Tremfya One-Press 100mgml Solution for Injection

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

GUSELKUMAB

Διαθέσιμο από:

JOHNSON & JOHNSON SDN. BHD.

INN (Διεθνής Όνομα):

GUSELKUMAB

Μονάδες σε πακέτο:

1 Units

Κατασκευάζεται από:

Cilag AG

Φύλλο οδηγιών χρήσης

TREMFYA
® SOLUTION FOR INJECTION
TREMFYA
® ONE-PRESS
® SOLUTION FOR
INJECTION
Guselkumab (100mg/ml)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What TREMFYA is used for
2.
How TREMFYA works
3.
Before you use TREMFYA
4.
How to use TREMFYA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TREMFYA
8.
Instructions for Use
9.
Product description
10.
Manufacturer and Product
Registration Holder
11.
Date of revision
WHAT TREMFYA IS USED FOR
PLAQUE PSORIASIS:
TREMFYA is used to treat adults with
moderate to severe “plaque psoriasis”, an
inflammatory condition affecting the skin
and nails. TREMFYA can improve skin
clearance and nail appearance and reduce
symptoms of psoriasis, such as scaling,
shedding, flaking, itching, pain and
burning. TREMFYA may improve your
health related quality of life.
PALMOPLANTAR PUSTULOSIS:
TREMFYA is used to treat adults with
palmoplantar pustulosis, an inflammatory
condition causing redness and pustules
affecting the palms of the hands and/or
soles of the feet.
PSORIATIC ARTHRITIS:
TREMFYA is used to treat adults with
active psoriatic arthritis, an inflammatory
disease of the joints, usually accompanied
by psoriasis. If you have active psoriatic
arthritis you will be given TREMFYA
alone or in combination with a
conventional Disease Modifying Anti-
Rheumatic Drug (DMARD) such as
methotrexate.
HOW TREMFYA WORKS
TREMFYA contains the active substance
guselkumab which is a type of protein
called a monoclonal antibody. This
medicine works by neutralizing the
activity of a protein called IL-23, which is
present at increased levels in people with
psoriasis.
BEFORE YOU USE TREMFYA
-
_When you must not use it _
TREMFYA may lower your ability to
fight infections and may increase your risk
of infections. Do not use TREMFYA if
you have any symptoms of infection
unless you are instructed to by your
healthcare provider.
_Children and adolescents _
TREMFYA is not recommended for
children and adolescents under 18 years of
age because it has not been

Αρχείο Π.Χ.Π.

PRODUCT NAME
TREMFYA
®
(guselkumab)
TREMFYA
®
One-Press
®
(guselkumab)
DOSAGE FORMS AND STRENGTHS
Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ)
monoclonal antibody (mAb)
that binds selectively to the extracellular human interleukin 23
(IL-23) protein with high
specificity and affinity. Guselkumab is produced in a mammalian cell
line using recombinant
DNA technology.
TREMFYA is available as a solution for injection in the following
presentations:
PRE-FILLED SYRINGE
Each 100 mg Prefilled syringe contains 100 mg of guselkumab per 1 mL
PRE-FILLED PEN
Each 100 mg Prefilled pen contains 100 mg of guselkumab per 1 mL
For excipients, see
_List of Excipients_
(Pharmaceutical Information).
CLINICAL INFORMATION
INDICATIONS
PLAQUE PSORIASIS
TREMFYA is indicated for the treatment of adults with moderate to
severe plaque psoriasis who
are candidates for systemic therapy or phototherapy.
PSORIATIC ARTHRITIS
TREMFYA, alone or in combination with methotrexate (MTX), is indicated
for the treatment of
active psoriatic arthritis in adult patients who have had an
inadequate response or who have been
intolerant to a prior disease-modifying antirheumatic drug (DMARD)
therapy.
PALMOPLANTAR PUSTULOSIS
TREMFYA is indicated for the treatment of moderate to severe
palmoplantar pustulosis (PPP) in
adult patients who do not adequately respond to conventional therapy.
DOSAGE AND ADMINISTRATION
DOSAGE – ADULTS (18 YEARS AND OLDER)
TREMFYA is administered by subcutaneous injection.
_ _
_PLAQUE PSORIASIS _
The recommended dose of TREMFYA is 100 mg to be given as subcutaneous
injection at week 0,
week 4 and every 8 weeks thereafter.
Consideration should be given to discontinuing treatment in patients
who have shown no response
after 16 weeks of treatment.
_PSORIATIC ARTHRITIS _
The recommended dose is 100 mg by subcutaneous injection at weeks 0
and 4, followed by a
maintenance dose every 8 weeks. For patients at high risk for joint
damage according to clinical
judgement, a dose of 100 mg every 4 weeks (q4w) may be considered.