WHO Drug Information Vol. 16, No. 2, 2002
(2002; 91 pages) View the PDF document
Table of Contents
Open this folder and view contentsHerbal Medicines
Open this folder and view contentsCurrent Topics
Open this folder and view contentsGood Clinical Practices
Open this folder and view contentsSafety Information
Close this folderRegulatory Action
View the documentAlosetron hydrochloride: restricted marketing
View the documentBaclofen: abrupt discontinuation dangerous
View the documentIrinotecan: prescribing changes
View the documentSodium oxybate/GHB approved for cataplexy
View the documentRofecoxib: new indication and label changes
Open this folder and view contentsEssential Medicines
Open this folder and view contentsRecent Publications and Sources of Information
View the documentProposed International Nonproprietary Names: List 87

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

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