Active Substance: palonosetron hydrochloride
Common Name: palonosetron
ATC Code: A04AA05
Marketing Authorisation Holder: Hospira UK Limited
Active Substance: palonosetron hydrochloride
Authorisation Date: 2016-04-08
Therapeutic Area: Nausea Vomiting Cancer
Pharmacotherapeutic Group: Antiemetics and antinauseants
Palonosetron Hospira is indicated in adults for:
- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy;
- the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Palonosetron Hospira is indicated in paediatric patients 1 month of age and older for:
- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
What is Palonosetron Hospira and what is it used for?
Palonosetron Hospira is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer). It is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Palonosetron Hospira is a ‘generic medicine’. This means that Palonosetron Hospira is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aloxi.
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 which should be given by a healthcare professional about 30 minutes before the start of chemotherapy. In adults, the recommended dose is 250 micrograms, injected into a vein over 30 seconds. It may be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting) to increase the effect. In children, the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
How does Palonosetron Hospira work?
The active substance in Palonosetron Hospira, palonosetron, is a ‘5HT3 antagonist’. This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut. When 5HT attaches to these receptors, it normally causes nausea and vomiting. By blocking these receptors, Palonosetron Hospira prevents the nausea and vomiting that often happen after chemotherapy.
How has Palonosetron Hospira been studied?
The company provided data from the published literature on palonosetron. No additional studies were needed as Palonosetron Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.
What are the benefits and risks of 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 is Palonosetron Hospira 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’s view was that, as for Aloxi, the benefit outweighs the identified risk. The Committee recommended that Palonosetron Hospira be approved for use 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.
Other information about Palonosetron Hospira
The European Commission granted a marketing authorisation valid throughout the European Union for Palonosetron Hospira on 8 April 2016.
For more information about treatment with Palonosetron Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.