What is Aloxi?
Aloxi is a solution for injection that contains the active substance palonosetron.
What is Aloxi used for?
Aloxi is an antiemetic (a medicine that prevents nausea and vomiting). It is used for the prevention of nausea and vomiting caused by chemotherapy (drugs used to treat cancer). Aloxi is used in highly emetogenic chemotherapy (strongly generating nausea and vomiting) (eg cisplatin) and in moderately emetogenic chemotherapy (eg cyclophosphamide, doxorubicin or carboplatin).
How is Aloxi used?
Aloxi is injected by a doctor or nurse about 30 minutes before the start of chemotherapy. The usual dose of Aloxi is 250 micrograms administered with a vein injection lasting 30 seconds. The effectiveness of Aloxi can be increased by adding a corticosteroid (a type of drug that can be used as an anti-emetic). Aloxi should only be given before chemotherapy. It is not recommended in patients under the age of 18 because there is not enough information on its effects in this age group.
How does Aloxi work?
The active ingredient in Aloxi, palonosetron, is a "5HT3 antagonist", meaning it prevents a chemical called 5-hydroxytryptamine (5HT, also known as serotonin) from binding to its receptors in the intestine. When it binds to these receptors, 5HT normally causes nausea and vomiting. By blocking these receptors, Aloxi prevents the nausea and vomiting that often arise after chemotherapy.
What studies have been carried out on Aloxi?
Aloxi has been studied in three main studies involving 1, 842 adults receiving highly or moderately emetogenic chemotherapy. Aloxi, given at two different doses, was compared with other antiemetic drugs of the same type (ondansetron and dolasetron). The number of patients who had not vomited within 24 hours of receiving chemotherapy was measured in the studies. In another study, the effectiveness of Aloxi in the prevention of nausea and vomiting was analyzed in cases of repeated chemotherapy cycles. In this study Aloxi was not compared with other antiemetics.
What benefit has Aloxi shown during the studies?
Aloxi has proved as safe and effective as other antiemetics. In highly emetogenic chemotherapy, 59% of patients treated with Aloxi did not vomit in the 24 following chemotherapy (132 out of 223), compared to 57% of those treated with ondansetron (126 out of 221).
In moderately emetogenic chemotherapy, 81% of patients treated with Aloxi did not vomit in the 24 following chemotherapy (153 out of 189), compared with 69% of those treated with ondansetron (127 out of 185). When compared with dolasetron, the corresponding values were 63% for Aloxi (119 of 189 patients) and 53% for dolasetron (101 of 191 patients). The effectiveness of Aloxi has also been found in repeated cycles of chemotherapy.
What is the risk associated with Aloxi?
The most common side effects of Aloxi (seen in between 1 and 10 patients in 100) are headache, dizziness, constipation and diarrhea. For the full list of all side effects reported with Aloxi, see the Package Leaflet.
Aloxi should not be used in people who may be hypersensitive (allergic) to palonosetron or other ingredients in the medicine.
Why has Aloxi been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aloxi's benefits are greater than its risks for the prevention of nausea and vomiting caused by highly or moderately emetogenic cancer chemotherapy. The committee recommended that Aloxi be given marketing authorization.
More information on Aloxi
On March 22, 2005, the European Commission granted Alyni a marketing authorization valid throughout the European Union to Helsinn Birex Pharmaceuticals Ltd.
The full EPAR for Aloxi can be found here
Last update of this summary: 01-2009.
