Flixabi - Infliximab

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 not been successful, to treat the following diseases:

  • rheumatoid arthritis (a disease of the immune system causing inflammation of the joints). Flixabi is used with methotrexate (a medicine that acts on the immune system);
  • Crohn's disease (a disease causing inflammation of the intestines), when the disease is moderate to severe or causes fistulas (abnormal passages between the intestines and other organs);
  • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the intestine);
  • 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 to form on the skin).

Flixabi is also used to treat severe Crohn's disease or ulcerative colitis in patients aged 6 to 17 who have not responded or who cannot be treated with other medicines or therapies.

For more information, see the Summary of Product Characteristics (included in the EPAR).

Flixabi contains the active substance 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, please see the questions. and answers by clicking here.

How is Flixabi used - Infliximab?

Treatment with Flixabi should be started and supervised by a specialist doctor who has experience in diagnosing and treating the 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 of body weight in rheumatoid arthritis, although the dose can be increased if necessary. For other diseases, the dose is 5 mg per kilogram. The frequency of repetition. of treatment depends on the disease being treated and the patient's response to the medicine.

Flixabi is given as an infusion lasting one to two hours. All patients are monitored for reactions during the infusion and for at least one to two hours thereafter. To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment. with Flixabi, or the infusion rate may be slowed down. 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 is designed to attach to a protein called tumor necrosis factor alpha (TNF-alpha) and block its activity. TNF-alpha contributes to inflammation and is found in high concentrations in patients with diseases treated with Flixabi. 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 the active substance in the body similar to those produced by Remicade.

Flixabi was also compared with Remicade in one 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 proportion of patients who had at least a 20% reduction in ACR scores (a measure of joint pain and swelling, as well as other symptoms) after 30 weeks of treatment. The results of this study showed that Flixabi was as effective as Remicade in reducing the symptoms of rheumatoid arthritis: 64% of patients treated with Flixabi (148 of 231 patients) had a reduction of at least 20% in their ACR score, compared to 66% of patients treated with Remicade (163 out of 247).

What is the risk associated with Flixabi - Infliximab?

The most common side effects with Flixabi (seen in more than 1 in 10 patients) are viral infections (such as the flu or herpes face), headache, upper respiratory tract infection (colds), sinusitis (sinus inflammation), nausea , abdominal pain (stomach pain), 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 reported with Flixabi, see the leaflet. illustrative.

Flixabi must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins, or any of the other ingredients in Flixabi. Also, Flixabi must not be used in patients with tuberculosis, other severe infections, or moderate to severe heart failure (inability of the heart to pump enough blood around the body).

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 exceed the identified risks and recommended that Flixabi be given a marketing authorization.

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 added to the summary of product characteristics and 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 a patient alert card and educational material for prescribers, summarizing information related to the medicine's safety.In particular, information will be made available for doctors who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that such patients may be at an increased risk of contracting infections and to remind them of the importance of carrying out regular tests. vaccinations.

More information about Flixabi - Infliximab

For the full version of Flixabi's EPAR, please consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Flixabi therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.

The information on Flixabi - 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.

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