Decanta for Injection is an anti-cancer medicine. It contains the active substance ‘Decitabine’.

What Decanta for Injection is used for
Decanta for Injection 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 Decanta for Injection when you are first diagnosed with AML. It is used in adults.
How Decanta for Injection works
Decanta for Injection 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 Decanta for Injection works or why this medicine has been prescribed for you.

Do not use Decanta for Injection:

•     if you are allergic to Decitabine or any of the other ingredients of this medicine (listed in section 6).

•     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 Decanta for Injection.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Decanta for Injection 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 Decanta for Injection.
Decanta for Injection can cause a serious immune reaction called ‘differentiation syndrome’ (see section 4 ‘Possible side effects’).

Tests or checks
You will have blood tests before you start treatment with Decanta for Injection 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
Decanta for Injection is not for use in children or adolescents under the age of 18.
Other medicines and Decanta for Injection
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 Decanta for Injection can affect the way some other medicines work. 
Also, some other medicines can affect the way Decanta for Injection 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 Decanta for Injection if you are pregnant as it may harm your baby. Tell your doctor immediately if you become pregnant during treatment with Decanta for Injection.
•     Do not breast-feed if you are using Decanta for Injection. 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 Decanta for Injection.
•     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 Decanta for Injection. If this happens, do not drive or use any tools or machines.
Decanta for Injection 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.

Decanta for Injection 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 Decanta for Injection. This depends on your height and weight (body surface area).
•     The dose is 20 mg/m2 body surface area.
•     You will receive Decanta for Injection 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 Decanta for Injection is given
The solution is given into a vein (as an infusion). This will take one hour.
If you are given more Decanta for Injection 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 Decanta for Injection
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).
•     Serious immune reaction (differentiation syndrome) that may cause fever, 
cough, difficulty breathing, rash, decreased urine, hypotension (low blood pressure), swelling of the arms or legs and rapid weight gain (not known).
Tell your doctor or nurse immediately if you notice any of the serious side effects above. 

Other side effects of Decanta for Injection 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, 

•     Your doctor, nurse or pharmacist is responsible for storing Decanta for Injection.
•     Keep this medicine out of the sight and reach of children.
•     Do not use this medicine after the expiry date, which is stated on the carton and on the vial label after EXP. The expiry date refers to the last day of that month.
•     Store below 30°C.
•     After reconstitution, the concentrate must be further diluted within 15 minutes using cold infusion fluids. This prepared diluted solution can be stored refrigerated at 2°C - 8°C for up to a maximum of 4 hours.
•     Your doctor, nurse or pharmacist is responsible for disposing of any unused Decanta for Injection correctly.