Cetuximab
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] . Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX 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 ERBITUX administration [see Warnings and Precautions ( 5.2 , 5.6 )] . WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete boxed warning. ERBITUX can cause serious and fatal infusion reactions. ( 5.1 , 6 ) Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions. ( 2.5 ) Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil.
Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration. ( 5.2 , 5.6 )
Epidermal Growth Factor Receptor Antagonist
Dosing in kidney impairment
Continue treatment until disease progression or unacceptable toxicity. ( 2.2 , 2.3 ) See full prescribing information for dosage adjustments for adverse reactions. 2.1 Patient Selection Select patients with metastatic colorectal cancer (CRC) for treatment with ERBITUX based on the presence of: Ras wild-type, EGFR-expressing CRC [see Clinical Studies], or BRAF V600E mutation-positive metastatic CRC [see Clinical Studies] Information on FDA-approved tests for the detection of K-Ras or BRAF V600E mutations in CRC in patients with metastatic CRC is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage for Squamous Cell Carcinoma of the Head and Neck (SCCHN) In combination with radiation therapy Initial dose: 400 mg/m 2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy.
Preparation and administration
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Preparation for Administration The solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, cetuximab particulates. Do not shake or dilute. Visually inspect for foreign particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if solution is discolored, cloudy, or contains foreign particulate matter.
Do not administer ERBITUX as an intravenous push or bolus. Administer via infusion pump or syringe pump. Do not exceed an infusion rate of 10 mg/min. Administer through a low protein binding 0.22-micrometer in-line filter.
| Adverse Reaction | Severitya | Dosage Modification |
|---|---|---|
| a National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0. | ||
| Infusion reactions [see Warnings and Precautions (5.1)] | Grade 1 or 2 | Reduce the infusion rate by 50%. |
| Grade 3 or 4 | Immediately and permanently, discontinue ERBITUX. | |
| Dermatologic toxicities and infectious sequelae (e.g., acneiform rash, mucocutaneous disease) [see Warnings and Precautions (5.4)] | 1st occurrence; Grade 3 or 4 | Delay infusion 1 to 2 weeks; if condition improves, continue at 250 mg/m2. If no improvement, discontinue ERBITUX. |
| 2nd occurrence; Grade 3 or 4 | Delay infusion 1 to 2 weeks; if condition improves, continue at 200 mg/m2. If no improvement, discontinue ERBITUX. | |
| 3rd occurrence; Grade 3 or 4 | Delay infusion 1 to 2 weeks; if condition improves, continue at 150 mg/m2. If no improvement, discontinue ERBITUX. | |
| 4th occurrence; Grade 3 or 4 | Discontinue ERBITUX. | |
| Pulmonary toxicity [see Warnings and Precautions (5.3)] | Acute onset or worsening pulmonary symptoms | Delay infusion 1 to 2 weeks; if condition improves, continue at the dose that was being administered at the time of occurrence. If no improvement in 2 weeks or interstitial lung disease (ILD) is confirmed, discontinue ERBITUX. |
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , ERBITUX can cause fetal harm when administered to a pregnant woman. There are no available data for ERBITUX exposure in pregnant women. In an animal reproduction study, intravenous administration of cetuximab once weekly to pregnant cynomolgus monkeys during the period of organogenesis resulted in an increased incidence of embryolethality and abortion. Disruption or depletion of EGFR in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development ( see Data ).
Human IgG is known to cross the placental barrier; therefore, cetuximab may be transmitted from the mother to the developing fetus. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data Animal Data Pregnant cynomolgus monkeys were administered cetuximab intravenously once weekly during the period of organogenesis (gestation day [GD] 20-48) at dose levels 0.4 to 4 times the recommended dose of ERBITUX based on body surface area (BSA).
Cetuximab was detected in the amniotic fluid and in the serum of embryos from treated dams on GD 49. While no fetal malformations occurred in offspring, there was an increased incidence of embryolethality and abortions at doses approximately 1 to 4 times the recommended dose of ERBITUX based on BSA. In mice, EGFR is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/postnatal survival and development.
Reduction or elimination of embryo-fetal or maternal EGFR signaling can prevent implantation, can cause embryo-fetal loss during various stages of gestation (through effects on placental development), and can cause developmental anomalies and early death in surviving fetuses. Adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted EGFR signaling.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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