Erelzi
Authorised
This medicine is authorised for use in the European Union
etanercept
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Erelzi is an anti-inflammatory medicine for treating the following immune system diseases:
- rheumatoid arthritis (a disease causing inflammation of the joints), used with another medicine, methotrexate, or alone;
- certain forms of juvenile idiopathic arthritis (diseases causing inflammation in the joints);
- plaque psoriasis (a disease causing red, scaly patches on the skin);
- psoriatic arthritis (psoriasis with inflammation of the joints);
- axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and non-radiographic axial spondyloarthritis which is when there are clear signs of inflammation but X-ray does not show disease.
Erelzi is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough or cannot be used. For detailed information on the use of Erelzi in all conditions, see the package leaflet or contact your doctor or pharmacist.
Erelzi contains the active substance etanercept and is a ‘biosimilar medicine’. This means that Erelzi is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Erelzi is Enbrel.
Erelzi is available for injection under the skin. The patient or the patient’s carer can give the injection after appropriate training. In adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week. Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis. In children, the dose depends on body weight. Erelzi is not for use in children who need doses other than 25 or 50 mg (e.g. those weighing less than 62.5 kg), because it is only available in these strengths; an alternative etanercept medicine should be used in such children. For more information, see the package leaflet. The medicine can only be obtained with a prescription. Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases that Erelzi is used for. For more information about using Erelzi, see the package leaflet or contact your doctor or pharmacist.
The active substance in Erelzi, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor alpha (TNF). This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Erelzi is used to treat. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Laboratory studies comparing Erelzi with Enbrel have shown that the active substance in Erelzi is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Because Erelzi is a biosimilar medicine, the studies on effectiveness and safety of etanercept carried out with Enbrel do not all need to be repeated for Erelzi. Studies were carried out to show that Erelzi produces similar levels of the active substance in the body to Enbrel.
Erelzi was also shown to be as effective as Enbrel in one main study involving 531 adults with plaque psoriasis. Over 70% of those given Erelzi (186 of 264 patients) and roughly 72% of those given Enbrel (191 of 267) had at least 75% reduction in their symptom score after 12 weeks of treatment.
The most common side effects with etanercept (seen in more than 1 patient in 10) are injection-site reactions (including bleeding, redness, itching, pain and swelling) and infections (including nose, throat, lung, bladder and skin infections). The doctor may stop Erelzi treatment in patients developing a serious infection. For the full list of side effects of Erelzi, see the package leaflet.
Erelzi must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with active infections.
For the full list of restrictions, see the package leaflet.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Erelzi has a highly similar structure, purity and biological activity to Enbrel and is distributed in the body in the same way. In addition, studies have shown that the safety and effectiveness of Erelzi is equivalent to that of Enbrel in plaque psoriasis.
The company that markets Erelzi will provide a card for patients that contains information on how to recognise serious side effects and know when to see their doctor urgently. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Erelzi have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Erelzi are continuously monitored. Side effects reported with Erelzi are carefully evaluated and any necessary action taken to protect patients.
Erelzi received a marketing authorisation valid throughout the EU for Erelzi on 23 June 2017.
Product information
Latest procedure affecting product information:
N/0056
10/10/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Erelzi
- Active substance
- etanercept
- International non-proprietary name (INN) or common name
- etanercept
- Therapeutic area (MeSH)
- Arthritis, Psoriatic
- Psoriasis
- Arthritis, Juvenile Rheumatoid
- Arthritis, Rheumatoid
- Spondylitis, Ankylosing
- Anatomical therapeutic chemical (ATC) code
- L04AB01
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Rheumatoid arthritis
Erelzi 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.
Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Etanercept, 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 arthritis
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.
Etanercept has not been studied in children aged less than 2 years.
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease?modifying antirheumatic drug therapy has been inadequate. Etanercept 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 spondyloarthritis
Ankylosing spondylitis (AS)
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Non-radiographic axial spondyloarthritis
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 non?steroidal anti?inflammatory drugs (NSAIDs).
Plaque psoriasis
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).
Paediatric plaque psoriasis
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.
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