ERBITUX PI PDF

Infusion reactions [see Warnings and Precautions 5. Grade 3 or 4 Immediately and permanently, discontinue Erbitux. If no improvement, discontinue Erbitux. If no improvement in 2 weeks or interstitial lung disease ILD is confirmed, discontinue Erbitux. Preparation for Administration Do not administer Erbitux as an intravenous push or bolus. Administer via infusion pump or syringe pump.

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This medicine is authorised for use in the European Union. It explains how the Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Erbitux.

Expand section Collapse section What is Erbitux? Erbitux is a solution for infusion drip into a vein that contains the active substance cetuximab. What is Erbitux used for? Erbitux is used to treat metastatic cancer of the colon or rectum large intestine. Erbitux is given in the following ways: together with anticancer treatments containing irinotecan; together with the oxaliplatin-containing treatment FOLFOX in patients who have not been treated before; on its own when previous treatment containing oxaliplatin and irinotecan has failed and the patient cannot receive irinotecan.

These types of cancer affect the cells of the lining of the mouth or the throat, or of organs such as the larynx voice box. In locally advanced cancer when the tumour has grown but has not spread , Erbitux is given in combination with radiotherapy treatment with radiation. The medicine can only be obtained with a prescription. How is Erbitux used? Erbitux should only be given under the supervision of a doctor who has experience in the use of anticancer medicines in a setting where facilities for resuscitation are available.

Before receiving Erbitux, the patient must be given an antihistamine and a corticosteroid to prevent an allergic reaction. Patients must also be closely observed for any signs of allergic reaction for at least one hour after the end of the infusion. Erbitux is given once a week. When it is used on its own or with other anticancer medicines, Erbitux is continued for as long as the patient responds. When it is used with radiotherapy, Erbitux is started one week before the radiotherapy starts and continued until the radiotherapy has finished.

How does Erbitux work? The active substance in Erbitux, cetuximab, is a monoclonal antibody. A monoclonal antibody is an antibody a type of protein that has been designed to recognise and attach to a specific structure called an antigen in the body. Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells.

EGFR is involved in switching on genes called RAS that are involved in the growth of cells; by attaching to EGFR, cetuximab prevents this from happening in the tumour cells and helps stop them growing.

How has Erbitux been studied? For metastatic cancer of the colon or rectum, Erbitux was studied in six main studies: two studies involved 1, patients who had not received chemotherapy before, looking at the effects of adding Erbitux to a treatment combination containing either irinotecan or oxaliplatin FOLFOX ; a third study also looked at the effects of adding Erbitux to two treatment combinations containing oxaliplatin one of which was similar to FOLFOX in 1, patients; three studies involved 2, patients whose disease had got worse while they were on previous treatment including irinotecan, oxaliplatin or both, or who could not receive these medicines.

For cancers of the head and neck, Erbitux was investigated in two main studies: the first study involved patients with locally advanced cancer, looking at the effects of adding Erbitux to radiotherapy; the second study involved patients with recurrent or metastatic cancer, looking at the effects of adding Erbitux to a platinum-based anticancer medicine combination.

All of the studies looked at how long the patients lived without their cancer getting worse or how long they survived. One of the studies also looked at the results separately in patients whose tumours carried wild-type forms of all RAS genes and patients with mutated forms of any RAS gene. What benefit has Erbitux shown during the studies? In the studies of cancer of the colon or rectum, Erbitux was shown overall to increase the time patients lived without their cancer getting worse or how long they survived: in patients who had not received chemotherapy before, patients who had wild-type KRAS in their tumours lived for longer without their disease getting worse when they received Erbitux in addition to chemotherapy including irinotecan 9.

However, in the third study, patients with wild-type KRAS only survived overall for Patients who had failed both oxaliplatin and irinotecan treatment lived for an average of 3.

Patients who had failed oxaliplatin treatment lived for an average of 4. In locally advanced head and neck cancers, the patients lived for longer without their disease getting worse when Erbitux was added to radiotherapy In recurrent or metastatic head and neck cancer, survival was longer when Erbitux was added to a platinum-based anticancer medicine combination What is the risk associated with Erbitux?

The most common side effects with Erbitux seen in more than 1 patient in 10 are skin reactions such as rash, hypomagnesaemia low blood magnesium levels , mild or moderate reactions linked to the infusion such as fever, chills, dizziness and difficulty breathing , mucositis inflammation of the lining of the mouth and raised levels of some liver enzymes.

For the full list of all side effects reported with Erbitux, see the package leaflet. Erbitux must not be used with oxaliplatin-containing chemotherapy for metastatic colorectal cancer in patients with mutated RAS or for whom RAS status is unknown.

For the full list of restrictions, see the package leaflet. Erbitux can be associated with severe reactions during the infusion, so the patients must be monitored carefully while the medicine is being given. Why has Erbitux been approved? Other information about Erbitux: The European Commission granted a marketing authorisation valid throughout the European Union for Erbitux on 29 June For more information about treatment with Erbitux, read the package leaflet also part of the EPAR or contact your doctor or pharmacist.

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ERBITUX PI PDF

Fenrijora The risk or severity of adverse effects can be increased when Cetuximab is combined with Nimotuzumab. In vitro assays and in vivo animal studies have shown that cetuximab inhibits the growth and survival of tumor cells that express the EGFR. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Dinutuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Dinutuximab.

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Brakazahn Cetuximab in the management of colorectal cancer Together, these effects pl EGFR-mediated signaling leading to cell cycle arrest in G1, and pro-apoptotic processes Huang et al ; Kiyota et al ; Harding and Burtness Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. In a study of patients with head and neck cancer, patients received either a combination of radiation and cisplatin a cancer drugor ERBITUX in combination with radiation and ebitux. Death occurred 27, 32, and 43 days after the last dose of Erbitux. No patient experienced grade 3 or 4 hypomagnesemia. Rontalizumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Rontalizumab. Erbitux can cause interstitial pj disease ILD. There is no information regarding the presence of ERBITUX in human milk, the effects of the breastfed infant, or the effects on milk production.

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This medicine is authorised for use in the European Union. It explains how the Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Erbitux. Expand section Collapse section What is Erbitux? Erbitux is a solution for infusion drip into a vein that contains the active substance cetuximab. What is Erbitux used for?

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