What is Palonosetron Accord and what is it used for?
Palonosetron Accord is a medicine used to prevent nausea and vomiting associated with chemotherapy (anticancer therapy). It is used in adults and children 1 year of age or older who are receiving chemotherapy with medicines whose potential to cause nausea and vomiting is high (such as cisplatin) or moderate (such as cyclophosphamide, doxorubicin or carboplatin).
Palonosetron Accord contains the active substance palonosetron. It is a "generic medicine". This means that Palonosetron Accord is similar to a 'reference medicine' already authorized in the European Union (EU) called Aloxi. For more information on generic medicines, see the questions and answers by clicking here.
How is Palonosetron Accord used?
Palonosetron Accord should only be given before chemotherapy. It is available as a solution for injection or infusion into a vein (drip) and should be given by a healthcare professional about 30 minutes before the start of chemotherapy. The recommended dose in adults is 250 micrograms, injected into a vein over 30 seconds. To increase effectiveness it can be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting). In children the solution should be administered as an infusion into a vein over 15 minutes at a dose of 20 micrograms per kilogram of body weight.
The medicine can only be obtained with a prescription.
How does Palonosetron Accord work?
The active ingredient of Palonosetron Accord, palonosetron, is an "antagonist of 5HT3", ie it prevents a chemical substance in the body, called 5-hydroxytryptamine (5HT, also known as serotonin), from binding to 5HT3 receptors in the intestine. When 5HT binds to these receptors, it usually causes nausea and vomiting. By blocking these receptors, Palonosetron Accord prevents nausea and vomiting that often occurs after chemotherapy.
What benefit has Palonosetron Accord shown during the studies?
The company presented data on palonosetron from the scientific literature. No further studies were needed as Palonosetron Accord is a generic medicine given by injection and contains the same active substance as the reference medicine, Aloxi.
What is the risk associated with Palonosetron Accord?
Because Palonosetron Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Palonosetron Accord been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Accord has been shown to be comparable to Aloxi. Therefore, the CHMP considered that, as in the case of Aloxi, the benefits outweigh the identified risks and recommended to approve the use of Palonosetron Accord in the EU.
What measures are being taken to ensure the safe and effective use of Palonosetron Accord?
A risk management plan has been developed to ensure that Palonosetron Accord 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 Palonosetron Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Palonosetron Accord
For the full EPAR version of Palonosetron Accord, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports.
For more information about treatment with Palonosetron Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency's website.
