BRENZYS etanercept (rch) 50 mg solution for injection auto-injector

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

Etanercept, Quantity: 50 mg

Beschikbaar vanaf:

Samsung Bioepis AU Pty Ltd

INN (Algemene Internationale Benaming):

Etanercept

farmaceutische vorm:

Injection, solution

Samenstelling:

Excipient Ingredients: water for injections; monobasic sodium phosphate monohydrate; sodium chloride; dibasic sodium phosphate heptahydrate; sucrose

Toedieningsweg:

Subcutaneous

Eenheden in pakket:

Pack of 4, Pack of 1 (starter pack)

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Adults (18 years and older),Rheumatoid Arthritis,Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Brenzys can be used in combination with methotrexate. Severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease.,Psoriatic Arthritis,The signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. Etanercept has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.,Plaque Psoriasis,Adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.,Ankylosing Spondylitis,The signs and symptoms of active ankylosing spondylitis in adults.,Non-radiographic Axial Spondyloarthritis,Treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs .,*Active disease is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4.

Product samenvatting:

Visual Identification: Auto-injector containing a pre-filled syringe with a clear type I glass barrel, with rubber plunger, stainless steel needle and rubber needle shield; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisatie-status:

Licence status A

Autorisatie datum:

2016-07-22

Bijsluiter

_ _
Version 13.0
_Brenzys_
_®_
_ - etanercept_
Page 1 / 11
BRENZYS
® ETANERCEPT SOLUTION FOR INJECTION (PRE-FILLED SYRINGE)
BRENZYS
® ETANERCEPT SOLUTION FOR INJECTION (AUTO-INJECTOR)
EACH SYRINGE OR AUTO-INJECTOR CONTAINS ETANERCEPT 50 MG
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Brenzys.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Brenzys against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT BRENZYS IS USED
FOR
Brenzys is used in adults for the
treatment of:

rheumatoid arthritis

ankylosing spondylitis

non-radiographic axial
spondyloarthritis (nr-AxSpA)

psoriatic arthritis

plaque psoriasis.
Tumour necrosis factor (TNF) is
a naturally occurring chemical
messenger in your bloodstream.
TNF plays a role in causing pain
and swelling in the joints.
Brenzys is a biotechnology-
derived protein that works by
binding to TNF and preventing it
from acting. This reduces the
pain and swelling of rheumatoid
arthritis and psoriasis, helps to
treat the skin lesions of psoriasis
and psoriatic arthritis, and
improves the condition of
patients with ankylosing
spondylitis and nr-AxSpA.
Your doctor may have prescribed
Brenzys for another reason. Ask
your doctor if you have any
questions about why Brenzys
has been prescribed for you.
This medicine is available only
with a doctor's prescription.
Brenzys is not addictive.
Brenzys is not indicated for use
in children less than 18 years of
age. Other etanercept products
are available for use in children.
BEFORE YOU USE BRENZYS
_WHEN YOU MUST NOT USE IT _
DO NOT USE BRENZYS IF:
1.
YOU HAVE AN ALLERGY TO
BRENZYS OR ANY OF THE
INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Symptoms of a

Productkenmerken

Version:13.0
Page 1 of 42
AUSTRALIAN PRODUCT INFORMATION – BRENZYS
® (ETANERCEPT)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Etanercept
Brenzys is a biosimilar medicine to Enbrel
®
. The evidence for comparability supports the use of
Brenzys for the listed indication(s).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
50 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 50 mg of etanercept.
50 mg solution for injection in Auto-injector
Each Auto-injector contains 50 mg of etanercept.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection (injection)
Brenzys solution for injection in the pre-filled syringe and in the
Auto-injector is a clear,
colourless or pale yellow solution with a pH of 6.2 ± 0.3.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Brenzys is indicated for the treatment of:
_ADULTS (≥ 18 YEARS) _
RHEUMATOID ARTHRITIS
Active, adult rheumatoid arthritis (RA) in patients who have had
inadequate response to one or
more disease-modifying antirheumatic drugs (DMARDs). Brenzys can be
used in combination
with methotrexate.
Severe, active rheumatoid arthritis in adults to slow progression of
disease-associated
structural damage in patients at high risk of erosive disease.
PSORIATIC ARTHRITIS
The signs and symptoms of active and progressive psoriatic arthritis
in adults, when the
response to previous disease-modifying antirheumatic therapy has been
inadequate. Etanercept
has been shown to reduce the rate of progression of joint damage as
measured by X-ray and to
improve physical function.
Version:13.0
Page 2 of 42
PLAQUE PSORIASIS
Adult patients with moderate to severe chronic plaque psoriasis, who
are candidates for
phototherapy or systemic therapy.
ANKYLOSING SPONDYLITIS
The signs and symptoms of active ankylosing spondylitis in adults.
NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS
Treatment of adults with active* non-radiographic axial
spondyloarthritis with objective signs
of inflammation as indicated by elevate