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Erbitux (Cetuximab) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ERBITUX, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy.

ERBITUX (Cetuximab) administered as a single agent is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy.

The effectiveness of ERBITUX is based on objective response rates (see CLINICAL STUDIES). Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX.

DOSAGE AND ADMINISTRATION

The recommended dose of ERBITUX, in combination with irinotecan or as monotherapy, is 400 mg/m2 as an initial loading dose (first infusion) administered as a 120-minute IV infusion (maximum infusion rate 5 mL/min). The recommended weekly maintenance dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 5 mL/min). Premedication with an H1 antagonist (eg, 50 mg of diphenhydramine IV) is recommended. Appropriate medical resources for the treatment of severe infusion reactions should be available during ERBITUX infusions. (See WARNINGS: Infusion Reactions.)

DOSE MODIFICATIONS

INFUSION REACTIONS

If the patient experiences a mild or moderate (Grade 1 or 2) infusion reaction, the infusion rate should be permanently reduced by 50%.

ERBITUX should be immediately and permanently discontinued in patients who experience severe (Grade 3 or 4) infusion reactions. (See WARNINGS and ADVERSE REACTIONS.)

DERMATOLOGIC TOXICITY AND RELATED DISORDERS

If a patient experiences severe acneform rash, ERBITUX treatment adjustments should be made according to Table 4. In patients with mild and moderate skin toxicity, treatment should continue without dose modification. (See WARNINGS and ADVERSE REACTIONS.)

Table 4: ERBITUX Dose Modification Guidelines
Severe Acneform Rash ERBITUX Outcome ERBITUX Dose Modification
1st occurrence Delay infusion
1 to 2 weeks
Improvement
No Improvement
Continue at 250 mg/m2
Discontinue ERBITUX
2nd occurrence Delay infusion
1 to 2 weeks
Improvement
No Improvement
Reduce dose to 200 mg/m2
Discontinue ERBITUX
3rd occurrence Delay infusion
1 to 2 weeks
Improvement
No Improvement
Reduce dose to 150 mg/m2
Discontinue ERBITUX
4th occurrence Discontinue ERBITUX

PREPARATION FOR ADMINISTRATION

DO NOT ADMINISTER ERBITUX AS AN IV PUSH OR BOLUS.

ERBITUX must be administered with the use of a low protein binding 0.22-micrometer in-line filter.

ERBITUX is supplied as a 50-mL, single-use vial containing 100 mg of Cetuximab at a concentration of 2 mg/mL in phosphate buffered saline. The solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, Cetuximab particulates. DO NOT SHAKE OR DILUTE.

ERBITUX CAN BE ADMINISTERED VIA INFUSION PUMP OR SYRINGE PUMP.

Infusion Pump:

  • Draw up the volume of a vial using a sterile syringe attached to an appropriate needle (a vented spike or other appropriate transfer device 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.
  • Administer through a low protein binding 0.22-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 5 mL/min.
  • Use 0.9% saline solution to flush line at the end of infusion.

Syringe Pump:

  • Draw up the volume of a vial using a sterile syringe attached to an appropriate needle (a vented spike may be used).
  • Place the syringe into the syringe driver of a syringe pump and set the rate.
  • Administer through a low protein binding 0.22-micrometer in-line filter rated for syringe pump use (placed as proximal to the patient as practical).
  • Connect up the infusion line and start the infusion after priming the line with ERBITUX.
  • Repeat procedure until the calculated volume has been infused.
  • Use a new needle and filter for each vial.
  • Maximum infusion rate should not exceed 5 mL/min.
  • Use 0.9% saline solution to flush line at the end of infusion.

ERBITUX should be piggybacked to the patient's infusion line.

Following the ERBITUX infusion, a 1-hour observation period is recommended.

HOW SUPPLIED

ERBITUX™ (Cetuximab) is supplied as a single-use, 50-mL vial containing 100 mg of Cetuximab as a sterile, preservative-free, injectable liquid. Each carton contains one ERBITUX vial (NDC 66733-948-23).

STABILITY AND STORAGE

Store vials under refrigeration at 2° C to 8° C (36° F to 46° F). DO NOT FREEZE. Increased particulate formation may occur at temperatures at or below 0° C. This product contains no preservatives. Preparations of ERBITUX in infusion containers are chemically and physically stable for up to 12 hours at 2° C to 8° C (36° F to 46° F) and up to 8 hours at controlled room temperature (20° C to 25° C; 68° F to 77° F). Discard any remaining solution in the infusion container after 8 hours at controlled room temperature or after 12 hours at 2° to 8° C. Discard any unused portion of the vial.

US Patent No. 6,217,866

ERBITUX™ is a trademark of ImClone Systems Incorporated.

Manufactured by ImClone Systems Incorporated, Branchburg, NJ 08876

Distributed and Marketed by Bristol-Myers Squibb Company, Princeton, NJ 08543

ImClone Systems Incorporated

Bristol-Myers Squibb Company

©2004 by ImClone Systems Incorporated and Bristol-Myers Squibb Company.

All rights reserved.

ER-B0001-06-04 Issued June 2004

Based on 51-022606-00, 1169848

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