Patient leaflet - Erbitux 5 mg / ml solution for infusion
1. What Erbitux is and what it is used for
What Erbitux is
Erbitux contains cetuximab, a monoclonal antibody. Monoclonal antibodies are proteins that specifi cally recognise and bind to other unique proteins called antigens. Cetuximab binds to the epidermal growth factor receptor (EGFR), an antigen on the surface of certain cancer cells. EGFR activates proteins called RAS. RAS proteins play an important role in the EGFR pathway
- a complex signalling cascade which is involved in the development and progression of cancer. As a result of this binding, the cancer cell can no longer receive the messages it needs for growth, progression and metastasis.
What Erbitux is used for
Erbitux is used to treat two diff erent types of cancer:
metastatic cancer of the large intestine. In these patients, Erbitux is
used alone or in combination with other anticancer medicines. Erbitux in combination with another medicine encorafenib is also used to treat a type of large intestine cancer when it has a particular change (mutation) in the ‘BRAF’ gene and has spread to other parts of the body in patients who have been previously treated with other anticancer medicines.
a certain type of cancer of the head and neck (squamous cell cancer).
In these patients, Erbitux is used in combination with radiation therapy or with other anticancer medicines.
2. What you need to know before you use Erbitux
Do not use Erbitux
Do not use Erbitux if you have ever had a severe hypersensitivity (allergic) reaction to cetuximab.
Before starting treatment for metastatic cancer of the large intestine your doctor will test your cancer cells if they contain the normal (wild-type) or mutant form of RAS. You must not receive Erbitux in combination with other anticancer treatment containing oxaliplatin if your cancer cells contain the mutant form of RAS.
If Erbitux is to be used in combination with encorafenib to treat large intestine cancer, read the encorafenib leafl et carefully as well as this leafl et. Before starting treatment, your doctor will also check for BRAF mutation.
Warnings and precautions
Talk to your doctor before using Erbitux, if any of the following information is not clear.
Erbitux may cause infusion-related side eff ects. Such reactions may be allergic in nature. Please read ‘Infusion-related side eff ects’ in section 4 for details, as they may have serious consequences for you, including life-threatening conditions. These side eff ects normally occur during the infusion, within 1 hour afterwards, or sometimes also after this period. To recognise early signs of such eff ects, your condition will be checked regularly while you receive each infusion of Erbitux and for at least 1 hour afterwards.
You are more likely to experience severe allergic reactions if you are allergic to red meat, or tick bites or had positive results for certain antibodies (seen in a test). Your doctor will discuss appropriate measures with you.
Erbitux may cause side eff ects concerning the skin. Your doctor will discuss with you whether you may need any preventive measures or early treatment. Please also read ‘Side eff ects concerning the skin’ in section 4 for details,
as some skin reactions may have serious consequences for you, including life-threatening conditions.
If you have heart problems, your doctor will discuss with you whether you can receive Erbitux in combination with other anticancer medicines, especially if you are 65 years of age or older.
Erbitux may cause side eff ects concerning the eyes. Please tell your doctor, if you have acute or worsening eye problems such as blurred vision, eye pain, red eyes and/or severe dry eye, if you have had such problems in the past or if you use contact lenses. Your doctor will discuss with you whether you need to consult a specialist.
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced. Your doctor will therefore monitor your blood and general condition for signs of infection (see also ‘Side eff ects in combination with other anticancer treatments’ in section 4).
If you receive Erbitux in combination with other anticancer medicines, including fl uoropyrimidines, it may be more likely that you experience heart problems which may be life-threatening. Your doctor will discuss with you whether you may need any particular supervision (see also ‘Side eff ects in combination with other anticancer treatments’ in section 4).
Children and adolescents
There is no relevant use of Erbitux in children and adolescents.
Other medicines and Erbitux
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy
Tell your doctor if you are pregnant or if you are not using reliable contraception (speak to your doctor if you are not sure). Your doctor will then discuss with you the risks and benefi ts of using Erbitux in these situations.
Breast-feeding
Do not breast-feed your baby during the period over which you are being treated with Erbitux and for two months after the last dose.
Driving and using machines
Do not drive or use any tools or machines if you experience treatment-related symptoms that aff ect your ability to concentrate and react.
3. How to use Erbitux
A doctor experienced in the use of anticancer medicines will supervise your Erbitux therapy. During each infusion and for at least 1 hour afterwards, your condition will be checked regularly for early signs of a possible infusion-related side eff ect.
Pre-treatment
Before the fi rst dose, you will receive an antiallergic medicine in order to reduce the risk of an allergic reaction. Your doctor will decide whether such pre-treatment is necessary for subsequent doses.
Dosage and administration
Erbitux is usually infused into a vein (given as a drip). Your doctor will calculate the correct dose of Erbitux for you. The dose of Erbitux depends on your body surface area and it depends on if you receive Erbitux either once a week or every two weeks.
Weekly infusion for treatment of squamous cell cancer of the head and neck and metastatic cancer of the large intestine:
The fi rst dose (400 mg/m² body surface area) is infused over a period of approximately 2 hours. Each subsequent dose (250 mg/m² body surface area) is infused in approximately 1 hour.
Every two weeks infusion for treatment of squamous cell cancer of the head and neck if used in combination with other anticancer medicines and metastatic cancer of the large intestine:
The dose of Erbitux (500 mg/m² body surface area) is infused in approximately 2 hours.
Detailed instructions for your doctor or your nurse on how to prepare the Erbitux infusion are included at the end of this package leafl et (see ‘Handling instructions’).
Duration of treatment
Erbitux is usually infused once a week. The duration of treatment may vary depending on your disease as well as from person to person and your doctor will therefore discuss with you how long you will receive Erbitux.
Combination with other anticancer treatments
If you receive Erbitux in combination with other anticancer medicines,
these medicines must be administered at least 1 hour after the end of the Erbitux infusion.
If you receive Erbitux in combination with radiation therapy, treatment with Erbitux is usually started one week before radiation therapy. If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side eff ects
Like all medicines, this medicine can cause side eff ects, although not everybody gets them.
The main side eff ects of Erbitux are infusion-related side eff ects and side eff ects concerning the skin:
Infusion-related side eff ects
More than 10 out of 100 patients are likely to experience infusion-related side eff ects; in more than 1 out of 100 patients these side eff ects are likely to be severe. Such reactions may be allergic in nature. They normally occur during the infusion, within 1 hour afterwards, or sometimes also after this period.
Mild or moderate infusion-related side eff ects include:
- fever
- chills
- dizziness
- breathing diffi culties
If such symptoms occur, please inform your doctor as soon as possible.
Your doctor may consider reducing the infusion rate of Erbitux to manage these symptoms.
Severe infusion-related side eff ects include:
- severe breathing diffi culties which develop rapidly
- hives
- fainting
- chest pain (a symptom of side eff ects on your heart)
If such symptoms occur, speak to a doctor immediately. These side eff ects may have serious consequences, in rare cases including life-threatening conditions, and require immediate attention. Treatment with Erbitux must then be stopped.
Side eff ects concerning the skin
More than 80 out of 100 patients are likely to experience side eff ects involving the skin. In about 15 out of 100 patients these skin reactions are likely to be severe. Most of these side eff ects develop within the fi rst three weeks of treatment. They usually disappear over time after the end of Erbitux therapy.
Main side eff ects concerning the skin include:
- acne-like skin alterations
- itching
- dry skin
- scaling
- excessive growth of hair
- nail disorders, for example infl ammation of the nail bed
In very rare cases (may aff ect up to 1 in 10,000 people) patients may experience blistering or peeling of the skin, which may indicate a severe skin reaction called “Stevens-Johnson syndrome”. If you experience these symptoms, please speak to a doctor immediately, because these signs may have serious consequences including life-threatening conditions.
If you notice other extensive skin alterations, please inform your doctor as soon as possible because the Erbitux dose or the time between infusions may need to be changed. Your doctor will decide whether treatment has to be stopped if skin reactions reappear after several dose reductions.
If you notice that already aff ected areas of your skin get worse, speak to a doctor immediately, especially if you also experience general signs of infection such as fever and tiredness. These signs may indicate a skin infection, which may have serious consequences including life-threatening conditions.
Side eff ects concerning the lungs
In uncommon cases (may aff ect up to 1 in 100 people) patients may experience an infl ammation of the lungs (called interstitial lung disease), which may have serious consequences including life-threatening conditions.
If you notice symptoms such as occurrence or worsening of breathing diffi culties, speak to a doctor immediately, especially if you also experience cough or fever. Your doctor will decide whether treatment has to be stopped.
Other side eff ects
Very common side eff ects (may aff ect more than 1 in 10 people)
infl ammation of the lining of the intestine, mouth, and nose
(in some cases severe), which may lead to nose bleeding in some patients
- decrease in blood levels of magnesium
- increase in blood levels of certain liver enzymes
Common side eff ects (may aff ect up to 1 in 10 people)
- headache
- tiredness
- irritation and redness of the eye
- diarrhoea
drying out which may be due to diarrhoea or reduced fl uid intake
- feeling sick
- vomiting
- loss of appetite, leading to weight decrease
- decrease in blood levels of calcium
Uncommon side eff ects (may aff ect up to 1 in 100 people)
- blood clots in the veins of the legs
- blood clots in the lungs
- infl ammation of the eye lid or the front part of the eye
Side eff ects of which the frequency is not known (cannot be estimated from the available data)
- infl ammation of the lining of the brain (aseptic meningitis)
Side eff ects in combination with other anticancer treatments
If you receive Erbitux in combination with other anticancer medicines, some of the side eff ects you may experience can also be related to the combination or the other medicines. Therefore, please make sure that you also read the package leafl et for the other medicines.
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced. This may lead to infectious complications including life-threatening conditions, especially if you experience skin reactions, infl ammation of the lining of the intestine and mouth or diarrhoea. Therefore, if you experience general signs of infection such as fever and tiredness, please speak to a doctor immediately. If you receive Erbitux in combination with an anticancer medicine containing fl uoropyrimidines, it is more likely that you experience the following side eff ects of this other medicine:
- chest pain
- heart attack
- heart failure
- redness and swelling of the palms of the hands or the soles of the feet which may cause the skin to peel (hand-foot syndrome)
If you receive Erbitux with radiation therapy, some of the side eff ects you may experience can also be related to this combination, such as:
- infl ammation of the lining of the intestine and mouth
- skin reactions typical for radiation therapy
- diffi culty in swallowing
- reduction in the number of white blood cells
If you receive Erbitux in combination with encorafenib, you may experience side eff ects that are known to occur with Erbitux or with encorafenib. In addition the following side eff ects may occur:
Very common (may aff ect more than 1 in 10 people)
- muscle pain, weakness or spasm
- stomach pain
- bleeding at various sites in the body
Common (may aff ect up to 1 in 10 people)
- dizziness
Reporting of side eff ects
If you get any side eff ects, talk to your doctor. This includes any possible side eff ects not listed in this leafl et. You can also report side eff ects directly via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eff ects you can help provide more information on the safety of this medicine.
5. How to store Erbitux
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Once opened, Erbitux is intended for immediate use.
If the medicine becomes discolored or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Erbitux contains
The active substance is cetuximab.
Each mL of the solution for infusion contains 5 mg cetuximab. Each vial of 20 mL contains 100 mg cetuximab.
- The other ingredients are sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide and water for injections.
What Erbitux looks like and contents of the pack
Erbitux 5 mg/mL solution for infusion is supplied in vials containing 20 mL. Each pack contains 1 vial.
Package leafl et: Information for the user UK61200296P95-A2.0
Erbitux® 5 mg/mL solution for infusion
(cetuximab) Manufacturer
Merck Healthcare KGaA
Frankfurter Straße 250
64293 Darmstadt
Germany
or
Merck KGaA
64271 Darmstadt
Germany
Procured from within the EU and repackaged for the PL Holder:
Abacus Medicine Ltd., Abbey House, 282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom
Erbitux 5 mg/mL solution for infusion
PL 45763/0746
POM
Erbitux® is a registered trademark of ImClone LLC
For any information about this medicine, please contact the local representative of the Product Licence Holder: Abacus Medicine Ltd. tel: +44(0)2036301244,
email: MedInfo@abacusmedicine.co.uk or
drugsafetyuk@abacusmedicine.co.uk
This leafl et was last revised on 16.06.2025.
Blind or partially sighted? Is this leafl et hard to see or read? Call 02036301310 or write to info@abacusmedicine.com to obtain the leafl et in a format suitable for you.
The following information is intended for medical or healthcare professionals only:
Handling instructions
Erbitux may be administered via a gravity drip, an infusion pump or a syringe pump. Since Erbitux is only compatible with sterile sodium chloride 9 mg/mL (0.9%) solution for injection, it must not be mixed with other intravenously applied medicinal products. A separate infusion line must be used for the infusion, and the line must be fl ushed with sterile sodium chloride 9 mg/mL (0.9%) solution for injection at the end of infusion.
Erbitux 5 mg/mL is compatible
with polyethylene (PE), ethyl vinyl acetate (EVA) or polyvinyl chloride
(PVC) bags,
with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA),
polyolefi ne thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets,
- with polypropylene (PP) syringes for syringe pump.
Erbitux 5 mg/mL is chemically and physically stable for up to 48 hours at 25°C, if the solution is prepared as described hereafter. However, since it does not contain any antimicrobial preservative or bacteriostatic agent, it is intended for immediate use. Care must be taken to ensure aseptic handling when preparing the infusion. Erbitux 5 mg/mL must be prepared as follows:
For administration with infusion pump or gravity drip (diluted with
sterile sodium chloride 9 mg/mL (0.9%) solution): Take an infusion bag of adequate size of sterile sodium chloride 9 mg/mL (0.9%) solution. Calculate the required volume of Erbitux. Remove an adequate volume of the sodium chloride solution from the infusion bag, using an appropriate sterile syringe with a suitable needle. Take an appropriate sterile syringe and attach a suitable needle. Draw up the required volume of Erbitux from a vial. Transfer the Erbitux into the prepared infusion bag. Repeat this procedure until the calculated volume has been reached. Connect the infusion line and prime it with the diluted Erbitux before starting the infusion. Use a gravity drip or an infusion pump for administration.
Weekly infusion for treatment of squamous cell cancer of the head and neck and metastatic cancer of the large intestine:
The fi rst dose (400 mg/m² body surface area) is infused over a period of approximately 2 hours. Each subsequent dose (250 mg/m² body surface area) is infused over a period of approximately 1 hour with an infusion rate not faster than 10 mg/min.
Every two weeks infusion for treatment of squamous cell cancer of the head and neck if used in combination with other anticancer medicines and metastatic cancer of the large intestine:
Initial and subsequent doses (500 mg/m² body surface area) is infused over a period of approximately 2 hours with an infusion rate not faster than 10 mg/min.
For administration with infusion pump or gravity drip (undiluted):
Calculate the required volume of Erbitux. Take an appropriate sterile syringe (minimum 50 mL) and attach a suitable needle. Draw up the required volume of Erbitux from a vial. Transfer the Erbitux into a sterile evacuated container or bag. Repeat this procedure until the calculated volume has been reached. Connect the infusion line and prime it with Erbitux before starting the infusion.
Weekly infusion for treatment of squamous cell cancer of the head and neck and metastatic cancer of the large intestine:
The fi rst dose (400 mg/m² body surface area) is infused over a period of approximately 2 hours. Each subsequent dose (250 mg/m² body surface area) is infused over a period of approximately 1 hour with an infusion rate not faster than 10 mg/min.
Every two weeks infusion for treatment of squamous cell cancer of the head and neck if used in combination with other anticancer medicines and metastatic cancer of the large intestine:
Initial and subsequent doses (500 mg/m² body surface area) is infused over a period of approximately 2 hours with an infusion rate not faster than 10 mg/min.
For administration with a syringe pump: Calculate the required volume of Erbitux. Take an appropriate sterile syringe and attach a suitable needle. Draw up the required volume of Erbitux from a vial. Remove the needle and put the syringe into the syringe pump. Connect the infusion line to the syringe and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution. Repeat this procedure until the calculated volume has been infused.
Weekly infusion for treatment of squamous cell cancer of the head and neck and metastatic cancer of the large intestine:
The fi rst dose (400 mg/m² body surface area) is infused over a period of approximately 2 hours. Each subsequent dose (250 mg/m² body surface area) is infused over a period of approximately 1 hour with an infusion rate not faster than 10 mg/min.
Every two weeks infusion for treatment of squamous cell cancer of the head and neck if used in combination with other anticancer medicines and metastatic cancer of the large intestine:
Initial and subsequent doses (500 mg/m² body surface area) is infused over a period of approximately 2 hours with an infusion rate not faster than 10 mg/min.