Azacitidine tablets

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 AML cells. Azacitidine can also stop AML cells making proteins. This can stop cancer cells growing and dividing.

The brand name for azacitidine tablets is Onureg.

Azacitidine tablets are used as a maintenance treatment for adults with AML. Your haematology team might recommend them for you if:

• Your AML went into complete remission after induction or consolidation therapy, even if your blood counts have not recovered completely AND
• You cannot currently have, or do not want, a stem cell transplant

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

• Blood tests to measure your blood counts
• Blood tests to check your liver and kidney function
• Bone marrow tests to check that your AML is still in remission

Azacitidine tablets come as film-coated tablets containing 200mg or 300mg of azacitidine. Most people take one tablet a day for 14 days of each month. Your dose should be printed on the named label on the medicine packaging. If you are not sure, ask your doctor or nurse.

• Your doctor will also give you tablets to help stop you feeling sick or being sick. You should take these 30 minutes before you take your azacitidine tablets. Usually, you only need to take the anti-sickness tablets for your first two treatment cycles, but your doctor will let you know if you need to take them for longer.
• You should take azacitidine as prescribed so it can work as well as possible. Try and take it at the same time of day if you can.
• Swallow the azacitidine tablet whole with a full glass of water. To make sure you get the right dose, do not break, crush, dissolve or chew the tablet.
• You can take the tablet with food or in between meals, whichever is best for you.
• If you are sick after taking a tablet, do not take another dose on the same day. Instead, wait until the next day and take your dose as normal. It is important not to take a double dose.
• If you forget to take your azacitidine tablet, take it as soon as you remember on the same day. If it is the next day, just take your usual dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
• If powder from a broken tablet touches your skin, wash it straight away and thoroughly with soap and water. If the powder gets into your eyes, nose or mouth, flush the area thoroughly with water.

Dose

Most adults with AML take 300mg azacitidine tablets. You usually have them in a treatment cycle of 28 days.

• You take azacitidine tablets every day for the first 14 days.
• This is followed by 14 days where you do not take the azacitidine tablets.

Your haematology team may suggest a different dose, depending on your circumstances. They will tell you what dose they recommend for you.

There are several precautions to be aware of when you are taking azacitidine tablets.

• Azacitidine tablets 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 tablets contain lactose. If you think you may have lactose intolerance, let your haematology team know.
• Tell your haematology team about any medicines or herbal supplements that you are taking.

Azacitidine tablets 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 taking azacitidine tablets and for 6 months after you stop.
• If you could make someone pregnant, it is important to use effective contraception while you are taking azacitidine tablets and for 3 months after you stop.
• If you are taking azacitidine tablets and think you may 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 taking azacitidine.

During your treatment with azacitidine tablets, you will have blood tests every 2 to 4 weeks.

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

• Check how well azacitidine tablets are working for you
• Make sure your blood counts have not dropped too low

You usually carry on taking azacitidine tablets unless:

• 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.

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

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
• Changing your treatment so you only take azacitidine tablets for 7 days each cycle

Very common side effects affect more than 10 in every 100 people who are taking azacitidine tablets.

Very common side effects include:

• Feeling sick or being sick
• Diarrhoea
• A low white blood cell count, which might mean that you get infections more often and any infections you get might last longer than usual
• Feeling tired or weak
• Constipation
• A low platelet count, which might lead to unexpected bruising or bleeding like nosebleeds, bleeding gums, blood spots or rashes
• Pain in your tummy
• Throat, nose or sinus infections
• Stiff or painful joints
• Loss of appetite
• Back pain
• Pains in your arms or legs
• Lung infections

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

Common side effects include:

• Flu
• Urine infections
• You may have darker or smellier pee, stinging when going for a pee or needing to pee more than usual
• Runny nose or cough
• Anxiety
• Weight loss

If azacitidine tablets are not working well, your haematology team might suggest increasing your treatment so you take the azacitidine tablets for more than 14 days during each cycle.

If this is not suitable for you, or does not work, your team will talk to you about your treatment options.