What is Nulojix - belatacept?
Nulojix is a powder for solution for intravenous infusion (drip into a vein) containing the active substance belatacept.
What is Nulojix - belatacept used for?
Nulojix is given in adults for the prevention of rejection of the transplanted kidney.
It is used in combination with corticosteroids and mycophenolic acid (other medicines to prevent organ rejection). In addition, during the first week after kidney transplantation, an interleukin-2 receptor antagonist should also be combined with Nulojix.
The medicine can only be obtained with a prescription.
How is Nulojix - belatacept used?
Treatment with Nulojix should only be prescribed and supervised by a physician experienced in the management of kidney transplant patients.
Nulojix should be administered by intravenous infusion over 30 minutes. Doses are calculated based on the patient's weight. In the initial phase the dosage is 10 mg per kilogram on day 1 (day of transplant or previous day) and then again on days 5, 14, 28 and at the end of the eighth and twelfth week.
After the initial phase, which lasts three months, a maintenance dose of 5 mg / kg is administered every four weeks, starting at the end of the sixteenth week.
How does Nulojix - belatacept work?
The active ingredient in Nulojix, belatacept, is an immunosuppressive drug that represses the activity of T cells, cells of the immune system that may be involved in organ rejection.
Before they can take action, the T lymphocytes must be "activated". This happens when certain molecules bind to receptors on their surface. Belatacept binds to two of these molecules, called CD80 and CD86, preventing them from activating T lymphocytes and thus helping to prevent rejection of the transplanted organ.
Belatacept is produced using a method known as "recombinant DNA technology": a cell receives a gene (DNA) that makes it able to produce it.
What studies have been performed on Nulojix - belatacept?
The effects of Nulojix were first tested in experimental models before being studied in humans.
Nulojix was compared with cyclosporin A (another medicine used to prevent organ rejection) in two pivotal studies involving a total of 1, 209 kidney transplant patients. Some patients were given intensive Nulojix treatment, which included an initial phase longer than six months. Corticosteroids, mycophenolic acid and basiliximab (an interleukin-2 receptor antagonist) were also administered during the first week after transplantation.
The main measures of effectiveness considered were the proportion of surviving patients with intact transplanted kidney and organ function. The studies also examined the number of organ discards that occurred within a year of transplantation.
What benefit has Nulojix - belatacept shown during the studies?
Nulojix was able to improve the patient's and organ's chances of survival following kidney transplantation. In the first study, 97% of patients treated with Nulojix survived with intact kidney (218 out of 226), compared with 93% of patients treated with cyclosporin A. Renal function was compromised in about 54% of patients treated with Nulojix and in 78% of those treated with cyclosporin A. The proportion of patients who had a rejection within a year of transplantation was 17% for Nulojix and 7% for cyclosporin A.
In the second study, 89% (155 of 175) of patients treated with Nulojix and 85% (157 of 184) of those treated with cyclosporin A survived with the intact kidney. Renal function was compromised in 77% of patients treated with Nulojix and 85% of those treated with cyclosporin A. The proportion of patients who had a rejection within a year of transplantation was 18% for Nulojix and 14% for cyclosporine A.
The intensive Nulojix-based treatment with an initial phase of six months produced results similar to the initial treatment phase of three months.
What are the risks associated with Nulojix - belatacept?
The most common serious side effects of Nulojix, found in more than 2% of patients, are: urinary tract infection (infection of the apparatus that carries urine), cytomegalovirus infection, pyrexia (fever), increased blood creatinine (markers of kidney problems), pyelonephritis (renal infection), diarrhea, gastroenteritis (diarrhea and vomiting), poor functionality of the transplanted kidney, leukopenia (low number of white blood cells), pneumonia (lung infection), basal cell carcinoma (a tumor), anemia (low number of red blood cells), dehydration. For the full list of all side effects reported with Nulojix, see the Package Leaflet.
Nulojix should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients. It must not be used in patients who have not been exposed to Epstein-Barr virus or whose exposure is uncertain. In fact, patients treated with Nulojix who have not been exposed to the virus are at greater risk of developing a type of cancer known as post-transplant lymphoproliferative disorder.
Why has Nulojix - belatacept been approved?
The CHMP noted that Nulojix does not have the toxic effects on kidney found with other immunosuppressive drugs commonly used in transplants. Although the studies show a greater number of discards after one year of treatment with Nulojix compared to cyclosporin A, patient and organ survival is not reduced after three years. Overall, the benefits of Nulojix are comparable to those of the comparator medicine. The CHMP therefore decided that Nulojix's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Nulojix - belatacept
On 17 June 2011, the European Commission issued a marketing authorization for Nulojix, valid throughout the European Union, to Bristol-Myers Squibb Pharma EEIG. The marketing authorization is valid for five years, after which it can be renewed.
For more information on treatment with Nulojix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 05-2011.
