Araxya
(Cetuximab)
What is it?
What is it?
Araxya® contains cetuximab, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognize and bind to 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 signaling cascade 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.
Indications
Indications
Araxya® is used to treat two different types of cancer:
• Metastatic cancer of the large intestine. In these patients, Araxya® is used alone or in combination with other anticancer medicines. It is also used to treat a type of large intestine cancer in combination with another medicine encorafenib 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 head and neck cancer (squamous cell cancer). In these patients, Araxya® is used in combination with radiation therapy or ther anticancer medicines.
Important information
What should be considered BEFORE treatment?
· Araxya® is to be used in combination with encorafenib to treat large intestine cancer, your doctor will also check for BRAF mutation.
· Do not use Araxya® 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 Araxya® in combination with other anticancer treatment containing oxaliplatin if your cancer cells contain the mutant form of RAS.
· Your doctor will discuss with you whether you may need any preventive measures or early treatment.
· If you have heart problems, your doctor will discuss with you whether you can receive cetuximab in combination with other anticancer medicines, especially if you are 65 years of age or older.
· Please tell your doctor, if you have acute or worsening eye problems such as blurred vision, eye pain, red eyes and/or severe dry eyes, 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.
· There is no relevant use of cetuximab in children and adolescents.
· Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
What should be considered DURING treatment?
· A doctor experienced in the use of anticancer medicines will supervise your Araxya® treatment. 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 effect.
· 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.
· Cetuximab may cause side effects concerning the skin. Your doctor will discuss with you whether you may need any preventive measures or early treatment.
· If you receive cetuximab 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. If you receive cetuximab in combination with other anticancer medicines, including fluoropyrimidines, it may be more likely that you experience heart problems. your doctor will discuss with you whether you may need any particular supervision.
· 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 benefits of using cetuximab in these situations.
· Do not breast-feed your baby during the period over which you are being treated with cetuximab and for two months after the last dose.
· Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
How to Use?
How to Use?
Pre-treatment: Before the first dose, you will receive an anti-allergic 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 Araxya® is usually infused into a vein (given as a drip) once a week or biweekly. Your doctor will calculate the correct dose of Araxya® for you because it depends on your body surface area. Weekly dosing: The first dose (400 mg/m² body surface area) is infused over a period of approximately 2 hours with an infusion rate not faster than 5 mg/min. Each subsequent dose (250 mg/m² body surface area) is infused in approximately 1 hour with an infusion rate not faster than 10 mg/min. Duration of treatment Araxya® is usually infused once a week. Biweekly dosing: It can also be administered with 500 mg/m² body surface area infused over 2 hours once every 2 weeks until disease progression or unacceptable toxicity. 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 Araxya®. Combination with other anticancer treatments. If you receive Araxya® in combination with other anticancer medicines, these medicines must be administered at least 1 hour after the end of the Araxya® infusion. If you receive Araxya® in combination with radiation therapy, treatment with Araxya® is usually started one week before radiation therapy. If you have any further questions on the use of this medicine, ask your doctor.
Side Effects
Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The main side effects of cetuximab are infusion related side effects and side effects concerning the skin.
Mild or moderate infusion-related side effects include: fever, chills, dizziness, breathing difficulties.
If such symptoms occur, please inform your doctor as soon as possible. Your doctor may consider reducing the infusion rate of cetuximab to manage these symptoms.
Severe infusion-related side effects include: severe breathing difficulties which develop rapidly, hives, fainting, chest pain (a symptom of side effects on your heart).
If such symptoms occur, speak to a doctor immediately. These side effects may have serious consequences, in rare cases including life-threatening conditions, and require immediate attention. Treatment with cetuximab must then be stopped.
Main side effects concerning the skin include: acne-like skin changes, itching, dry skin, scaling, excessive growth of hair, nail disorders (e.g., inflammation of the nail), and Stevens‑Johnson syndrome.
Side effects concerning the lungs include: inflammation of the lungs (called interstitial lung Disease).
Other side effects (very common) include: inflammation 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.
Other side effects (common) include: headache, tiredness, irritation and redness of the eye, diarrhea, drying out which may be due to diarrhea or reduced fluid intake, feeling sick, vomiting, loss of appetite, leading to weight decrease, decrease in blood levels of calcium.
Storage
How to store Araxya®
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”.
Store in a refrigerator (2-8°C).
Once opened, Araxya® is intended for immediate use.