O-f9r-~£.. 'i..'-7--ltO~-Page 1 of 141 Vectibix™ (panitumumab)2 For Intravenous Use OnlyWARNINGDermatologic Toxicity: Dermatologic toxicities, related to Vectibix™ blockade ofEGFbinding and subsequent inhibition ofEGFR-mediated signaling pathways, were reported in 89%of patients and were severe (NCI-CTC grade 3 and higher) in 12% of patients receivingVectibix™ monotherapy. The clinical manifestations included, but were not limited to,dermatitis acneiform, pruritus, eryhema, rash, skin exfoliation, paronychia, dry skin, and skinfissures. Severe dermatologic toxicities were complicated by infection including sepsis, septicdeath, and abscesses requiring incisions and drainage. Withhold or discontinue Vectibix™ andmonitor for inflamatory or infectious sequelae in patients with severe dermatologic toxicities(see WARNINGS: Dermatologic, Mucosal, and Ocular Toxicity; ADVERSE REACTIONS:Dermatologic, Mucosal, and Ocular Toxicity; and DOSAGE AND ADMINISTRATION:Dose Modifcations, Dermatologic Toxicity,Infusion Reactions: Severe infusion reactions occured with the administration ofVectibix™ inapproximately 1 % of patients. Severe infusion reactions were identified by reports ofanaphylactic reaction, bronchospasm, fever, chils, and hypotension (see WARNINGS:Infusion Reactions and ADVERSE REACTIONS: Infusion Reactions, Although fatalinfusion reactions have not been reported with Vectibix™, fatalities havc occurred with othermonoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending onthe severity and! or persistence of the reaction, permanently discontinue Vectibix ™ (seeDOSAGE AND ADMINISTRATION: Dose Modifications, Inlusion Reactions,34 DESCRIPTION5 V ectibix ™ (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody ...
