1. Name of the medicinal product
Vectibix® 20 mg/ml concentrate for solution for infusion.
Each ml of concentrate contains 20 mg panitumumab.
Each vial contains either 100 mg of panitumumab in 5 ml, 200 mg of panitumumab in 10 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.
Concentrate for solution for infusion (sterile concentrate).
Colourless solution that may contain, translucent to white, visible amorphous, proteinaceous panitumumab particles.
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.
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. Prior to infusion, Vectibix should be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection to a final concentration not to exceed 10 mg/ml (for preparation instructions see section 6.6).
Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions (see section 4.4).
Special populations
The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment.
There is no clinical data to support dose adjustments in the elderly.
Paediatric population
There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer.
Method of administration
Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter. The recommended infusion time is approximately 60 minutes. If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes. Doses higher than 1000 mg should be infused over approximately 90 minutes (for handling instructions, see section 6.6).
The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions.
A reduction in the rate of infusion of Vectibix may be necessary in cases of infusion-related reactions (see section 4.4).
Vectibix must not be administered as an intravenous push or bolus.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Patients with interstitial pneumonitis or pulmonary fibrosis (see section 4.4).
The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown (see section 4.4).
