How does it work?

Erbitux infusion contains the active ingredient cetuximab, whichis a type of medicine called a humanised monoclonal antibody. It is used totreat head and neck cancer, and cancer of the large intestine and rectum(colorectal cancer) that has spread to other parts of the body.

Many cancer cells have structures called epidermal growth factorreceptors (EGFRs) on their surfaces. These receptors allow a protein calledepidermal growth factor (EGF) to attach to the cells. When the epidermal growthfactor attaches to the receptor, it triggers chemical processes inside thecancer cells that make the cells grow, multiply and spread.

Cetuximab acts by binding to the EGFR. It works in a similar wayto the natural antibodies produced by our immune system. Our natural antibodiesrecognise foreign invaders and bind to them, helping our immune systems toattack them and protect us from infections. Monoclonal antibodies likecetuximab are made in laboratories and are designed to attack particularproteins in a similar way.

Cetuximab specifically recognises and binds to the EGFR proteinon the surface of the cancer cells. This blocks the receptor, stopping growthfactors from attaching to it and stimulating the cells to grow and multiply. Italso triggers the immune system to attack the cancerous cells.

Your doctor may do various tests to check the level of EGFR onyour cancer cells, as this can predict if your cancer is likely to respond tothe treatment.

Cetuximab is given to treat colorectal cancer that has spread toother parts of the body and has not responded to treatment with a chemotherapymedicine called irinotecan. It is given in combination with theirinotecan.

Cetuximab is given in combination with radiation therapy totreat head and neck cancer.

Cetuximab is given as a drip into a vein (intravenous infusion)once a week. The first dose is administered over two hours. If this is welltolerated, further doses may be given over 60 minutes. Some people can have anallergic reaction to the medicine (see warning below), so to reduce the chanceof this you will usually be given an antihistamine before the drip to helpprevent a reaction.

What is it used for?

• Cancer of the large bowel (colon) and rectum (colorectal cancer) that has spread to other areas of the body.
• Locally advanced head and neck cancer.

Warning!

• You may experience infusion-related reactions during treatment with this medicine. These are usually mild to moderate but can be more severe. Symptoms may include shortness of breath, fever, chills, nausea, vomiting, headache, dizziness, hoarseness, difficulty breathing or speaking, low blood pressure or loss of consciousness. Reactions usually occur during the first infusion or up to an hour after it has finished, but can also occur after several hours or after subsequent infusions. You will be monitored closely during your infusion and for about an hour afterwards, but it is very important to tell your nurse or doctor if you get these or any other symptoms either during or after each treatment.
• The most common side effects associated with this medicine are skin reactions, usually beginning in the first three weeks of treatment. These may include an acne-like rash, itching and dry or scaly skin. If you have any skin changes, let your doctor know straight away. If you have very severe skin problems the length of time between your treatments may need to be extended or the dose may be lowered.
• If you feel wheezy or short of breath while having treatment with this medicine, you should let your doctor know.
• This medicine may potentially be harmful to an unborn baby. For this reason, women receiving this medicine should use an effective method of contraception to prevent pregnancy during treatment and possibly for a few months after treatment is finished. You should inform your doctor immediately if you get pregnant.
• It is recommended that you have regular blood tests to monitor the levels of electrolytes (salts such as magnesium, potassium and calcium) in your blood while you are having treatment with this medicine.
• The manufacturer has not studied this medicine in children, or in people with kidney or liver problems, or low white blood cell, red blood cell or platelet counts.

Use with caution in

• Elderly people
• Heart or lung disorders.

Not to be used in

• Allergy to cetuximab
• Breastfeeding.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine has not been studied in pregnant women, but it could be harmful to a developing foetus. It should not be used during pregnancy unless considered essential by your doctor and only if the potential benefits to the mother outweigh the possible risk to the foetus. Women who could get pregnant should use an effective method of contraception to prevent pregnancy while having treatment with this medicine and possibly for a few months after the treatment is finished. Seek medical advice from your doctor. Inform your doctor immediately if you get pregnant at any point during treatment.
• It is not known if this medicine passes into breast milk. However, as it could harm the development of the infant if it does pass into breast milk; mothers should not breastfeed during treatment with this medicine, or for at least two months after the last dose. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

• Skin reactions such as rash, itching, dry or scaly skin (see warning above)
• Increased hair growth
• Nail disorders
• Increased susceptibility to skin infections
• Infusion-related reactions, such as fever, chills, nausea, vomiting, headache, dizziness, or shortness of breath (see warning above)
• Sore mouth
• Shortness of breath
• Change in liver function
• Conjunctivitis
• Decreased level of magnesium in the blood

The side effects listed above may not include all of the sideeffects reported by the drug's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

Formal studies have not been performed to determine the effectof this medicine on other medicines, or vice versa. You should tell your doctoror pharmacist if you are taking any other medicines, including those boughtwithout a prescription and herbal medicines, before treatment with thismedicine is started. Similarly, you should also check with your doctor orpharmacist before taking any new medicines while you are still receivingtreatment with this medicine, so they can check that thecombination is safe.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain cetuximab as the active ingredient.