WHO Drug Information Vol. 16, No. 2, 2002
(2002; 91 pages) Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuHerbal Medicines
Ouvrir ce répertoire et afficher son contenuCurrent Topics
Ouvrir ce répertoire et afficher son contenuGood Clinical Practices
Ouvrir ce répertoire et afficher son contenuSafety Information
Fermer ce répertoireRegulatory Action
Afficher le documentAlosetron hydrochloride: restricted marketing
Afficher le documentBaclofen: abrupt discontinuation dangerous
Afficher le documentIrinotecan: prescribing changes
Afficher le documentSodium oxybate/GHB approved for cataplexy
Afficher le documentRofecoxib: new indication and label changes
Ouvrir ce répertoire et afficher son contenuEssential Medicines
Ouvrir ce répertoire et afficher son contenuRecent Publications and Sources of Information
Afficher le 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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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 29 octobre 2018