See you at <strong>the</strong> jointECCO 15 and 34 TH ESMOMultidisciplinary CongressBERLIN, 20-24 SEPTEMBER 2009www.ecco-org.eu<strong>European</strong> <strong>Society</strong>for Medical <strong>Oncology</strong>
Introducing Vectibix ® : <strong>the</strong> first 100% human anti-EGFR monoclonalantibody for mCRC* patients with nonmutated (wild type) KRAS 1The power ofindividualised <strong>the</strong>rapy…NOW IN YOUR HANDS*mCRC: metastatic colorectal cancerReference: 1.Vectibix ® Summary of Product Characteristics 2007.VECTIBIX ® (panitumumab)ABBREVIATED PRESCRIBING INFORMATIONPlease refer to <strong>the</strong> Summary of Product Characteristicsbefore prescribing Vectibix ® (panitumumab).PHARMACEUTICAL FORM: Vectibix ® 20 mg/ml concentratefor solution for infusion. Each vial contains 100 mgof panitumumab in 5 ml. Excipients: sodium chloride,sodium acetate trihydrate, acetic acid (glacial [for pHadjustment]), water for injection.INDICATION: Mono<strong>the</strong>rapy for <strong>the</strong> treatment of patientswith EGFR-expressing, metastatic colorectal carcinoma(mCRC) with nonmutated (wild type) KRAS after failureof fluoropyrimidine-, oxaliplatin-, and irinotecancontainingchemo<strong>the</strong>rapy regimens.DOSAGE AND ADMINISTRATION: The recommended doseof Vectibix ® is 6 mg/kg of bodyweight given onceevery two weeks. The recommended infusion time isapproximately 60 minutes. Doses higher than 1000 mgshould be infused over approximately 90 minutes.CONTRAINDICATIONS: Hypersensitivity to <strong>the</strong> activesubstance or to any of <strong>the</strong> excipients, interstitialpneumonitis or pulmonary fibrosis.© 2007 Amgen. All rights reserved. PMO-AMG-620-2007SPECIAL WARNINGS AND PRECAUTIONS: Dermatologicreactions: Dermatologic reactions are experiencedwith nearly all patients (approximately 90%) treatedwith Vectibix ® ; <strong>the</strong> majority are mild to moderate innature. If a patient develops dermatologic reactionsthat are grade 3 (NCI-CTC/CTCAE) or higher orconsidered intolerable, temporarily withhold Vectibix ®until <strong>the</strong> reactions have improved to grade 2. Onceimproved to grade 2, reinstate administration at50% of <strong>the</strong> original dose. If reactions do not recur,escalate <strong>the</strong> dose by 25% increments until <strong>the</strong>recommended dose is reached. If reactions do notresolve (to grade 2) or if reactions recur or becomeintolerable at 50% of <strong>the</strong> original dose, <strong>the</strong> useof Vectibix ® should be permanently discontinued.Pulmonary complications: If pneumonitis or lunginfiltrates are diagnosed, Vectibix ® should bediscontinued and <strong>the</strong> patient should be treatedappropriately. Hypomagnesaemia: Patients shouldbe periodically monitored for hypomagnesaemia andaccompanying hypocalcaemia every 2 weeks duringVectibix ® treatment, and for 8 weeks after <strong>the</strong>completion of treatment.INTERACTIONS: Concomitant use of Vectibix ® and IFLor bevacizumab and chemo<strong>the</strong>rapy combinations is notrecommended. Increased deaths were observed whenpanitumumab was administered in combination withbevacizumab and chemo<strong>the</strong>rapy combinations. Patientsreceiving Vectibix ® in combination with IFL regimen,leucovorin and irinotecan experienced severe diarrhoea;<strong>the</strong>refore administration of Vectibix ® in combinationwith IFL should be avoided.PREGNANCY AND LACTATION: There are no adequate datafrom <strong>the</strong> use of Vectibix ® in pregnant women. In womenof childbearing potential, appropriate contraceptivemeasures must be used during treatment and for6 months following <strong>the</strong> last dose. It is recommendedthat women do not breast-feed during treatment withVectibix ® and for 3 months after <strong>the</strong> last dose.UNDESIRABLE EFFECTS: Very common ( 1/10): Rash,erythaema, skin exfoliation, pruritus, dry skin,skin fissures, paronychia, diarrhoea, fatigue,nausea, vomiting, dyspnoea, cough. Common( 1/100 to < 1/10): Infusion reactions (pyrexia, chills),hypomagnesaemia, hypocalcaemia, hypokalaemia,dehydration, headache, conjunctivitis, growth ofeyelashes, increased lacrimation, ocular hyperaemia, dry eye,eye pruritus, stomatitis, mucosal inflammation,onycholysis, hypertrichosis, alopecia, nasal dryness,dry mouth.PHARMACEUTICAL PARTICULARS: Store in a refrigerator(2°C – 8°C). Do not freeze. Store in <strong>the</strong> original cartonin order to protect from light. Chemical and physicalin-use stability has been demonstrated for 24 hoursat 25°C. Vectibix ® should be diluted in 0.9% sodiumchloride injection using aseptic conditions.LEGAL CLASSIFICATION: Medicinal product subject tomedical prescription.MARKETING AUTHORISATION HOLDER: AmgenEurope B.V., Minervum 7061, NL-4817 ZK Breda, TheNe<strong>the</strong>rlands. Fur<strong>the</strong>r information is available fromAmgen (Europe) GmbH, Dammstrasse 23, PO Box 1557,Zug, Switzerland, CH-6301. Additional informationmay be obtained from your local Amgen office.Marketing Authorisation Number 100 mg vial:EU/1/07/423/001
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