Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Enbrel, 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.
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years 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 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 who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel 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.
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Treatment 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).
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis. Patients treated with Enbrel should be given the Patient Alert Card.
Enbrel is available in strengths of 10, 25 and 50 mg.
25 mg Enbrel administered twice weekly is the recommended dose. Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.
For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly. Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1). Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Enbrel is indicated, the same guidance on treatment duration should be followed. The dose should be 25 mg twice weekly or 50 mg once weekly.
No dose adjustment is required.
No dose adjustment is required. Posology and administration are the same as for adults 18-64 years of age.
The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly. Discontinuation of treatment should be considered in patients who show no response after 4 months.
The 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
No formal clinical trials have been conducted in children aged 2 to 3 years. However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously (see section 5.1).
There is generally no applicable use of Enbrel in children aged below 2 years in the indication juvenile idiopathic arthritis.
The recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks.
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.
There is generally no applicable use of Enbrel in children aged below 6 years in the indication plaque psoriasis.
Enbrel is administered by subcutaneous injection. Enbrel powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, “Instructions for use.” Detailed instructions on unintentional dosing or scheduling variations, including missed doses, are provided in section 3 of the package leaflet.
No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. The highest dose level evaluated has been an intravenous loading dose of 32 mg/m² followed by subcutaneous doses of 16 mg/m² administered twice weekly. One rheumatoid arthritis patient mistakenly self-administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects. There is no known antidote to Enbrel.
4 years.
Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution. From a microbiological point of view, the reconstituted medicinal product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at temperatures of up to 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions
Store in a refrigerator (2°C–8°C). Do not freeze.
Enbrel may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Enbrel should be discarded if not used within four weeks of removal from refrigeration.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Clear glass vial (2 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps.
Cartons contain 4 vials of Enbrel with 8 alcohol swabs.
Enbrel is reconstituted with 1 ml water for injections before use and administered by subcutaneous injection. Enbrel contains no antibacterial preservative, and therefore, solutions prepared with water for injections should be administered as soon as possible and within 6 hours following reconstitution. The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes or particles. Some white foam may remain in the vial – this is normal. Enbrel should not be used if all the powder in the vial is not dissolved within 10 minutes. If this is the case, start again with another vial.
Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for use."
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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