You are using an outdated browser. We suggest you update your browser for a better experience. Click here for update.
Close this notification.
Skip to main content Skip to search

COVID-19: Get the latest updates or take a self-assessment.

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Find out more about hepatitis B virus screening and management.

Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.

A - Regimen Name

CETU Regimen
Cetuximab


Disease Site
Skin
Squamous cell


Intent
Palliative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

For the treatment of locally advanced, unresectable or metastatic squamous cell carcinoma of the skin.

Note: Recommendation based on a single arm phase II study in 36 patients with a response rate of 28%; two prolonged complete responses were reported. Nine of 10 responding patients had local or regional disease only.

 
B - Drug Regimen

Loading Dose:

cetuximab
400 mg /m² IV Week 1
(This drug is not currently publicly funded for this regimen and intent)


THEN Maintenance Doses (Week 2 and onwards):

cetuximab
250 mg /m² IV Week 2 and onwards
(This drug is not currently publicly funded for this regimen and intent)
back to top
 
C - Cycle Frequency

For maintenance dose:

REPEAT WEEKLY

Until disease progression or unacceptable toxicity.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
 

Premedications (prophylaxis for infusion reaction):

  • H1-receptor antagonist (e.g. diphenhydramine 50 mg IV) 30-60 minutes prior to the dose.
  • Corticosteroid IV 30-60 minutes prior to the dose.
  • Consider discontinuing pre-medications after the 2nd infusion based on clinical judgment and the presence/severity of IR.
     

Other Supportive Care:

  • Patients should use sun protection while receiving cetuximab and for 2 months after treatment completion.
  • Consider pre-emptive therapy for EGFR inhibitor-related skin toxicity; the following was shown to be of benefit with panitumumab treatment, starting the day before treatment and continued until week 6. (Lacouture et al, 2010):
    • Skin moisturizer applied to the face, hands, feet, neck, back and chest in the morning
    • Sunscreen to exposed areas (SPF > 15, UVA and UVB) before going outdoors
    • Hydrocortisone 1% cream to the face, hands, feet, neck, back and chest at bedtime
    • Doxycycline (or minocycline) PO
  • Refer to the Canadian recommendations for the management of skin rash during EGFR-targeted monoclonal antibody treatment for GI malignancies. (Melosky et al, 2009)

 

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated.

 

Dosage with toxicity

Dose Level Cetuximab Dose
(mg/m² weekly)
0 250
-1 200
-2 150
-3 Discontinue


 

Toxicity

Action

Next cycle

Pneumonitis

Hold and investigate

Discontinue if confirmed.

Keratitis

Hold and refer to ophthalmologist

Consider discontinuation.

 

Dosage modification for skin toxicity:

Grade 3 or 4 Rash

Action

Outcome

Cetuximab Dose

1st occurrence

Delay infusion
1 to 2 weeks

Improvement

Resume at same dose

No improvement

Discontinue

2nd occurrence

Delay infusion
1 to 2 weeks

Improvement

Resume at 1 dose level ↓

No improvement

Discontinue

3rd occurrence

Delay infusion
1 to 2 weeks

Improvement Resume at 1 dose level ↓
No improvement Discontinue

4th occurrence
OR
any occurrence of SJS/TENS

Discontinue


Management of Infusion-related reactions:

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

Grade Management Re-challenge
1 or 2
  • Stop or slow the infusion rate.
  • Manage the symptoms.

Restart:

  • The infusion may be restarted at a slower rate (50% of the rate at which the IR occurred) once symptoms have resolved.
  • Re-challenge with a reduced infusion rate of 50% at which the infusion reaction occurred.
3 or 4
  • Stop treatment.
  • Aggressively manage symptoms.

Restart:

  • Once symptoms resolve, the infusion can be restarted at a slower rate, unless a serious reaction occurred (i.e., vital signs compromised; anaphylaxis).
  • Permanently discontinue (do not re-challenge).



Hepatic Impairment

 Population pharmacokinetics suggest no significant impact.


Renal Impairment

Population pharmacokinetics suggest no significant impact.


 
F - Adverse Effects

Refer to cetuximab drug monograph(s) for additional details of adverse effects.


Very common

(≥ 50%)

Common

(25-49%)

Less common

(10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Rash (may be severe)
  • Fatigue
  • Anorexia
  • Nausea, vomiting
  • Abdominal pain
  • Constipation
  • Neuropathy
  • Cough, dyspnea
  • Hypomagnesemia
  • Infection (may be severe)
  • Diarrhea
  • Headache
  • Mucositis
  • Insomnia
  • Nail disorder
  • Flu-like symptoms
  • Infusion-related reaction (may be severe)
  • Mood changes, Confusion
  • Musculoskeletal pain
  • Dry mouth
  • Increased LFTs
  • Dizziness
  • Dysgeusia
  • Hemorrhage
  • Arterial/venous thromboembolism
  • Arrhythmia
  • GI obstruction/perforation
  • Pancreatitis
  • Pneumonitis
  • Keratitis
  • Nephrotoxicity
  • Stevens-Johnson syndrome
  • Toxic epidermal necrolysis
 
G - Interactions

Refer to cetuximab drug monograph(s) for additional details.

 

 
H - Drug Administration and Special Precautions

Refer to cetuximab drug monograph(s) for additional details.


Administration:

  • Do not shake or further dilute the solution.
  • DO NOT administer as an IV push or bolus.
  • Transfer undiluted solution into a compatible empty infusion container.
  • Cetuximab is compatible with:
    • glass,
    • polyolefin, polyethylene, ethylene vinyl acetate (EVA), DEHP plasticized PVC, or PVC bags,
    • polyethylene, EVA, PVC, polybutadiene or polymethane infusion sets, and
    • polyethersulfone, polyamide or polysulfone in-line filters.
  • Administer the undiluted solution via a low protein binding 0.22-micrometer in-line filter, piggybacking to the patient’s infusion line.
  • Infuse initial loading dose over 2 hours, and maintenance dose over 1 hour (maximum rate 10 mg/min). (May require infusion at slower rate in those who experienced infusion reactions).
  • Prime administration line with drug solution before infusion. May use NS to flush line at the end of infusion.
  • A 1-hour observation period is recommended following each cetuximab infusion. Longer observation periods may be required in those who experienced infusion reactions.
  • Should not be mixed or diluted with other drugs.
  • Store unopened vials at 2-8°C.
     

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.


Contraindications:

  • Patients with known hypersensitivity to this drug or any of its components
     

Other Warnings/Precautions:

  • Patients with a history of, or pre-existing keratitis, dry eyes or contact lens use
  • Patients with poor performance status, or cardiopulmonary disease are at increased risk of severe hypersensitivity
     

Pregnancy/Lactation:

  • This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
  • Breastfeeding is not recommended during treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
  • Fertility effects: Unknown

 

 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
 

Recommended Clinical Monitoring

  • Electrolytes, including serum magnesium, potassium and calcium; Baseline, weekly, and monthly for 2 months following completion of therapy

  • CBC; Baseline and as clinically indicated

  • Renal function; Baseline and as clinically indicated

  • Clinical toxicity assessment for infusion reactions, skin, nail, cardiac, thromboembolism, GI, hypersensitivity, respiratory symptoms, fatigue and keratitis; at each visit

  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


back to top
 
J - Administrative Information

Approximate Patient Visit
First cycle; 2.5 hours; Subsequent cycles: 1.5 hours
Pharmacy Workload (average time per visit)
24.85 minutes
Nursing Workload (average time per visit)
55.595 minutes
 
K - References

Cetuximab drug monograph, Ontario Health (Cancer Care Ontario).

Lacouture, ME, Mitchell EP, Piperdi B et al. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-emptive skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol 2010; 28: 1351-7.

Maubec E, Petrow P, Scheer-Senyarich I, et al. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. J Clin Oncol 2011;29(25):3419-26.

Melosky B, Burkes R, Rayson D, et al. Management of skin rash during EGFR-targeted monoclonal antibody treatment for gastrointestinal malignancies: Canadian recommendations. Current Oncology 2009; 16(10): 14-24.

July 2023 Updated other supportive care, adverse effects, administration, special precautions, and monitoring sections


back to top
 
M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.