What is Inflectra and what is it used for?
Inflectra is an anti-inflammatory medicine that contains the active substance infliximab. It is usually used when other medicines or treatments are not working in adults with the following diseases:
- rheumatoid arthritis (a disease of the immune system causing inflammation of the joints). Inflectra 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 formation of 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 scaly red patches to form on the skin).
Inflectra is also used to treat severe, active Crohn's disease or severe, active ulcerative colitis, in patients aged six to 17 who have not responded or who cannot be treated with other medicines or therapies. For full details, see the Summary of Product Characteristics (included in the EPAR). Inflectra is a 'biosimilar' medicine. This means that Inflectra is similar to a biological medicine (the 'reference medicine') already authorized in the Union. (EU) and that Inflectra and the reference medicine contain the same active substance. The reference medicine for Inflectra is Remicade. For more information on biosimilar medicines, see the question and answer document here.
How is Inflectra used - infliximab?
Inflectra is available as a powder to be made up into a solution for infusion (drip) into a vein. The medicine can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in the diagnosis and treatment of the diseases for which Inflectra is used. Inflectra 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. Treatment depends on the disease being treated and the patient's response to the medicine. Inflectra is given as an infusion lasting one to two hours. All patients are monitored for any 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 treatment with Inflectra, or the rate of infusion may be slowed. For more information, see the package leaflet. Patients treated with Inflectra should receive a special alert card, which summarizes the information regarding the safety of the medicine.
How does Inflectra - infliximab work?
The active substance in Inflectra, infliximab, is a monoclonal antibody, which is an antibody (a type of protein) designed to recognize a specific structure (called an antigen) in the body and attach itself to it.Infliximab is designed to attach to a chemical messenger in the body called tumor necrosis factor alpha (TNF-alpha). This messenger is involved in the inflammatory process and is found at high levels in patients with the diseases for which Inflectra is indicated. By blocking TNF-alpha, infliximab improves inflammation and other disease symptoms. Inflectra is produced by a method known as 'recombinant DNA technology'. Infliximab is made up of cells that have received a gene (DNA), which makes them able to produce it.
What benefit has Inflectra - infliximab shown during the studies?
Inflectra was studied to show that it is comparable to the reference medicine, Remicade. Inflectra was compared with Remicade in one main study involving 606 adult patients with rheumatoid arthritis. Patients were treated with Inflectra or Remicade in addition to methotrexate for 30 weeks. The main measure of effectiveness was the change in symptoms. After 30 weeks of treatment, Inflectra was as effective as Remicade, with approximately 60% of patients responding to treatment with either medicine.
An additional study was performed in 250 patients with ankylosing spondylitis to show that Inflectra produces levels of the active substance in the body that are comparable to those of the reference medicine, Remicade.
What is the risk associated with Inflectra - infliximab?
The most common side effects with Inflectra (seen in more than 1 in 10 patients) are viral infections (such as flu or cold sores), headache, upper respiratory 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 adults. For the full list of side effects reported with Inflectra, see the leaflet. illustrative. Inflectra must not be used in patients who have had hypersensitivity (allergy) to infliximab in the past or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Inflectra. Inflectra must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (inability of the heart to pump enough blood around the body). For the full list of restrictions, see the package leaflet.
Why has Inflectra - infliximab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Inflectra 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 that Inflectra be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Inflectra - infliximab?
A risk management plan has been developed to ensure that Inflectra 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 Inflectra, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Inflectra will provide educational material for doctors to prescribe the medicine for adults and children, including advice on the medicine's safety and an alert card to give to patients. The company will also carry out studies to confirm the long-term safety of the medicine.
More information about Inflectra - infliximab
On 10 September 2013, the European Commission issued a "Marketing Authorization" for Inflectra, valid throughout the European Union.
For more information about Inflectra therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. This summary was last updated on 09/2013.
The information on Inflectra - 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.
