TREMFYA guselkumab (rch) 100 mg solution for injection pre-filled pen (One-Press (R) patient controlled injector)

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

guselkumab, Quantity: 100 mg

Dostupno od:

Janssen-Cilag Pty Ltd

Farmaceutski oblik:

Injection, solution

Sastav:

Excipient Ingredients: water for injections; histidine; sucrose; polysorbate 80; histidine hydrochloride monohydrate

Administracija rute:

Subcutaneous

Jedinice u paketu:

1 pre-filled pen

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Plaque psoriasis,TREMFYA is indicated for the treatment of adult patients (18 years or older) 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 to, or are intolerant to prior DMARD therapy.

Proizvod sažetak:

Visual Identification: Pre-filled syringe enclosed in a patient-controlled injector device with a clear, colourless to light yellow solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Registered

Datum autorizacije:

2020-05-13

Uputa o lijeku

TREMFYA® (220518) ACMI
1

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
TREMFYA
®
_Guselkumab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TREMFYA
(pronounced trem-fye-ah). It does not
contain all the available information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using TREMFYA
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TREMFYA IS
USED FOR
TREMFYA contains the active
substance guselkumab which is a
type of protein called a monoclonal
antibody. This medicine works by
neutralising the activity of a protein
called IL-23, which is present in
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 in which psoriasis
usually occurs in association with
arthritis. 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TREMFYA
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
TREMFYA for another reason.
BEFORE YOU USE
TREMFYA
_WHEN YOU MUST NOT USE IT _
DO NOT USE TREMFYA IF:
1.
YOU HAVE AN ALLERGY TO
GUSELKUMAB (THE ACTIVE
INGREDIENT IN THE MEDI

Svojstava lijeka

13.210211
Page 1
TREMFYA (220713) API
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems
.
TREMFYA
®
GUSELKUMAB
AUSTRALIAN PRODUCT INFORMATION
1
NAME OF THE MEDICINE
Guselkumab.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TREMFYA 100 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Each pre-filled syringe contains 100 mg of guselkumab per 1 mL
solution.
TREMFYA 100 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
Each pre-filled pen contains 100 mg of guselkumab per 1 mL solution
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.
For a full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection in a prefilled syringe or a pre-filled pen
(One-Press® patient controlled
injector).
TREMFYA is a clear, colourless to light yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Plaque psoriasis _
TREMFYA is indicated for the treatment of adult patients (18 years or
older) 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 to, or are intolerant to prior DMARD
therapy.
▼
13.210211
Page 2
TREMFYA (220713) API
4.2
DOSE AND METHOD OF ADMINISTRATION
TREMFYA is administered by subcutaneous injection.
DOSAGE (DOSE AND INTERVAL)
_Plaque psoriasis _
The recommended dose of TREMFYA is 100 mg 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 treatme