TRISENOX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ARSENIC TRIOXIDE

Available from:

MEDISON PHARMA LTD

ATC code:

L01XX27

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ARSENIC TRIOXIDE 1 MG/ML

Administration route:

I.V

Prescription type:

Not required

Manufactured by:

CP PHARMACEUTICALS LTD, U.K.

Therapeutic group:

ARSENIC TRIOXIDE

Therapeutic area:

ARSENIC TRIOXIDE

Therapeutic indications:

TRISENOX is indicated for induction of remission, and consolidation in adult patients with:• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 1000/μl) in combination with all-trans-retinoic acid (ATRA)• Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Authorization date:

2014-02-28

Patient Information leaflet

)תוחיטב עדימ ( הרמחה לע העדוה
:ךיראת
13.12.12 :תילגנאב רישכת םש
TRISENOX 1 MG/ML
:םושיר רפסמ
140-10-31787-00
מ"עב המראפ ןוסידמ :םושירה לעב םש
ןולעב םייונישה
בוהצ עקר לע םינמוסמ
אפורל ןולעב
םי/שקובמה םי/יונישה לע םיטרפ
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.2 POSOLOGY AND
METHOD OF
ADMINISTRATION
The same dose is recommended for children,
adults, and elderly.
Consolidation schedule:
Consolidation treatment must begin 3 to 4
weeks after completion of induction therapy.
TRISENOX is to be administered
intravenously at a dose of 0.15 mg/kg/day for
25 doses given 5 days per week, followed by
2 days interruption, repeated for 5 weeks.
Paediatric use: The experience in children is
limited. Of 7 patients under 18 years of age
(range 5 to 16 years) treated with TRISENOX
at the recommended dose of 0.15 mg/kg/day,
5 patients achieved a complete response.
Safety and effectiveness in paediatric patients
under 5 years of age have not been studied.
The same dose is recommended for children,
adults, and elderly.
Consolidation schedule:
Consolidation treatment must begin 3 to 4
weeks after completion of induction therapy.
TRISENOX is to be administered
intravenously at a dose of 0.15 mg/kg/day for
25 doses given 5 days per week, followed by
2 days interruption, repeated for 5 weeks.
Paediatric use: The experience in children is
limited. Of 7 patients under 18 years of age
(range 5 to 16 years) treated with
TRISENOX at the recommended dose of
0.15 mg/kg/day, 5 patients achieved a
complete response. Safety and effectiveness
in paediatric patients under 5 years of age
have not been studied.
.םייק אל
.הז םוקימב םייק אל
.הז םוקימב םייק אל
Dose delay, modification and reinitiation
Treatment with TRISENOX must be
interrupted, adjusted, or discontinued before
the scheduled end of therapy at any time that
a toxicity grade 3 or greater on the National
Canc

Summary of Product characteristics

Physician's Prescribing Information
1
This leaflet format has been determined by the Ministry of Health and
the content
thereof has been checked and approved
in February
2018
1.
NAME OF THE MEDICINAL PRODUCT
TRISENOX
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of TRISENOX contains 1 mg of arsenic trioxide
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
Sterile, clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRISENOX is indicated for induction of remission, and consolidation in
adult patients with:

Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia
(APL) (white blood
cell count, ≤ 10 x 10
3
/µl) in combination with all-
_trans_
-retinoic acid (ATRA)

Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous
treatment should have
included a retinoid and chemotherapy) characterised by the presence of
the t(15;17)
translocation and/or the presence of the Pro-Myelocytic
Leukaemia/Retinoic-Acid-Receptor-
alpha (PML/RAR-alpha) gene.
The response rate of other acute myelogenous leukaemia subtypes to
arsenic trioxide has not been
examined.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TRISENOX must be administered under the supervision of a physician who
is experienced in the
management of acute leukaemias, and the special monitoring procedures
described in section 4.4 must
be followed.
_ _
Posology
The same dose is recommended for adults and elderly
_. _
_Newly diagnosed low-to-intermediate risk acute promyelocytic
leukaemia (APL) _
_Induction treatment schedule _
TRISENOX must be administered intravenously at a dose of 0.15
mg/kg/day, given daily until
complete remission is achieved. If complete remission has not occurred
by day 60, dosing must be
discontinued.
Physician's Prescribing Information
2
_Consolidation schedule _
TRISENOX must be administered intravenously at a dose of 0.15
mg/kg/day, 5 days per week.
Treatment should be continued for 4 weeks on and 4 weeks off, for a
total of 4 cyc