TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MGML

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Guselkumab

Tilgjengelig fra:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC-kode:

L04AC16

Legemiddelform:

INJECTION, SOLUTION

Sammensetning:

Guselkumab 100mg/ml

Administreringsrute:

SUBCUTANEOUS

Resept typen:

Prescription Only

Produsert av:

Cilag AG

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2020-01-17

Informasjon til brukeren

Page 1 of 14
TREMFYA
®
(GUSELKUMAB)
READ ALL OF THIS PACKAGE INSERT CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this package insert. You may need to read it again.
•
If you have any questions, ask your doctor or nurse.
WHAT IS IN THIS PACKAGE INSERT
1.
What TREMFYA
®
is and what it is used for
2.
What you need to know before you use TREMFYA
®
3.
How to use TREMFYA
®
4.
What are the possible side effects of TREMFYA
®
5.
How to store TREMFYA
®
6.
Contents of the pack and other information
1.
WHAT TREMFYA
® IS AND WHAT IT IS USED FOR
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.
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.
•
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.
•
adults with moderate to severe palmoplantar pustulosis (PPP), an
inflammatory condition
causing redness and pustules affecting the palms of the hands and/or
soles of the feet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TREMFYA
®
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse, before taking TREMFYA
®
.
If you think you may be allergic to guselkumab or any other
ingredients of this medicine, ask
your doctor for advice before using TREMFYA
®
.
Infections
BEFORE STARTING TREMFYA
®
, TELL YOUR HEALTHCARE PROVIDER IF YOU:
•
are being treated for an infection
•
have an infection that does not go away or that keep

Preparatomtale

Page 1 of 37
PRODUCT NAME
TREMFYA
®
(guselkumab)
DOSAGE FORM 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
presentation:
PRE-FILLED PEN
Each 100mg Prefilled pen contains 100mg of guselkumab per 1mL
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
PLAQUE PSORIASIS
_ADULTS_
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
®
is indicated for the treatment of adult patients with active psoriatic
arthritis who have
had an inadequate response or who have been intolerant to a prior
disease-modifying antirheumatic
drug (DMARD) therapy.
PALMOPLANTAR PUSTULOSIS
TREMFYA
®
by subcutaneous (SC) administration 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 of TREMFYA
®
is 100 mg to be given as subcutaneous injection at weeks
0 and 4 and every 8 weeks thereafter. For patients at high risk for
joint damage according to
Page 2 of 37
clinical judgement, a dose of 100 mg every 4 weeks may be considered
(see
_ Clinical studies, _
_Radiographic response_
).
TREMFYA
®
may be administered alone or in combination with a conv