CELAZADINE azacitidine 100mg powder for injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
28-09-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
azacitidine
Available from:
Celgene Pty Ltd
INN (International Name):
Azacitidine
Authorization status:
Registered
Patient Information leaflet
CELAZADINE
_POWDER FOR INJECTION_
_azacitidine 100 mg_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Celazadine.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Celazadine
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS
CELAZADINE USED
FOR
Celazadine is an anti-cancer agent.
This product contains a medicine
called azacitidine which prevents the
growth of cancer cells. Celazadine
has been prescribed by your doctor
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT HOW THIS MEDICINE
WORKS, OR WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Celazadine will only be prescribed to
you by a doctor who has experience
in medicines to treat cancers of the
blood.
BEFORE YOU ARE
GIVEN CELAZADINE
_WHEN YOU MUST NOT BE GIVEN_
_CELAZADINE_
TELL YOUR DOCTOR:
•
IF YOU ARE ALLERGIC TO AZACITIDINE
OR ANY OF THE OTHER INGREDIENTS
OF THE PRODUCT LISTED AT THE END
OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
•
IF YOU HAVE ADVANCED LIVER
CANCER.
•
IF YOU ARE PREGNANT.
•
IF YOU HAVE SEVERE PROBLEMS
WITH YOUR KIDNEY FUNCTION.
_BEFORE YOU ARE GIVEN_
_CELAZADINE_
1.
USE BY WOMEN
AVOID BECOMING PREGNANT WHILE
RECEIVING THIS MEDICINE B
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Summary of Product characteristics
Celazadine® (azacitidine) 100 mg Powder for Injection – AU PI
Celgene V2.7 – 24 July 2020 (CCDS V12)
1
AUSTRALIAN PI – CELAZADINE
® (AZACITIDINE 100 MG) POWDER
FOR INJECTION
1
NAME OF THE MEDICINE
Australian approved name: azacitidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg azacitidine.
For the full list of excipients, see section 6.1.
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
Celazadine contain 100 mg of azacitidine and 100 mg mannitol as a
white to off-white, sterile
lyophilised powder.
Azacitidine is a white to off-white solid. It is insoluble in acetone,
ethanol, and methyl ethyl ketone.
Azacitidine is slightly soluble in ethanol/water (50/50) and propylene
glycol; it is sparingly soluble in
water (13.8 mg/mL), 5% glucose in water and in normal saline.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Celazadine 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 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.
DOSE
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, follow
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