Arsenic trioxide Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Arsenic trioxide

Available from:

Mylan Ireland Limited

ATC code:

L01XX27

INN (International Name):

arsenic trioxide

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Leukemia, Promyelocytic, Acute

Therapeutic indications:

Arsenic trioxide Mylan 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 promyelocytic leukaemia/retinoic acid receptor alpha (PML/RAR alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2020-04-01

Patient Information leaflet

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARSENIC TRIOXIDE MYLAN 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 or your
pharmacist or nurse.
-
If you get any side effects, talk to your doctor or 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 Mylan is and what it is used for
2.
What you need to know before you are given Arsenic trioxide Mylan
3.
How to use Arsenic trioxide Mylan
4.
Possible side effects
5.
How to store Arsenic trioxide Mylan
6.
Contents of the pack and other information
1.
WHAT ARSENIC TRIOXIDE MYLAN IS AND WHAT IT IS USED FOR
Arsenic trioxide Mylan 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 MYLAN
_ _
Arsenic trioxide Mylan must be given under the supervision of a
physician experienced in the
treatment of acute leukaemias.
YOU MUST NOT RECEIVE ARSENIC TRIOXIDE MYLAN
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 Arsenic
trioxide Mylan, 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 Arsenic trioxide Mylan.
-
You should have an electrical recording o

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Arsenic trioxide Mylan 1 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate contains 1 mg of arsenic trioxide.
Each 10 ml vial 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 with a pH of 7.5 to 8.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arsenic trioxide Mylan 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
Arsenic trioxide Mylan 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 _
Arsenic trioxide Mylan 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.
_Consolidation schedule _
Arsenic trioxide Mylan must be administered intravenously at a dose of
0.15 mg/kg/day, 5 days per
week. Treatment should be continued f