Adult Dosing

Squamous cell CA of the head and neck

As adjunct to chemotherapy

• Initial Dose; 400 mg/m² IV over 120 mins (max: 10 mg/min) 1 wk prior to initiation of chemotherapy; premedicate with an H1 antagonist 30-60 minutes before treatment
• Subsequent doses: 250 mg/m² IV over 60 mins (max: 10 mg/min) qwk for 6-7 wks; complete administration 1 hr prior to radiation therapy

Monotherapy

• Initial Dose; 400 mg/m² IV over 120 mins (max: 10 mg/min); premedicate with an H1 antagonist 30-60 minutes before treatment
• Subsequent doses: 250 mg/m² IV over 60 mins (max: 10 mg/min) qwk until disease progression or unacceptable toxicity

K-Ras Mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer as determined by FDA-approved tests, (monotherapy or in combination with irinotecan or FOLFIRI (irinotecan/5-fluorouracil/leucovorin)

• Initial Dose; 400 mg/m² IV over 120 mins (max: 10 mg/min); premedicate with an H1 antagonist 30-60 minutes before treatment
• Subsequent doses: 250 mg/m² IV over 60 mins (max: 10 mg/min) qwk until disease progression or unacceptable toxicity

Note:

• Refer package insert prior to prescribing and for toxicity-related dose adjustments; If the drug is given along with radiation therapy, loading dose should be given 1 week prior to radiation course. Weekly maintenance dose should be given 1 hour before to radiation for 6-7 weeks or course duration
• Complete cetuximab administration 1 hour prior to FOLFIRI (irinotecan/5-fluorouracil/leucovorin)

Pediatric Dosing

• Safety and effectiveness in pediatric population have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Locally/regionally advanced squamous cell carcinoma of the head and neck (combination with radiotherapy)
• Recurrent or metastatic squamous cell carcinoma of the head and neck in patients in whom prior platinum-based therapy has failed
• K-Ras Mutation-negative, epidermal growth factor receptor (EGFR) expressing metastatic colorectal carcinoma in combination with irinotecan/5-fluorouracil/leucovorin for first line treatment
• K-Ras Mutation-negative, epidermal growth factor receptor (EGFR) expressing metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy
• K-Ras Mutation-negative, epidermal growth factor receptor (EGFR) expressing metastatic colorectal cancer after failure of both irinotecan and oxaliplatin based regimens and in patients who are intolerant to irinotecan based regimens

• Not indicated for treatment of K-Ras mutation-positive colorectal cancer

• Hypersensitivity to cetuximab or any other ingredients of the product
• Hypersensitivity to murine proteins

Infusion Reactions

• Immediately and permanently D/C treatment for serious reactions; 3% incidence of severe infusion reaction, rarely fatal (<1 in 1000)

Cardiopulmonary Arrest

• Patients treated with radiations in combination with cetuximab had 2% incidence cardiopulmonary arrest and/or sudden death in head/neck squamous cell CA; electrolytes incl. Mg, K, and Ca should be closely monitored during/after treatment

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Serious infusion reactions, including rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), hypotension, shock, loss of consciousness, myocardial infarction, and/or cardiac arrest), requiring medical intervention and immediate, permanent discontinuation have occurred. Closely monitor patient during and for 1 hr following each infusion for signs and symptoms of infusion reaction
• Cardiopulmonary arrest and/or sudden death has occurred in 4 (2%) of 208 patients treated with radiation therapy and cetuximab
• Interstitial lung disease (ILD), has occurred in <0.5% of patients; interrupt tx for acute onset or worsening of pulmonary symptoms, permanently discontinue for confirmed ILD
• Dermatologic toxicities, including acneform rash, skin drying and fissuring, paronychial inflammation, infectious sequelae and hypertrichosis have occurred
• Safety of cetuximab in combination with radiation therapy and cisplatin has not been established; Serious cardiotoxicity and deaths were observed in a single-arm trial with cetuximab, radiation therapy, and cisplatin (100 mg/m2) in patients with locally advanced SCCHN
• Avoid pregnancy during treatment and 6 months after discontinuing
• Avoid breastfeeding during treatment and 2 months after discontinuing
• Avoid UV light/sun exposure during treatment and 2 months after discontinuing
• Hypomagnesemia and accompanying electrolyte abnormalities may occur days to months after initiation of cetuximab. Monitor periodically for hypomagnesemia, hypocalcemia and hypokalemia
• Cetuximab is not recommended for colorectal cancer treatment with KRAS mutations in codon 12 or 13

Cautions: Use cautiously in

• Concomitant radiation and cisplastin therapy (safety not established)
• CAD (XRT adjunct for head and neck CA)
• CHF (XRT adjunct for head and neck CA)
• Arrhythmias (XRT adjunct for head and neck CA)
• History of pulmonary disease

Supplemental Patient Information

• Limit sun exposure for 2 months following the last dose and while receiving cetuximab

Pregnancy Category:C

Breastfeeding: Safety unknown; use not recommended

• CNS: Asthenia/malaise, depression, headache, insomnia, anxiety, confusion
• EENT: Conjunctivitis
• RESP: Pharyngitis, dyspnea, cough, interstitial lung disease
• CV: Cardiopulmonary arrest (SCCHN pts), arrhythmias, pulmonary embolism
• GI: Nausea, vomiting, diarrhea, abdominal pain, constipation, stomatitis, dyspepsia, anorexia, mouth dryness, elevated liver transaminases
• GU: Renal failure
• DERM: Nail changes, acneform dermatitis, radiation dermatitis, alopecia, dry skin, pruritus, skin desquamation
• METABOLIC: Dehydration, hypomagnesemia (severe), hypokalemia, hypocalcemia, peripheral edema, weight loss.
• HEMA: Anemia, leukopenia
• MUSC: Back pain
• MISC: Infusion reactions (pyrexia, chills, rigors, dyspnea, bronchospasm, angioedema, urticaria, hypertension, and hypotension), fever, infection, chills, photosensitivity, sepsis

• Monoclonal antibody; binds specifically to epidermal growth factor receptor, inhibiting cell growth and differentiation processes; Induces apoptosis, and decreases MMP’s and vascular EGF production. Combination with irinotecan enhances antitumor effects of irinotecan
• Metabolism: Unknown; CYP450: Unknown
• Excretion: Unknown
• Half life: 112 hrs (63-230 hrs)

US Trade Name(s)

• Erbitux

US Availability

Erbitux

• INJ: 2 mg/mL (50, 100 mL vials)

Canadian Trade Name(s)

• Erbitux

Canadian Availability

Erbitux

• INJ: 2 mg/mL (50, 100 mL vials)

UK Trade Name(s)

• Erbitux

UK Availability

Erbitux

• INJ: 5 mg/mL (10, 20, 50, 100 mL vials)

Australian Trade Name(s)

• Erbitux

Australian Availability

Erbitux

• INJ: 5 mg/mL (20, 100 mL vials)

[Outline]

Hematology/Oncology

Antineoplastics

Monoclonal Antibodies

Pricing data from www.DrugStore.com in U.S.A.

• Erbitux 200 MG/100ML SOLN [Vial] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
  100 100ml = $1061.94
  300 100ml = $3114.96
• Erbitux 100 MG/50ML SOLN [Vial] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
  50 50ml = $575.99
  150 50ml = $1625.88

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.