Cetuximab

Indications

Cetuximab is used for: Advanced colorectal cancer, Squamous cell carcinoma of the head and neck

Adult Dose

Intravenous Advanced colorectal cancer Adult: Loading: As monotherapy or in combination with irinotecan, flourouracil, leucovorin (FOLFIRI): 400 mg/m2 via IV infusion over 120 minutes. Maintenance dose: 250 mg/m2 once weekly via IV infusion over 60 minutes. Squamous cell carcinoma of the head and neck Adult: As monotherapy or in combination with radiation therapy or platinum-based therapy and fluorouracil: Initial dose: 400 mg/m2 via IV infusion over 120 minutes 1 week prior to initiation of treatment. Maintenance dose: 250 mg/m2 infused over 60 minutes for 6-7 weeks during the duration of radiation therapy or until disease progression, or unacceptable toxicity when administered with platinum-based therapy.

Child Dose

Renal Dose

Administration

IV Preparation Do not shake or dilute Discard unused portion after 8 hr at room temp & 12 hr if refrigerated IV Administration Do not administer as an IV push or bolus Administer via infusion pump or syringe pump IV infusion: initial dose over 2 hr and weekly maintenance dose over 1 hr Do not exceed an infusion rate of 10 mg/min Administer through low protein binding 0.22-micrometer in-line filter Visually inspect for particulate matter and discoloration prior to administration; solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, cetuximab particulates Do not shake or dilute

Contra Indications

Precautions

Infusion rate should be reduced if patient exhibits signs of toxicity. Discontinue treatment if there is severe infusion reactions. Caution when used in patients with history of coronary artery disease, heart failure and arrhythmias. Monitor serum electrolytes during and after (for at least 8 wk) cetuximab therapy. Exposure to sunlight may worsen skin reactions. Risk of interstitial lung disease in patients with preexisting lung disease. Dose should be modified if there is occurrence of severe acneiform rash, refer to product insert/SPG for dosing guidelines. Lactation There is no information regarding the presence of 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 potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 2 months after last dose

Pregnancy-Lactation

Pregnancy 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 prior to initiating treatment Human IgG is known to cross the placental barrier; therefore, cetuximab may be transmitted from the mother to the developing fetus Contraception Advise females of reproductive potential to use effective contraception during treatment and for 2 months after 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 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 potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 2 months after last dose

Interactions

Adverse Effects

Side effects of Cetuximab : >10% (Monotherapy) Rash/desquamation (95%) Fatigue (91%) Nausea (64%) Other pain (59%) Dry skin (57%) Constipation (53%) Dyspnea (49%) Pruritus (47%) Sensory neuropathy (45%) Diarrhea (42%) Vomiting (40%) Headache (38%) Infections with neutropenia (38%) Other dermatology (35%) Stomatitis (32%) Fatigue (31%) Nail changes (31%) Insomnia (27%) Fever (25%) Other gastrointestinal (22%) Infusion reactions (18%) Confusion (18%) Other pain, Grade 3 or 4 (18%) Rigors or chills (16%) Dyspnea, Grade 3 or 4 (16%) Rash/desquamation, Grade 3 or 4 (16%) Anxiety (14%) Depression (14%) Dehydration (13%) Mouth dryness (12%) Other gastrointestinal, Grade 3 or 4 (12%) Infections with neutropenia, Grade 3 or 4 (11%) 1-10% (Monotherapy) Taste disturbance (10%) Nausea (6%) Confusion, Grade 3 or 4 (6%) Vomiting, Grade 3 or 4 (5%) Bone pain (4%) Infusion reactions, Grade 3 or 4 (3%) Fever, Grade 3 or 4 (3%) Constipation, Grade 3 or 4 (3%) Arthralgia, Grade 3 or 4 (3%) Diarrhea, Grade 3 or 4 (2%) Pruritus, Grade 3 or 4 (2%) Headache, Grade 3 or 4 (2%) Rigors or chills, Grade 3 or 4 (1%) Stomatitis, Grade 3 or 4 (1%)

Mechanism of Action

Cetuximab is a recombinant human/mouse chimeric monoclonal antibody. It binds specifically to the epidermal growth factor receptor (EGFR), thus competitively inhibiting the binding of epidermal growth factor (EGF) and other ligands. This blocks phosphorylation and activation of receptor-associated kinases, thus inhibiting cell growth, inducing apoptosis and decreases matrix metalloproteinase and vascular EGF production.