ct their physician if symptoms of a hypersensitivity reaction occur.
Other precautions
This medicinal product contains 0.150 mmol sodium (which is 3.45 mg sodium) per ml of concentrate. To be taken into consideration by patients on a controlled sodium diet.
Vectibix in combination with irinotecan, bolus 5-flourouracil, and leucovorin (IFL) chemotherapy
Patients receiving Vectibix in combination with the IFL regimen [bolus 5-fluorouracil (500 mg/m2), leucovorin (20 mg/m2) and irinotecan (125 mg/m2)] experienced a high incidence of severe diarrhoea (see section 4.8). Therefore administration of Vectibix in combination with IFL should be avoided (see section 4.5).
Vectibix in combination with bevacizumab and chemotherapy regimens
A randomised, open-label, multicentre study of 1,053 patients eva luated the efficacy of bevacizumab and oxaliplatin- or irinotecan-containing chemotherapeutic regimens with and without Vectibix in the first-line treatment of metastatic colorectal cancer. Shortened progression free survival time and increased deaths were observed in the patients receiving Vectibix in combination with bevacizumab and chemotherapy. A greater frequency of pulmonary embolism, infections (predominantly of dermatologic origin), diarrhoea, electrolyte imbalances, nausea, vomiting and dehydration was also observed in the treatment arms using Vectibix in combination with bevacizumab and chemotherapy. An additional analysis of efficacy data by KRAS status did not identify a subset of patients who benefited from Vectibix in combination with oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. A trend towards worse survival was observed with Vectibix in the wild-type KRAS subset of the bevacizumab and oxaliplatin cohort, and a trend towards worse survival was observed with Vectibix in the bevacizumab and irinotecan cohort regardless of KRAS mutational status. Therefore, Vectibix should not be administered in combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1).
Vectibix in combination with oxaliplatin-based chemotherapy in patients with mutant KRAS mCRC or for whom KRAS tumour status is unknown
The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant KRAS mCRC or for whom KRAS mCRC status is unknown. In a phase 3 study (n = 1183, 656 patients with wild-type KRAS and 440 patients with mutant KRAS tumours) eva luating panitumumab in combination with infusional 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) compared to FOLFOX alone as first-line therapy for mCRC, a shortened progression-free survival and overall survival time were observed in patients with mutant KRAS tumours who received panitumumab and FOLFOX (n = 221) vs. FOLFOX alone (n = 219).
KRAS mutational status should be determined using a validated test method by an experienced laboratory. If Vectibix is to be used in combination with FOLFOX then it is recommended that mutational status be determined by a laboratory that participates in a KRAS European Quality Assurance program or wild-type status be confirmed in a duplicate test.
Acute renal failure
Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration.
Ocular toxicities
Serious cases of keratitis and ulcerative keratitis have been rarely reported in the post-marketing setting. Patients presenting with signs and symptoms suggestive of keratitis s |
