Cetuximab injection is available as a 2-mg/mL solution in 50- or 100-mL preservative-free single-dose vials containing 100 or 200 mg, respectively, of cetuximab.3370 Each mL of solution contains cetuximab 2 mg, sodium chloride 8.48 mg, sodium phosphate dibasic heptahydrate 1.88 mg, and sodium phosphate monobasic monohydrate 0.41 mg in water for injection.3370
pH
7 to 7.4.3370
Trade Name(s)
Erbitux
Cetuximab is administered undiluted by intravenous infusion using an infusion pump or syringe pump.3370 The infusion rate should not exceed 10 mg/min.3370 Do not administer by intravenous push or bolus injection.3370 Administer through a low-protein-binding 0.22-µm inline filter.3370
Cetuximab injection is a clear, colorless solution which may contain a small amount of visible white, amorphous particulates.3370
Intact vials should be stored at 2 to 8°C.3370 Do not freeze or shake.3370 Increased particulate formation may occur at temperatures at or below 0°C.3370
The manufacturer states doses prepared in infusion containers should be discarded after 8 hours when stored at controlled room temperature or after 12 hours when stored at 2 to 8°C.3370 Any unused portion of the vials should be discarded.3370
Stability of cetuximab (Merck KGaA, Germany) 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 Cetuximab 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 cetuximab 1.5 and 4 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
In another study, undiluted and diluted solutions of cetuximab were found to be stable for up to 90 days at 4°C.4016 In this study, cetuximab 5 mg/mL injection (Merck KGaA, Germany) was retained in opened, original vials, transferred undiluted to empty polypropylene bags, or diluted to 1 mg/mL in sodium chloride 0.9% in polyolefin bags, and stored at 4°C.4016 Several methods were used to assess physicochemical stability (e.g., visual inspection, pH measurement, spectrophotometry, dynamic light scattering, ion chromatography, size exclusion chromatography).4016 Undiluted solutions transferred to empty polypropylene bags or diluted solutions in sodium chloride 0.9% in polyolefin bags were stable for 90 days at 4°C.4016; 4017 The study also separately investigated the effects of a temperature excursion simulating refrigerator failure on undiluted and diluted solutions of cetuximab.4016; 4017 Undiluted cetuximab 5 mg/mL in opened vials or transferred to empty polypropylene bags and diluted solutions of 1 mg/mL in sodium chloride 0.9% in polyolefin bags were exposed to 25°C for 72 hours followed by storage at 4°C.4016; 4017 All solutions remained stable when tested at 30 days following the 72-hour temperature excursion.4016; 4017
Filtration
Cetuximab should be administered through a low-protein-binding 0.22-µm inline filter.3370
For a list of references cited in the text of this monograph, search the monograph titled References.