cetuximab

REMS

Locally or regionally advanced squamous cell carcinoma of the head and neck (in combination with radiation therapy).
Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.
Recurrent or metastatic squamous cell carcinoma of the head and neck (in combination with platinum-based therapy with 5-fluorouracil).
K-ras wild-type, epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer in patients who have not responded to irinotecan and oxaliplatin or are intolerant to irinotecan.
K-ras wild-type, EGFR-expressing metastatic colorectal cancer in patients who have not responded to irinotecan alone (in combination with irinotecan).
First-line treatment of K-ras wild-type, EGFR-expressing metastatic colorectal cancer (in combination with irinotecan, 5-fluorouracil, and leucovorin [FOLFIRI]).
Metastatic colorectal cancer with a BRAF V600E mutation (in combination with encorafenib).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to cetuximab or murine (mouse) proteins
RAS-mutant metastatic colorectal cancer or unknown RAS mutation status (↑ mortality and tumor progression)
OB: Pregnancy
Lactation: Lactation.

Use Cautiously in:

Exposure to sunlight (may exacerbate dermatologic toxicity)
History of tick bites, red meat allergy, or in presence of IgE antibodies directed against galactose-α-1,3-galactose (alpha-gal) (↑ risk of anaphylaxis)
Rep: Women of reproductive potential
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Most adverse reactions reflect combination therapy with irinotecan

CV: CARDIOPULMONARY ARREST, peripheral edema, SUDDEN CARDIAC DEATH.

Derm: acneform dermatitis, hypertrichosis, nail disorder, pruritus, skin desquamation, skin infection, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

EENT: conjunctivitis, ulcerative keratitis.

F and E: dehydration, hypomagnesemia.

GI: abdominal pain, constipation, diarrhea, nausea, vomiting, ↓ weight, anorexia, stomatitis.

GU: ↓ fertility (females), renal failure.

Hemat: anemia, leukopenia.

MS: back pain.

Neuro: malaise, depression, headache, insomnia.

Resp: cough, dyspnea, INTERSTITIAL LUNG DISEASE, PULMONARY EMBOLISM.

Misc: fever, INFUSION REACTIONS (INCLUDING ANAPHYLAXIS).

Interactions ⬆ ⬇

Drug-Drug:

None reported.

Availability ⬆ ⬇

Solution for injection: 2 mg/mL;

Route/Dosage ⬆ ⬇

Head and Neck Cancer with Radiation

IV (Adults): 400 mg/m² administered 1 wk prior to initiation of radiation therapy, followed by 250 mg/m² once weekly for the duration of radiation therapy or until disease progression or unacceptable toxicity (complete infusion 1 hr prior to radiation therapy).

Head and Neck Cancer Monotherapy or in Combination with Platinum-Based Therapy and 5-Fluorouracil

IV (Adults): Monotherapy (weekly regimen): 400 mg/m² initially, followed by 250 mg/m² once weekly until disease progression or unacceptable toxicity. Monotherapy (biweekly regimen): 500 mg/m² every 2 wk until disease progression or unacceptable toxicity. Combination therapy with platinum-based therapy and 5-fluorouracil (weekly regimen): 400 mg/m² initially, followed by 250 mg/m² once weekly until disease progression or unacceptable toxicity (complete infusion 1 hr to prior to administering platinum-based therapy with 5-fluorouracil). Combination therapy with platinum-based therapy and 5-fluorouracil (biweekly regimen): 500 mg/m² every 2 wk until disease progression or unacceptable toxicity (complete infusion 1 hr prior to administering platinum-based therapy with 5-fluorouracil).

Colorectal Cancer

IV (Adults): Monotherapy (weekly regimen): 400 mg/m² initially, followed by 250 mg/m² once weekly until disease progression or unacceptable toxicity. Monotherapy (biweekly regimen): 500 mg/m² every 2 wk until disease progression or unacceptable toxicity. Combination therapy with irinotecan or FOLFIRI (weekly regimen): 400 mg/m² initially, followed by 250 mg/m² once weekly until disease progression or unacceptable toxicity (complete infusion 1 hr prior to administering irinotecan or FOLFIRI). Combination therapy with irinotecan or FOLFIRI (biweekly regimen): 500 mg/m² every 2 wk until disease progression or unacceptable toxicity (complete infusion 1 hr prior to administering irinotecan or FOLFIRI). Combination therapy with encorafenib: 400 mg/m² initially, followed by 250 mg/m² once weekly until disease progression or unacceptable toxicity.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds specifically to EGFR, thereby preventing the binding of endogenous epidermal growth factor. This prevents cell growth and differentiation processes.

Therapeutic Effects:

Decreased tumor growth and spread.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: 97–114 hr.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose of cetuximab and potential side effects to patient.
Advise patient to notify health care professional promptly if dermatologic changes (itchy, dry, scaly, or cracking skin, and inflammation, infection or swelling at base of nails or loss of the nails), conjunctivitis, blepharitis, or decreased vision, and signs and symptoms of pulmonary toxicity (new or worsening cough, chest pain, shortness of breath), infusion reactions (fever, chills, or breathing problems) promptly. Risk for infusion reactions in patients who have had a tick bite or red meat allergy.
Caution patient to wear sunscreen and hats and limit sun exposure during therapy during and for 2 mo following last dose of cetuximab.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 2 mo after last dose of therapy and to avoid breast feeding during and for 2 mo following therapy. May impair female fertility.

section name header

Indications ⬇