Xeljanz Film-Coated Tablets 5mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Tofacitinib Citrate

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Tofacitinib Citrate

Unit dalam pakej:

14tablet Tablets; 56tablet Tablets

Dikeluarkan oleh:

Pfizer Manufacturing Deutschland GmbH.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
XELJANZ
® FILM-COATED TABLETS
Tofacitinib citrate (5 mg)
1
WHAT IS IN THIS LEAFLET
1.
What XELJANZ is used for
2.
How XELJANZ works
3.
Before you use XELJANZ
4.
How to use XELJANZ
5.
While you are using
XELJANZ
6.
Side Effects
7.
Storage and Disposal of
XELJANZ
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT XELJANZ IS USED FOR
XELJANZ is used for the
treatment of adult patients with
moderately to severely active
rheumatoid arthritis in whom
methotrexate did not work well
or have had difficulty handling
methotrexate due to its side
effects. It may be used as a single
agent or in combination with
methotrexate or other
nonbiologic disease-modifying
antirheumatic drugs (DMARDs).
XELJANZ is also used for the
treatment of adult patients with
active psoriatic arthritis (PsA) in
whom methotrexate or other
similar medicines called
nonbiologic disease-modifying
antirheumatic drugs (DMARDs)
did not work well or cannot be
tolerated.
XELJANZ is also used for the
treatment of adult patients with
moderately to severely active
ulcerative colitis (UC) in whom
tumour necrosis factor (TNF)
blockers did not work well or
cannot be tolerated.
HOW XELJANZ WORKS
XELJANZ contains the active
substance tofacitinib which block
proteins called JAK. It
preferentially inhibits JAK1 and
JAK3 which prevents the
activation and reduce the activity
of several inflammatory signals
called cytokines. These
inflammatory signals are
important in the activation,
function and multiplication of
our body's white blood cells.
Hence, blocking these signals
will help to control our body's
immune responses involved in
rheumatoid arthritis and psoriatic
arthritis.
By blocking excess
inflammation, XELJANZ helps
to reduce symptoms such as pain
and swelling in your joints and
can improve your performance of
daily tasks.
BEFORE YOU USE XELJANZ
-
_When you must not use it_
Do not take XELJANZ if:
•
You are allergic to tofacitinib
citrate or any of

Ciri produk

FORMATTED: Hidden
XELJANZ
®
TOFACITINIB CITRATE
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY AND THROMBOSIS
SERIOUS INFECTIONS
Patients treated with XELJANZ are at increased risk for developing
serious infections that may lead to
hospitalization or death
_(see sections 4.4 and 4.7)_
. Most patients who developed these infections were
taking concomitant immunosuppressants such as methotrexate or
corticosteroids.
If a serious infection develops, interrupt XELJANZ until the infection
is controlled.
Reported infections include:
•
Active tuberculosis, which may present with pulmonary or
extrapulmonary disease. Patients should be
tested for latent tuberculosis before XELJANZ use and during therapy.
Treatment for latent infection
should be initiated prior to XELJANZ use.
•
Invasive fungal infections, including cryptococcosis and
pneumocystosis. Patients with invasive fungal
infections may present with disseminated, rather than localized,
disease.
•
Bacterial, viral, including herpes zoster, and other infections due to
opportunistic pathogens.
The risks and benefits of treatment with XELJANZ should be carefully
considered prior to initiating therapy
in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and
symptoms of infection during and
after treatment with XELJANZ, including the possible development of
tuberculosis in patients who tested
negative for latent tuberculosis infection prior to initiating therapy
_(see section 4.4)_
.
MORTALITY
Rheumatoid arthritis patients 50 years of age and older with at least
one cardiovascular (CV) risk factor
treated with XELJANZ 10 mg twice a day had a higher rate of all-cause
mortality, including sudden CV
death, compared to those treated with XELJANZ 5 mg given twice daily
or TNF blockers in a large,
ongoing, postmarketing safety study
_(see section 4.4)_
.
MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated
with XELJANZ. Epstein Barr
Virus-associated post-transplant lymphoprol