Remicade
Authorised
This medicine is authorised for use in the European Union
infliximab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Remicade is an anti‑inflammatory medicine. It is usually used when other medicines or treatments have failed, in adults with the following diseases:
- rheumatoid arthritis (an immune system disease causing inflammation of the joints). Remicade is used with methotrexate (a medicine that acts on the immune system);
- Crohn’s disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
- ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
- ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
- psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
- psoriasis (a disease causing red, scaly patches on the skin).
Remicade is also used in patients aged between 6 and 17 years with severe, active Crohn’s disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Remicade contains the active substance infliximab.
Remicade is available as a powder that is made up into a solution for infusion (drip into a vein). Remicade can only be obtained with a prescription and must be given under the supervision and monitoring of a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remicade can be used to treat.
Remicade is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary. The dose is 5 mg per kilogram for the other diseases. How often the treatment is repeated depends on which disease is being treated, and on the patient’s response to the medicine.
Remicade is given as an infusion lasting one or two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remicade or the infusion time may be slowed down. For more information about using Remicade, see the package leaflet or contact your doctor or pharmacist.
The active substance in Remicade, infliximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha). This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remicade is used to treat. By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Rheumatoid arthritis
Remicade has been studied in a total of 1,432 patients with rheumatoid arthritis in two studies. In these studies, more patients taking Remicade in combination with methotrexate showed a reduction in symptoms than those taking methotrexate alone, as well as less damage to the joints and greater improvements in physical function.
Crohn’s disease
In Crohn’s disease in adults, Remicade was compared with placebo (a dummy treatment) in 1,090 adults in four studies. In these studies Remicade produced a greater improvement in symptoms, led to fistulae healing in more patients and increased the time that patients continued to respond to treatment.
The effects of adding Remicade to existing treatment have also been studied in 103 children and adolescents with Crohn’s disease who were aged between 6 and 17 years. Most of the patients showed a reduction in symptoms after adding Remicade to their existing treatment.
A sixth study in 508 adult patients looked at the number of patients whose symptoms improved and who did not need additional treatment with corticosteroids (other medicines used in Crohn’s disease). The patients were treated for 6 months with Remicade, another medicine azathioprine, or the combination of Remicade and azathioprine. Remicade alone and in combination with azathioprine was more effective than azathioprine alone.
Ulcerative colitis, ankylosing spondylitis and psoriatic arthritis
For ulcerative colitis (728 adults), ankylosing spondylitis (70 adults) and psoriatic arthritis (104 adults), Remicade has been compared with placebo. More adult patients receiving Remicade had a reduction in symptoms than those receiving placebo.
In a study with 60 children aged between 6 and 17 years with ulcerative colitis 73% of patients responded to treatment with Remicade at week eight (44 out of 60).
Psoriasis
In a study in 627 adults with psoriasis, Remicade led to a greater improvement in symptoms than placebo.
The most common side effects with Remicade (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain. Some side effects, including infections, may be more common in children than in adults. For the full list of side effects of Remicade, see the package leaflet.
Remicade must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remicade. Remicade must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
The European Medicines Agency decided that Remicade’s benefits are greater than its risks and it can be authorised for use in the EU.
Patients who receive Remicade must be given a special reminder card. The card will include safety information about the medicine and a record of the dates and results of specific tests that the patient has had so these can be shared with any treating doctor.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Remicade have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Remicade are continuously monitored. Side effects reported with Remicade are carefully evaluated and any necessary action taken to protect patients.
Remicade received a marketing authorisation valid throughout the EU on 13 August 1999.
Product information
Latest procedure affecting product information:
VR/0000224494
30/01/2025
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
- Remicade
- Active substance
- infliximab
- International non-proprietary name (INN) or common name
- infliximab
- Therapeutic area (MeSH)
- Spondylitis, Ankylosing
- Arthritis, Rheumatoid
- Psoriasis
- Crohn Disease
- Arthritis, Psoriatic
- Colitis, Ulcerative
- Anatomical therapeutic chemical (ATC) code
- L04AB02
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Rheumatoid arthritis
Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
- adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate;
- adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.
Adult Crohn's disease
Remicade is indicated for:
- treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies;
- treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Paediatric Crohn's disease
Remicade is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Remicade has been studied only in combination with conventional immunosuppressive therapy.
Ulcerative colitis
Remicade is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Paediatric ulcerative colitis
Remicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Ankylosing spondylitis
Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis
Remicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Remicade should be administered:
- in combination with methotrexate;
- or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Remicade 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.
Psoriasis
Remicade is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA).
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