Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Etanercept, Quantity: 50 mg
Pfizer Australia Pty Ltd
Etanercept
Injection, solution
Excipient Ingredients: sucrose; monobasic sodium phosphate dihydrate; sodium chloride; water for injections; dibasic sodium phosphate dihydrate; arginine hydrochloride
Subcutaneous
1 auto-injector containing a pre-filled syringe in Starter Pack OR 4 auto-injectors containing a pre-filled syringe each
(S4) Prescription Only Medicine
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.
Visual Identification: Colourless to yellow or pale brown liquid. Clear to opalescent liquid.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2009-04-07
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 Read the complete document
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 Read the complete document