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Dacogen (decitabine) – Package leaflet - L01BC08

Updated on site: 06-Oct-2017

Medication nameDacogen
ATC CodeL01BC08
Substancedecitabine
ManufacturerJanssen-Cilag International N V  

Package leaflet: Information for the user

Dacogen 50 mg powder for concentrate for solution for infusion decitabine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Dacogen is and what it is used for

2.What you need to know before you use Dacogen

3.How to use Dacogen

4.Possible side effects

5.How to store Dacogen

6.Contents of the pack and other information

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.

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.

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. 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 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 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 per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free’.

This medicine contains 0.29 mmol sodium per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains between 0.6-6 mmol sodium per dose depending on the infusion fluid for dilution. This is to be taken into consideration if you are on a controlled sodium 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 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]).

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 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)

headache

nose bleeds

diarrhoea

vomiting

nausea

fever

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

Uncommon (may affect up to 1 in 100 people)

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

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:

België/Belgique/Belgien

Lietuva

Janssen-Cilag NV

UAB "JOHNSON & JOHNSON"

Tel/Tél: +32 14 64 94 11

Tel: +370 5 278 68 88

България

Luxembourg/Luxemburg

„Джонсън & Джонсън България” ЕООД

Janssen-Cilag NV

Тел.: +359 2 489 94 00

Tél/Tel: +32 14 64 94 11

Česká republika

Magyarország

JANSSEN-CILAG s.r.o.

JANSSEN-CILAG Kft.

Tel: +420 227 012 227

Tel: +36 1 884 2858

Danmark

Malta

JANSSEN-CILAG A/S

AM MANGION LTD.

Tlf: +45 45 94 82 82

Tel: +356 2397 6000

Deutschland

Nederland

JANSSEN-CILAG GmbH

JANSSEN-CILAG B.V.

Tel: +49 2137 955-955

Tel: + 31 76 711 1111

Eesti

Norge

UAB "JOHNSON & JOHNSON" Eesti filiaal

JANSSEN-CILAG AS

Tel: +372 617 7410

Tlf: +47 24 12 65 00

Ελλάδα

Österreich

JANSSEN-CILAG Φαρμακευτική Α.Ε.Β.Ε.

JANSSEN-CILAG Pharma GmbH

Tηλ: +30 210 80 90 000

Tel: +43 1 610 300

España

Polska

JANSSEN-CILAG, S.A.

JANSSEN-CILAG Polska Sp. z o.o.

Tel: +34 91 722 81 00

Tel: +48 22 237 60 00

France

Portugal

JANSSEN-CILAG

JANSSEN-CILAG FARMACÊUTICA, LDA.

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Tel: +351 21 43 68 835

Hrvatska

România

Johnson & Johnson S.E. d.o.o.

Johnson & Johnson România SRL

Tel: +385 1 6610 700

Tel: +40 21 207 1800

Ireland

Slovenija

JANSSEN-CILAG Ltd.

Johnson & Johnson d.o.o.

Tel: +44 1 494 567 444

Tel: +386 1 401 18 30

Ísland

Slovenská republika

JANSSEN-CILAG AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

JANSSEN-CILAG SpA

JANSSEN-CILAG OY

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ,

JANSSEN-CILAG AB

Τηλ: +357 22 207 700

Tel: +46 8 626 50 00

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

JANSSEN-CILAG Ltd.

Tel: +371 678 93561

Tel: +44 1 494 567 444

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

-----------------------------------------------------------------------------------------------------------------

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 0.1 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

A vial is for single use only and any remaining solution must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.

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