treated with Erbitux and radiation therapy and in 3% of patients Limitation of Use: Erbitux is not indicated for treatment of K-Ras mutation- positive colorectal. Each mL of solution for infusion contains 5 mg cetuximab. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck All sections. PI reformatted.
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Erbitux – FDA prescribing information, side effects and uses
An FDA-approved test is used to determine if tumors have these particular traits. Severe Grades 3 and 4 infusion reactions occurred in 2.
Knowing more about your treatment may help you feel more prepared. Learn about a complimentary self-care kit, access financial assistance services, download educational brochures, and find helpful links to support groups and other cancer-related resources. Download a discussion guide with a list of questions based on the type of cancer you have.
You can use it to start a conversation with your doctor at your next appointment. You are encouraged to report negative side effects of Prescription drugs to erbtux FDA. This site is intended for US residents ages 18 and over. Models used for illustrative purposes only. Click to Chat Click to Chat.
Select the type of cancer you have. Colorectal cancer that has spread Head and neck cancer that has spread to local tissue or nearby lymph nodes Head and neck cancer that has come back or spread. In combination with FOLFIRI irinotecan, fluorouracil, leucovorin for first-line treatment In combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy As a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan Limitations of Use: In pj with radiation therapy for the initial treatment of a certain type of locally or regionally advanced head and neck cancer In combination with platinum-based chemotherapy and fluorouracil for the initial treatment of patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body For use alone to treat patients with a certain type of head and pu cancer whose tumor has returned in the same location or spread to other parts of the body and whose disease has progressed following platinum-based chemotherapy Metastatic Colorectal Cancer ERBITUX is approved for the treatment of certain patients who have colorectal cancer that has spread to other erbittux of the body.
In combination with FOLFIRI irinotecan, fluorouracil, leucovorin for patients who are being treated for this type of cancer for li first time In combination with another chemotherapy drug, irinotecan, for patients whose disease has progressed after receiving chemotherapy eritux irinotecan As a single agent: For patients whose disease has progressed after receiving both irinotecan and oxaliplatin For patients who are unable to tolerate chemotherapy with irinotecan ERBITUX is not approved to treat colorectal cancer in patients whose tumors have mutations in genes called RAS often called “RAS mutant”or erbitud patients for whom the mutational status of the genes is not known.
Caution must be exercised with every ERBITUX infusion as erbitix reactions may occur during or several hours following completion of the infusion.
Premedicate with a histamine-1 H 1 receptor antagonist as recommended. Monitor patients for at least 1 hour following each ERBITUX infusion in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis.
eebitux In patients requiring treatment for infusion reactions, monitor for more than 1 hour to confirm resolution of the reaction. In 3 patients with prior history of coronary artery disease, death occurred 27, 32, and 43 days respectively after the last dose of ERBITUX.
Carefully consider the use of ERBITUX with radiation therapy, or with platinum-based therapy with fluorouracil, in head and neck cancer patients with a history of coronary artery disease, congestive heart failure, or arrhythmias. The risk erbifux anaphylactic reactions may be increased in patients with a history of tick bites, red meat allergy, or in the presence of certain antibodies which can react to ERBITUX.
Your doctor or nurse should watch you closely for these symptoms during treatment and for at least 1 hour following treatment and may need to stop therapy in erbiitux event of an allergic reaction. After the allergic reaction resolves, your doctor may be able to restart therapy. Notify your doctor if you have a history of any heart disease.
Please see additional Important Safety Information below. Find help and support. Find out how pj order a self-care kit. Questions to ask your doctor. ILD, which was fatal in one case, occurred in Dermatologic Toxicities ERBITUX can cause dermatologic toxicities, including acneiform rash, skin drying and fissuring, paronychial inflammation, infectious pl e. Severe Grades 3 or 4 acneiform rash occurred in 9. Acneiform rash usually developed within the first 2 weeks of therapy; the rash lasted more than 28 days after stopping ERBITUX in most patients.
Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has been observed in patients who received ERBITUX.
It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects e. Sun exposure may exacerbate these effects. The addition of ERBITUX resulted in an increase ervitux the incidence of Grade 3 and 4 mucositis, radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances srbitux to radiation and cisplatin alone.
No patient experienced grade 3 or 4 hypomagnesemia. Monitor patients weekly during treatment for hypomagnesemia, hypocalcemia, and hypokalemia, and for at least 8 weeks following the completion of ERBITUX. Replete electrolytes as necessary.
Retrospective subset analyses of Ras -mutant and wild-type populations across several randomized clinical trials, including CRYSTAL, were conducted to investigate the role of Ras mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies. Use of cetuximab in patients pii Ras mutations resulted in no clinical benefit with treatment related toxicity. 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 erbituc models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. Advise pregnant women of the potential risk to a fetus. The overall incidence of late radiation erbigux any grade frbitux higher for patients receiving ERBITUX in combination with radiation therapy, versus radiation therapy alone.
The following sites were affected: The most common grade adverse reactions included: Use in Specific Populations Lactation: There is no information regarding the presence of ERBITUX in human milk, the effects of the breastfed infant, or the effects on milk production. Human IgG antibodies can be excreted in human milk.
Cetuximab in the management of colorectal cancer
No new safety signals were identified in pediatric patients when ERBITUX in combination with irinotecan was administered in an open-label, single-arm dose-finding study in 27 patients with refractory solid tumors erbltux 1 to 12 years old and in 19 patients aged 13 to 18 years old.
Lung disease occurred in less than 0. Sun exposure may worsen these effects. Severe reactions with symptoms of rash; blistering of the skin, mouth, eyes, and genitals; and shedding of the skin have been seen in patients treated with ERBITUX. These reactions may be life-threatening and possibly lead to death. In a study of patients with head and neck cancer, patients received either a combination of radiation and cisplatin a cancer erbutuxor ERBITUX in combination with radiation and cisplatin.
In areas treated with radiation therapy, the addition of ERBITUX to the radiation therapy increases the risk of damage to surrounding healthly tissues in the area treated with radiation. It is possible that U.
In this study, the type and severity of side effects seen with European cetuximab were similar to other studies of U. The most common serious side effects reported included: If you have any history of heart disease or a heart condition.
Cetuximab in the management of colorectal cancer
If you have a history of breathing problems or other lung problems. If you are pregnant or if you plan on becoming pregnant. If you become pregnant during your treatment or within 2 months after your last dose, discuss this with your doctor.
If you are breastfeeding or plan to breastfeed.
Tell your doctor about all the medications you are taking, including prescription and over-the-counter medications.