Aloxi

palonosetron

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This is a summary of the European public assessment report (EPAR) for Aloxi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aloxi.

What is Aloxi?

Aloxi is a medicine that contains the active substance palonosetron. It is available as a solution for injection (250 micrograms in 5 ml) and as capsules (500 micrograms).

What is Aloxi used for?

Aloxi is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer). The solution for injection 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). The capsules are only used in adults for chemotherapy that is a moderate trigger of nausea and vomiting in adults.

The medicine can only be obtained with a prescription.

How is Aloxi used?

Aloxi should only be given before chemotherapy. The solution for injection should be given by a healthcare professional about 30 minutes before the start of chemotherapy. In adults, the solution should be injected into a vein over 30 seconds at a dose of 250 micrograms. It may be made more effective by the addition of a corticosteroid (a type of medicine that can be used to prevent nausea and vomiting). 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.

In adults, if the capsules are used, the patient should take one capsule one hour before the start of chemotherapy.

For more information, see the package leaflet.

How does Aloxi work?

The active substance in Aloxi, 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, Aloxi prevents the nausea and vomiting that often happen after chemotherapy.

How has Aloxi been studied?

Aloxi solution for injection has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting. Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type).

Aloxi solution for injection has also been investigated in one study involving 502 children receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting, where Aloxi was compared with ondansetron.

A further study compared three doses of Aloxi capsules (250, 500 and 750 micrograms) with the solution for injection in 651 adults receiving chemotherapy that was a moderate trigger of nausea and vomiting.

All of the studies measured the number of patients who did not vomit after receiving chemotherapy.

What benefit has Aloxi shown during the studies?

Aloxi solution for injection was as effective as the comparator medicines. With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving ondansetron (126 out of 221). With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185). When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of 191).

In the study in children receiving chemotherapy that was a strong or moderate trigger of nausea and vomiting, 59% of the children receiving Aloxi solution for injection at a dose of 20 micrograms/kilogram did not vomit in the 24 hours after chemotherapy (98 out of 165), which was the same percentage as seen in patients receiving ondansetron (95 out of 162).

In the study looking at Aloxi capsules, all three doses of Aloxi were as effective as the solution for injection over 24 hours, with around three-quarters of the patients not vomiting. However, only the 500 microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500 microgram capsule or the injection did not vomit during this period.

What is the risk associated with Aloxi?

The most common side effect with Aloxi (seen in between 1 and 10 patients in 100) is headache. With the solution for injection, dizziness, constipation and diarrhoea are also seen in between 1 and 10 adults in 100. For the full list of all side effects and restrictions with Aloxi, see the package leaflet.

Why has Aloxi been approved?

The CHMP decided that the benefits of Aloxi are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Aloxi?

A risk management plan has been developed to ensure that Aloxi 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 Aloxi, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Aloxi

The European Commission granted a marketing authorisation valid throughout the European Union for Aloxi on 22 March 2005.

For more information about treatment with Aloxi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Aloxi : EPAR - Summary for the public BG = bălgarski 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public ES = español 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public CS = čeština 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public DA = dansk 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public DE = Deutsch 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public ET = eesti keel 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public EL = elliniká 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public EN = English 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public FR = français 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public IT = italiano 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public LV = latviešu valoda 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public LT = lietuvių kalba 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public HU = magyar 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public MT = Malti 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public NL = Nederlands 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public PL = polski 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public PT = português 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public RO = română 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public SK = slovenčina 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public SL = slovenščina 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public FI = suomi 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public SV = svenska 2009-03-13 2015-04-09
Aloxi : EPAR - Summary for the public HR = Hrvatski 2009-03-13 2015-04-09

This EPAR was last updated on 09/04/2015 .

Authorisation details

Product details

Product details for Aloxi
NameAloxi
Agency product numberEMEA/H/C/000563
Active substance

palonosetron hydrochloride

International non-proprietary name (INN) or common name

palonosetron

Therapeutic area VomitingCancer
Anatomical therapeutic chemical (ATC) code A04AA05

Publication details

Publication details for Aloxi
Marketing-authorisation holder

Helsinn Birex Pharmaceuticals Ltd.

Revision20
Date of issue of marketing authorisation valid throughout the European Union22/03/2005

Contact address:

Helsinn Birex Pharmaceuticals Ltd.
Damastown
Mulhuddart
Dublin 15
Ireland

Product information

Product information

24/02/2015  Aloxi -EMEA/H/C/000563 -II/0038

Name Language First published Last updated
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09
Aloxi : EPAR - Product Information HR = Hrvatski 2009-08-04 2015-04-09

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08
Aloxi : EPAR - All Authorised presentations HR = Hrvatski 2008-01-17 2010-07-08

Pharmacotherapeutic group

Anti-emetics and antinauseants

Therapeutic indication

Aloxi 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.

Aloxi 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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Aloxi : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-08-16  
Aloxi : EPAR - Scientific Discussion HR = Hrvatski 2006-08-16  

Authorised

This medicine is approved for use in the European Union