Trisenox
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
25-05-2023
Produktets egenskaber
(SPC)
25-05-2023
Offentlige vurderingsrapport
(PAR)
25-01-2017
Aktiv bestanddel:
Arsenic trioxide
Tilgængelig fra:
Teva B.V.
ATC-kode:
L01XX27
INN (International Name):
arsenic trioxide
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Leukemia, Promyelocytic, Acute
Terapeutiske indikationer:
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 103/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.
Produkt oversigt:
Revision: 31
Autorisation status:
Authorised
Autorisation dato:
2002-03-05
Indlægsseddel
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRISENOX 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
arsenic trioxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What TRISENOX is and what it is used for
2.
What you need to know before you are given TRISENOX
3.
How TRISENOX is given
4.
Possible side effects
5.
How to store TRISENOX
6.
Contents of the pack and other information
1.
WHAT TRISENOX IS AND WHAT IT IS USED FOR
TRISENOX is used in adult patients with newly diagnosed
low-to-intermediate risk acute
promyelocytic leukaemia (APL), and in adult patients, whose disease
has not responded to other
therapies. APL is a unique type of myeloid leukaemia, a disease in
which abnormal white blood cells
and abnormal bleeding and bruising occur.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRISENOX
TRISENOX must be given under the supervision of a physician
experienced in the treatment of acute
leukaemias.
YOU MUST NOT RECEIVE TRISENOX
If you are allergic to arsenic trioxide or any of the other
ingredients of this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
You must talk to your doctor or nurse before you are given TRISENOX,
if
-
you have impaired kidney function.
-
you have any liver problems.
Your doctor will take the following precautions:
-
Tests will be performed to check the amount of potassium, magnesium,
calcium and creatinine
in your blood before your first dose of TRISENOX.
-
You should have an electrical recording of the heart
(electrocardiogram ECG) performed before
your first dose.
-
Blood tests (potassium, calcium, magnesium and liver function) should
be repeated during your
treatment wi
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TRISENOX 1 mg/ml concentrate for solution for infusion
TRISENOX 2 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRISENOX 1 mg/ml concentrate for solution for infusion
Each ml of concentrate contains 1 mg of arsenic trioxide.
Each ampoule of 10 ml contains 10 mg of arsenic trioxide.
TRISENOX 2 mg/ml concentrate for solution for infusion
Each ml of concentrate contains 2 mg of arsenic trioxide.
Each vial of 6 ml contains 12 mg of arsenic trioxide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
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 promyelocytic
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
_. _
3
_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
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