ALOXI (palonosetron), injectable antiemetic
GASTROENTEROLOGY - New indication
Opinions on drugs -
Posted on
Apr 14 2016
Reason for request
Extension of Inclusion
No clinical benefit demonstrated in the prevention of nausea and vomiting caused by cancer chemotherapy in children aged > 1 month by comparison with ondansetron.
- ALOXI 250 µg now has Marketing Authorisation in paediatric patients 1 month of age and older for the prevention of acute nausea and vomiting associated with highly or moderately emetogenic cancer chemotherapy.
- It is the first setron to have been granted Marketing Authorisation in infants aged between 1 and 6 months. Other setrons are used in this age group, but off-label. There are only very limited clinical data in children under 2 years of age, particularly in infants aged between 1 and 6 months.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |
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