Azacitidine Rowex 25 mg/ml Powder for suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azacitidine

Available from:

Rowex Ltd

ATC code:

L01BC07

INN (International Name):

Azacitidine

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Powder for suspension for injection

Therapeutic area:

azacitidine

Authorization status:

Marketed

Authorization date:

2020-06-12

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2024
CRN00F1LS
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azacitidine Rowex 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 Rowex 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 Rowex 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/m2 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 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