COSENTYX secukinumab (rch) 150 mg/1 mL solution for injection in prefilled pen

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Secukinumab, Quantity: 150 mg/mL

Disponible desde:

Novartis Pharmaceuticals Australia Pty Ltd

Designación común internacional (DCI):

Secukinumab

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: trehalose dihydrate; water for injections; methionine; nitrogen; polysorbate 80; histidine hydrochloride monohydrate

Vía de administración:

Subcutaneous

Unidades en paquete:

1 pen, 2 pens

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Plaque psoriasis,COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.,Psoriatic arthritis,COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis including axial manifestations of psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.,Axial spondyloarthritis (axSpA) with or without radiographic damage,Ankylosing spondylitis (axSpA with radiographic damage),COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis.,Non-radiographic axial spondyloarthritis (axSpA without radiographic damage),COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change, who have had an inadequate response to, or are intolerant to, NSAIDs.,Juvenile Idiopathic Arthritis (JIA),Enthesitis-Related Arthritis (ERA),Cosentyx is indicated for the treatment of active enthesitis-related arthritis in patients 4 years and older who have had an inadequate response or were intolerant to at least one NSAID and at least one DMARD.,Juvenile Psoriatic Arthritis (JPsA),Cosentyx is indicated for the treatment of active juvenile psoriatic arthritis in patients 2 years and older who have had an inadequate response or were intolerant to at least one NSAID and at least one DMARD.,Hidradenitis Suppurativa (HS),COSENTYX is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

Resumen del producto:

Visual Identification: Pen containing a clear, colourless-slightly yellow liquid in 1 mL glass syringe, with seal bridges, cap, and label.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Estado de Autorización:

Licence status A

Fecha de autorización:

2015-01-12

Información para el usuario

COSENTYX
®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING COSENTYX?
COSENTYX contains the active ingredient secukinumab. COSENTYX is used
to treat plaque psoriasis, psoriatic arthritis, juvenile
idiopathic arthritis, ankylosing spondylitis, and non-radiographic
axial spondyloarthritis.
For more information, see Section 1. Why am I using COSENTYX? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE COSENTYX?
Do not use if you have ever had an allergic reaction to secukinumab or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
COSENTYX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with COSENTYX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE COSENTYX?
•
Your healthcare provider will prescribe the dose of COSENTYX that is
right for you. Use COSENTYX exactly as prescribed.
•
Do not try to inject COSENTYX yourself until you or your caregiver has
been shown how by your healthcare provider.
•
If you have forgotten to inject a dose of COSENTYX, do not take a
double dose to make up for the dose you missed.
More instructions can be found in Section 4. How do I use COSENTYX? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING COSENTYX?
THINGS YOU
SHOULD DO
•
DISCONTINUE TREATMENT AND TELL YOUR DOCTOR OR PHARMACIST IMMEDIATELY
IF YOU GET ANY SIGNS
OR SYMPTOMS OF A POTENTIALLY SERIOUS INFECTION OR AN ALLERGIC REACTION
DURING TREATMENT WITH
COSENTYX.
•
TELL YOUR DOCTOR YOU ARE TAKING COSENT

Ficha técnica

1
This medicinal product is subject to additional monitoring in
Australia due to approval of an
extension of indications. This will allow quick identification of new
safety information. Healthcare
professionals are asked to report any suspected adverse events at
www.tga.gov.au/reporting-
problems.
AUSTRALIAN PRODUCT INFORMATION
COSENTYX
® (SECUKINUMAB [RCH])
75 MG/0.5 ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE
150 MG/1 ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE
150 MG/1 ML SOLUTION FOR INJECTION IN PREFILLED PEN
150 MG POWDER FOR INJECTION IN VIAL
300 MG/2 ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE
300 MG/2 ML SOLUTION FOR INJECTION IN PREFILLED PEN
1
NAME OF THE MEDICINE
Secukinumab (rch)
Chemical name: Recombinant human monoclonal anti-human Interleukin-17A
(IL-17A, IL-17) antibody
of the IgG1/kappa isotype
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Secukinumab is a recombinant fully human monoclonal antibody selective
for interleukin-17A.
Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary
(CHO) cells.
3
PHARMACEUTICAL FORM
POWDER FOR INJECTION
Each vial of powder for injection contains 150 mg of secukinumab as a
lyophilised cake in glass vials.
SOLUTION FOR INJECTION
Solution for injection in a single-use, 0.5mL pre-filled syringe
containing 75 mg secukinumab.
Solution for injection in a single-use, 1 mL pre-filled syringe and/or
pen (auto-injector) containing 150
mg of secukinumab.
Solution for injection in a single-use, 2 mL pre-filled syringe and/or
pen (auto-injector) containing 300
mg of secukinumab.
▼

2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PLAQUE PSORIASIS
COSENTYX is indicated for the treatment of moderate to severe plaque
psoriasis in patients 6 years
and older who are candidates for systemic therapy or phototherapy.
PSORIATIC ARTHRITIS
COSENTYX is indicated for the treatment of adult patients with active
psoriatic arthritis including axial
manifestations of psoriatic arthritis when the response to previous
disease-modifying anti-rheumatic
drug (DMAR