Javlor is a concentrate for solution for infusion (drip into a vein). It contains the active substance vinflunine (25 mg/l).
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Javlor is used for the treatment of adults with advanced or metastatic ?transitional cell carcinoma of the urothelial tract? (a cancer that affects the lining of the bladder and the rest of the urinary tract). ?Metastatic? means that the cancer has spread to other parts of the body. Javlor is used when previous treatment with a platinum-containing anticancer medicine has failed.
The medicine can only be obtained with a prescription.
Treatment with Javlor should be started under the supervision of a doctor qualified to use anticancer medicines. Before administering Javlor, the patient should have a blood test to verify the levels of neutrophils, a type of white blood cell. This is because neutropenia (low levels of neutrophils) is a frequent side effect of the medicine.
The dose of Javlor to be given is based on the patient?s body surface area (calculated using height and weight). The recommended dose is 320 mg per m 2. Javlor is given as a drip into a vein over a period of 20 minutes once every three weeks. The doctor may adjust the dose by taking into account the patient?s age, general condition, previous treatment and whether the patient has neutropenia or problems affecting the liver or kidneys. For more information, see the summary of product characteristics (also part of the EPAR).
The active substance in Javlor, vinflunine, belongs to the group of anticancer medicines known as the vinca alkaloids. It attaches to a protein in cells called ?tubulin?, which is important in the formation of the internal ?skeleton? that cells need to assemble when they divide. By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.
In one main study of 370 adults with advanced or metastatic transitional cell carcinoma of the urothelial tract, patients who were given Javlor treatment were compared with patients who were not given any anticancer medicine. During the study all patients received best supportive care (any medicines or techniques to help patients, but not other anticancer medicines). All the patients had previously received treatment with a platinum-containing medicine which failed. The main measure of effectiveness was how long the patients lived. The study also looked separately at the results in eligible patients who fulfilled strict criteria such as having had a worsening of the disease after treatment with a platinum-containing medicine.
Javlor with best supportive care was more effective than best supportive care alone in prolonging the lives of patients with advanced or metastatic transitional cell carcinoma of the urothelial tract. Among all patients in the study, there was no clear evidence of a difference in survival between patients who received Javlor and those who did not. However, there was a difference among patients who fulfilled the strict criteria entry requirements for the study. In this group, those given Javlor lived for 6.9 months compared with 4.3 months for patients who were not given the Javlor.
The most common side effects with Javlor (seen in more than 1 patient in 10) are neutropenia, leucopenia (low white blood cell counts), anaemia (low red blood cell counts), thrombocytopenia (low platelet count), loss of appetite, peripheral sensory neuropathy (damage to the nerves outside the brain and spinal cord that results in reduced sensation), constipation, abdominal (tummy) pain, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), diarrhoea, alopecia (hair loss), myalgia (muscle pain), asthenia (weakness), injection site reaction, fever and weight loss. For the full list of all side effects reported with Javlor, see the package leaflet.
Javlor should not be used in people who may be hypersensitive (allergic) to vinflunine or other vinca alkaloids. It must not be used in patients who have or have had a severe infection within the past two weeks or in patients with a neutrophil count of less than 1,500 per mm 3 or a platelet count less than 100,000 per mm 3. It must also not be used in breastfeeding mothers.