Azacitidine Seacross 25 mg/ml powder for suspension for injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Azacitidine

Dostupné s:

Seacross Pharma (Europe) Limited

ATC kód:

L01BC07

INN (Mezinárodní Name):

Azacitidine

Dávkování:

25 milligram(s)/millilitre

Léková forma:

Powder for suspension for injection

Terapeutické oblasti:

azacitidine

Stav Autorizace:

Marketed

Datum autorizace:

2021-10-08

Informace pro uživatele

ie-pl-v6.1-clean-20231130 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZACITIDINE SEACROSS 25 MG/ML POWDER FOR SUSPENSION FOR INJECTION
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 Azacitidine Seacross
is and what it is used for
2.
What you need to know before you use Azacitidine Seacross
3.
How to use Azacitidine Seacross
4.
Possible side effects
5
How to store Azacitidine Seacross
6.
Contents of the pack and other information
1.
WHAT AZACITIDINE SEACROSS IS AND WHAT IT IS USED FOR
WHAT AZACITIDINE
SEACROSS IS
Azacitidine Seacross is an anti-cancer agent which belongs to a group
of medicines called ‘anti-
metabolites’. Azacitidine Seacross
contains the active substance ‘azacitidine’.
WHAT AZACITIDINE
SEACROSS IS USED FOR
Azacitidine Seacross 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 AZACITIDINE SEACROSS WORKS
Azacitidine Seacross 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

Charakteristika produktu

Health Products Regulatory Authority
07 March 2024
CRN00F150
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azacitidine Seacross 25 mg/ml powder for suspension for injection
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 powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azacitidine Seacross 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
Azacitidine Seacross 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 b