Azacitidine betapharm

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

azacitidine

Available from:

betapharm Arzneimittel GmbH

ATC code:

L01BC07

INN (International Name):

azacitidine

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute

Therapeutic indications:

Azacitidine betapharm 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 % to 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification,AML with > 30 % marrow blasts according to the WHO classification.

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2020-03-24

Patient Information leaflet

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZACITIDINE BETAPHARM 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 betapharm is and what it is used for
2.
What you need to know before you use Azacitidine betapharm
3.
How to use Azacitidine betapharm
4.
Possible side effects
5
How to store Azacitidine betapharm
6.
Contents of the pack and other information
1.
WHAT AZACITIDINE BETAPHARM IS AND WHAT IT IS USED FOR
WHAT AZACITIDINE BETAPHARM IS
Azacitidine betapharm is an anti-cancer agent which belongs to a group
of medicines called ‘anti-
metabolites’. Azacitidine betapharm contains the active substance
‘azacitidine’.
WHAT AZACITIDINE BETAPHARM IS USED FOR
Azacitidine betapharm 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 BETAPHARM WORKS
Azacitidine betapharm 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 leukaemi

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Azacitidine betapharm 25 mg/mL powder for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder 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 to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azacitidine betapharm 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 % to 29 % marrow
blasts without
myeloproliferative disorder,
•
acute myeloid leukaemia (AML) with 20 % to 30 % blasts and
multi-lineage dysplasia,
according to World Health Organization (WHO) classification,
•
AML with > 30 % marrow blasts according to the WHO classification.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Azacitidine betapharm 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 necess