TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG1ML

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Viambatanisho vya kazi:

guselkumab

Inapatikana kutoka:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC kanuni:

L04AC16

Dawa fomu:

INJECTION, SOLUTION

Tungo:

guselkumab 100mg/mL

Njia ya uendeshaji:

SUBCUTANEOUS

Dawa ya aina:

Prescription Only

Viwandani na:

Cilag AG

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

2018-06-21

Taarifa za kipeperushi

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.
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 keeps coming back
•
have tuberculosis (TB) or have been in close contact with someone with
TB
•
think you have an infection or have symptoms of an infection such as:
o
fever or flu like symptoms
o
muscle aches
o
cough
o
shortness of breath
o
burning when you urinate or urinating more often than normal
Page 2 of 14
o
blood in your phlegm (mucus)
o
weight loss
o
diarrhea or stomach pain
o
warm, red, or painful skin or sores on your body different from your
psoriasis
AFTER STARTING

Tabia za bidhaa

Page 1 of 25
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 SYRINGE
Each 100 mg pre-filled syringe contains 100 mg of guselkumab per 1 mL.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
TREMFYA
®
is indicated for the treatment of adults with moderate-to-severe
plaque psoriasis
who are candidates for systemic therapy or phototherapy.
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.
GENERAL CONSIDERATIONS FOR ADMINISTRATION
TREMFYA
®
is intended for use under the guidance and supervision of a physician.
TREMFYA
®
may be administered by a health care professional, or a patient may
self-inject after proper training
in subcutaneous injection technique.
Comprehensive instructions for the administration of TREMFYA
®
are given in “Instructions for
use, handling, and disposal” and in the package leaflet,
“Instructions for preparation and giving an
injection of TREMFYA
®
.” Full amount of TREMFYA
®
should be injected according to the
directions provided in the patient information leaflet.
SPECIAL POPULATIONS
_PEDIATRICS (BELOW 18 YEARS OF AGE) _
The safety and efficacy of TREMFYA
®
in pediatric patients have not been evaluated; therefore,
no recommendations on dosing can be made (see
_Pharmacodynamic Properties_
).
_ELDERLY (65 YEARS OF AGE AND OLDER)