ALOXI Soft capsule Ref.[8703] Active ingredients: Palonosetron

Aloxi should be used only before chemotherapy administration.

Posology

Adults

500 micrograms palonosetron administered orally approximately one hour before the start of chemotherapy.

Elderly population

No dose adjustment is necessary for the elderly.

Paediatric population

The safety and efficacy of Aloxi in children have not been established. Currently available data are described in section 5.1 and section 5.2, but no recommendation on posology can be made.

Hepatic impairment

No dose adjustment is necessary for patients with impaired hepatic function.

Renal impairment

No dose adjustment is necessary for patients with impaired renal function. No data are available for patients with end stage renal disease undergoing haemodialysis.

Method of administration

For oral use.

Aloxi can be taken with or without food.

No case of overdose has been reported.

Doses of up to 6 mg have been used in clinical trials. 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.

4 years.

This medicinal product does not require any special storage conditions.

Polyamide/aluminium/PVC blister containing one or five soft capsules.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.