Erbitux 5 mg/ml solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Erbitux 5mg/ml solution for infusion
cetuximab
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor.
- If you experience any adverse reactions, consult your doctor, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Erbitux is and what it is used for
- What you need to know before you start using Erbitux
- How to use Erbitux
- Possible adverse effects
- How to store Erbitux
- Contents of the pack and other information
1. What Erbitux is and what it is used for
What Erbitux is
Erbitux contains cetuximab, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognise and bind to other unique proteins called antigens. Cetuximab binds to the epidermal growth factor receptor (EGFR), an antigen found on the surface of certain cancer cells. EGFR activates proteins called RAS. RAS proteins play an important role in the EGFR pathway, a complex signaling cascade involved in cancer development and progression. As a result of this binding, the cancer cell can no longer receive the signals it needs for growth, progression, and metastasis.
What Erbitux is used for
Erbitux is used to treat two different types of cancer:
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Metastatic colorectal cancer. In these patients, Erbitux is used alone or in combination with other anticancer medicines.
-
A specific type of head and neck cancer (squamous cell carcinoma). In these patients, Erbitux is used in combination with radiotherapy or with other anticancer medicines.
2. What you need to know before using 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 colorectal cancer, your doctor will analyze your cancer cells to determine whether they contain the normal (wild-type) or mutant form of the RAS gene. You should not receive Erbitux in combination with other anticancer treatments containing oxaliplatin if your cancer cells contain the mutant form of the RAS gene.
Warnings and precautions
Talk to your doctor before starting to use Erbitux if any part of the following information is unclear.
Erbitux may cause infusion-related adverse reactions. These reactions may be allergic in nature. Read the section “Infusion-related adverse reactions” in section 4 for detailed information, as these reactions can have serious consequences for you, including life-threatening situations. These adverse reactions usually occur during or within one hour after the infusion, although sometimes they may also occur later. To detect early signs of these reactions, you will be monitored regularly during each Erbitux infusion and for at least 1 hour after the infusion ends.
You may be more likely to experience severe allergic reactions if you are allergic to red meat or tick bites, or if you tested positive for certain antibodies (detected in a test). Your doctor will discuss appropriate measures with you.
Erbitux may cause adverse effects affecting the skin. Your doctor will discuss whether preventive measures or early treatment may be needed. Also read "Skin-related adverse effects" in section 4 for more detailed information, as some skin reactions may have serious consequences for you, even becoming life-threatening.
If you have heart problems, your doctor will discuss whether you can receive Erbitux in combination with other anticancer medicines, especially if you are 65 years of age or older.
Erbitux may cause adverse effects affecting the eyes. Inform your doctor if you experience worsening of existing eye problems or new acute eye problems such as blurred vision, eye pain, eye redness, and/or severe dry eyes, if you have had such problems in the past, or if you wear contact lenses. Your doctor will advise whether you should consult a specialist.
If you receive Erbitux in combination with anticancer medicines, including platinum-based agents, it is more likely that your white blood cell count may decrease. Therefore, your doctor may monitor your blood and general condition to detect signs of infection (see also “Adverse effects occurring when combined with other anticancer treatments” in section 4).
If you receive Erbitux in combination with other anticancer medicines, including fluoropyrimidines, you may have an increased risk of heart problems that could be life-threatening. Your doctor will discuss whether special monitoring may be needed (see also “Adverse effects occurring when combined with other anticancer treatments” in section 4).
Children and adolescents
There is no specific recommendation for the use of Erbitux in the pediatric population.
Other medicines and Erbitux
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Pregnancy
If you are pregnant or not using a reliable method of contraception (consult your doctor if you have any doubts), inform your doctor. Your doctor will discuss with you the potential risks and benefits of using Erbitux in these situations.
Breast-feeding
Do not breast-feed your child during treatment with Erbitux and for two months after the last dose.
Driving and use of machines
Do not drive or operate tools or machinery if you experience treatment-related symptoms that affect your ability to concentrate or react.
3. How to use Erbitux
Treatment with Erbitux will be supervised by a doctor experienced in the use of anticancer medicines. Regular monitoring is required during the infusion and for at least 1 hour after its completion to detect early signs of a possible infusion-related adverse reaction.
Premedication
Before the first dose, you will receive an antiallergic medication to reduce the risk of allergic reactions. Your doctor will decide whether this treatment needs to be repeated during subsequent infusions.
Dosage and administration
Erbitux is usually administered into a vein (given as an infusion). Your doctor will calculate the appropriate dose of Erbitux for you. The dose of Erbitux depends on your body surface area and whether you receive Erbitux once weekly or once every two weeks.
Weekly infusion for the treatment of head and neck squamous cell carcinoma and metastatic colorectal cancer:
The initial dose (400 mg/m² body surface area) is infused over approximately 2 hours. Each subsequent dose (250 mg/m² body surface area) is infused over approximately 1 hour.
Infusion every two weeks for the treatment of head and neck squamous cell carcinoma when used in combination with other anticancer agents and for metastatic colorectal cancer:
The dose of Erbitux (500 mg/m² body surface area) is infused over approximately 2 hours.
At the end of this leaflet, detailed instructions are provided for your doctor or nurse on the preparation of the Erbitux infusion (see “Instructions for use and handling”).
Duration of treatment
Erbitux is usually administered once a week. The duration of treatment may vary depending on your disease or from patient to patient; therefore, your doctor will discuss with you how long you should continue treatment with Erbitux.
Combination with other anticancer treatments
If you receive Erbitux in combination with other anticancer medicines, these medicines should be administered at least 1 hour after completion of the Erbitux infusion.
If you receive Erbitux in combination with radiotherapy, treatment with Erbitux usually starts one week before radiotherapy.
If you have any further questions about the use of this medicine, ask your doctor.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The main adverse effects of Erbitux are infusion-related effects and skin-related effects:
Infusion-related adverse effects
More than 10 in every 100 patients are likely to experience adverse effects related to the infusion; these are severe in more than 1 in every 100 patients. These reactions may be of an allergic nature. They usually occur during the infusion, within the following hour, or sometimes even later.
Mild or moderate infusion-related adverse effects include:
- fever
- chills
- dizziness
- difficulty breathing
If you experience these symptoms, contact your doctor as soon as possible. Your doctor may consider reducing the infusion rate of Erbitux to control these symptoms.
Severe infusion-related adverse effects include:
- severe and rapid-onset breathing difficulty
- hives (urticaria)
- fainting
- chest pain (a symptom of adverse cardiac effects)
If you experience these symptoms, inform your doctor immediately. These adverse effects can have serious consequences and, although rarely, may even be life-threatening, requiring immediate medical attention. Treatment with Erbitux should then be discontinued.
Skin-related adverse effects
More than 80 in every 100 patients are likely to experience skin-related adverse effects. In around 15 out of every 100 patients, these skin (cutaneous) reactions may be severe. Most of these adverse effects appear during the first three weeks of treatment. They usually resolve over time after discontinuation of Erbitux treatment.
The main skin-related adverse effects are:
- acne-like skin changes
- itching
- dry skin
- peeling
- excessive hair growth
- nail changes (e.g., inflammation of the nail bed)
In very rare cases (may affect up to 1 in 10,000 people), patients may develop blistering or skin peeling, which could indicate a more severe skin reaction called "Stevens-Johnson syndrome". If you experience these symptoms, inform your doctor immediately, as these signs may have serious consequences, including life-threatening conditions.
If you notice other extensive skin changes, consult your doctor as soon as possible, since it may be necessary to modify the dose of Erbitux or the time between infusions. Your doctor will decide whether treatment should be interrupted if skin reactions recur after several dose reductions.
If you notice that the affected skin areas worsen, inform your doctor immediately, especially if you also experience general signs of infection such as fever or fatigue. These signs may indicate a skin infection, which can have serious, potentially life-threatening consequences.
Adverse effects affecting the lungs
In uncommon cases (may affect up to 1 in 100 people), patients may experience inflammation of the lungs (called interstitial lung disease), which can have serious consequences, including life-threatening conditions.
If you notice symptoms such as onset or worsening of breathing difficulties, inform your doctor immediately, especially if you also experience cough or fever. Your doctor will decide whether treatment should be discontinued.
Other adverse effects
Very common adverse effects (may affect more than 1 in 10 people)
- inflammation of the tissue lining the intestines, mouth, and nose (in some cases severe), which may cause nosebleeds in some patients
- decreased blood magnesium levels
- increased blood levels of certain liver enzymes
Common adverse effects (may affect up to 1 in 10 people)
- headache
- fatigue
- eye irritation and redness (conjunctivitis)
- diarrhea
- dehydration, which may result from diarrhea or reduced fluid intake
- nausea
- vomiting
- loss of appetite, leading to weight loss
- decreased blood calcium levels
Uncommon adverse effects (may affect up to 1 in 100 people)
- blood clots in the leg veins
- blood clots in the lungs
- inflammation of the eyelid or cornea (front part of the eye)
Adverse effects of unknown frequency (cannot be estimated from available data)
- inflammation of the lining of the brain (aseptic meningitis)
Adverse effects occurring when combined with other anticancer treatments
If you receive Erbitux in combination with other anticancer medicines, some of the adverse effects you may experience could be related to the combination or to the other medicines. Therefore, make sure to also read the package leaflet of the other medicines.
If you receive Erbitux in combination with anticancer medicines, including platinum-based agents, it is more likely that your white blood cell count will be reduced. This may lead to infectious complications, which can even be life-threatening, especially if you also have skin reactions, inflammation of the intestinal and oral linings, or diarrhea. Therefore, if you experience general signs of infection such as fever and fatigue, inform your doctor immediately.
If you receive Erbitux in combination with an anticancer medicine containing fluoropyrimidines, you may experience the following adverse effects related to the other medicine:
- chest pain
- heart attack (myocardial infarction)
- heart failure
- redness and swelling of the palms of the hands or soles of the feet, which may cause the skin to peel (hand-foot syndrome)
If you receive Erbitux together with radiotherapy, some of the adverse effects you may experience could be related to this combination, for example:
- inflammation of the intestinal and oral linings
- skin reactions typical of radiotherapy
- difficulty swallowing
- reduced white blood cell count
Reporting of adverse effects
If you experience any adverse effects, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Erbitux
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "EXP". The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C). Once opened, Erbitux must be used immediately.
6. Pack contents and other information
Composition of Erbitux
- The active substance is cetuximab.
Each ml of solution for infusion contains 5 mg of cetuximab.
Each 20 ml vial contains 100 mg of cetuximab.
Each 100 ml vial contains 500 mg of cetuximab.
- The other components are sodium chloride, glycine, polysorbate 80, monohydrate citric acid, sodium hydroxide and water for injections.
Presentation of the product and pack contents
Erbitux 5 mg/ml solution for infusion is available in 20 ml or 100 ml vials.
Each pack contains 1 vial.
Only certain vial sizes may be marketed.
Marketing Authorisation Holder
Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
Netherlands
Manufacturer
Merck Healthcare KGaA
Frankfurter Straße 250
64293 Darmstadt
Germany
Date of the most recent revision of this leaflet: 12/2024
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
This information is intended for medical or healthcare professionals only:
Instructions for use and handling
Erbitux can be administered by gravity drip, infusion pump or syringe pump. Since Erbitux is compatible only with sterile 9 mg/ml (0.9 %) sodium chloride injection solution, this medicine must not be mixed with other intravenous medicinal products. The infusion should be given through a dedicated infusion line, which should be flushed with sterile 0.9 % (9 mg/ml) sodium chloride injection solution at the end of the infusion.
Erbitux 5 mg/ml is compatible with:
- polyethylene (PE), ethylene vinyl acetate (EVA) or polyvinyl chloride (PVC) bags,
- infusion sets made of polyethylene (PE), polyurethane (PUR), ethylene vinyl acetate (EVA), thermoplastic polyolefin (TP) or polyvinyl chloride (PVC),
- polypropylene (PP) syringes for syringe pumps.
Physical and chemical stability of Erbitux 5 mg/ml has been demonstrated for up to 48 hours at 25°C during use, provided the solution is prepared as described below. However, since it contains no antimicrobial preservative or bacteriostatic agent, it is intended for immediate use. Aseptic conditions must be ensured during preparation of the infusion. Erbitux 5 mg/ml should be prepared as follows:
- For administration via infusion pump or gravity drip (diluted with sterile 9 mg/ml [0.9 %] sodium chloride solution): Select a sterile 0.9 % (9 mg/ml) sodium chloride infusion bag of appropriate size. Calculate the required volume of Erbitux. Using a suitable sterile syringe with an appropriate needle, withdraw the corresponding volume of sodium chloride solution from the infusion bag. Using a suitable sterile syringe, attach an appropriate needle and withdraw the required volume of Erbitux from a vial. Transfer the Erbitux into the prepared infusion bag. Repeat this procedure until the calculated volume is reached. Connect the infusion line and prime it with diluted Erbitux before starting the infusion. Administer using a gravity drip set or infusion pump.
Weekly infusion for the treatment of squamous cell carcinoma of the head and neck and metastatic colorectal cancer:
The initial dose (400 mg/m² body surface area) is infused over approximately 2 hours. Each subsequent dose (250 mg/m² body surface area) is infused over approximately 1 hour at an infusion rate not exceeding 10 mg/min.
Biweekly infusion for the treatment of squamous cell carcinoma of the head and neck when used in combination with other antineoplastic agents and metastatic colorectal cancer:
The initial and subsequent doses (500 mg/m² body surface area) are infused over approximately 2 hours at an infusion rate not exceeding 10 mg/min.
- For administration via infusion pump or gravity drip (undiluted): Calculate the required volume of Erbitux. Select a suitable sterile syringe (minimum 50 ml) and attach an appropriate needle. Withdraw the required volume of Erbitux from a vial. Transfer the Erbitux into a sterile empty bag or container. Repeat this procedure until the calculated volume is reached. Connect the infusion line and prime it with undiluted Erbitux before starting the infusion.
Weekly infusion for the treatment of squamous cell carcinoma of the head and neck and metastatic colorectal cancer:
The initial dose (400 mg/m² body surface area) is infused over approximately 2 hours. Each subsequent dose (250 mg/m² body surface area) is infused over approximately 1 hour at an infusion rate not exceeding 10 mg/min.
Biweekly infusion for the treatment of squamous cell carcinoma of the head and neck when used in combination with other antineoplastic agents and metastatic colorectal cancer:
The initial and subsequent doses (500 mg/m² body surface area) are infused over approximately 2 hours at an infusion rate not exceeding 10 mg/min.
- For administration via syringe pump: Calculate the required volume of Erbitux. Select a suitable sterile syringe and attach an appropriate needle. Withdraw the required volume of Erbitux from a vial. Remove the needle, and insert the syringe into the syringe pump. Connect the infusion line to the syringe and begin the infusion after priming the line with Erbitux or with sterile 0.9 % (9 mg/ml) sodium chloride solution. Repeat this procedure until the calculated volume has been infused.
Weekly infusion for the treatment of squamous cell carcinoma of the head and neck and metastatic colorectal cancer:
The initial dose (400 mg/m² body surface area) is infused over approximately 2 hours. Each subsequent dose (250 mg/m² body surface area) is infused over approximately 1 hour at an infusion rate not exceeding 10 mg/min.
Biweekly infusion for the treatment of squamous cell carcinoma of the head and neck when used in combination with other antineoplastic agents and metastatic colorectal cancer:
The initial and subsequent doses (500 mg/m² body surface area) are infused over approximately 2 hours at an infusion rate not exceeding 10 mg/min.