What is Yervoy - ipilimumab?
Yervoy is a medicine that contains the active substance ipilimumab. It is available as a concentrate for solution for infusion (drip into a vein).
What is Yervoy used for - ipilimumab?
Yervoy is used for the treatment of advanced melanoma (a type of skin cancer associated with cells called melanocytes). It is used in patients who have had previous treatment that has not worked or is no longer working.
The medicine can only be obtained with a prescription.
How is Yervoy used - ipilimumab?
Treatment with Yervoy should be initiated and supervised by specialist doctors with experience in the treatment of cancer.
The doctor should perform blood tests to check the patient's liver and thyroid function before starting treatment and regularly during treatment.
Yervoy is administered as an intravenous infusion lasting 90 minutes. The patient receives a total of four doses, at three-week intervals between doses. The recommended dose for each infusion is 3 mg / kg body weight.
How does Yervoy work - ipilimumab?
The active substance in Yervoy, ipilimumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize a specific structure (called an antigen) present in certain cells of the body and attach itself to it.
Ipilimumab was created to attach to a protein called CTLA-4, which is present on the surface of T cells (a type of white blood cell), and block its activity. The CTLA-4 protein inhibits the activity of T cells. Ipilimumab, by blocking CTLA-4, allows the activation and diffusion of T cells, which infiltrate the cancer cells left in the body after a previous therapy and destroy them.
How has Yervoy been studied - ipilimumab?
The effects of Yervoy were first tested in experimental models before being studied in humans.
One main study was conducted involving 676 patients who were given Yervoy, an investigational medicine called 'gp100' or a combination of Yervoy and gp100. All patients had previously undergone advanced melanoma therapy. The main measure of effectiveness was overall survival (their lifespan).
What benefit has Yervoy - ipilimumab shown during the studies?
Yervoy has been shown to improve overall survival. Patients on Yervoy or combined therapy survived for approximately 10 months, compared with 6 months for gp100 monotherapy.
What is the risk associated with Yervoy - ipilimumab?
Yervoy is usually associated with side effects due to excessive activity of the immune system, including severe reactions and inflammation. Most side effects go away with adequate therapy or when Yervoy is stopped. The most common single side effects, seen in more than 10% of patients, are diarrhea, skin rash, itching, tired feeling, nausea, vomiting, loss of appetite and abdominal pain. For the full list of side effects seen with Yervoy, see the package leaflet.
Yervoy must not be used in people who may be hypersensitive (allergic) to ipilimumab or any of the other ingredients.
Why has Yervoy - ipilimumab been approved?
The CHMP noted that Yervoy has been shown to improve survival in a situation where overall survival rates are low. As for the side effects of the medicine, the most common were mild to moderate in severity. The CHMP therefore decided that Yervoy's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.
What measures are being taken to ensure the safe use of Yervoy - ipilimumab?
The company that makes Yervoy must ensure that all healthcare professionals who may prescribe the medicine and all patients receive a leaflet with information on the medicine's safety, inter alia with regard to side effects related to overactive immune system. Patients will also receive an alert card from their doctor with a summary of key information on the safety of the medicine.
Other information about Yervoy - ipilimumab
On 13.07.2011 the European Commission issued a "marketing authorization" for Yervoy, valid throughout the European Union.
For more information about Yervoy therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 06-2011.
The information on Yervoy - ipilimumab 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.
