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PrERBITUXTM (Cetuximab) Reimbursement/ Coverage
ERBITUXTM (Cetuximab) DIN 02271249
ERBITUXTM Product Monograph
Body Surface Area Calculator
ERBITUXTM is an eligible benefit through some private insurance plans and some provincial/territorial funding agencies and federal drug plans. For more detailed information on reimbursement through specific programs please choose the appropriate drug plan/program from the left sidebar menu.
1-877-967-6626
Reaching out to as many patients as possible.
The program will assist patients throughout the ERBITUX TM (cetuximab) reimbursement process. For treating physicians who wish to print the Patient Enrolment Form, please click here.
Indication:
ERBITUXTM is indicated for:
ERBITUXTM (cetuximab), used in combination with irinotecan, is indicated for the treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to other irinotecan-based chemotherapy regimens.
ERBITUXTM 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.
ERBITUXTM (cetuximab) as a single agent, is also indicated for the treatment of patients with EGFR-expressing metastatic colorectal carcinoma after failure of both irinotecan- and oxaliplatin-based regimens and who have received a fluoropyrimidine, whose tumours have a wild-type (non-mutated) Kirsten rat sarcoma (KRAS) gene. The benefit is based on overall survival in an analysis of patients whose tumours have a wild-type KRAS gene. In the same analysis, there was no treatment benefit with ERBITUX in patients whose tumours have KRAS mutations. Use of ERBITUX is not indicated for the treatment of colorectal cancer in patients with KRAS mutations.
ERBITUXTM (cetuximab) is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.
Serious Warnings and Precautions - Infusion reactions: Severe infusion reactions occurred with the administration of ERBITUXTM in approximately 3% of patients in clinical trials, rarely with fatal outcome (< 1 in 1000). Approximately 90% of severe infusion reactions were associated with the first infusion of ERBITUXTM. Severe infusion reactions are characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), hypotension, loss of consciousness and/or cardiac arrest. Fatal anaphylactic reactions may occur despite the use of prophylactic pre-medications. Severe infusion reactions require immediate interruption of the ERBITUXTM infusion and permanent discontinuation from further treatment.
- Cardiopulmonary arrest: Cardiopulmonary arrest and/or sudden death occurred in 2% of 208 patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUXTM. Carefully consider use of ERBITUXTM in combination with radiation therapy in head and neck cancer patients with a history of coronary artery disease, congestive heart failure, or arrhythmias in light of these risks. Closely monitor serum electrolytes, including serum magnesium, potassium and calcium, during and after treatment with ERBITUXTM.
Additional information - Infusion reactions
- Caution must be exercised with every ERBITUXTM infusion, as there are patients who experienced their first severe infusion reaction during later infusions. A 1-hour observation period is recommended following the ERBITUXTM infusion. Longer observation periods may be required in patients who experience infusion reactions to confirm resolution of the event.
- Appropriate physician supervision and supportive medical resources for the treatment of severe infusion reactions, anaphylaxis and cardiac arrest/myocardial infarction must be available. Monitor patients for 1 hour following ERBITUXTM infusions in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, parenteral corticosteroids, intravenous antihistamines, bronchodilators, vasopressors and oxygen).
Pulmonary toxicity
- Interstitial lung disease (ILD), including 1 fatality, occurred in 4 (< 0.5%) patients receiving ERBITUXTM in clinical trials. In the events of acute onset or worsening pulmonary symptoms, ERBITUXTM therapy should be interrupted and a prompt investigation of these symptoms should occur. If ILD is confirmed, ERBITUXTM should be discontinued and the patient should be treated appropriately.
Carcinogenesis, mutagenesis, impairment of fertility
- Long-term animal studies have not been performed to test ERBITUXTM for the carcinogenic potential or potential to impair fertility. No mutagenic or clastogenic potential of ERBITUXTM was observed in the Salmonella-Escherichia coli (AMES) assay or in the in vivo rat micronucleus test. It is not known if ERBITUXTM can impair fertility in humans.
Immunogenicity
- As with all therapeutic proteins, there is potential for immunogenicity. Although the data are limited, there does not appear to be any relationship between the appearance of antibodies to ERBITUXTM and the safety or antitumor activity of the molecule.
Dermatologic Toxicity
- Acneiform rash occurred in 76-88% of patients receiving ERBITUXTM in clinical trials. Severe acneiform rash occurred in 1-17% of patients. Acneiform rash usually developed within the first two weeks of therapy and resolved in a majority of the patients after cessation of treatment, although in nearly half, the event continued beyond 28 days.
- Patients developing dermatologic toxicities while receiving ERBITUXTM should be monitored for the development of inflammatory or infectious sequelae, and appropriate treatment of these symptoms initiated.
- Dose modifications of any future ERBITUXTM infusions should be instituted in case of severe acneiform rash. Instruct patients to limit sun exposure during treatment with ERBITUXTM and for 2 months following the last dose of ERBITUXTM.
Monitoring and Laboratory Tests
- In patients evaluated during clinical trials, hypomagnesemia occurred in 55% of patients (199/365) receiving ERBITUXTM and was severe (NCI-CTC Grade 3 and 4) in 6-17%. Patients should be monitored for hypomagnesemia, and accompanying hypocalcemia and hypokalemia, before and periodically during and following the completion of ERBITUXTM therapy. Monitoring should continue for a period of time commensurate with the half-life and persistence of the product; i.e. at least 8 weeks following the completion of ERBITUXTM therapy. Replenish electrolytes as necessary.
Use of ERBITUXTM in combination with radiation and cisplatin
- The safety of ERBITUXTM in combination with radiation therapy and cisplatin has not been established.
Special Populations
- Pregnant Women: ERBITUXTM should not be given to a pregnant woman or any woman not employing adequate contraception unless the potential benefit justifies the potential risk to the fetus.
- Nursing Women: It is not known whether ERBITUXTM is excreted in human milk. Because human IgG is excreted in human milk, and the potential for absorption and harm to the infant is unknown, women should be advised to discontinue nursing during treatment with ERBITUXTM and for 60 days after the last dose of ERBITUXTM.
- Pediatrics: The safety and effectiveness of ERBITUXTM in pediatric patients have not been established.
- Geriatrics: Of the total number of patients who received ERBITUXTM with irinotecan or ERBITUXTM monotherapy in five studies of advanced colorectal cancer, 363 patients were 65 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients.Clinical studies in head and neck cancer did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects.
ERBITUXTM Product Monograph
Resources for Healthcare Professionals
The following websites are external links. DrugCoverage assumes no responsibility for the content of these sites.
Body Surface Area Calculator
Initial dose (1X): 400 mg/m2 administered as a 120 minute infusion
Weekly dose: 250 mg/m2 administered as a 60 minute infusion
Please refer to ERBITUXTM Product Monograph for complete dosing information.
ERBITUXTM (Cetuximab), Part III Consumer Information
Colorectal Cancer Association
Cancer Advocacy Coalition of Canada
ERBITUXTM is a trademark of Imclone Systems Incorporated.
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