Panitumumab is available as a 20-mg/mL concentrate for injection in 5- or 20-mL preservative-free single-dose vials containing 100 or 400 mg, respectively, of panitumumab.3278 Each 5-mL vial contains panitumumab 100 mg, sodium acetate 34 mg, and sodium chloride 29 mg in water for injection.3278 Each 20-mL vial contains panitumumab 400 mg, sodium acetate 136 mg, and sodium chloride 117 mg in water for injection.3278 The concentrate must be diluted prior to administration.3278
To prepare the drug for intravenous infusion, the appropriate dose of the concentrate should be withdrawn from the vial and diluted in sodium chloride 0.9% to a final panitumumab concentration not exceeding 10 mg/mL.3278 Doses of 1000 mg or lower should be diluted to a total volume of 100 mL.3278 Doses higher than 1000 mg should be diluted to a total volume of 150 mL.3278 The solution should be mixed by gentle inversion.3278 Any unused portion remaining in vials should be discarded.3278
pH
5.6 to 6.3278
Trade Name(s)
Vectibix
Panitumumab is diluted in sodium chloride 0.9% and administered by intravenous infusion through a peripheral line or indwelling intravenous catheter using an infusion pump.3278 The drug should not be administered by intravenous push or bolus injection.3278 Diluted solutions for infusion should be administered through a low protein-binding 0.2- to 0.22-µm inline filter.3278 The infusion line should be flushed with sodium chloride 0.9% prior to and following administration of the drug.3278
For doses of 1000 mg or lower, the first infusion should be administered over 60 minutes.3278 If the first infusion is tolerated, subsequent infusions may administered over 30 to 60 minutes.3278 Doses higher than 1000 mg should be administered over 90 minutes.3278
Intact vials of panitumumab should be stored at 2 to 8°C in the original carton and protected from direct sunlight.3278 Vials must not be shaken or frozen.3278
Panitumumab concentrate for injection is a colorless solution which may contain a small amount of visible translucent to white, amorphous, proteinaceous particles.3278 Do not use if the solution is discolored, cloudy, or if particulate matter other than translucent to white proteinaceous particles is present.3278
The manufacturer states diluted solutions for infusion should be used within 6 hours if stored at room temperature, or 24 hours if stored at 2 to 8°C.3278 Diluted solutions should not be frozen.3278
Stability of panitumumab concentrate for injection (Amgen Europe) in opened vials and diluted solutions was evaluated in a study using a variety of methods to assess physicochemical stability (visual inspection, pH measurement, spectrophotometry, calculated aggregation index, UV spectroscopy, size exclusion high-performance liquid chromatography).3991 In addition, the drug's ability to bind to epidermal growth factor receptor (EGFR) and antiproliferative and proapoptotic effects in Caco-2 cells were assessed to determine functional activity of the drug.3991 Panitumumab concentrate for injection in the original vial following puncture with a closed-system transfer device (Spike CS-51, ICU Medical) was stable for 180 days at 2 to 8°C protected from light.3991 Diluted solutions of panitumumab 3 and 6 mg/mL in sodium chloride 0.9% in polyolefin/polyamide bags (Baxter) was stable for 30 days when stored at 2 to 8°C protected from light, or exposed to 25°C for 15 hours followed by storage at 2 to 8°C protected from light.3991
Filtration
Diluted solutions for infusion should be administered through a low protein-binding 0.2- to 0.22-µm inline filter.3278
For a list of references cited in the text of this monograph, search the monograph titled References.