Azacitidine STADA Arzneimittel 25 mg/ml, poeder voor suspensie voor injectie

Nazione: Paesi Bassi

Lingua: olandese

Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Principio attivo:

AZACITIDINE 100 mg/flacon

Commercializzato da:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

INN (Nome Internazionale):

AZACITIDINE 100 mg/flacon

Forma farmaceutica:

Poeder voor suspensie voor injectie

Composizione:

MANNITOL (D-) (E 421)

Via di somministrazione:

Subcutaan gebruik

Data dell'autorizzazione:

1900-01-01

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
AZACITIDINE STADA ARZNEIMITTEL 25 MG/ML, POEDER VOOR SUSPENSIE VOOR
INJECTIE
azacitidine
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.
-
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 is and what it is used for
2. What you need to know before you use
3. How to use
4. Possible side effects
5
How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
WHAT IS
is an anti-cancer agent which belongs to a group of
medicines called ‘anti-
metabolites’. contains the active substance
‘azacitidine’.
WHAT IS USED FOR
is used in adults who are not able to have a stem cell
transplantation to
treat:
•
higher-risk myelodysplastic syndromes (MDS)
•
chronic myelomonocytic leukaemia (CMML)
•
acute myeloid leukaemia (AML)
These are diseases which affect the bone marrow and can cause problems
with normal
blood cell production.
HOW WORKS
works by preventing cancer cells from growing.
Azacitidine becomes
incorporated into the genetic material of cells (ribonucleic acid
(RNA) and deoxyribonucleic
acid (DNA)). It is thought to work by altering the way the cell turns
genes on and off and also
by interfering with the production of new RNA and DNA. These actions
are thought to correct
problems with the maturation and growth of young blood cells in the
bone marrow that cause
myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Talk to your doctor or nurse if you have any questions about how
works

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Azacitidine STADA Arzneimittel 25 mg/ml, poeder voor suspensie voor
injectie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg azacitidine. After reconstitution, each mL
of suspension contains
25 mg azacitidine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for suspension for injection.
White lyophilised cake or powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
is indicated for the treatment of adult patients who
are not eligible for
haematopoietic stem cell transplantation (HSCT) with:
•
intermediate-2
and
high-risk
myelodysplastic
syndromes
(MDS)
according
to
the
International Prognostic Scoring System (IPSS),
•
chronic
myelomonocytic
leukaemia
(CMML)
with
10-29 %
marrow
blasts
without
myeloproliferative disorder,
•
acute
myeloid
leukaemia
(AML)
with
20-30 %
blasts
and
multi-lineage
dysplasia,
according to World Health Organisation (WHO) classification,
•
AML with > 30 % marrow blasts according to the WHO classification.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
treatment should be initiated and monitored under the
supervision of a
physician
experienced
in
the
use
of
chemotherapeutic
agents.
Patients
should
be
premedicated with anti-emetics for nausea and vomiting.
Posology
The recommended starting dose for the first treatment cycle, for all
patients regardless of
baseline
haematology
laboratory
values,
is
75 mg/m
2
of
body
surface
area,
injected
subcutaneously, daily for 7 days, followed by a rest period of 21 days
(28-day treatment
cycle).
It is recommended that patients be treated for a minimum of 6 cycles.
Treatment should be
continued for as long as the patient continues to benefit or until
disease progression.
Patients should be monitored for haematologic response/toxicity and
renal toxicities (see
section 4.4); a delay in starting the next cycle or a dose reduction
as described below may be
necessary.

should
not
be
used