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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Cetuximab: Drug information

Cetuximab: Drug information
(For additional information see "Cetuximab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Infusion reactions:

Cetuximab can cause serious and fatal infusion reactions. Immediately interrupt and permanently discontinue cetuximab for serious infusion reactions.

Cardiopulmonary arrest:

Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving cetuximab with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after cetuximab administration.

Brand Names: US
  • Erbitux
Brand Names: Canada
  • Erbitux
Pharmacologic Category
  • Antineoplastic Agent, Epidermal Growth Factor Receptor (EGFR) Inhibitor;
  • Antineoplastic Agent, Monoclonal Antibody
Dosing: Adult

Note: Premedicate with an H1 antagonist IV 30 to 60 minutes prior to the first dose; premedication for subsequent doses may be necessary based on clinical judgment. The use of nebulized albuterol-based premedication to prevent infusion reaction has been reported (Tra 2008).

Colorectal cancer, metastatic, KRAS-wild type, EGFR expressing

Colorectal cancer, metastatic, KRAS-wild type, EGFR expressing: Cetuximab single agent therapy or in combination with irinotecan or FOLFIRI (irinotecan, fluorouracil, and leucovorin): Note: When given in combination with irinotecan or FOLFIRI, complete cetuximab dose 1 hour prior to chemotherapy.

Weekly dosing:

Initial loading dose: IV: 400 mg/m2 infused over 120 minutes.

Maintenance dose: IV: 250 mg/m2 infused over 60 minutes once weekly until disease progression or unacceptable toxicity.

Biweekly dosing:

Initial and subsequent doses: IV: 500 mg/m2 infused over 120 minutes once every 2 weeks until disease progression or unacceptable toxicity.

Off-label combination: IV: Initial loading dose: 400 mg/m2, followed by maintenance dose: 250 mg/m2 once weekly (in combination with fluorouracil, leucovorin, and oxaliplatin [FOLFOX4 or mFOLFOX6]) (Bokemeyer 2011; Venook 2017).

Colorectal cancer, metastatic, BRAF V600E mutation-positive

Colorectal cancer, metastatic, BRAF V600E mutation-positive: Initial loading dose: IV: 400 mg/m2 infused over 120 minutes, followed by maintenance dose: 250 mg/m2 infused over 60 minutes once weekly (in combination with encorafenib) until disease progression or unacceptable toxicity (Kopetz 2019; Tabernero 2021).

Head and neck cancer, squamous cell

Head and neck cancer, squamous cell:

In combination with radiation therapy:

Initial loading dose: IV: 400 mg/m2 infused over 120 minutes 1 week prior to initiation of radiation therapy course.

Maintenance dose: IV: 250 mg/m2 infused over 60 minutes once weekly for the duration of radiation therapy (6 to 7 weeks); complete cetuximab dose 1 hour prior to radiation therapy.

Single agent cetuximab or in combination with a platinum-based therapy with fluorouracil: Note: When given in combination with platinum/fluorouracil chemotherapy, complete cetuximab dose 1 hour prior to chemotherapy.

Weekly dosing:

Initial loading dose: IV: 400 mg/m2 infused over 120 minutes.

Maintenance dose: IV: 250 mg/m2 infused over 60 minutes once weekly until disease progression or unacceptable toxicity.

Biweekly dosing:

Initial and subsequent doses: IV: 500 mg/m2 infused over 120 minutes once every 2 weeks until disease progression or unacceptable toxicity.

Penile cancer, squamous cell, advanced or metastatic

Penile cancer, squamous cell, advanced or metastatic (off-label use; based on limited data): IV: Initial loading dose: 400 mg/m2, followed by maintenance dose: 250 mg/m2 once weekly (as monotherapy or in combination with other chemotherapy agents) (Carthon 2014).

Squamous cell skin cancer, unresectable

Squamous cell skin cancer, unresectable (off-label use): IV: Initial loading dose: 400 mg/m2, followed by maintenance dose: 250 mg/m2 once weekly until disease progression (Maubec 2011).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Adjustment for Toxicity: Adult
Cetuximab Recommended Dosage Modifications for Adverse Reactions

Adverse reaction

Severity

Dosage modification

Dermatologic toxicity and infectious sequelae (eg, acneiform rash, mucocutaneous disease)

First occurrence, grade 3 or 4

Delay cetuximab infusion 1 to 2 weeks. If improvement, continue cetuximab at 250 mg/m2. If no improvement, discontinue cetuximab.

Second occurrence, grade 3 or 4

Delay cetuximab infusion 1 to 2 weeks. If improvement, continue cetuximab at 200 mg/m2. If no improvement, discontinue cetuximab.

Third occurrence, grade 3 or 4

Delay cetuximab infusion 1 to 2 weeks. If improvement, continue cetuximab at 150 mg/m2. If no improvement, discontinue cetuximab.

Fourth occurrence, grade 3 or 4

Permanently discontinue cetuximab.

Electrolyte imbalance

Replete electrolytes as clinically indicated.

Infusion reaction

Grade 1 or 2

Reduce the cetuximab infusion rate by 50%.

Grade 3 or 4

Immediately and permanently discontinue cetuximab.

Pulmonary toxicity

Acute onset or worsening pulmonary symptoms

Delay cetuximab infusion 1 to 2 weeks; if improvement, continue at the dose that was being administered at the time of occurrence. If no improvement in 2 weeks, discontinue cetuximab.

Interstitial lung disease (confirmed)

Permanently discontinue cetuximab.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Erbitux: 100 mg/50 mL (50 mL); 200 mg/100 mL (100 mL) [contains galactose-alpha-1,3-galactose]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Erbitux: 100 mg/50 mL (50 mL, 100 mL) [contains galactose-alpha-1,3-galactose]

Administration: Adult

IV: For weekly dosing schedule, infuse loading dose over 120 minutes and weekly maintenance dose over 60 minutes. For biweekly dosing schedule, infuse each dose over 120 minutes. Administer through a low protein-binding 0.22 micrometer in-line filter. Administer via infusion pump or syringe pump at a rate not to exceed 10 mg/minute. Do not administer as IV push or bolus. Do not shake or dilute.

Premedicate with an H1 antagonist prior to the initial dose; premedication for subsequent doses may be necessary if clinically indicated. Monitor for at least 1 hour following infusion; longer observation time (following an infusion reaction) may be required.

Use: Labeled Indications

Colorectal cancer, metastatic (BRAF V600E mutation-positive): Treatment of metastatic colorectal cancer in adults with a BRAF V600E mutation, as detected by an approved test (in combination with encorafenib) after prior therapy.

Colorectal cancer, metastatic (KRAS wild-type, EGFR expressing): Treatment of KRAS wild-type (without mutation), epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer as determined by an approved test (in combination with FOLFIRI [irinotecan, fluorouracil, and leucovorin] as first-line treatment, in combination with irinotecan [in patients refractory to irinotecan-based chemotherapy], or as a single agent in patients who have failed irinotecan- and oxaliplatin-based chemotherapy or who are intolerant to irinotecan).

Limitation of use: Cetuximab is not indicated for the treatment of RAS-mutant colorectal cancer or when results of the RAS mutation tests are unknown.

Head and neck cancer, squamous cell: Treatment of squamous cell cancer of the head and neck (as a single agent for recurrent or metastatic disease after platinum-based chemotherapy failure; in combination with radiation therapy as initial treatment of locally or regionally advanced disease; in combination with platinum-based therapy with fluorouracil as first-line treatment of locoregional or metastatic disease).

Use: Off-Label: Adult

Penile cancer (squamous cell, advanced or metastatic); Squamous cell skin cancer, unresectable

Medication Safety Issues
Sound-alike/look-alike issues:

Cetuximab may be confused with bevacizumab, cemiplimab, loncastuximab tesirine, margetuximab

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its lists of drug classes which have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults. Adverse reactions reported with cetuximab monotherapy or in combination with radiation.

>10%:

Dermatologic: Acneiform eruption (87%), changes in nails (31%), desquamation (≤95%), pruritus (16% to 47%), radiodermatitis (86%), skin rash (≤95%), xeroderma (57%)

Endocrine & metabolic: Dehydration (13% to 25%), hypomagnesemia (55%), weight loss (84%)

Gastrointestinal: Constipation (53%), diarrhea (19% to 42%; grades 3/4: 2%), dyspepsia (14%), nausea (49% to 64%; grades 3/4: 2% to 6%), stomatitis (32%; grades 3/4: 1%), vomiting (29% to 40%; grades 3/4: 2% to 5%), xerostomia (12%)

Hepatic: Increased serum alanine aminotransferase (43%), increased serum alkaline phosphatase (33%), increased serum aspartate aminotransferase (38%)

Infection: Infection (13%), infection without neutropenia (38%)

Local: Application site reaction (18%)

Nervous system: Anxiety (14%), chills (≤16%), confusion (18%), depression (14%), fatigue (91%), headache (19% to 38%), insomnia (27%), pain (59%), peripheral sensory neuropathy (45%; grades 3/4: 1%), rigors (≤16%)

Neuromuscular & skeletal: Arthralgia (14%), asthenia (56%), ostealgia (15%)

Respiratory: Cough (30%), dyspnea (49%), pharyngitis (26%)

Miscellaneous: Fever (25% to 29%), infusion related reaction (18%; severe infusion related reaction: <2%)

1% to 10%:

Gastrointestinal: Dysgeusia (10%)

Immunologic: Antibody development (<5%)

<1%: Respiratory: Interstitial pulmonary disease

Postmarketing:

Dermatologic: Bullous pemphigoid, exfoliation of skin, skin blister, skin erosion, Stevens-Johnson syndrome, toxic epidermal necrolysis

Gastrointestinal: Mucosal swelling

Nervous system: Aseptic meningitis

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Known severe hypersensitivity to cetuximab or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Cardiopulmonary arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving cetuximab with radiation therapy or cetuximab with platinum-based therapy and fluorouracil.

• Dermatologic toxicity: Cetuximab may cause dermatologic toxicities, including acneiform rash, dry skin and fissuring, paronychial inflammation, infectious sequelae (eg, Staphylococcus aureus sepsis, abscess formation, cellulitis, blepharitis, conjunctivitis, keratitis/ulcerative keratitis with decreased visual acuity, cheilitis), and hypertrichosis. Acneiform rash occurred commonly; grades 3 or 4 acneiform rashes have been reported. Acneiform rash typically developed within the first 2 weeks of therapy and in most patients lasted >28 days after cetuximab discontinuation. In colorectal cancer, the presence of acneiform rash correlates with treatment response and prolonged survival (Cunningham 2004). Life-threatening and fatal bullous mucocutaneous disease (with blisters, erosions, and skin sloughing) has been observed with cetuximab; it is unknown if due to epidermal growth factor receptor (EGFR) inhibition or to idiosyncratic immune-related effects (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). Instruct patients to limit sun exposure during cetuximab treatment.

• Electrolyte abnormalities: Hypomagnesemia is common with cetuximab (may be severe); accompanying electrolyte abnormalities may also occur. The onset of electrolyte disturbance may occur within days to months after initiation of treatment.

• Infusion reactions: Cetuximab may cause serious and fatal infusion reactions. Reactions have included rapid onset airway obstruction (bronchospasm, stridor, hoarseness), hypotension, loss of consciousness, shock, myocardial infarction, and/or cardiac arrest. The risk for anaphylactic reactions may be increased in patients with a history of tick bites, allergies to red meat, or when IgE antibodies against galactose-α-1,3-galactose (alpha-gal) are present. Approximately 90% of reactions occur with the first infusion despite the use of prophylactic antihistamines. Infusion reactions may occur during or several hours after the infusion is complete. Immediate treatment for anaphylactic/anaphylactoid reactions should be available during administration. Severe hypersensitivity reaction has been reported more frequently in patients living in the middle south area of the United States, including North Carolina and Tennessee (Chung 2008; O'Neil 2007).

• Pulmonary toxicity: Cetuximab may cause interstitial lung disease, including some fatal cases.

Disease-related concerns:

• Colorectal cancer and mutation status: Select patients for cetuximab treatment based on the presence of RAS-wild type, EGFR-expressing colorectal cancer (CRC), or BRAF V600E mutation-positive CRC. Information on tests approved for detection of KRAS or BRAF V600E mutations in patients with metastatic CRC is available at http://www.FDA.gov/CompanionDiagnostics. In patients with EGFR-expressing metastatic CRC, cetuximab is only indicated for patients without RAS (KRAS or NRAS) mutations. Determine RAS mutation status prior to treatment. Patients with a codon 12 and 13 (exon 2), codon 59 and 61 (exon 3), and codon 117 and 146 (exon 4) RAS mutation are unlikely to benefit from EGFR inhibitor therapy (while experiencing toxicities) and should not receive cetuximab treatment; cetuximab is not effective for CRC with RAS mutations. The American Society of Clinical Oncology (ASCO) provisional clinical opinion update recommends that all patients with metastatic CRC who are candidates for anti-EGFR therapy should be tested (in a certified lab) for mutations in both KRAS and NRAS exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146); anti-EGFR monoclonal antibody therapy should only be considered in patients whose tumors lack mutations after extended RAS testing (ASCO [Allegra 2016]).

Concurrent drug therapy issues:

• Combination with cisplatin and radiation therapy: In a study of radiation therapy and cisplatin with or without cetuximab in patients with squamous cell head and neck cancer, an increase in the incidence of adverse reactions (eg, grade 3/4 mucositis, radiation recall, acneiform rash, electrolyte abnormalities, and cardiac events including ischemia) was noted in patients receiving cetuximab, including fatal reactions. There was no improvement in the primary end point of progression-free survival. Cetuximab is not approved in combination with radiation and cisplatin for the treatment of squamous cell head and neck cancers.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Verify pregnancy status prior to treatment initiation in patients who may become pregnant. The manufacturer recommends that patients who may become pregnant use effective contraception during therapy and for 2 months following the last dose of cetuximab.

Pregnancy Considerations

Based on animal data and the mechanism of action, cetuximab may be expected to cause fetal harm if administered during pregnancy.

Breastfeeding Considerations

It is not known if cetuximab is present in breast milk.

IgG antibodies can be detected in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer does not recommend breastfeeding during therapy or for 2 months after the last dose of cetuximab.

Monitoring Parameters

EGFR expression, BRAF V600E, and KRAS genotyping of tumor tissue in patients with colorectal cancer. Monitor serum magnesium, calcium, and potassium (weekly during treatment and for at least 8 weeks following completion of treatment). Evaluate pregnancy status (prior to treatment initiation in patients who can become pregnant). Monitor vital signs during infusion and observe for at least 1 hour postinfusion (monitor beyond 1 hour and until resolution in patients who experience a reaction). Monitor for signs/symptoms of dermatologic toxicities (including for the development of infectious complications) and pulmonary toxicities.

Patients with galactose-α-1,3-galactose (alpha-gal) IgE antibodies may have an increased risk of anaphylactic reactions; consider testing for alpha-gal IgE antibodies prior to treatment (although severe infusion reactions may still occur with negative result).

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands. Binding to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. EGFR signal transduction results in RAS wild-type activation; cells with RAS mutations appear to be unaffected by EGFR inhibition. In BRAF-mutant colorectal cancer, the combination of a BRAF inhibitor and an anti-EGFR agent has been shown to overcome induction of EGFR-mediated MAPK pathway activation (resistance mechanism); the combination of cetuximab and encorafenib had an anti-tumor effect greater than either agent alone in an animal model of BRAF V600E mutated colorectal cancer.

Pharmacokinetics

Distribution: Vd: ~2 to 3 L/m2

Half-life elimination: ~112 hours (range: 63 to 230 hours)

Pricing: US

Solution (Erbitux Intravenous)

100 mg/50 mL (per mL): $17.48

200 mg/100 mL (per mL): $17.48

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Cetuxim (BD);
  • Erbituks (UA);
  • Erbitux (AE, AR, AT, AU, BB, BE, BG, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MT, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PT, RO, RU, SE, SG, SI, SK, SV, TH, TR, TW, VE, VN, ZA)


For country abbreviations used in Lexicomp (show table)
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  14. Kopetz S, Grothey A, Yaeger R, et al. Encorafenib, binimetinib, and cetuximab in BRAF V600E-mutated colorectal cancer. N Engl J Med. 2019;381(17):1632-1643. doi:10.1056/NEJMoa1908075 [PubMed 31566309]
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