(2002; 91 pages)
Irinotecan: prescribing changes
United States of America - Changes in the prescribing information for irinotecan (Campto-sar®), indicated as a component of therapy for first-line treatment of metastatic colorectal cancer in combination with 5-fluorouracil (5-FU) and leucov-orin (LV) and for treatment of metastatic colorectal cancer that has recurred or progressed following initial 5-FU based treatment.
The following labelling changes arose following recommendations made at a meeting of the Food and Drug Administration’s Oncologic Drugs Advisory Committee.
• Both the bolus and the infusional regimens of CAMPTOSAR plus 5-FU/LV® remain approved for the first-line treatment of patients with meta-static colorectal cancer.
• The starting dose and schedule for both regimens remain unchanged.
The prescribing information has been revised to identify patients at higher risk of severe toxicity, to clarify dose modification guidelines, and to augment the information about management of treatment-related toxicities.
Reference: Pharmacia Oncology Web site http://www.pharmaciaoncology.com