IMBRUVICA 420 mg film-coated tablets

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

ibrutinib

Inapatikana kutoka:

JOHNSON & JOHNSON SDN. BHD.

INN (Jina la Kimataifa):

ibrutinib

Vitengo katika mfuko:

30 Tablets

Viwandani na:

Cilag AG

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
IMBRUVICA
TM
Ibrutinib (140 mg), capsules
Ibrutinib (140 mg, 280 mg, 420 mg) film-coated tablets
1
WHAT IS IN THIS LEAFLET
1.
What IMBRUVICA is used for
2.
How IMBRUVICA works
3.
Before you use IMBRUVICA
4.
How to use IMBRUVICA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
IMBRUVICA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IMBRUVICA IS USED FOR
IMBRUVICA is an anticancer
medicine that contains the active
substance ibrutinib. It belongs to a
class of medicines called protein
kinase inhibitors.
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 lymphocyte
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.
•
IMBRUVICA is also used to treat
chronic graft versus host disease, a
condition in which transplanted
cells from another person (the
donor) attack the body (the host)
causing organ damage.
HOW IMBRUVICA WORKS
In MCL, CLL and WM,
IMBRUVICA works by blocking
Bruton's tyrosine kinase, a protein in
the body that helps these cancer cells
grow and survive. By blocking this
protein, IMBRUVICA helps kill and
reduce the number of cancer cells. It
also slows down the worsening of the
cancer.
BEFORE YOU USE IMBRUVICA
-
_When you must not use it _
_Do not take IMBRUVICA _
•
if you are allergic

Tabia za bidhaa

1
1.
NAME OF THE MEDICINAL PRODUCT
Capsules
IMBRUVICA 140 mg hard capsules.
Tablets
IMBRUVICA 140mg film-coated tablets
IMBRUVICA 280mg film-coated tablets
IMBRUVICA 420mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IMBRUVICA 140mg hard capsules
Each hard capsule contains 140 mg of ibrutinib.
IMBRUVICA 140mg film-coated tablets
Each film-coated tablet contains 140 mg of ibrutinib.
Excipients with known effect
Each 140mg film-coated tablet contains 28mg of lactose monohydrate.
IMBRUVICA 280mg film-coated tablets
Each film-coated tablet contains 280mg of ibrutinib.
Excipients with known effect
Each 280mg film-coated tablet contains 56mg of lactose monohydrate.
IMBRUVICA 420mg film-coated tablets
Each film-coated tablet contains 420mg of ibrutinib.
Excipients with known effect
Each 420mg film-coated tablet contains 84mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules
IMBRUVICA 140mg hard capsules
Hard capsule (capsule).
White opaque, hard capsule of 22 mm in length, marked with “ibr 140
mg” in black ink.
Tablets
IMBRUVICA 140mg film-coated tablets
Yellow-green to green round tablets (9mm), debossed with “ibr” on
one side and "140" on the other side.
IMBRUVICA 280mg film-coated tablets
Purple oblong tablets (15mm in length and 7mm in width), debossed with
"ibr" on one side and
"280" on the other side.
IMBRUVICA 420mg film-coated tablets
Yellow-green to green oblong tablets (17.5mm in length and 7.4mm in
width), debossed with "ibr"
on one side and "420" on the other side.
2
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 bendamustin