Ilaris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Canakinumab 150mg

Available from:

Novartis New Zealand Ltd

INN (International Name):

Canakinumab 150 mg

Dosage:

150 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Canakinumab 150mg Excipient: Histidine Histidine hydrochloride Polysorbate 80 Sucrose

Units in package:

Combination pack, 1 vial diluent plus 1 vial Ilaris, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Novartis Pharma SAS

Therapeutic indications:

Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children aged 2 years and older including: · Familial Cold Autoinflammatory Syndrome (FCAS) /Familial Cold Urticaria (FCU) · Muckle-Wells Syndrome (MWS) · Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA).

Product summary:

Package - Contents - Shelf Life: Vial, glass, Ilaris: Type I clear glass with chlorobutyl rubber stopper coated with fluoro resin laminate - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Ilaris: Type I clear glass with chlorobutyl rubber stopper coated with fluoro resin laminate - 4 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2010-07-09

Patient Information leaflet

New Zealand Consumer Medicine Information
1
ILARIS
®
_CANAKINUMAB _
150mg powder for solution for injection
150 mg/1mL solution for injection
WHAT IS IN THIS LEAFLET
Read all of this leaflet carefully before you start using this
medicine.
This leaflet answers some common questions about ILARIS. 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 being given
ILARIS against the benefits your doctor expects it will have for you.
This medicine has been
prescribed only for you. Do not give it to anybody else or use it for
any other illnesses.
If any of the side effects affects you severely, or if you notice any
side effects not listed in this
leaflet, or if you have any concerns about being given this medicine,
ask your doctor, nurse
or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT ILARIS IS USED FOR
ILARIS is intended for treatment of Cryopyrin-Associated Periodic
Syndromes (CAPS). It
belongs to a group of medicines called interleukin inhibitors. The
active substance in ILARIS
is canakinumab, a fully-human monoclonal antibody. It blocks the
activity of a substance
called interleukin-1 beta (IL-1 beta), which is present at increased
levels in inflammatory
diseases such as CAPS.
ILARIS is used in adults, adolescents and children aged 2 years and
older with a body weight
of 7.5kg and above to treat the following auto-inflammatory diseases
which are collectively
known as Cryopyrin-Associated Periodic Syndromes (CAPS), including:
•
Muckle-Wells Syndrome (MWS),
•
Neonatal-Onset Multisystem Inflammatory Disease (NOMID) also called
Chronic Infantile
Neurological, Cutaneous, Articular Syndrome (CINCA),
•
Severe forms of Familial Cold Autoinflammatory Syndrome (FCAS), also
called Familial
Cold Urticaria (FCU), presenting with signs and symptoms of
cold-induced urticarial rash.
In patients with CAPS, the body produces excessive amounts of a
chemical

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 13
1 PRODUCT NAME
ILARIS

150 mg Powder for Injection
ILARIS

150 mg/mL Solution for injection vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
A reconstituted single-use vial delivers 150 mg canakinumab per 1 mL.
Active ingredient:
Canakinumab
Canakinumab is a high-affinity human anti-human-IL-1β monoclonal
antibody
that belongs to the IgG1/κ isotype subclass. It is expressed in a
murine myeloma
SP2/0 cell line.
Chemical name:
Immunoglobulin G1, anti-(human interleukin-1beta (IL-1β)) human
monoclonal
ACZ885; (1Glu>Glp)-γ1 heavy chain (221-214’)-disulfide with kappa
light chain,
dimer (227-227”:230-230”)-bisdisulfide
CAS number:
402710-25-2 (variable heavy γ1 chain)
402710-27-4 (variable light κ chain)
Molecular weight:
Approximately 145.157kDa
Structure:
Canakinumab comprises two 447(or 448)-residue heavy chains and two
214-
residue light chains.
For the full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Powder for solution for injection
Ilaris is a sterile, white, lyophilised powder that is reconstituted
with water for injections and
administered as a subcutaneous (SC) injection.
Solution for injection
Ilaris is a colourless to slightly brownish yellow solution, in a 2 mL
colourless glass vial with grey rubber
stopper and green flip off cap and administered as a SC injection.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic
Syndromes (CAPS), in adults and
children aged 2 years and older including:
•
Familial Cold Autoinflammatory Syndrome (FCAS) /Familial Cold
Urticaria (FCU)
•
Muckle-Wells Syndrome (MWS)
NEW ZEALAND DATA SHEET
Page 2 of 13
•
Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic
Infantile Neurological,
Cutaneous, Articular Syndrome (CINCA).
4.2
Dose and method of administration
Treatment should be initiated and supervised by a specialist physician
experienced in the diagnosis
and treatment of CAPS.
The recommended starting d