What is Flixabi - Infliximab and what is it used for?
Flixabi is an anti-inflammatory medicine. It is used in adults, usually when other medicines or treatments cannot be used or have failed to treat the following diseases:
- rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints). Flixabi is used with methotrexate (a medicine that acts on the immune system);
- Crohn's disease (a disease that causes inflammation of the intestine), when the disease is moderate to severe or causes fistulas (abnormal passages between the intestine and other organs);
- ulcerative colitis (a disease that causes inflammation and ulcers in the lining of the intestine);
- ankylosing spondylitis (a disease that causes inflammation and pain in the joints of the spine);
- psoriatic arthritis (a disease that causes red and scaly patches on the skin and inflammation of the joints);
- psoriasis (a disease that causes the formation of red and scaly spots on the skin).
Flixabi is also used to treat severe forms of Crohn's disease or ulcerative colitis in patients aged between 6 and 17 who have not responded or cannot be treated with other medicines or therapies.
For more information, see the summary of product characteristics (included with EPAR).
Flixabi contains the active ingredient infliximab and is a "biosimilar medicine". This means that Flixabi is similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine for Flixabi is Remicade. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Flixabi - Infliximab used?
Treatment with Flixabi should be started and followed by a specialist who has experience in the diagnosis and treatment of diseases for which Flixabi is indicated. The medicine can only be obtained with a prescription.
Flixabi is usually given at a dose of 3 mg per kilogram body weight in rheumatoid arthritis, although the dose may be increased if necessary. For other diseases, the dose is 5 mg per kilogram. The frequency of repetition of the treatment depends on the disease treated and the patient's response to the medicine.
Flixabi is given as an infusion lasting one or two hours. All patients are monitored, to check for possible reactions, during the infusion and for at least one or two hours later. To reduce the risk of infusion-related reactions, patients may be given other medicines before or during Flixabi treatment, or the infusion rate may be slowed. For more information, see the package leaflet.
How does Flixabi - Infliximab work?
The active substance in Flixabi, infliximab, is a monoclonal antibody (a type of protein) that was designed to bind to a protein called tumor necrosis factor alpha (TNF-alpha) and block its activity. TNF-alpha helps cause inflammation and is found in high concentrations in patients with Flixabi-treated diseases. By blocking TNF-alpha, infliximab improves inflammation and other symptoms of these diseases.
What benefit has Flixabi - Infliximab shown during the studies?
Studies have been conducted to show that Flixabi is comparable to Remicade, including a study to show that it generates levels of active ingredient in the body similar to those produced by Remicade.
Flixabi was also compared to Remicade in a main study involving 584 patients with moderate to severe rheumatoid arthritis who had previously been treated with methotrexate. The main measure of effectiveness was the percentage of patients who had a reduction of at least 20% in ACR scores (a measure of pain and swelling of joints, as well as other symptoms) after 30 weeks of treatment. The results of this study showed that Flixabi is as effective as Remicade in reducing symptoms of rheumatoid arthritis: 64% of patients treated with Flixabi (148 of 231 patients) had a reduction of at least 20% in the ACR score compared to 66% of patients treated with Remicade (163 of 247).
What is the risk associated with Flixabi - Infliximab?
The most common side effects with Flixabi (seen in more than 1 patient in 10) are viral infections (such as flu or facial herpes), headache, upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), nausea, 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 all side effects reported with Flixabi, see the package leaflet.
Flixabi should not be used in patients who are hypersensitive (allergic) to infliximab, murine proteins or any of the other ingredients in Flixabi. In addition, Flixabi should not be used in patients with tuberculosis, other serious infections, or with heart failure (an inability of the heart to pump enough blood into the body) from moderate to severe.
Why has Flixabi - Infliximab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Flixabi has been shown to have a comparable quality, safety and efficacy profile to Remicade. Therefore, the CHMP considered that, as in the case of Remicade, the benefits outweigh the identified risks and recommended the granting of a marketing authorization for Flixabi.
What measures are being taken to ensure the safe and effective use of Flixabi - Infliximab?
A risk management plan has been developed to ensure that Flixabi is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Flixabi, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that markets Flixabi will provide an alert card for patients and information material for prescribers, summarizing information regarding the safety of the medicine. In particular, information will be made available to physicians who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that such patients may present an increased risk of acquiring infections and to remember the importance of regularly performing vaccinations.
More information on Flixabi - Infliximab
For the full EPAR of Flixabi, consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Flixabi therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
