Azacitidine Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

azacitidine

Available from:

Mylan Ireland Limited

ATC code:

L01BC07

INN (International Name):

azacitidine

Therapeutic group:

Antineoplastic agents

Therapeutic area:

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

Therapeutic indications:

Azacitidine Mylan 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.

Product summary:

Revision: 7

Authorization status:

Authorised

Authorization date:

2020-03-27

Patient Information leaflet

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZACITIDINE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you use Azacitidine Mylan
3.
How to use Azacitidine Mylan
4.
Possible side effects
5.
How to store Azacitidine Mylan
6.
Contents of the pack and other information
1.
WHAT AZACITIDINE MYLAN IS AND WHAT IT IS USED FOR
WHAT AZACITIDINE MYLAN IS
Azacitidine Mylan is an anti-cancer agent which belongs to a group of
medicines called
‘anti-metabolites’. Azacitidine Mylan contains the active
substance ‘azacitidine’.
WHAT AZACITIDINE MYLAN IS USED FOR
Azacitidine Mylan 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 MYLAN WORKS
Azacitidine Mylan 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 qu

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT_ _
Azacitidine Mylan 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 (powder for injection).
White lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azacitidine Mylan 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 Mylan 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.
Azacitidine Myl