Kyntheum

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

brodalumab

Saatavilla:

LEO Pharma A/S

ATC-koodi:

L04AC12

INN (Kansainvälinen yleisnimi):

brodalumab

Terapeuttinen ryhmä:

Immunosuppressants

Terapeuttinen alue:

Psoriasis

Käyttöaiheet:

Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

Tuoteyhteenveto:

Revision: 6

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-07-17

Pakkausseloste

26
B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KYNTHEUM 210 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
brodalumab
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 Kyntheum is and what it is used for
2.
What you need to know before you use Kyntheum
3.
How to use Kyntheum
4.
Possible side effects
5.
How to store Kyntheum
6.
Contents of the pack and other information
1.
WHAT KYNTHEUM IS AND WHAT IT IS USED FOR
Kyntheum contains the active substance brodalumab. Brodalumab is a
monoclonal antibody, a
specialised type of protein that recognises and attaches to certain
proteins in the body.
Brodalumab belongs to a group of medicines called interleukin (IL)
inhibitors. This medicine works
by blocking the activity of IL-17 proteins, which are present at
increased levels in diseases such as
psoriasis.
Kyntheum is used to treat a skin condition called “plaque
psoriasis”, which causes inflammation and
scaly plaque formation on the skin. Kyntheum is used in adults with
moderate to severe plaque
psoriasis affecting large areas of the body.
Using Kyntheum will benefit you by leading to improvements of skin
clearance and reducing psoriasis
signs and symptoms, such as itch, redness, scaling, burning, stinging,
cracking, flaking and pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KYNTHEUM
DO NOT USE KYNTHEUM
•
if you are allergic to brodalumab or any of the other ingredients of
this medicine (listed in
section 6). If you think you may be

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Kyntheum 210 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
1 ml solution contains 140 mg brodalumab.
Brodalumab is a human monoclonal antibody 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 to slightly opalescent, colourless to slightly
yellow and free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kyntheum is indicated for the treatment of moderate to severe plaque
psoriasis in adult patients who
are candidates for systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kyntheum is intended for use under the guidance and supervision of a
physician experienced in the
diagnosis and treatment of psoriasis.
Posology
The recommended dose is 210 mg administered by subcutaneous injection
at weeks 0, 1, and 2
followed by 210 mg every 2 weeks.
Consideration should be given to discontinuing treatment in patients
who have shown no response
after 12-16 weeks of treatment. Some patients with initial partial
response may subsequently improve
with continued treatment beyond 16 weeks.
_Elderly (aged 65 years and over) _
No dose adjustment is recommended in elderly patients (see section
5.2).
_Renal and hepatic impairment _
Kyntheum has not been studied in these patient populations. No dose
recommendations can be made.
_ _
_Paediatric population _
The safety and efficacy of Kyntheum in children and adolescents below
the age of 18 years have not
yet been established. No data are available.
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Method of administration
Kyntheum is administered by subcutaneous injection. Each pre-filled
syringe is for single use only.
Kyntheum should not be injected into areas where the skin is tender,
bruised, red