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ERBITUX is a brand name for Cetuximab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .................................................................................................................................... 3 CONTRAINDICATIONS ......................................................................................................................................................…
Verbatim from this product's HC label. Tap a section to expand.
Recommended Dose and Dosage Adjustment COLORECTAL CANCER Whenever ERBITUX in combination with irinotecan or FOLFIRI is scheduled to be administered in the same week, irinotecan or FOLFIRI should be administered after the end of the ERBITUX infusion.
The recommended initial dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 400 mg/m2 administered as a 120-minute infusion (maximum infusion rate 10 mg/min). The recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until progression of the underlying disease or unacceptable toxicity.
SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN) ERBITUX is administered in combination with radiation therapy as follows: The recommended initial dose is 400 mg/m2 administered one week prior to initiation of a course of radiation therapy as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min).
The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6-7 weeks). Complete ERBITUX administration 1 hour prior to radiation therapy Dose Modifications Infusion Reactions (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
If the patient experiences a mild or moderate (NCI CTC Grade 1 or 2) infusion reaction, the infusion rate should be reduced by 50%. It is recommended that the ERBITUX infusion rate remain at the lower value for all subsequent infusions.
Occurrences of a severe (Grade 3 or 4) infusion reaction require immediate and permanent discontinuation of ERBITUX therapy and may necessitate emergency treatment and/or hospitalisation. Dermatologic Toxicity (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
If a patient experiences severe acneiform rash (grade 3 or 4), ERBITUX treatment adjustment should be made according to Table 5. If the rash improves and is no longer severe, treatment Page 42 of 78 may be resumed without any change in dose level.
The recurrence of severe acneiform rash may require further interruption of therapy with dose reductions at pretreatment after improvement (initially to 200 mg/m2 and subsequently to 150 mg/m2) or discontinuation of therapy. 22-micron in-line filter.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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DO NOT ADMINISTER ERBITUX AS AN IV PUSH OR BOLUS. DO NOT SHAKE. DO NOT DILUTE. Recommended Premedication Premedication with an H1 antagonist (eg, 50 mg of IV diphenhydramine) intravenously 30-60 minutes prior to the first dose should be used.
Premedication with an intravenous corticosteroid prior to the first dose may be used. Premedication may be administered for subsequent ERBITUX doses based upon clinical judgment and presence/severity of prior infusion reactions. Anaphylactic reactions may occur despite the use of prophylactic premedications.
Physicians should always remain vigilant for signs and symptoms of severe infusion reactions. (see WARNINGS AND PRECAUTIONS - Infusion Reactions). How ERBITUX is Supplied ERBITUX is supplied as 50 mL and 100 mL ready-to-use vials that contain 100 mg and 200 mg cetuximab, respectively, at a concentration of 2 mg/mL in phosphate buffered saline.
The solution should be clear and colourless and may contain a small amount of easily visible, white, amorphous cetuximab particulates. The particulates are product-related and do not affect the quality of the product. Preparation for Administration DO NOT SHAKE OR DILUTE.
PREPARE INFUSION USING APPROPRIATE ASEPTIC TECHNIQUE. ERBITUX SHOULD BE ADMINISTERED VIA INFUSION PUMP OR SYRINGE PUMP. To obtain the recommended dose, multiple vials should be pooled aseptically into an infusion Page 43 of 78 container prior to administration.
To prevent vacuum formation, a vented needle may be used. ERBITUX should not be mixed or diluted with other drugs as no studies have been conducted on the physical or biochemical compatibility of ERBITUX mixed with other agents. For squamous cell carcinoma of the head and neck complete ERBITUX administration 1 hour prior to radiation therapy.
For colorectal cancer patients receiving ERBITUX in combination with irinotecan/irinotecan- based regimen, the irinotecan dosage and dose modifications should be performed according to the Product Monograph for Irinotecan (Camptosar®).
Whenever ERBITUX and irinotecan are scheduled to be administered in the same week, irinotecan should be administered after the end of the ERBITUX infusion. Saline may be used to clear the infusion set of ERBITUX and to ensure complete dose delivery.
ERBITUX can be administered in an appropriate outpatient setting. Infusion Pump • Draw up the volume of a vial using a sterile syringe attached to an appropriate needle (a vented needle or pin may be used). • Fill ERBITUX into a sterile evacuated container or bag such as glass containers, polyolefin bags (eg, Baxter Intravia), ethylene vinyl acetate bags (eg, Baxter Clintec), DEHP plasticized PVC bags (eg, Abbott Lifecare), or PVC bags.
• Repeat procedure until the calculated volume has been put into the container. Use a new needle for each vial. 22-micrometer in-line filter (placed as proximal to the patient as practical). • Affix the infusion line and prime it with ERBITUX before starting the infusion.
• Maximum infusion rate should not exceed 10 […]