Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland
Aloxi is indicated in adults for:
Aloxi is indicated in paediatric patients 1 month of age and older for:
Aloxi should be used only before chemotherapy administration. This medicinal product should be administered by a healthcare professional under appropriate medical supervision.
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. Aloxi should be injected over 30 seconds.
The efficacy of Aloxi in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
No dose adjustment is necessary for the elderly.
Children and Adolescents (aged 1 month to 17 years): 20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.
The safety and efficacy of Aloxi in children aged less than 1 month have not been established. No data are available. There are limited data on the use of Aloxi in the prevention of nausea and vomiting in children under 2 years of age.
No dose adjustment is necessary for patients with impaired hepatic function.
No dose adjustment is necessary for patients with impaired renal function. No data are available for patients with end stage renal disease undergoing haemodialysis.
For intravenous use.
No case of overdose has been reported.
Doses of up to 6 mg have been used in adult clinical studies. The highest dose group showed a similar incidence of adverse reactions compared to the other dose groups and no dose response effects were observed. In the unlikely event of overdose with Aloxi, this should be managed with supportive care. Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Aloxi overdose.
No case of overdose has been reported in paediatric clinical studies.
5 years.
Upon opening of the vial, use immediately and discard any unused solution.
This medicinal product does not require any special storage conditions.
Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap.
Available in packs of 1 vial containing 5 ml of solution.
Single use only, any unused solution should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
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