AZACITIDINE ACCORD azacitidine 100mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

azacitidine, Quantity: 100 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Azacitidine

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: mannitol

Administration route:

Intravenous, Subcutaneous

Units in package:

1 vial pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AZACITIDINE ACCORD is indicated for the treatment of patients with,? Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), ,? Chronic Myelomonocytic Leukemia (CMMoL (10-29 percent marrow blasts without Myeloproliferative Disorder)), ,? Acute Myeloid Leukemia (AML) with 20-30 percent blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO), ,in whom allogenic stem cell transplantation is not indicated.

Product summary:

Visual Identification: White lyophilized powder or cake filled in a type-I clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-05-08

Patient Information leaflet

Azacitidine Accord - version 4
1
AZACITIDINE ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING AZACITIDINE ACCORD?
Azacitidine Accord contains the active ingredient azacitidine.
Azacitidine Accord is used for the treatment of myelodysplastic
syndrome (MDS). Myelodysplastic syndrome is a blood disorder in which
the bone marrow is not working normally and does
not produce enough mature blood cells. This causes a lack of healthy
blood cells that can function properly in the body.
For more information, see Section 1. Why am I using Azacitidine
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AZACITIDINE ACCORD?
Do not use if you have ever had an allergic reaction to azacitidine or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
Azacitidine Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Azacitidine Accord and affect how it
works.
See Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW DO I USE AZACITIDINE ACCORD?
Azacitidine Accord is an injection and will be given to you by your
doctor or nurse.
More instructions can be found in Section 4. How do I use Azacitidine
Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AZACITIDINE ACCORD?
THINGS YOU
SHOULD DO
•
Tell any other doctors, dentists, and pharmacists who are treating you
that you are being treated
with Azacitidine Accord
•
Tell your doctor immediately if you stop passing urine or if you are
passing less urine than normal
•
If you are about to be started on any new medicine, tell your doctor,
dentist or pharmacist that you
are being treated with this medicine
•
If you become pregnant while taking

Summary of Product characteristics

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
AZACITIDINE ACCORD (AZACITIDINE) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Azacitidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 100 mg azacitidine.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
The finished product is supplied in a sterile form for reconstitution
as a suspension for subcutaneous
injection or reconstitution as a solution with further dilution for
intravenous infusion. Vials of azacitidine
injection contain white sterile lyophilised powder or cake.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Azacitidine injection is indicated for the treatment of patients with:
•
Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according
to the International
Prognostic Scoring System (IPSS),
•
Chronic Myelomonocytic Leukemia [CMMoL (10%-29% marrow blasts without
Myeloproliferative
Disorder)],
•
Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage
dysplasia, according to World
Health Organisation Classification (WHO),
in whom allogenic stem cell transplantation is not indicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Azacitidine Accord treatment should only be administered under the
supervision of a physician
experienced in the use of cancer chemotherapeutic agents. Patients
should be premedicated for nausea
and vomiting.
Azacitidine Accord is for single use in one patient only. Discard any
residue.
RECOMMENDED DOSAGE IN ADULTS
First treatment cycle
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 given subcutaneously or by intravenous
infusion, daily for seven days, followed by a rest period of 21 days
(28-day treatment cycle).
Subsequent treatment cycles
Cycles should be repeated every 28 days. It is recommended that
patients be treated for a minimum of 6
cycles. However, complete or partial response may require more than 6
treatment cycles. Treatment m