Dacogen

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

decitabine

Saadav alates:

Janssen-Cilag International N.V.  

ATC kood:

L01BC08

INN (Rahvusvaheline Nimetus):

decitabine

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Leukemia, Myeloid

Näidustused:

Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.

Toote kokkuvõte:

Revision: 16

Volitamisolek:

Authorised

Loa andmise kuupäev:

2012-09-20

Infovoldik

22
B. PACKAGE LEAFLET
23
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

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
NAME OF THE MEDICINAL PRODUCT
Dacogen 50 mg powder for concentrate for solution for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for concentrate for solution for infusion contains
50 mg decitabine.
After reconstitution with 10 ml of water for injections, each ml of
concentrate contains 5 mg of
decitabine.
Excipients with known effect
Each vial contains 0.29 mmol sodium (E524).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
infusion).
White to almost white lyophilized powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dacogen is indicated for the treatment of adult patients with newly
diagnosed _de novo_ or secondary
acute myeloid leukaemia (AML), according to the World Health
Organisation (WHO) classification,
who are not candidates for standard induction chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dacogen administration must be initiated under the supervision of
physicians experienced in the use of
chemotherapeutic medicinal products.
Posology
In a treatment cycle, Dacogen is administered at a dose of 20 mg/m
2
body surface area by intravenous
infusion over 1 hour repeated daily for 5 consecutive days (i.e., a
total of 5 doses per treatment cycle).
The total daily dose must not exceed 20 mg/m
2
and the total dose per treatment cycle must not exceed
100 mg/m
2
. If a dose is missed, treatment should be resumed as soon as
possible. The cycle should be
repeated every 4 weeks depending on the patient's clinical response
and observed toxicity. It is
recommended that patients be treated for a minimum of 4 cycles;
however, a complete or partial
remission may take longer than 4 cycles to be obtained. Treatment may
be continued as long as the
patient shows response, continues to benefit or exhibits stable
disease, i.e., in the absence of overt
progression.
If after 4 cycles, the patient’s haematological values (e.g.,
platelet counts or abs