RINVOQ 15mg Extended Release Film Coated Tablets

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

Upadacitinib Hemihydrate

Commercializzato da:

ABBVIE SDN BHD

INN (Nome Internazionale):

Upadacitinib Hemihydrate

Confezione:

28 Tablets

Prodotto da:

Abbvie Ireland NL B.V

Foglio illustrativo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
RINVOQ
®
15 mg Extended-Release Film Coated Tablets
Upadacitinib (15 mg)
_________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What RINVOQ
®
is used for
2.
How RINVOQ
®
works
3.
Before you use RINVOQ
®
4.
How to use RINVOQ
®
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
RINVOQ
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT RINVOQ
®
IS USED FOR
RINVOQ
®
is used to treat adults with:
-
moderately
to
severely
active
rheumatoid
arthritis.
Rheumatoid
arthritis
is
a
disease
that
causes
inflamed joints.
-
active psoriatic arthritis. Psoriatic
arthritis
is
a
disease
that
causes
inflamed joints and psoriasis.
- active ankylosing spondylitis.
Ankylosing spondylitis is a disease
that primarily causes inflammation in
the spine.
RINVOQ
®
is used to treat adults and
adolescents 12 years and older with
moderate to severe atopic
dermatitis,
also
known
as
atopic
eczema. RINVOQ
®
may be used with
eczema medicines that you apply to
the skin or it may be used on its own.
HOW RINVOQ
®
WORKS
RINVOQ
®
works
by
reducing
the
activity of an enzyme in the body
called ‘Janus kinase’.
Rheumatoid arthritis
RINVOQ
®
can help to reduce pain,
stiffness and swelling in your joints,
reduce tiredness, and it can slow down
damage to the bone and cartilage in
your joints. These effects can ease
your
normal daily activities and so
improve your quality of life.
Psoriatic arthritis
RINVOQ
®
can help to reduce pain,
stiffness, and swelling in and around
your joints, pain and stiffness in your
spine,
psoriatic
skin
rash,
and
tiredness,
and
it
can
slow
down
damage to the bone and cartilage in
your joints. These effects can ease
your
normal daily activities and so
improve your quality of life.
Atopic Dermatitis
Taking RINVOQ
®
can improve the
condition
of
your
skin and reduce
itching and flares. RINVOQ
®
can help
improve symptoms of

Scheda tecnica

1
RINVOQ®15 mg extended-release film coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended-release tablet contains upadacitinib hemihydrate,
equivalent to 15 mg of upadacitinib.
For the full list of excipients, see LIST OF EXCIPIENTS section.
PHARMACEUTICAL FORM
Extended-release tablet.
RINVOQ® 15 mg extended-release film coated tablets
Purple 14 x 8 mm, oblong biconvex extended-release tablets imprinted
on one side with ‘a15’.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
RINVOQ® is indicated for the treatment of moderate to severe active
rheumatoid arthritis in adult
patients who have responded inadequately to, or who are intolerant to
one or more disease-modifying
anti-rheumatic drugs (DMARDs). RINVOQ® may be used as monotherapy or
in combination with
methotrexate.
Psoriatic arthritis
RINVOQ® is indicated for the treatment of active psoriatic arthritis
in adult patients who have
responded inadequately to, or who are intolerant to one or more
DMARDs. RINVOQ® may be used
as monotherapy or in combination with methotrexate.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic
dermatitis in adults and
adolescents 12 years and older who are candidates for systemic
therapy.
Ankylosing Spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis
in adult patients who have
responded inadequately to conventional therapy.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with upadacitinib should be initiated and supervised by
physicians experienced in the
diagnosis and treatment of conditions for which upadacitinib is
indicated.
Posology
Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
2
The recommended dose of upadacitinib is 15 mg once daily.
Consideration should be given to discontinuing treatment in patients
with ankylosing spondylitis who
have shown no clinical response after 16 weeks of treatment. Some
patients with initial partial
response may subsequently