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

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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