AZACITIDINE MSN azacitidine 100 mg powder for injection vial

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

azacitidine, Quantity: 100 mg

Inapatikana kutoka:

Juno Pharmaceuticals Pty Ltd

Dawa fomu:

Injection, powder for

Tungo:

Excipient Ingredients: mannitol

Njia ya uendeshaji:

Intravenous Infusion, Subcutaneous

Vitengo katika mfuko:

1 vial

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Azacitidine 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.

Bidhaa muhtasari:

Visual Identification: White to off white lyophilized cake or powder in 30 mL Type-I clear glass vial, grey rubber stopper and flip off seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

2021-10-21

Taarifa za kipeperushi

Azacitidine
1
AZACITIDINE MSN
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 MSN?
Azacitidine MSN contains the active ingredient azacytidine, which
prevents the growth of cancer cells.
For more information, see Section 1. Why am I using Azacitidine MSN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AZACITIDINE MSN?
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 MSN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Azacitidine MSN and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE AZACITIDINE MSN?
Your doctor will choose the correct dose of Azacitidine MSN for you.
Azacitidine MSN will be given to you as an injection under
the skin (subcutaneously i.e. under the skin on your thigh, abdomen or
upper arm) or as an intravenous infusion by a doctor or
a nurse.
More instructions can be found in Section 4. How do I use Azacitidine
MSN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AZACITIDINE MSN?
THINGS YOU
SHOULD DO
•
Remind any other doctors, dentists, and pharmacists who are treating
you that you are being
treated with Azacitidine MSN.
•
Tell your doctor immediately if you stop passing urine or if you are
passing less urine than normal.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
•
Keep all your doctor's appointments so that your progress can be
checked.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how
Azacitidine MSN affects you.
L

Tabia za bidhaa

Azacitidine MSN PI Ver 2.0
1
AUSTRALIAN PRODUCT INFORMATION –AZACITIDINE MSN (AZACITIDINE)
1.
NAME OF THE MEDICINE
Azacitidine
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Azacitidine MSN is supplied in a sterile powder form for
reconstitution as a suspension for
subcutaneous injection or intravenous infusion. Vials contain 100 mg
of azacitidine.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
White to off-white, sterile lyophilised powder in a 30 mL glass vial.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azacitidine MSN 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
DOSE AND METHOD OF ADMINISTRATION
Azacitidine MSN 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.
Injectable
azacitidine
should
not
be
used
interchangeably
with
oral
azacitidine
due
to
differences in the exposure, dose and schedule of treatment (see
Section 5.2 [Pharmacokinetic
Properties]). Healthcare professionals are recommended to verify drug
name, dose, and
administration route.
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).
Azacitidine MSN PI Ver 2.0
2
Subsequent Treatment Cycles
Cycles should b