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Enbrel TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: etanercept

Brand name

(ARTG)

: ENBREL etanercept (rch) 50 mg solution for injection cartridge

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

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.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, solution
  • Subcutaneous
  • Colourless to yellow or pale brown liquid. Clear to opalescent liquid.

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Protect from Light
  • Do not Freeze
  • Refrigerate
  • Shelf lifetime is 30 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 1 cartridge in Starter Pack pack
  • 4 cartridges pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient etanercept

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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