Imbruvica

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Ibrutinib

Διαθέσιμο από:

Janssen-Cilag International NV

Φαρμακολογική κατηγορία (ATC):

L01EL01

INN (Διεθνής Όνομα):

ibrutinib

Θεραπευτική ομάδα:

Antineoplastic agents, Protein kinase inhibitors

Θεραπευτική περιοχή:

Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Θεραπευτικές ενδείξεις:

IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.

Περίληψη προϊόντος:

Revision: 31

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-10-21

Φύλλο οδηγιών χρήσης

113
B. PACKAGE LEAFLET
114
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMBRUVICA 140 MG HARD CAPSULES
ibrutinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 IMBRUVICA is and what it is used for
2.
What you need to know before you take IMBRUVICA
3.
How to take IMBRUVICA
4.
Possible side effects
5.
How to store IMBRUVICA
6.
Contents of the pack and other information
1.
WHAT IMBRUVICA IS AND WHAT IT IS USED FOR
WHAT IMBRUVICA IS
IMBRUVICA is an anticancer medicine that contains the active substance
ibrutinib. It belongs to a
class of medicines called protein kinase inhibitors.
WHAT IMBRUVICA IS USED FOR
It is used to treat the following blood cancers in adults:

Mantle cell lymphoma (MCL), a type of cancer affecting the lymph
nodes, when the disease has
come back or has not responded to treatment.

Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white
blood cells called
lymphocytes that also involves the lymph nodes. IMBRUVICA is used in
patients who have not
previously been treated for CLL or when the disease has come back or
has not responded to
treatment.

Waldenström’s macroglobulinaemia (WM), a type of cancer affecting
white blood cells called
lymphocytes. It is used in patients who have not previously been
treated for WM or when the
disease has come back or has not responded to treatment or in patients
for whom chemotherapy
given together with an antibody is not a suitable therapy.
HOW IMBRUVICA WORKS
In MCL, CLL and WM, IMBRUVICA works by blocking

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IMBRUVICA 140 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 140 mg of ibrutinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
White opaque, hard capsule of 22 mm in length, marked with “ibr 140
mg” in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IMBRUVICA as a single agent is indicated for the treatment of adult
patients with relapsed or
refractory mantle cell lymphoma (MCL).
IMBRUVICA as a single agent or in combination with rituximab or
obinutuzumab or venetoclax is
indicated for the treatment of adult patients with previously
untreated chronic lymphocytic leukaemia
(CLL) (see section 5.1).
IMBRUVICA as a single agent or in combination with bendamustine and
rituximab (BR) is indicated
for the treatment of adult patients with CLL who have received at
least one prior therapy.
IMBRUVICA as a single agent is indicated for the treatment of adult
patients with Waldenström’s
macroglobulinaemia (WM) who have received at least one prior therapy,
or in first line treatment for
patients unsuitable for chemo-immunotherapy. IMBRUVICA in combination
with rituximab is
indicated for the treatment of adult patients with WM.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with this medicinal product should be initiated and
supervised by a physician experienced
in the use of anticancer medicinal products.
Posology
_MCL_
The recommended dose for the treatment of MCL is 560 mg (four
capsules) once daily.
_CLL and WM_
The recommended dose for the treatment of CLL and WM, either as a
single agent or in combination,
is 420 mg (three capsules) once daily (for details of the combination
regimens, see section 5.1).
Treatment with IMBRUVICA should continue until disease progression or
no longer tolerated by the
patient. In combination with venetoclax for the treatment of CLL,
IMBRUVICA should be
administered as a single agent for 3 cycles