What is Palonosetron Hospira used for and what is it used for?
Palonosetron Hospira is indicated for the prevention of 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 strong (such as cisplatin) or moderate (such as cyclophosphamide, dexorubicin or carboplatin).
Palonosetron Hospira is a "generic medicine". This means that Palonosetron Hospira 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.
Palonosetron Hospira contains the active substance palonosetron.
How is Palonosetron Hospira used?
Palonosetron Hospira should only be given before chemotherapy and can only be obtained with a prescription. It is available as a solution for injection 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 the medicine can be administered 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 (drip) in a 15-minute vein at a dose of 20 micrograms per kilogram of body weight.
How does Palonosetron Hospira work?
The active ingredient in Palonosetron Hospira, palonosetron, is an "antagonist of 5HT3", ie it prevents a chemical 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 Hospira prevents nausea and vomiting that often occur after chemotherapy.
What benefit has Palonosetron Hospira shown during the studies?
The company presented data on palonosetron taken from the published literature. No further studies were needed as Palonosetron Hospira 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 Hospira?
Because Palonosetron Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Palonosetron Hospira been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Hospira 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 Hospira in the EU.
What measures are being taken to ensure the safe and effective use of Palonosetron Hospira?
A risk management plan has been developed to ensure that Palonosetron Hospira 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 Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Palonosetron Hospira
For the full EPAR version of Palonosetron Hospira, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Palonosetron Hospira, 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.
