Arsenic trioxide medac

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Arsenic trioxide

Available from:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC code:

L01XX27

INN (International Name):

arsenic trioxide

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Leukemia, Promyelocytic, Acute

Therapeutic indications:

Arsenic trioxide medac 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 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/RARα) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2020-09-17

Patient Information leaflet

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARSENIC TRIOXIDE MEDAC 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 any further questions, 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 Arsenic trioxide medac is and what it is used for
2.
What you need to know before you are given Arsenic trioxide medac
3.
How Arsenic trioxide medac is used
4.
Possible side effects
5.
How to store Arsenic trioxide medac
6.
Contents of the pack and other information
1.
WHAT ARSENIC TRIOXIDE MEDAC IS AND WHAT IT IS USED FOR
Arsenic trioxide medac contains the active substance arsenic trioxide
which is an anticancer medicine.
The mechanism of action of Arsenic trioxide medac is not completely
understood.
Arsenic trioxide medac 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 ARSENIC TRIOXIDE MEDAC
Please tell your doctor,pharmacist or nurse if you are taking or have
recently taken any other
medicines, including medicines obtained without a prescription.
YOU WILL NOT BE GIVEN ARSENIC TRIOXIDE MEDAC
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, pharmacist or nurse before you are given
Arsenic trioxide medac, if
•
you have impaired kidney function.
•
you have any liver problems.
29
Your doctor will take th

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Arsenic trioxide medac 1 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 1 mg of arsenic trioxide.
One vial of 10 ml contains 10 mg of arsenic trioxide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Sterile, clear, colourless, aqueous solution, free from particles. The
pH of the solution is 6.0-8.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arsenic trioxide medac 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 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/RARα) gene.
The response rate of other acute myelogenous leukaemia subtypes to
arsenic trioxide has not been
examined.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Arsenic trioxide medac 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 APL _
_ _
_Induction treatment schedule _
Arsenic trioxide medac must be administered intravenously at a dose of
0.15 mg/kg/day, given daily
until complete remission (CR) is achieved. If CR has not occurred by
day 60, dosing must be
discontinued.
3
_Consolidation schedule _
Arsenic trioxide medac 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 w