What Decitabine is

Decitabine is an anti-cancer medicine. It contains the active substance ‘decitabine’.

What Decitabine is used for

Decitabine is used to treat a type of cancer called ‘acute myeloid leukaemia’ or ‘AML’. This is a type of cancer that affects your blood cells. You will be given Decitabine when you are first diagnosed with AML. It is used in adults.

How Decitabine works

Decitabine works by stopping cancer cells from growing. It also kills cancer cells.

Talk to your doctor or nurse if you have any questions about how Decitabine works or why this medicine has been prescribed for you.

Do not use Decitabine

• if you are allergic to decitabine or any of the other ingredients of this medicine.
• if you are breast-feeding.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using decitabine

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using decitabine if you have

•        low numbers of platelets, red blood cells or white blood cells,

•        an infection,

•        liver disease,

•        a serious kidney disorder,

•        a heart disorder.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using decitabine.

Tests or checks

You will have blood tests before you start treatment with decitabine and at the start of each treatment cycle. These tests are to check that:

•        you have enough blood cells, and

•        your liver and kidneys are working properly.

Talk to your doctor about what your blood test results mean.

Children and adolescents

Decitabine is not for use in children or adolescents under the age of 18.

Other medicines and Decitabine

Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because decitabine can affect the way some other medicines work. Also, some other medicines can affect the way decitabine works.

Pregnancy and breast-feeding

·       If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

·       You should not use decitabine if you are pregnant as it may harm your baby. Tell your doctor immediately if you become pregnant during treatment with decitabine.

·       Do not breast-feed if you are using decitabine. This is because it is not known if the medicine passes into the mother’s milk.

·

Male and female fertility and contraception

•        Men should not father a child while using decitabine.

•        Men should use effective contraception during treatment and for up to 3 months after treatment has stopped.

•        Talk to your doctor if you wish to conserve your sperm before starting treatment.

•        Women must use effective contraception during treatment. It is unknown when it is safe for women to become pregnant after treatment has stopped.

•        Talk to your doctor if you wish to freeze your eggs before starting treatment.

Driving and using machines

You may feel tired or weak after using decitabine. If this happens, do not drive or use any tools or machines.

Decitabine contains potassium and sodium

•        This medicine contains 0.5 mmol potassium in each vial. After preparing the medicine, it contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free’.

•        This medicine contains 0.29 mmol (6.67 mg) sodium (main component of cooking/table salt) in each vial. After preparing the medicine, it contains between 13.8 mg-138 mg sodium per dose, equivalent to 0.7-7% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor if you are on a low salt diet.

Decitabine will be given to you by a doctor or nurse who is trained in giving this type of medicine.

How much to use

•        Your doctor will work out your dose of Decitabine. This depends on your height and weight (body surface area).

•        The dose is 20 mg/m2 body surface area.

•        You will receive Decitabine every day for 5 days, then 3 weeks without the medicine. This is called a ‘treatment cycle’ and it is repeated every 4 weeks. You will usually receive at least 4 treatment cycles.

•        Your doctor may delay your dose and change the total number of cycles, depending on how you respond to the treatment.

How Decitabine is given

The solution is given into a vein (as an infusion). This will take one hour.

If you are given more Decitabine than you should

This medicine will be given by your doctor or nurse. In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects and manage them accordingly.

If you forget your appointment to have Decitabine

If you miss an appointment, make another one as soon as possible. This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Tell your doctor or nurse immediately if you notice any of the following serious side effects

•        Fever: this may be a sign of an infection caused by low levels of white blood cells (very common).

•        Chest pain or shortness of breath (with or without fever or cough): these may be signs of an infection of the lung called “pneumonia” (very common) or inflamed lungs (interstitial lung disease [frequency not known]) or cardiomyopathy (heart muscle disease [uncommon]) which can be accompanied with swelling of ankles, hands, legs and feet.

•        Bleeding: including blood in the stools. This may be a sign of bleeding in the stomach or gut (common).

•        Difficultly with moving, speaking or understanding or seeing; sudden severe headache, seizure, numbness or weakness in any part of the body. These may be signs of bleeding inside your head (common).

•        Difficulty breathing, swelling of the lips, itching or rash: This may be due to an allergic (hypersensitivity) reaction (common).

Tell your doctor or nurse immediately if you notice any of the serious side effects above.

Other side effects of Decitabine include

Very common (may affect more than 1 in 10 people)

•        urine infection

•        other infection in any part of the body, caused by bacteria, virus or fungi

•        bleeding or bruising more easily - these may be signs of a drop in the number of blood platelets (thrombocytopaenia)

•        feeling tired or looking pale - these may be signs of a drop in the number of red blood cells (anaemia)

•        high level of sugar in the blood

•        headache

•        nose bleeds

•        diarrhoea

•        vomiting

•        nausea

•        fever

•        abnormal liver function

Common (may affect up to 1 in 10 people)

•        an infection of the blood caused by bacteria - this may be a sign of a low level of white blood cells

•        sore or runny nose, sore sinuses

•        mouth or tongue ulcers

•        high level of ‘bilirubin’ in the blood

Uncommon (may affect up to 1 in 100 people)

•        a drop in the number of red blood cells, white blood cells and platelets (pancytopaenia)

•        heart muscle disease

•        red, raised painful patches on the skin, fever, an increase in white blood cells - these may be signs of ‘Acute Febrile Neutrophilic Dermatosis’ or ‘Sweet’s Syndrome’

Not known (frequency cannot be estimated from the available data)

•        inflamed gut (enterocolitis, colitis and caecitis), with symptoms of abdominal pain, bloating, or diarrhoea. Enterocolitis may lead to septic complications and may be associated with fatal outcome.

•

Your doctor, nurse or pharmacist store, prepare and dispose Decitabine for you. Do not use this medicine after the expiry date. It is stated on the carton and vial labels.

Store below 30°C.