Rilonacept Regeneron (previously Arcalyst)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Rilonacept

Διαθέσιμο από:

Regeneron UK Limited

Φαρμακολογική κατηγορία (ATC):

L04AC08

INN (Διεθνής Όνομα):

rilonacept

Θεραπευτική ομάδα:

Immunosuppressants

Θεραπευτική περιοχή:

Cryopyrin-Associated Periodic Syndromes

Θεραπευτικές ενδείξεις:

Rilonacept Regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) with severe symptoms, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children aged 12 years and older.

Περίληψη προϊόντος:

Revision: 5

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2009-10-23

Φύλλο οδηγιών χρήσης

Medicinal product no longer authorised
27
B. PACKAGE LEAFLET
Medicinal product no longer authorised
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
RILONACEPT REGENERON 80 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
rilonacept
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 further questions, ask your doctor or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Rilonacept Regeneron is and what it is used for
2.
What you need to know before you use Rilonacept Regeneron
3.
How to use Rilonacept Regeneron
4.
Possible side effects
5.
How to store Rilonacept Regeneron
6.
Contents of the pack and other information
1.
WHAT RILONACEPT REGENERON IS AND WHAT IT IS USED FOR
Rilonacept Regeneron is used to treat adults and adolescents aged 12
years and older with severe
symptoms of Familial Cold Autoinflammatory Syndrome (FCAS) and
Muckle-Wells Syndrome (MWS).
Rilonacept Regeneron belongs to a group of medicines called
interleukin inhibitors. Rilonacept Regeneron
blocks the activity of substances including interleukin-1 beta (IL-1
beta). In patients with CAPS, the body
produces excessive amounts of IL-1 beta. This may lead to symptoms
such as fever, headache, fatigue,
skin rash, or painful joints and muscles. By blocking the activity of
IL-1 beta, Rilonacept Regeneron leads
to an improvement in these symptoms.
If you have any questions about how Rilonacept Regeneron works or why
this medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RILONACEPT REGENERON
DO NOT USE RILONACEPT REGENERON:
•
if you are allergic to rilonacept or any of the other ingredients of
this m

Αρχείο Π.Χ.Π.

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Rilonacept Regeneron 80 mg/ml powder and solvent for solution for
injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 220 mg of rilonacept. After
reconstitution, each ml of solution contains 80
mg rilonacept.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white to off-white.
The solvent is a clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rilonacept Regeneron is indicated for the treatment of
Cryopyrin-Associated Periodic Syndromes (CAPS)
with severe symptoms, including Familial Cold Autoinflammatory
Syndrome (FCAS) and Muckle-Wells
Syndrome (MWS), in adults and children aged 12 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a specialist physician
experienced in the diagnosis and
treatment of CAPS.
After proper training in the correct injection technique, patients may
self-inject Rilonacept Regeneron if
their physician determines that it is appropriate and with medical
follow-up as necessary.
Posology
_Adults _
Treatment in adults should be initiated with a loading dose of 320 mg.
Dosing should be continued with a
once-weekly injection of 160 mg. Rilonacept Regeneron should not be
given more often than once
weekly.
_Paediatric population (12 to 17 years old) _
Treatment should be initiated with a loading dose of 4.4 mg/kg, up to
a maximum of 320 mg. Dosing
should be continued with a once-weekly injection of 2.2 mg/kg, up to a
maximum of 160 mg (see Table
1). Dosing in children must be adjusted as the child grows. The
patient or care giver should be advised to
speak to the treating physician before adjusting the dose. The
experience in children is limited. In the
clinical program for CAPS, 8 adolescents aged 12-17 were treated for
up to 18 months.
M