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Author: Helsinn Birex Pharmaceuticals Ltd.


Long information

What is it?

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 beige capsules (500 micrograms).

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it 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 for chemotherapy that is 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 for chemotherapy that is a moderate trigger of nausea and vomiting in adults.

How is it used?

Aloxi should only be given before chemotherapy by a healthcare professional.
The injection is given into a vein over 30 seconds about 30 minutes before the start of chemotherapy, 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).
Alternatively, the patients should take one capsule one hour before the start of chemotherapy.

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How does it work?

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 it 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). 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 benefits has it 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 patients 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 patients 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 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?

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 patients in 100. 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 any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Aloxi are greater than its risks and recommended that it be given marketing authorisation.

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