Tremfya
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
22-07-2022
Fachinformation
(SPC)
22-07-2022
Öffentlichen Beurteilungsberichts
(PAR)
20-07-2022
Wirkstoff:
Guselkumab
Verfügbar ab:
Janssen-Cilag International NV
ATC-Code:
L04AC
INN (Internationale Bezeichnung):
guselkumab
Therapiegruppe:
Immunosuppressants
Therapiebereich:
Psoriasis
Anwendungsgebiete:
Plaque psoriasis Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 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 (see section 5.1).,
Produktbesonderheiten:
Revision: 8
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-11-10
Gebrauchsinformation
45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
TREMFYA 100 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
guselkumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
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.
Possible side effects
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 blocking the activity of a protein called
IL-23, which is present at increased
levels in people with psoriasis and psoriatic arthritis.
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 the condition of the skin and appearance of nails
and reduce symptoms, such as
scaling, shedding, flaking, itching, pain and burning.
PSORIATIC ARTHRITIS
Tremfya is used to treat a condition called “psoriatic arthritis”,
an inflammatory disease of the joints,
often accompanied by plaque psoriasis. If you have psoriatic arthritis
you will first be given other
medicines. If you do not respond well enough to these medicines or in
case of intolerance, you will be
given Tremfya to reduce the signs and symptoms of the disease. Tremfya
can be used alone or with
another medicine named methotrexate.
Using Tremfya in psoriatic arthritis w
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tremfya 100 mg solution for injection in pre-filled syringe
Tremfya 100 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tremfya 100 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 100 mg of guselkumab in 1 mL
solution.
Tremfya 100 mg solution for injection in pre-filled pen
Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution.
Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ)
monoclonal antibody (mAb)
produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
The solution is clear and colourless to light yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plaque psoriasis
Tremfya is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are
candidates for systemic therapy.
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 (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is intended for use under the guidance and
supervision of a physician
experienced in the diagnosis and treatment of conditions for which it
is indicated.
Posology
_Plaque psoriasis_
The recommended dose is 100 mg by subcutaneous injection at weeks 0
and 4, followed by a
maintenance dose every 8 weeks (q8w).
Consideration should be given to discontinuing treatment in patients
who have shown no response
after 16 weeks of treatment.
3
_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 do
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