5 mg / ml solution for infusion .
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
- Save this information, you may need to read it again.
- If you have any further questions, ask your doctor.
- If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.
This leaflet contains information on:
1. What Erbitux is and what it is used for
2. What you need to know before using Erbitux
3. How to use Erbitux
4. Possible side effects
5. How to store Erbitux 6. Contents of the pack
and other ingredients 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 recognize 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 EGFR’s signaling pathway – a complex signaling cascade involved in the development and progression of cancer. This binding means that the cancer cell can no longer receive the signals it needs for growth, survival, and spread.
What Erbitux is used for
Erbitux is used to treat two different types of cancer:
- metastatic cancer of the colon. In these patients, Erbitux is used either as a single drug or in combination with other cancer drugs.
- a special form of cancer of the head and neck ( squamous cell carcinoma ). In these patients, Erbitux is used in combination with radiation therapy or with other cancer drugs.
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 reaction ( allergic reaction ) to cetuximab.
Before starting treatment for colon metastatic cancer, your doctor will test your cancer cells to find out if they contain the normal (wild-type) or mutated form of RAS. You must not be treated with Erbitux in combination with other cancer medicines containing oxaliplatin if your cancer cells contain the mutated form of RAS.
Warnings and cautions
Talk to your doctor before using Erbitux, if any of the information below is unclear.
Erbitux may cause infusion-related side effects. Such reactions may be of an allergic nature. Read the text under “Infusion-related side effects” in section 4 for details, as the side effects can have serious consequences, including life-threatening conditions. These side effects usually occur during infusion one, within 1 hour thereafter, or sometimes later. To detect such effects, your condition will be checked every time you receive an infusion of Erbitux and for at least 1 hour afterward.
You are more likely to have severe allergic reactions if you are allergic to red meat, tick bites, or have positive results for certain antibodies (noted in a test). Your doctor will discuss appropriate measures with you.
Erbitux can cause side effects that affect the skin. Your doctor will talk to you if you need any preventative measures or early treatment. Also read “Side Effects Affecting Your Skin” in Section 4 for more information, as certain skin reactions can have serious consequences for you, including life-threatening conditions.
If you have heart problems, your doctor will talk to you about whether you can get Erbitux in combination with other anticancer medicines, especially if you are 65 years of age or older.
Erbitux can cause eye side effects. Tell your doctor if you have acute or worsening eye problems, such as blurred vision, eye pain, red eyes, and/or very dry eyes, if you have had such problems before, or if you wear contact lenses. Your doctor will talk to you if you need to consult a specialist.
If you receive Erbitux in combination with platinum-containing cancer drugs, the probability of a white blood cell count decreases. Your doctor will therefore check your blood and general condition for signs of infection (see also “Side effects in combination with other cancer medicines” in section 4).
If you are taking Erbitux in combination with other anticancer medicines, including fluoropyrimidines, you may be more likely to have life-threatening heart problems. Your doctor will discuss with you if you may need any special control (see also “Side effects in combination with other cancer treatments” in section 4).
Children and young people
There is no relevant use of Erbitux for 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.
Tell your doctor if you are pregnant or not using a reliable method of contraception (talk to your doctor if you are not sure). Your doctor will then discuss with you the risks and benefits of using Erbitux in such situations.
You should not breast-feed while you are being treated with Erbitux. After receiving the last dose, wait two months before you can start breast-feeding.
Driving and using machines
Do not drive or use any tools or machines if you experience symptoms of treatment that affect your ability to concentrate or react.
3. How to use Erbitux
A doctor with experience in drugs for the treatment of cancer will lead your treatment with Erbitux. With each infusion and for at least 1 hour afterward, your condition will be checked regularly to detect early signs of any infusion-related side effect.
Before the first dose, you will receive a medicine against allergies to reduce the risk of an allergic reaction. Your doctor will decide if such treatment is necessary for the subsequent doses.
Dosage and administration
Erbitux is usually given in a vein (as a drip) once a week. Your doctor will calculate the correct dose of Erbitux for you as it depends on your body surface area. The first dose is 400 mg / m² body surface area and is given for about 2 hours at an infusion rate not exceeding 5 mg/min. Each subsequent dose is 250 mg / m² body surface area and is given for approximately 1 hour at an infusion rate not exceeding 10 mg/min.
Detailed instructions for your doctor or nurse on how to prepare Erbitux for infusion can be found at the end of this leaflet (see “Handling instructions”).
Duration of treatment
Erbitux is usually given once a week. The duration of treatment may vary depending on your illness and from person to person and your doctor will therefore discuss with you how long you should receive Erbitux.
Combination with other cancer treatments
If you are receiving Erbitux in combination with other cancer medicines, these medicines must be given at least 1 hour after stopping treatment with Erbitux.
If you are receiving Erbitux in combination with radiation therapy, treatment with Erbitux usually starts one week before the radiation therapy.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The main side effects with Erbitux are infusion-related side effects and side effects that affect the skin:
Infusion-related side effects ar
More than 10 out of 100 patients are expected to experience infusion-related side effects; in more than 1 in 100 patients these side effects are expected to be serious. Such reactions may be of an allergic nature. These side effects usually occur during infusion one, within 1 hour thereafter, or sometimes later.
Mild or moderate infusion-related side effects include:
- breathing difficulties
If any such symptoms occur, tell your doctor as soon as possible. Your doctor may consider reducing the infusion rate of Erbitux to manage such symptoms.
Severe infusion-related side effects include:
- severe respiratory problems that develop rapidly
- chest pain (a symptom of a side effect in the heart)
If any such symptoms occur, talk to a doctor immediately. These side effects can have serious consequences, in rare cases even cause life-threatening conditions, and require immediate action. Treatment with Erbitux must then be stopped.
Side effects are those that affect the skin
More than 80 out of 100 patients are expected to have skin side effects. In about 15 out of 100 patients, these skin reactions are expected to be severe. Most of these side effects occur during the first three weeks of treatment. They usually disappear with time after finishing treatment with Erbitux.
The main side effects that affect the skin include:
- acne-like skin changes
- dry skin
- increased hair growth
- nail diseases, e.g. inflammation of the nail bed a
In very rare cases (which may affect up to 1 in 10,000 people), patients may experience blistering or peeling, which may indicate a serious skin reaction called “Stevens-Johnson syndrome”. If you experience such symptoms, talk to a doctor right away as these signs can have serious consequences, including life-threatening conditions.
If you get any other major skin changes, tell your doctor as soon as possible as the dose one for Erbitux and the time between infusions may need to be changed. Your doctor will decide if treatment should be stopped if the skin reactions return after several dose reductions.
If such skin changes worsen, talk to a doctor immediately, especially if you also have general symptoms of infection such as fever and fatigue. These symptoms may indicate a skin infection that may have serious consequences, including life-threatening conditions.
Side effects are those that affect the lungs
In less common cases (which may affect up to 1 in 100 people), patients may develop an inflammation of the lungs (called interstitial lung disease) which can have serious consequences, including life-threatening conditions.
If you experience symptoms such as new or worsening breathing difficulties, talk to a doctor immediately, especially if you also have a cough or fever. Your doctor will decide if treatment needs to be stopped.
Other side effects ar
A very common side effect is (can occur in more than 1 in 10)
- inflammation of the mucous membranes of the intestine, mouth, and nose (in some cases severe) which can lead to nosebleeds in some patients
- lowering the magnesium level in the blood
- increase in liver enzyme levels
Common side effects are (may affect up to 1 in 10 people)
- irritation and redness of the eyes
- dehydration which may be due to diarrhea or decreased fluid intake
- loss of appetite leading to weight loss
- lowering the level of calcium in the blood
Less common side effects are (may affect up to 1 in 100 people)
- blood clots in blood vessels (veins) in the legs
- blood clots in the lungs
- inflammation in the eyelid or the most superficial part of the eye
Adverse reactions whose frequency is not known (cannot be calculated from the available data)
- meningitis (aseptic meningitis )
Side effects are in combination with other cancer treatments
If you are taking Erbitux in combination with other cancer medicines, some of the side effects that you may experience may be due to the combination or to the other medicines. Therefore, be sure to also read the package leaflet for the other medicines.
If you receive Erbitux in combination with platinum-containing cancer drugs, the probability of a white blood cell count decreases. This can lead to infectious complications, including life-threatening conditions, especially if you get skin reactions, inflammation of the mucous membranes of the intestines and mouth, or diarrhea. Therefore, if you get general symptoms of infection, such as fever and fatigue, talk to a doctor straight away.
If you are taking Erbitux in combination with a cancer medicine that contains fluoropyrimidines, you are more likely to get the following side effects from this other medicine:
- chest pain
- heart attack
- heart failure
- redness and swelling in the palms or soles of the feet, which may cause the skin to flake (hand-foot syndrome)
If you receive Erbitux in combination with radiation therapy, some of the side effects you may experience are due to this combination, such as:
- inflammation of the mucous membranes of the intestine and mouth
- skin reactions typical of radiation therapy
- difficulty swallowing
- reduction in the number of white blood cells
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 carton after “EXP” and “EXP” respectively. that ”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Once the package has been opened, Erbitux should be used immediately.
6. Contents of the packaging and other information
- The active substance is cetuximab.
1 ml solution for infusion contains 5 mg cetuximab.
A vial of 20 ml contains 100 mg cetuximab.
A vial of 100 ml contains 500 mg cetuximab.
- The other ingredients are sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, and water for injections.
What the medicine looks like and the contents of the pack
Erbitux 5 mg/ml solution for infusion is supplied in vials containing 20 ml or 100 ml. One pack contains 1 vial.
Vials of all sizes may not be marketed.
Marketing Authorisation Holder
Merck Europe BV
Gustav Mahlerplein 102
1082 MA Amsterdam
Merck Healthcare KGaA
Frankfurter Strasse 250
Other sources of information
Further information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.