stomach, which can cause black or tarry stools, or the bowel, which can cause bright red blood in your stools or on the toilet paper. Let your healthcare team know straight away if you have this.

Breathlessness and looking pale

You might be breathless and look pale due to a drop in red blood cells. This is called anaemia.

Anaemia may cause low blood oxygen levels. Your skin may appear bluish when this happens.

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 have ​diabetes​ .

Liver changes

The changes are usually very mild and unlikely to cause symptoms. They will almost certainly go back to normal when treatment is finished.

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.

High 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.

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:

• an allergic reaction that can cause a rash, shortness of breath, redness or swelling of the face and dizziness - some allergic reactions can be life threatening, alert your nurse or doctor if notice any of these symptoms

• 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)

• difficulty swallowing

• tummy pain

• feeling and being sick

• diarrhoea

• skin changes such as redness, an itchy raised rash, hives, inflammation of blood vessels in the skin and hair loss. Rarely you may have skin ulcers, itching, burning pain in your palms and soles, or flat, dark spots on the skin (liver spots). Let your healthcare team know if you have these symptoms. They can prescribe medications to relieve symptoms

• digestive system problems such as inflammation and ulcers of the mouth or back passage (anus), rarely, it may include the food pipe (oesophagus).

• inflammation that causes a blood clot to form and block a vein at an injection site. Symptoms include warmth and tenderness of the affected area, as well as redness and swelling

• loss of appetite

• 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

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:

• gas filled cysts in the wall of the bowel (pneumatosis cystoides intestinalis ), inflammation and death of bowel tissue, or infection of the inner lining of the tummy - symptoms include a swollen and tender tummy. Contact your advice line if you have this

• an infection at an injection site that causes redness, swelling and pain

• inflammation of the layers of tissue that surrounds the heart (pericarditis), causing chest pain

• headaches

• numbness or tingling in your fingers or toes

• inflammation of the lungs (pneumonia), causing a cough or breathing problems

• shortness of breath

• a sore throat

• 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:

• inflammation of the pancreas – symptoms may include feeling or being sick, indigestion or a fever. Contact your advice line if you have a temperature

• freckles or bleeding from the skin

• the kidneys stopping working – you will have regular blood tests to check this

• dizziness, inflammation of a nerve, nerve pain or a rash

• an eye infection (conjunctivitis) – the eye may feel gritty, itchy, sticky from pus, watery and look red

• 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

• cytarabine syndrome - this sometimes happens about 6 to 12 hours after having cytarabine. You may have a combination of symptoms including a high temperature, aching muscles, bone pain, occasionally chest pain, a rash, sore eyes, and extreme weakness. Steroids can help to prevent or treat this syndrome

• not enough fluid in your body (dehydration)

• heart changes that may include the heart muscle becoming stiff and not being able to pump enough blood around the body – symptoms include shortness of breath, swollen legs and feet, an enlarged liver, fluid collecting in the tummy (ascites) or layers of tissue around the lungs (pleural effusion). Or chest pain because of a lack of blood flow to the heart muscle (angina). Or a heart attack – symptoms include chest pain, pain spreading down the arms, jaw, neck, back or tummy, feeling lightheaded, sweating or feeling and being sick. Or inflammation of the heart muscle – symptoms include chest pain or tiredness 

• shock caused by a sudden drop of blood flow through the body

• episodes of feeling warm and reddening of the skin (flushing)

• skin over previous areas of radiotherapy becoming red and inflamed

• skin and nails turning darker

• periods stopping

• no sperm in semen

• inflammation of a vein near the surface of the skin causing pain, warmth, itching or redness in the affected area or the vein hardening

• 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

Coping with side effects

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

Read more about how to cope with side effects

What else do I need to know?

Other medicines, foods and drinks

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.

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 might harm a baby developing in the womb. It is important not to become pregnant or get someone pregnant while you are having treatment. You need to use 2 effective methods of contraception during treatment and for 7 months afterwards if you’re a woman and 4 months if you’re a man. 

Talk to your doctor or nurse about effective contraception before starting treatment. Let them know straight away if you or your partner become 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 and for 1 month afterwards.

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, and yellow fever.

You can usually 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 a vaccine in relation to your cancer treatment.

Contact with others who have had immunisations 

You can be in contact with other people who have had live vaccines as injections. If someone has had a live vaccine by mouth or nasal spray there may be a small risk the vaccine virus can be passed onto you if your ​immune system​ is weakened.

Your healthcare team will let you know if you need to take any precautions if you are in close contact with someone who has had a live vaccine.

Read more about immunisations and cancer treatment

More information

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

eMC website

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

Report a side effect to the MHRA