What is Inflectra and what is it used for - infliximab?
Inflectra is an anti-inflammatory medicine that contains the active substance infliximab . It is usually used, when other medicines or treatments are not effective, in adults suffering from the following diseases:
- rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints). Inflectra is used with methotrexate (a medicine that acts on the immune system);
- Crohn's disease (a disease that causes inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with formation of 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 the formation of red scaly spots on the skin and inflammation of the joints);
- psoriasis (a disease that causes the formation of red scaly spots on the skin).
Inflectra is also used in the treatment of severe active Crohn's disease or severe active ulcerative colitis in patients aged between six and 17 who have not responded or cannot be treated with other medicines or therapies. For complete details, see the summary of product characteristics (included with EPAR). Inflectra is a "biosimilar" medicine. This means that Inflectra is similar to a biological medicine (the 'reference medicine') already authorized in the European 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 must be started and supervised by a specialist doctor experienced in the diagnosis and treatment of diseases for which Inflectra is indicated. Inflectra is usually given at a dose of 3 mg per kilogram of 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. Inflectra 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 treatment with Inflectra, or the infusion rate may be slowed. For more information, see the package leaflet. Patients treated with Inflectra must receive a special alert card, which summarizes the information regarding the safety of the medicine.
How does Inflectra work - infliximab?
The active ingredient in Inflectra, infliximab, is a monoclonal antibody, which is an antibody (a type of protein) designed to recognize a specific structure (called an antigen) present in the body and bind to it. Infliximab was designed to bind 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 suffering from 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 composed 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 has been designed to demonstrate its comparability to the reference medicine, Remicade. Inflectra was compared with Remicade in a 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 found to be as effective as Remicade, with about 60% of patients responding to treatment with either medicine.
An additional study was performed on 250 patients with ankylosing spondylitis to show that Inflectra produces levels of the active substance in the body 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 patient in 10) are viral infections (such as flu or cold sores), 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 Inflectra, see the package leaflet. Inflectra should not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past or who are hypersensitive (allergic) to mouse proteins or to any of the other components of Inflectra. Inflectra should not be used in patients with tuberculosis, other serious infections or moderate or severe heart failure (inability of the heart to pump enough blood into the body). For the full list of limitations, see the package leaflet.
Why has Inflectra been approved - infliximab?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has 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 the approval of the use of Inflectra 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 included in the summary of product characteristics and the 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 information material to doctors who will prescribe the medicine to adults and children, including information on the safety of the medicine and an alert card to be delivered to patients. The company will also perform studies to confirm the long-term safety of the medicine.
More information on Inflectra - infliximab
On 10 September 2013, the European Commission issued Inflectra a marketing authorization valid throughout the European Union.
For more information about therapy with Inflectra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09/2013.
