Pixuvri

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

pixantrone dimaleate

Διαθέσιμο από:

Les Laboratoires Servier

Φαρμακολογική κατηγορία (ATC):

L01DB11

INN (Διεθνής Όνομα):

pixantrone dimaleate

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Lymphoma, Non-Hodgkin

Θεραπευτικές ενδείξεις:

Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.

Περίληψη προϊόντος:

Revision: 23

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2012-05-10

Φύλλο οδηγιών χρήσης

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
PIXUVRI 29 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
pixantrone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-
If you get any side effect, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pixuvri is and what it is used for
2.
What you need to know before you use Pixuvri
3.
How to use Pixuvri
4.
Possible side effects
5.
How to store Pixuvri
6.
Content of the pack and other information
1.
WHAT PIXUVRI IS AND WHAT IT IS USED FOR
Pixuvri belongs to a pharmacotherapeutic group of medicines known as
‘antineoplastic agents’. These
are used to treat cancer.
Pixuvri is used for the treatment of adult patients with multiply
relapsed or refractory aggressive
Non-Hodgkin Lymphomas. Pixuvri kills cancer cells by binding to DNA,
resulting in cell death. It is
used for patients whose cancer does not respond or has returned after
they have received other
chemotherapy treatments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PIXUVRI
_ _
DO NOT USE PIXUVRI
-
if you are allergic to pixantrone dimaleate or any of the other
ingredients of this medicine
(listed in section 6).
-
if you have recently received a vaccine.
-
if you have been told that you have persistent, long-term low numbers
of red blood cells, white
blood cells, and platelets.
-
if you have very severe liver problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Pixuvri:
-
if you have been told that your white blood cell count is very low.
-
if you have heart disease or uncontrolled high blood pressure,
especially if you have ever been
told you had heart failure or if you have had a heart attack within
the last six months.
-
if you have an infection.
-
if you have ever been treated for cancer.
-
if you follow a sp

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pixuvri
29 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains pixantrone dimaleate equivalent to 29 mg pixantrone
After reconstitution, each ml of concentrate contains pixantrone
dimaleate equivalent to 5.8 mg
pixantrone.
Excipient with known effect:
One vial contains 39 mg sodium.
Upon reconstitution and dilution, this medicinal product contains
approximately 1g (43 mmol) sodium
per dose, equivalent to 50% of the WHO recommended maximum daily
intake of 2 g sodium for an
adult.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Dark blue lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pixuvri is indicated as monotherapy for the treatment of adult
patients with multiply relapsed or
refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL). The benefit
of pixantrone treatment has
not been established in patients when used as fifth line or greater
chemotherapy in patients who are
refractory to last therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Pixuvri must be administered by physicians who are familiar with the
use of antineoplastic agents and
have the facilities for regular monitoring of clinical,
haematological, and biochemical parameters during
and after treatment (see section 6.6).
Posology
The recommended dose is 50 mg/m
2
of pixantrone on days 1, 8, and 15 of each 28-day cycle for up to
6 cycles.
Please note:
In the EU recommended dose refers to the base of the active substance
(pixantrone). Calculation of the
individual dose to be administered to a patient must be based on the
strength of the reconstituted
solution that contains 5.8mg/ml pixantrone and the dose recommendation
of 50 mg/m
2
. In some trials
and publications, the recommended dose is based on the salt form
(pixantrone dimaleate)
However, the dose has to be adjusted before the start of each cycle
based on nad