Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
panitumumab
Amgen Europe B.V.
L01XC08
panitumumab
Antineoplastic agents
Colorectal Neoplasms
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): , in first-line in combination with Folfox or Folfiri., in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)., as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Revision: 34
Authorised
2007-12-03
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE USER VECTIBIX 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION panitumumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor. • If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vectibix is and what it is used for 2. What you need to know before you use Vectibix 3. How to use Vectibix 4. Possible side effects 5. How to store Vectibix 6. Contents of the pack and other information 1. WHAT VECTIBIX IS AND WHAT IT IS USED FOR Vectibix is used in the treatment of metastatic colorectal cancer (cancer of the bowel) for adult patients with a certain type of tumour known as a “Wild-type _RAS _ tumour”. Vectibix is used alone or in combination with other anti-cancer medicines. Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins, which specifically recognise and attach (bind) to other unique proteins in the body. Panitumumab recognises and binds specifically to a protein known as epidermal growth factor receptor (EGFR), which is found on the surface of some cancer cells. When growth factors (other body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide. Panitumumab binds onto the EGFR and prevents the cancer cell from receiving the messages it needs for growth and division. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VECTIBIX DO NOT USE VECTIBIX • if you are allergic to panitumumab or any of the other ingredients of this medicine (listed in section 6). • if you have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in t Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg panitumumab. Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL. When prepared according to the instructions given in section 6.6, the final panitumumab concentration should not exceed 10 mg/mL. Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology. Excipient with known effect Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, proteinaceous panitumumab particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vectibix is indicated for the treatment of adult patients with wild-type _RAS_ metastatic colorectal cancer (mCRC): • in first-line in combination with FOLFOX or FOLFIRI. • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Evidence of wild-type _RAS_ ( _KRAS_ and _NRAS_ ) status is required before initiating treatment with Vectibix. Mutational status should be determined by an experienced laboratory using validated test methods for detection of _KRAS_ (exons 2, 3, and 4) and _NRAS_ (exons 2, 3, and 4) mutations. Posology The recommended dose of Vectibix is 6 mg/kg of bodyweight given once every two weeks. 3 Modification of the dose of Vectibix may be necessary in cases of severe Lesen Sie das vollständige Dokument