Azacitidine injections

Azacitidine is a chemotherapy medicine that can turn on genes that have been turned off. This includes cancer-suppressing genes that are often turned off in cancer cells. Azacitidine can stop cancer cells making proteins. This can stop them growing and dividing.

Brand names for azacitidine injections include:

• Azacitidine betapharm
• Azacitidine Sandoz
• Azacitidine Seacross
• Azacitidine Tillomed
• Vidaza

Azacitidine injections are used to treat some adults with acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS) and chronic myelomonocytic leukaemia (CMML).

Your haematology team might recommend azacitidine injections for you if:

• You cannot have, or do not want, a stem cell transplant AND
  • You have MDS that has a medium or high chance of progressing quickly OR
  • You have AML or CMML and your leukaemia cell count meets a certain threshold

Sometimes, your doctor might suggest azacitidine in other circumstances. They will explain what they recommend and why.

If you have AML, you might have azacitidine on its own, or with other treatments like venetoclax or ivosidenib, both of which you take by mouth.

This webpage is about azacitidine used on its own. We have separate information about azacitidine with venetoclax and azacitidine with ivosidenib.

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Before starting azacitidine, your haematology team will carry out checks to make sure it’s suitable for you. These might include:

• Blood tests to measure your blood counts
• Blood tests to check your liver and kidney function
• Bone marrow test

You usually have azacitidine injections in a treatment cycle of 28 days. Depending on how you cope with treatment, and how well it works, your doctor might make some changes to the length of your treatment cycle or how many days you have injections.

• You usually have azacitidine injections over 7 days at the start of each cycle. This is usually 5 days of treatment, a weekend off, then another 2 days of treatment.
• For the rest of your treatment cycle, you do not have azacitidine injections.
• You usually go to a hospital day unit to have each injection, and go home the same day.
• Your doctor will give you tablets to help stop you feeling sick or being sick. You usually take these 30 minutes before you have your azacitidine injection.
• Your doctor or nurse will give you the injection just under your skin in your tummy, thigh or upper arm.

Dose

Your doctor will work out the best dose of azacitidine for you based on your height, weight and how well you respond to treatment. They will tell you what dose they recommend for you.

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There are several precautions to be aware of when you are having azacitidine injections.

• Azacitidine injections may make you feel tired or weak or make it difficult to concentrate. Take care if you are driving or using tools or machinery.
• Azacitidine can affect how well your kidneys work. If you stop peeing, or you’re peeing less than usual, tell your doctor straight away.
• Tell your haematology team about any other medicines or herbal supplements that you are taking.

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Azacitidine injections may harm unborn babies, especially during the early stages of pregnancy.

• If you could get pregnant, it is important to use effective contraception while you are having azacitidine injections and for 6 months after you stop.
• If you could make someone pregnant, it is important for you to use effective contraception while you are having azacitidine injections and for 3 months after you stop.
• If you are having azacitidine and think you might be pregnant, tell your haematology team as soon as possible. They may recommend stopping treatment for a while or switching to a different treatment.
• If you are planning to get pregnant, or make someone pregnant, tell your haematology team. They can discuss your treatment options with you.

Breastfeeding

Scientists are not sure if azacitidine passes into breastmilk. If it does, it could be a risk for breastfed babies or children. You should not breastfeed when having azacitidine.

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During your treatment with azacitidine injections you will have blood tests before starting each cycle of treatment. You may also have further blood and bone marrow tests during your treatment cycle. Your haematology team will let you know what tests you will need and how often.

Your haematology team will use the results of these tests to:

• Check how well azacitidine injections are working for you
• Make sure your blood counts have not dropped too low
• Check how well your liver and kidneys are working

Tumour lysis syndrome

Chemotherapy kills cancer cells. When lots of cancer cells breakdown quickly, they can release a large amount of chemicals into your blood. This is known as tumour lysis syndrome. It can affect how well your kidneys work, as well as causing changes to your heartbeat and sometimes fits (seizures).

Tumour lysis syndrome is rare. It happens to less than 1 in every 1,000 people having azacitidine injections.

If you have a very high leukaemia cell count before treatment, your haematology team might give you medicine to help prevent tumour lysis syndrome. They will monitor you closely so they can treat it quickly if it happens.

Differentiation syndrome

Very rarely, azacitidine injections might cause a serious problem called differentiation syndrome. This can happen if recovering white blood cells release too many immune chemicals, which can trigger a severe reaction.

Your haematology team will monitor you for signs of differentiation syndrome. If it happens, it can be treated with steroids.

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Most people have at least three to six cycles of treatment. After this, you usually carry on having azacitidine injections unless:

• It has not worked well enough
• It stops working well
• You are having side effects that are difficult to cope with

If this happens, your haematology team might stop azacitidine, adjust your dose, or recommend a different treatment.

Do not stop having azacitidine injections without talking to your haematology team.

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You may get some side effects while you are having azacitidine injections. Some people may have very few side effects, whereas other people experience more serious side effects.

Here we cover side effects you might experience. Tell your haematology team if you get any side effects. They may be able to suggest things to help.

If you are getting side effects that are difficult to cope with, they might suggest:

• Temporarily stopping treatment
• Lowering your dose of azacitidine
• Delaying your next treatment cycle

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Very common side effects affect more than 10 in every 100 people who are having azacitidine injections. Very common side effects include:

• A cold, blocked or runny nose, sore throat or coughing
• A low white blood cell count, which makes you more likely to get infections, and can mean that any infections you do get are more serious
• Loss of appetite or losing weight
• Low potassium levels which can cause muscle weakness, muscle cramps and a fast and irregular heartbeat
• Finding it hard to get to sleep or stay asleep
• Dizziness, headaches
• Shortness of breath
• Nosebleeds
• Feeling sick or being sick
• Tummy pain
• Reddish or purple spots, bruising or discolouration of your skin caused by bleeding (this may look different on black or brown skin)
• Itching
• Rash
• Pain in your joints or muscles
• Fever
• Fatigue
• Feeling weak
• Chest pain
• Redness, pain or another type of reaction around where you had the injection
  • Evening primrose oil or hydrocortisone cream can help to reduce the pain and redness – discuss this with your haematology team
• Diarrhoea or constipation

Common side effects affect more than 1 but less than 10 out of every 100 people who are having azacitidine injections.

Common side effects include:

• Infections. Signs of infection include:
  • A high temperature (38°C or higher)
  • Sore throat, sneezing, blocked or runny nose or cough
  • Itchy nose, throat and eyes
  • Headache or pain around your eyes, nose and forehead
  • Shortness of breath
  • Burning or stinging when you pee, or peeing more often than usual
  • Painful, hot, red swollen area of skin, blisters or peeling of skin (this may look different on black or brown skin)
  • Cold sores around your lips, mouth or tongue
  • Red patches, ulcers, loss of taste or pain, burning or swelling in your mouth
• Pain in your tummy, constipation, diarrhoea, blood in your poo or bloating
• Dehydration
• Feeling confused or anxious
• Bleeding in your brain which can cause you to feel drowsy, faint, lose consciousness or feel low on energy
• Bleeding in your eyes
• A build up of fluid around your heart which can cause shortness of breath, difficulty breathing when lying down and chest pain
• High or low blood pressure
• Painful, swollen, red bruises (this may look different on black or brown skin)
• A build up of fluid around your lungs which can cause chest pain, cough and shortness of breath
• Shortness of breath when exercising or doing something physical
• Indigestion, heartburn
• Purple or reddish skin or blood spots under the skin (this may look different on black or brown skin)
• Hair loss
• Hives and itchy skin
• Muscle spasms, or muscle aches and pains
• Kidney failure
• Blood in your pee
• Thickening and hardening of your skin
• Inflammation, skin changes or bleeding where you have the injections
• Feeling generally unwell
• Chills

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If azacitidine injections are not working well, your haematology team might suggest altering your treatment cycle or stopping treatment if your blood counts drop.

If this is not suitable for you, or does not work, they will talk to you about your treatment options. These may include:

• Other low dose chemotherapy options
• A clinical trial, if there is one suitable for you
• Treatment to relieve your symptoms and improve your quality of life, rather than treat the cancer itself

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