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1 x 0.25 mg
Paloxi should be used only before chemotherapy administration. This medicinal product should be administered by a healthcare professional under appropriate medical supervision.
Adults: 250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. Paloxi should be injected over 30 seconds.
The efficacy of Paloxi in the revention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Elderly: No dose adjustment is necessary for the elderly.
Paediatric population: Children and Adolescents (aged 1 month to 17 years):
20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetronadministered as a single 15 minute intravenous infusion beginning approximately 30 minutes beforethe start of chemotherapy.
The safety and efficacy of Paloxi in children aged less than 1 month have not been established. Nodata are available. There are limited data on the use of Paloxi in the prevention of nausea and vomitingin children under 2 years of age.
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 intravenous use.
Paloxi is indicated in adults and in paediatric patients 1 month of age and older for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Hypersensitivity to the active substance or to any of the excipients.
As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms.
At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval. A specific thorough QT/QTc study was conducted in healthy volunteers for definitive data demonstrating the effect of palonosetron on QT/QTc.
However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval. These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmias, conduction disturbances and in patients taking anti-arrhythmic agents
or other medicinal products that lead to QT prolongation or electrolyte abnormalities. Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3-antagonist administration.
There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs). Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Paloxi should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree’.
In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to Paloxi, were headache (9 %) and constipation (5 %).
See prescribing information for full details.
Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes. Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Chemotherapeutic agents: In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
Metoclopramide: In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
CYP2D6 inducers and inhibitors: In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin)
and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine).
Corticosteroids: Palonosetron has been administered safely with corticosteroids.
Serotonergic Drugs (e.g. SSRIs and SNRIs): There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).
Other medicinal products: Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.
Pregnancy and Lactation
Pregnancy: For Palonosetron no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Only limited data from animal studies are available regarding the placental transfer.
There is no experience of palonosetron in human pregnancy. Therefore, palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Breast-feeding: As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy.
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 Paloxi, 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 Paloxi overdose.
Paediatric population: No case of overdose has been reported in paediatric clinical studies.
Incompatibilities: This medicinal product must not be mixed with other medicinal products.
Storage: Store below 25°C.
Upon opening of the vial, use immediately and discard any unused solution.