Cetuximab

Cetuximab is a prescription medication used for the treatment of advanced squamous cell carcinoma of the head and neck (SCCHN), KRAS wild-type, EGFR expressing metastatic colorectal cancer, and BRAF V600E mutation-positive metastatic colorectal cancer.

• Cetuximab is available under the following different brand names: Erbitux

Adult dosage

Injectable solution

• 2mg/mL (50mL, 100mL single use vials)
• KRAS Wild-type, EGFR Expressing Metastatic Colorectal Cancer

Adult dosage

Weekly dosage

• Initial dose: 400 mg/m2 IV x 1 dose
• Subsequent doses: 250 mg/m2/week until disease progression or unacceptable toxicity

Biweekly dosage

• Initial and subsequent doses: 500 mg/m2 IV every 2Weeks until disease progression or unacceptable toxicity
• BRAF V600E Mutation-Positive Metastatic Colorectal Cancer

Adult dosage

• Initial: 400 mg/m2 IV x 1 dose
• Subsequent doses: 250 mg/m2/week until disease progression or unacceptable toxicity

Advanced Squamous Cell Carcinoma of Head & Neck

Adult dosage

Weekly dosage

• Initial dose: 400 mg/m2 IV x 1 dose
• Subsequent doses: 250 mg/m2/week until disease progression or unacceptable toxicity
• With radiation: Initiate 1 week before beginning radiation therapy, continue every Week x 6-7 weeks

Biweekly dosage

• Initial dose and subsequent doses: 500 mg/m2 IV every 2Weeks until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Cetuximab include:

• rash,
• itching,
• dry or cracked skin,
• nail changes,
• headache,
• diarrhea,
• nausea,
• vomiting,
• upset stomach,
• weight loss,
• weakness, and
• respiratory, skin, and mouth infections.

Serious side effects of Cetuximab include:

• low blood magnesium,
• low potassium,
• low calcium,
• life-threatening allergic reactions, and
• heart attacks, especially if the patient was also obtaining chemotherapy or radiotherapy.

Rare side effects of Cetuximab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Cetuximab has no noted severe interactions with any other drugs.
• Cetuximab has no noted serious interactions with any other drugs.
• Cetuximab has no noted moderate interactions with any other drugs.
• Cetuximab has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cetuximab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cetuximab?”

Cautions

• Use in colorectal cancer only with confirmed KRAS mutation-negative (wild-type); confirm Ras mutation status in tumor specimens before initiating therapy
• Risk of cardiopulmonary arrest and sudden death (see Black Box Warnings); carefully consider use with radiation therapy or platinum-based therapy with fluorouracil in patients with squamous cell carcinoma of the head and neck (SCCHN) with a history of coronary artery disease, congestive heart failure, or arrhythmias; monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after therapy
• Increases risk of electrolyte depletion, especially hypomagnesemia; hypomagnesemia and accompanying electrolyte abnormalities can occur days to months after initiating therapy; monitor patients weekly during treatment for hypomagnesemia; hypomagnesemia of any grade reported in 4% of patients receiving cetuximab, carboplatin, and fluorouracil; monitor patients weekly during and for at least 8 weeks following completion of therapy; replete electrolytes as necessary
• The risk of anaphylactic reactions may increase in patients with a history of tick bites, red meat allergy, or in the presence of IgE antibodies directed against galactose-α-1,3-galactose (alpha-gal); consider testing patients for alpha-gal IgE antibodies using FDA-cleared methods before initiating therapy; negative results for alpha-gal antibodies do not rule out the risk of severe infusion reactions
• Risk of infusion reactions; monitor patients following infusion; discontinue therapy for serious infusion reactions (see Black Box Warnings); premedicate with a histamine-1 (H1) receptor antagonist; monitor patients for at least 1 hour following each infusion, in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis; in patients requiring treatment for infusion reactions, monitor for more than 1 hour to confirm resolution of the reaction; interrupt the infusion and upon recovery, resume the infusion at a slower rate or permanently discontinue therapy based on the severity
• Mucocutaneous adverse reactions may occur; limit sun exposure; wear sunscreen and hats
• Dermatologic toxicities (eg, life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, skin sloughing, acneiform rash, skin drying and fissuring, paronychial inflammation, infectious sequelae [eg, Streptococcal aureus sepsis, abscess formation, cellulitis, blepharitis, conjunctivitis, keratitis/ulcerative keratitis with decreased visual acuity, cheilitis], hypertrichosis); monitor for inflammatory or infectious sequelae
• Withhold, reduce the dose or permanently discontinue therapy based on the severity of acneiform rash or mucocutaneous disease
• Increased incidence of grade 3-4 mucositis, radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances when used in combination with radiation and cisplatin; coadministration did not improve progression-free survival
• Interstitial lung disease reported; interrupt treatment for acute onset or worsen of pulmonary symptoms; monitor patients for signs and symptoms of pulmonary toxicity
• Increased tumor progression, increased mortality, or lack of benefit in patients with Ras-mutant metastatic colorectal cancer (mCRC)
• Fetal harm may occur when administered to a pregnant woman (see Pregnancy)

Pregnancy and Lactation

• Based on findings from animal studies and its mechanism of action, cetuximab can cause fetal harm when administered to pregnant women
• There are no available data in pregnant women; advise pregnant women of the potential risk to a fetus
• Verify pregnancy status in females of reproductive potential before initiating treatment
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose
• Infertility
  • Based on animal studies, cetuximab may impair fertility in females of reproductive potential
• Lactation
  • There is no information regarding the presence of the drug in human milk, the effects on the breastfed infant, or the effects on milk production
  • Human IgG antibodies can be excreted in human milk
  • Due to the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 2 months after the last dose