BRENZYS 50 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ETANERCEPT

Available from:

SAMSUNG BIOEPIS IL LTD, ISRAEL

ATC code:

L04AB01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ETANERCEPT 50 MG/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

FUJIFILM DIOSYNTH BIOTECHNOLOGIES DENMARK APS, DENMARK

Therapeutic area:

ETANERCEPT

Therapeutic indications:

Rheumatoid arthritisBrenzys is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate. Brenzys can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis. Brenzys, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents wighing at least 62.5 Kg who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years weighing at least 62.5 Kg who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of enthesitis-related arthritis in adolescents from the age of 12 years weighing at least 62.5 Kg who have had an inadequate response to, or who have proved intolerant of conventional therapy.Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Brenzys has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease.Axial spondyloarthritisAnkylosing spondylitis (AS)Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).Plaque psoriasisTreatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.Paediatric plaque psoriasisTreatment of chronic severe plaque psoriasis in children and adolescents weighing at least 62.5 Kg who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies

Authorization date:

2023-12-31

Patient Information leaflet

Patient Safety
Information Card
Brenzys 50 mg/ml
Etanercept
This card contains important safety information that you need to be
aware of before you are given
Brenzys and during treatment with Brenzys 50 mg/ml. If you do not
understand this information,
please ask your doctor to explain it to you.
●
Show this card to any doctor involved in your or your child’s
treatment.
Use in children and adolescents
Brenzys 50 mg/ml is not indicated for use in children and adolescents
weighing less than 62.5 kg.
Please ask your doctor if you have any questions about this.
Infections
Brenzys 50 mg/ml may increase your risk of getting infections, which
could be serious.
●
You should not use Brenzys 50 mg/ml if you have an infection. If you
are not sure, ask your
doctor.
●
If you develop symptoms suggestive of infections, such as fever,
persistent cough, shortness of
breath, chills, weakness or weight loss, seek medical attention
immediately.
●
You should be referred by your doctor for evaluation and diagnosis of
tuberculosis prior to
the treatment initiation and during the treatment if needed. Ask your
doctor to record the
dates and the results of your last screening for TB below:
Test:
Test:
Date:
Date:
Results:
Results:
●
Please inform your doctor if you are intended to be vaccinated. There
are vaccinations you
should not get during the treatment.
●
Please inform your doctor if you receive or recently received other
medicines, including non-
prescription medicines and nutritional supplements.
●
Please ask your doctor to list your other medicines that may increase
your risk of infection.
Congestive heart failure
●
If you have congestive heart failure, and you think your symptoms
(e.g., shortness of breath,
cough, tiredness or swelling of the feet or in the abdomen) are
becoming worse, or you
experience new onset of such symptoms, seek medical attention
immediately.
Malignancies
●
If you have or have had cancer, please tell your doctor. Periodic
dermatological examination is
recommended. In addition, you shoul

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Brenzys 50 mg/ml solution for injection
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 pre-filled pen
Each pre-filled pen contains 50 mg of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion
protein produced by recombinant
DNA technology in a Chinese hamster ovary (CHO) mammalian expression
system. Etanercept is a
dimer of a chimeric protein genetically engineered by fusing the
extracellular ligand binding domain
of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc
domain of human IgG1. This Fc
component contains the hinge, CH
2
and CH
3
regions, but not the CH
1
region of IgG1. Etanercept
contains 934 amino acids and has an apparent molecular weight of
approximately 150 kilodaltons. The
specific activity of etanercept is 1.7 × 10
6
units/mg.
For the full list of excipients, see section 6.1.
Patient safety information Card
The marketing of Brenzys is subject to a risk management plan (RMP)
including a ‘Patient safety
information card’. The ‘Patient safety information card’,
emphasizes important safety information
that the patient should be aware of before and during treatment.
Please explain to the patient the
need to review the card before starting treatment.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is clear to slightly opalescent, colourless or pale
yellow, and is formulated at pH 6.2 ±
0.3. The osmolality of the solution is 325 ± 35 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Rheumatoid arthritis
Brenzys is indicated for the treatment of active rhematoid arthritis
in adults when the response to
disease-modifying antirheumatic drugs (DMARDs) including methotrexate
(unless contraindicated)
has been inadequate. Brenzys can be used in combination with
methotrexate in patients who do not
respond adequately to methotrexate alone. Reducing signs and sym