What is Inlyta - axitinib?
Inlyta is a medicine that contains the active substance axitinib . It is available as tablets (1, 3, 5 and 7 mg)
What is Inlyta - axitinib used for?
Inlyta is used in adults for the treatment of advanced renal cell carcinoma, a type of kidney cancer. "Advanced" means that the cancer has begun to spread. Inlyta is used when treatment with Sutent (sunitinib) or "cytokines" (another anticancer medicine) has failed. The medicine can only be obtained with a prescription.
How is Inlyta - axitinib used?
Treatment with Inlyta should be started by a doctor who has experience in the use of anticancer medicines. The recommended starting dose is 5 mg twice a day, taken approximately 12 hours apart. The dose can be varied depending on the patient's response. In patients who tolerate the 5 mg dose well, do not suffer from high blood pressure and are not taking blood pressure medicines, the dose may be increased initially to 7 mg and thereafter up to a maximum of 10 mg twice a day. To manage certain side effects, it may be necessary to reduce the dose or stop treatment. In patients who use certain other drugs, your doctor may need to change the dose of Inlyta. Patients with moderately reduced liver function should be given an initial dose of 2 mg twice a day. Inlyta should not be used in patients who have severe impairment of liver function.
How does Inlyta - axitinib work?
The active substance in Inlyta, axitinib, works by blocking certain enzymes known as tyrosine kinases that occur in the receptors of the "vascular endothelial growth factor" (VEGF) on the surface of tumor cells. VEGF receptors contribute to the growth and spread of cancer cells and the development of blood vessels that feed the tumor. By blocking these receptors, Inlyta helps to slow down the growth and spread of the tumor and to interrupt the flow of blood that allows cancer cells to grow.
How has Inlyta - axitinib been studied?
Inlyta was compared with sorafenib (another anticancer medicine) in a main study involving 723 patients with advanced renal cell carcinoma who did not respond positively to previous treatment with other anticancer medicines such as sunitinib or cytokines. The main measure of effectiveness was the period of time during which patients lived without worsening the tumor.
What benefit has Inlyta - axitinib shown during the studies?
Inlyta was more effective than sorafenib in the treatment of advanced renal cell carcinoma. Patients treated with Inlyta lived on average 6.7 months without their disease getting worse, compared to 4.7 months for patients treated with sorafenib. The effects were better in those patients who had previously been treated with cytokines instead of sunitinib.
What is the risk associated with Inlyta - axitinib?
The most serious side effects of Inlyta are events related to heart failure (when the heart is unable to pump enough blood into the body), embolic and thrombotic arterial or venous events (blood clots in the arteries or veins), bleeding (bleeding), gastrointestinal perforation (perforation of the intestine) and formation of fistulas (abnormal communication channels that are created between the intestine and other organs), hypertensive crisis (severe increase in blood pressure) and reversible posterior encephalopathy syndrome (swelling reversible in the brain). The most common side effects with Inlyta (seen in more than 20% of patients) are diarrhea, hypertension (high blood pressure), fatigue (tiredness), dysphonia (speech disorder), nausea (feeling sick), decreased palmo-plantar appetite and erythrodysaesthesia (rash and numbness of the palms of the hands and soles of the feet). For the full list of restrictions and side effects reported with Inlyta, see the package leaflet.
Why has Inlyta - axitinib been approved?
The CHMP concluded that the efficacy of Inlyta has been demonstrated in the treatment of patients with advanced renal cell carcinoma for which therapy with Sutent or a cytokine was not successful. Regarding safety, the side effects of the medicine are similar to those of other drugs of the same class and are considered acceptable and manageable. Therefore, the CHMP decided that Inlyta's benefits are greater than its risks and recommended that it be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Inlyta - axitinib?
A risk management plan has been developed to ensure that Inlyta 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 Inlyta, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Inlyta - axitinib
On 3 September 2012, the European Commission issued a marketing authorization valid for Inlyta, valid throughout the European Union. For more information about treatment with Inlyta, read the package leaflet (also part of the EPAR) or contact your doctor or the pharmacist. Last update of this summary: 06-2014.
