Posology : מינונים

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 body weight given once every two weeks.
Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows:
Occurrence of           Administration                   Outcome              Dose regulation skin symptom(s):          of Vectibix
≥ grade 31
Initial occurrence        Withhold 1 or            Improved (< grade 3)        Continuing infusion 2 doses                                         at 100% of original dose Not recovered               Discontinue
At the second           Withhold 1 or            Improved (< grade 3)        Continuing infusion occurrence               2 doses                                          at 80% of original dose Not recovered               Discontinue
At the third          Withhold 1 or            Improved (< grade 3)        Continuing infusion occurrence              2 doses                                          at 60% of original dose Not recovered              Discontinue
At the fourth           Discontinue                       -                          - occurrence
1
Greater than or equal to grade 3 is defined as severe or life-threatening 
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.

Pediatric population

There is no relevant use of Vectibix in the pediatric population in the indication treatment of colorectal cancer.

Method of administration

Vectibix must be administered as an intravenous infusion via an infusion pump.
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).

Vectibix must be administered using a low protein binding 0.2 or 0.22 micrometer 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 1,000 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.