Erbitux

Erbitux (Cetuximab) doses are based on body size. For both colorectal cancer treatment and treatment of squamous cell carcinoma of the head and neck, the recommended first dose of Erbitux (Cetuximab), is 400 mg per m² of body surface area. After this, a dose of 250 mg per m² of body surface area is given at weekly intervals. Your doctor will calculate the appropriate dose, based on body size.

Erbitux (Cetuximab) is given by intravenous (into a vein) infusion. Erbitux (Cetuximab) is usually injected into a vein through a site on your skin that has been specially prepared for this purpose. Very careful handling of Erbitux (Cetuximab) is required. It is always given under the direct supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important Erbitux (Cetuximab) be given exactly as recommended by your doctor. If you miss an appointment to receive Erbitux (Cetuximab), contact your doctor as soon as possible to reschedule your appointment.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each mL of sterile, clear, colourless liquid for intravenous administration contains 2 mg of Erbitux (Cetuximab). Nonmedicinal ingredients: sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium chloride, sodium hydroxide (NF as 10 M Solution For pH adjustment), hydrochloric acid (NF as 6 M Solution For pH adjustment), water for injection.

Do not use Erbitux (Cetuximab) if you are allergic to Erbitux (Cetuximab) or any ingredients of the medication.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Erbitux (Cetuximab).

Contact Lenses: Erbitux (Cetuximab) can cause severe eye irritation. Wearing contact lenses makes this irritation more likely to occur. It is recommended that you wear glasses while you are receiving treatment with Erbitux (Cetuximab), to reduce the risk of permanently damaging your vision.

Fluid and electrolyte balance: Erbitux (Cetuximab) may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Erbitux (Cetuximab). If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Erbitux (Cetuximab).

Heart problems: Serious and potentially life-threatening heart problems such as heart attack and sudden death have occurred rarely in people who were using Erbitux (Cetuximab). If you have a heart problem (e.g., arrhythmia, Angina, heart failure), you will be monitored closely by your doctor during the infusion and immediately after the infusion is finished.

Kidney function: Erbitux (Cetuximab) may cause decreased kidney function and rarely, kidney failure. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Erbitux (Cetuximab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erbitux (Cetuximab), and whether any special monitoring is needed.

If you experience a decrease in urine produced or the number of times you need to urinate daily, let your doctors know as soon as possible.

Infection: As well as killing cancer cells, Erbitux (Cetuximab) can reduce the number of cells that fight infection in the body (white blood cells). This increases the risk of developing an infection or reactivating an inactive infection (e.g., herpes, Shingles). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of white blood cells in your blood.

Infusion-related reactions: There have been reports of severe infusion-related reactions, sometimes resulting in death, in people with who were given Erbitux (Cetuximab). Your health care provider will closely monitor you during and after the infusion. These reactions usually occur within 30 minutes to 2 hours of starting the infusion. Your doctor will probably want you to stay at the clinic for at least one hour after the infusion is finished, to watch for signs of an infusion reaction.

If you experience symptoms of an infusion reaction, such as fever, chills, difficulty breathing, tightness of chest or throat, stomach upset, and rash, tell your health care provider immediately.

It is important to take the medication(s) recommended by your doctor before your infusion of Erbitux (Cetuximab). If you experience a severe infusion reaction, your doctor will give you additional medications to treat the reaction. Ask your doctor for more information.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking Erbitux (Cetuximab). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Erbitux (Cetuximab) contact your doctor immediately.

Skin problems: Erbitux (Cetuximab) can cause skin disorders, such as an acne-like rash, dry and cracked skin and inflammation. These may lead to infection of the skin. If you notice cuts or sores that become inflamed and do not heal, or wounds that develop discharge, let your doctor know immediately.

Erbitux (Cetuximab) can also cause the skin to be more sensitive to sunlight resulting in Sunburn, skin blisters, skin rash, redness, itching, or discolouration. If you experience any of these skin reactions, contact your doctor. Try to limit the length of time you are out in the sunlight or using tanning beds while you are receiving Erbitux (Cetuximab) treatment and for 2 months after your last dose of Erbitux (Cetuximab).

Pregnancy: It is not known if Erbitux (Cetuximab) causes harm to the developing baby if it is used by the mother during pregnancy. Erbitux (Cetuximab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Erbitux (Cetuximab), contact your doctor immediately. A reliable form of birth control should be used by both males and females during and for 6 months after the last dose of Erbitux (Cetuximab).

Breast-feeding: It is not known if Erbitux (Cetuximab) passes into breast milk. If you are a breast-feeding mother and are taking Erbitux (Cetuximab), it may affect your baby. Breast-feeding should be stopped while you are being treated with Erbitux (Cetuximab) and should not be re-started until at least 60 days after the last dose of medication.

Children: The safety and effectiveness of using Erbitux (Cetuximab) have not been established for children.