Dacogen - patient leaflet, side effects, dosage

1. What Dacogen is and what it is used for

What Dacogen is

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

What Dacogen is used for

Dacogen 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 Dacogen when you are first diagnosed with AML. It is used in adults.

How Dacogen works

Dacogen 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 Dacogen works or why this medicine has been prescribed for you.

2. What you need to know before you are given Dacogen

Do not use Dacogen

• 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 Dacogen.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Dacogen 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 Dacogen.

Dacogen 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 Dacogen 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

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

Other medicines and Dacogen

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 Dacogen can affect the way some other medicines work. Also, some other medicines can affect the way Dacogen 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 Dacogen if you are pregnant as it may harm your baby. If you are able to

become pregnant, your doctor will ask you to take a pregnancy test before you start treatment with Dacogen. Tell your doctor immediately if you become pregnant during treatment with Dacogen.

• Do not breast-feed if you are using Dacogen. 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 Dacogen.
• 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 who are able to become pregnant must use effective contraception during treatment and

for 6 months following completion of treatment.

• 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 Dacogen. If this happens, do not drive or use any tools or machines.

Dacogen 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.

3. How to use Dacogen

Dacogen 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 Dacogen. This depends on your height and weight (body surface area).
• The dose is 20 mg/m2 body surface area.
• You will receive Dacogen 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 Dacogen is given

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

If you are given more Dacogen 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 Dacogen

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.

4. Possible side effects

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 ofan 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 Dacogen 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.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dacogen

• Your doctor, nurse or pharmacist is responsible for storing Dacogen.
• 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.

• Do not store above 25°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 3 hours, followed by up to 1 hour at room temperature (20°C – 25°C) before administration.

• Your doctor, nurse or pharmacist is responsible for disposing of any unused Dacogen correctly.

6. Contents of the pack and other information

What Dacogen contains

• The active substance is decitabine. Each vial of powder contains 50 mg decitabine. After

reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine.

• The other ingredients are potassium dihydrogen phosphate (E340), sodium hydroxide(E524),

and hydrochloric acid (for pH-adjustment). See section 2.

What Dacogen looks like and contents of the pack

Dacogen is a white to almost white powder for concentrate for solution for infusion. It is supplied in a 20 ml glass vial containing 50 mg decitabine. Each pack contains 1 vial.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last revised in MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:. -----------------------------------------------------------------------------------------------------------------

The following information is intended for medical or healthcare professionals only:

• 1. RECONSTITUTION

Skin contact with the solution should be avoided and protective gloves must be worn. Standard procedures for dealing with cytotoxic medicinal products should be adopted.

The powder should be aseptically reconstituted with 10 ml of water for injections. Upon reconstitution, each ml contains approximately 5 mg of decitabine at pH 6.7 to 7.3. Within 15 minutes of reconstitution, the solution must be further diluted with cold (2°C – 8°C) infusion fluids (sodium chloride 9 mg/ml [0.9%] solution for injection or 5% glucose solution for injection) to a final concentration of 0.15 to 1.0 mg/ml.

For the shelf-life and the precautions for storage after reconstitution, see section 5 of the leaflet.

• 2. ADMINISTRATION

Infuse the reconstituted solution intravenously over 1 hour.

• 3. DISPOSAL