ARSENIC TRIOXIDE-AFT arsenic trioxide 12 mg/12 mL concentrated solution for injection vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

arsenic trioxide, Quantity: 12 mg

Disponible des:

AFT Pharmaceuticals Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections

Vía de administración:

Intravenous

Unidades en paquete:

10 vials

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

For the induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.,For the induction of remission and consolidation in patients with previously untreated acute promyelocytic leukaemia (APL) in combination with all-trans retinoic acid (ATRA) and/or chemotherapy and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.

Resumen del producto:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

2023-02-27

Informació per a l'usuari

Arsenic trioxide - AFT
1
ARSENIC TRIOXIDE - AFT
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 ARSENIC TRIOXIDE - AFT?
Arsenic trioxide - AFT contains the active ingredient arsenic
trioxide. Arsenic trioxide - AFT is used to treat acute promyelocytic
leukaemia also known as APL.
For more information, see Section 1. Why am I using Arsenic trioxide -
AFT? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ARSENIC TRIOXIDE - AFT?
Do not use if you have ever had an allergic reaction to arsenic
trioxide 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
Arsenic trioxide - AFT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Arsenic trioxide - AFT 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 ARSENIC TRIOXIDE - AFT?
Arsenic trioxide – AFT injections are administered to you by doctors
or nurses in hospital.
More instructions can be found in Section 4. How do I use Arsenic
trioxide - AFT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ARSENIC TRIOXIDE - AFT?
THINGS YOU
SHOULD DO
•
Remind any doctor, surgeon, dentist or pharmacist you visit that you
are using Arsenic trioxide - AFT.
•
If you become pregnant or are about to have any blood tests, tell your
doctor that you are being given
this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Arsenic trioxide - AFT
affects you. Refer to full CMI for details.
LOOKING AFTER
YOUR MEDICINE
•
Arsenic trioxide – AFT will be stored in

Fitxa tècnica

1
AUSTRALIAN PRODUCT INFORMATION
ARSENIC TRIOXIDE - AFT
(ARSENIC TRIOXIDE) CONCENTRATED SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Arsenic trioxide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Arsenic trioxide – AFT: Each 10 mL glass ampoule contains 10 mg
arsenic trioxide as the
active ingredient. Each 12 mL glass vial contains 12 mg arsenic
trioxide as the active
ingredient
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMCEUTICAL FORM
ARSENIC TRIOXIDE – AFT is clear, colourless, concentrated solution
for injection. It is a
sterile solution for single use. The pH of ARSENIC TRIOXIDE – AFT is
between 7.0-8.5. It
must be diluted before use for Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the induction of remission and consolidation in patients with
acute promyelocytic
leukaemia (APL) who are refractory to, or have relapsed from, retinoid
and anthracycline
chemotherapy,
and
whose
APL
is
characterised
by
the
presence
of
the
t(15:17)
translocation or PML/RAR-alpha gene expression.
For the induction of remission and consolidation in patients with
previously untreated
acute promyelocytic leukaemia (APL) in combination with all-trans
retinoic acid (ATRA)
and/or chemotherapy and whose APL is characterised by the presence of
the t(15:17)
translocation or PML/RAR-alpha gene expression.
4.2
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
0.15 mg/kg/day diluted with 100 - 250 mL of 5% glucose injection or
0.9% sodium
chloride injection and administered intravenously (iv) over two hours.
Cycles of treatment are given to achieve complete remission, defined
as the complete
disappearance
of
all
leukaemic
myeloblasts
and
promyelocytes
and
<
5%
overall
myeloblasts by morphological examination of the marrow. After
induction of remission,
consolidation cycles may be given, and maintenance therapy considered.
Arsenic trioxide
–
AFT
may
be
given
in
combination
with
all-trans
retinoic
acid
(ATRA)
and/or
chemotherapy.
2
_IN PATIENTS WITH NEWLY DIAGNOSED/DE N