What is Remicade?
Remicade is a powder that is made up into a solution for infusion (drip into a vein) and contains the active substance infliximab.
What is Remicade used for?
Remicade is an anti-inflammatory medicine. It is usually used in cases where other medicines or treatments have not given an adequate response in adults with the following diseases:
- rheumatoid arthritis (a disease of the immune system causing inflammation of the joints). Remicade is used in combination with methotrexate (a medicine that acts on the immune system);
- Crohn's disease (a disease that causes inflammation of the digestive tract) severe or fistulising (with formation of fistulas, abnormal communication between the intestine and other organs);
- ulcerative colitis (a disease causing inflammation and ulceration of the intestinal lining);
- 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 given to patients aged six to 17 with severe active Crohn's disease, when they have not responded or cannot take other medicines or cannot be treated with other treatments.
For more information read the Summary of Product Characteristics (included in the EPAR).
The medicine can only be obtained with a prescription.
How is Remicade used?
Remicade must be administered under close supervision and supervision by a physician experienced in the diagnosis and treatment of the diseases for which the use of Remicade may be indicated.
The dose of Remicade for rheumatoid arthritis is usually 3 mg per kilogram of body weight, although this dose can be increased if necessary. For other diseases, the dose is 5 mg per kilogram. The frequency of treatment depends on the treatment. the disease to be treated and the patient's individual response to the medicine.
Remicade is given as a one to two hour infusion. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Patients may be given other medicines before or during treatment with Remicade to reduce the risk of infusion-related reactions. For more information, see the package leaflet.
Patients receiving Remicade must be provided with the special alert card which summarizes all safety information about the medicine.
How does Remicade work?
The active substance in Remicade, infliximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) developed to recognize and attach to a specific structure (called an antigen) in the body. Infliximab was developed to attach to a chemical messenger in the body called tumor necrosis factor alpha (TNF-alpha). This messenger helps cause inflammation and is found in high amounts in patients with the diseases that Remicade is indicated to treat. By blocking TNF-alpha, infliximab relieves inflammation and other symptoms of the diseases.
How has Remicade been studied?
Remicade has been studied in a total of 1 432 patients in two studies for the treatment of rheumatoid arthritis. Remicade was given in combination with methotrexate and was then compared with methotrexate treatment alone (alone). The main measure of effectiveness was the change in symptoms, joint injuries and physical function for up to 54 weeks.
For Crohn's disease, Remicade was compared with placebo (a dummy therapy) in 1,090 adults in four studies. The main measures of efficacy of the product were the improvement of the severity of symptoms or the healing of the fistulas. The effects of adding Remicade to an existing therapy were also studied on 103 children and adolescents with Crohn's disease with age between six and 17 years.
For ulcerative colitis (728 patients), ankylosing spondylitis (70 patients), psoriatic arthritis (104 patients) and psoriasis (627 patients), Remicade was compared with placebo. In all these studies, the main measure of effectiveness was symptomatology improved for up to 16 weeks.
What benefit has Remicade shown during the studies?
In all studies, Remicade was more effective than the comparator medicines:
- with regard to rheumatoid arthritis, more patients treated with Remicade combined with methotrexate experienced a decrease in symptoms compared to patients treated with methotrexate alone as well as fewer joint injuries and greater improvement in physical function ;
- in adults with Crohn's disease, Remicade, compared to placebo, produced more marked improvement in symptoms, resulted in healing of fistulas in more patients, and lengthened patients' response time to treatment. Most children and adolescents with Crohn's disease also showed a reduction in symptoms after adding Remicade to their previous treatment;
- in the study of ulcerative colitis, ankylosing spondylitis and psoriatic arthritis, more patients taking Remicade also showed a greater reduction in symptoms than was seen with placebo;
- in psoriasis, Remicade produced more marked improvement in symptoms than was seen with placebo.
What is the risk associated with Remicade?
Most of the side effects seen in patients treated with Remicade are related to the infusion and not to the medicine itself. These effects include dyspnoea (difficulty breathing), hives (itchy rash) and headache. Some patients may experience anaphylactic shock. (a severe allergic reaction) during the infusion or delayed hypersensitivity (an allergic reaction that occurs after the first exposure to the medicine). Patients who experience these symptoms need to slow down the infusion of the medicine or stop treatment.
The most frequent side effects with Remicade (seen in 1 to 10 patients in 100) are viral infections (e.g. flu or febrile herpes), serum sickness-like reactions (including skin rash, joint pain or fever), headache, dizziness (dizziness), flushing, upper respiratory tract infections (cold), deep respiratory tract infections (such as bronchitis or pneumonia), wheezing, sinusitis (inflammation of the sinuses), nausea, diarrhea, abdominal pain (stomach pain), dyspepsia (heartburn), erythema, itching, hives, increased sweating, dry skin, fatigue (tiredness), chest pain, fever and an increase in enzyme values liver in the blood. Some side effects, including infections, may be more common in children than in adults. For a full list of all side effects reported with Remicade, see the package leaflet.
Remicade must not be used in patients who have previously had hypersensitivity (allergy) to infliximab, or who are hypersensitive (allergic) to mouse proteins or any of the substances in Remicade. Remicade must not be used in patients who have moderate or severe tuberculosis, other serious infections or heart failure (inability of the heart to pump enough blood around the body).
Why has Remicade been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Remicade's benefits are greater than its risks for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis in patients who have not responded adequately or who cannot be treated with other therapies and therefore recommended the release of the product marketing authorization.
Remicade was originally authorized under 'exceptional circumstances', as, for scientific reasons, limited information was available on the medicine at the time of the product's approval. As the company submitted the requested additional information, the condition referred to 'exceptional circumstances' it was removed on March 8, 2004.
What measures are being taken to ensure the safe use of Remicade?
The company that makes Remicade will organize an information program for doctors who want to prescribe the medicine to children with Crohn's disease to illustrate the risks of the therapy.
Other information about Remicade:
On 13 August 1999, the European Commission issued Centocor B.V. a "Marketing Authorization" for Remicade, valid throughout the European Union. The "Marketing Authorization" was renewed on August 13, 2004 and August 13, 2009.
For the full version of Remicade's EPAR, click here.
Last update of this summary: 08-2009.
The information on Remicade - infliximab published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
