Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
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.
The recommended dose of Vectibix is 6 mg/kg of bodyweight 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 skin symptom(s): ≥ grade 31 | Administration of Vectibix | Outcome | Dose regulation |
|---|---|---|---|
| Initial occurrence | Withhold 1 or 2 doses | Improved (< grade 3) | Continuing infusion at 100% of original dose |
| Not recovered | Discontinue | ||
| At the second occurrence | Withhold 1 or 2 doses | Βελτίωση (< βαθμού 3) | Continuing infusion at 80% of original dose |
| Not recovered | Discontinue | ||
| At the third occurrence | Withhold 1 or 2 doses | Improved (< grade 3) | Continuing infusion at 60% of original dose |
| Not recovered | Discontinue | ||
| At the fourth occurrence | Discontinue | - | - |
1 Greater than or equal to grade 3 is defined as severe or life-threatening
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.
There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer.
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 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 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.
Doses up to 9 mg/kg have been tested in clinical trials. There have been reports of overdose at doses up to approximately twice the recommended therapeutic dose (12 mg/kg). Adverse events observed included skin toxicity, diarrhoea, dehydration and fatigue and were consistent with the safety profile at the recommended dose.
Vial: 3 years.
Diluted solution: Vectibix does not contain any antimicrobial preservative or bacteriostatic agent. The product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C-8°C. The diluted solution must not be frozen.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
Type I glass vial with an elastomeric stopper, aluminium seal and flip-off plastic cap. One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of concentrate for solution for infusion.
Pack of 1 vial.
Vectibix is intended for single use only. Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection by healthcare professional using aseptic technique. Do not shake or vigorously agitate the vial. Vectibix should be inspected visually prior to administration. The solution should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous particulates (which will be removed by in-line filtration). Do not administer Vectibix if its appearance is not as described above. Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the necessary amount of Vectibix for a dose of 6 mg/kg. Do not use needle-free devices (e.g. vial adapters) to withdraw vial contents. Dilute in a total volume of 100 mL. The final concentration should not exceed 10 mg/mL. Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection (see section 4.2). The diluted solution should be mixed by gentle inversion, do not shake.
No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) solution for injection in polyvinyl chloride bags or polyolefin bags.
Discard the vial and any liquid remaining in the vial after the single-use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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