SAFETY AND PHARMACOKINETIC EVALUATION OF REPEATED DOSING OF PALONOSETRON IN PATIENTS RECEIVING HIGH OR MODERATE EMETIC RISK CHEMOTHERAPY

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Abstract

Aim

To assess the safety, pharmacokinetics and tolerability of repeated dosing of palonosetron in patients receiving chemotherapy categorized as high or moderate emetic risk.

Method

Sixteen patients undergoing high or moderate enemic risk chemotherapy were administered palonosetron 0.75 mg IV once daily 30 min before chemotherapy on days 1 and 3. Blood samples were collected for pharmacokinetics analysis at several point on days 1–5.

Result

The observed mean Cmax values on day 1 and 3 were 2.05 and 2.90 ng/ml, respectively, with coefficients of variation (CVs) of 30.9% and 34.2%. Mean AUC0-48 h values were 42.4 and 58.3 ng h/ml on days 1 and 3, with a CV of 21.2% and 23.2%, respectively. T1/2 of palonosetron was approximately 40 h and was constant in days 1 and 3. Accumulation of palonosetron on day 3 was 1.42-fold for Cmax and 1.37-fold for AUC0-48 h. Treatment-related adverse events were constipation and loss of appetite. CR (no emesis, no rescue medication) rates of acute phase and late phase were 100% and 68%, respectively.

Conclusions

Repeated dosing of palonosetron on days 1 and 3 was safe and well tolerated for the prevention of nausea and vomiting induced by high or moderate emetic risk chemotherapy.

Conclusions

This study was reviewed and approved by the Fukuoka University Ethics Committee and Institutional Review Board of Fukuoka University Hospital. All patients provided written informed consent.

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