ENBREL etanercept (rch) 25 mg powder for injection vial and diluent syringe composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

water for injections, Quantity: 1 mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Diluent, not applicable

Composition:

Excipient Ingredients:

Administration route:

Subcutaneous

Units in package:

4 vials powder for injection, 4 syringes diluent with 4 needles and 8 alcohol swabs

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ENBREL is indicated for the treatment of: Adults Rheumatoid Arthritis Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). ENBREL 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. ENBREL 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.,Children and Adolescents Juvenile Idiopathic Arthritis Active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more DMARDs. Active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. Active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy. Active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. ENBREL has not been studied in children aged less than 2 years. Paediatric Plaque Psoriasis Chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant PASI response is not achieved.

Product summary:

Visual Identification: Clear, colourless liquid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2003-03-18

Patient Information leaflet

ENBREL
®
E
N
B
R
E
L
®
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.
1.
WHY AM I USING ENBREL?
Enbrel contains the active ingredient etanercept. Enbrel is used to
treat specific types of joint inflammation and skin conditions,
namely rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing
spondylitis, non-radiographic axial spondyloarthritis (nr-AxSpA),
psoriatic arthritis and plaque psoriasis.
For more information, see Section 1. Why am I using Enbrel? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ENBREL?
Do not use if you have ever had an allergic reaction to etanercept 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
Enbrel? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Enbrel 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 ENBREL?
•
Enbrel is given in adults either once a week as a 50 mg dose, or as
two separate 25 mg doses 3-4 days apart. In children, the
dose and frequency depend on weight and the disease.
•
Enbrel is injected under the skin and is for single use in one patient
only. Refer to Instructions for Use provided in the pack.
•
Enbrel dose-dispenser cartridges are intended for use with the
SmartClic injection device.
More instructions can be found in Section 4. How do I use Enbrel? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ENBREL?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Enbrel.
•
Tell your doctor if you have latex allergies.
•
Ensure children are up to date with vaccinations prior to starting
Enbrel.
•
Tell your doctor if you are at risk

Summary of Product characteristics

Version: pfpenbra10322
Supersedes: pfpenbra20321
Page 1 of 42
AUSTRALIAN
PRODUCT
INFORMATION
–
ENBREL
® (ETANERCEPT)
1.
NAME OF THE MEDICINE
Etanercept
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 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. Etanercept is now manufactured using a serum-free
process.
The potency is determined by measuring the ability of etanercept to
neutralise the TNF

-mediated
growth inhibition of A375 cells. The specific activity of etanercept
is 1.7 x 10
6
units/mg.
Each vial of ENBREL powder for injection contains 25 mg of the active
ingredient, etanercept.
The content of the diluent syringe is 1 mL of sterile water for
injections.
Each syringe of ENBREL solution for injection contains either 25 mg*
(in 0.5 mL) or 50 mg (in
1 mL) of etanercept.
Each dose-dispenser cartridge of ENBREL solution for injection
contains either 25 mg (in 0.5 mL)
or 50 mg (in 1 mL) of etanercept.
The ENBREL pre-filled Auto-injector contains 50 mg of etanercept.
Not all presentations may be marketed.
For the full list of excipients, see section 6.1 – List of
excipients.
3.
PHARMACEUTICAL FORM
POWDER FOR SOLUTION FOR INJECTION
Following reconstitution with water for injections, ENBREL is a
colourless to slightly yellow or
pale brown and clear to slightly opalescent solution, with a pH of
7.1-7.7.
SOLUTION FOR INJECTION
ENBREL solution for injection in the pre-filled syringe, Auto-injector
and dose-dispenser cartridge
is a clear to opalescent, colourless to yellow or pale brown solution
with a