Erbitux

Erbitux is a prescription medication used to treat cancers of the colon and rectum. It is also used to treat head and neck cancer. This medication may be used in combination with other medicines or radiation therapy. Erbitux belongs to a group of drugs called epidermal growth factor receptor (EGFR) antagonists, which inhibit cancer cells from growing.

This medication comes in an injectable form and is to be injected intravenously (into a vein) at a hospital or clinic. It is usually given once a week.

Common side effects of Erbitux include acne-like rash, dry or cracking skin, and hair loss.

Erbitux is a prescription medicine approved for use in adults for the treatment of the following cancers:

• head and neck (squamous cell carcinoma)
• cancer of the colon and rectum (advanced colorectal cancer)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Bristol-Myers Squibb Co.

• ImClone LLC

Erbitux may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• acne-like rash
• dry or cracking skin
• swelling or pain in the fingernails or toenails
• red, watery, or itchy eye(s)
• red or swollen eyelid(s)
• pain or burning sensation in eye(s)
• sensitivity of eyes to light
• hair loss
• dry mouth
• chapped lips
• mouth sores
• difficulty swallowing
• headache
• tiredness
• weakness
• difficulty falling asleep or staying asleep
• depression
• nausea
• vomiting
• constipation
• stomach pain
• heartburn
• loss of appetite
• weight loss
• pain, especially in the back
• pain, redness, or swelling at injection spot

Some side effects can be serious. If you experience any of these side effects, call your doctor immediately:

• swelling of the hands, feet, ankles, or lower legs
• fast heartbeat
• coughing up blood or dry cough
• shortness of breath or unusual tiredness during exercise
• fainting
• decreased urination
• muscle cramps
• shaking of the hands that you cannot control
• sudden tightening of the hands or feet
• twitching of the body that you cannot control
• sore throat, fever, chills, and other signs of infection
• diarrhea
• confusion
• itching
• hives
• red, swollen, or infected skin

Erbitux may cause other side effects. Call your doctor if you have any unusual problems while using this medication

Tell your doctor and pharmacist about all the medicines you are taking including prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products. Especially tell your doctor if you are receiving cisplatin (Platinol). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Tell your doctor if you are allergic to Erbitux or any medicines that are made from mouse proteins.

Serious and sometimes fatal reactions have occurred with Erbitux treatment. Tell your doctor if you experience infusion reactions such as fever, chills, or breathing problems during treatment.

Tell your doctor if you have heart or lung problems. 

Tell your doctor if you develop shortness of breath while receiving Erbitux.

Erbitux should not be used during pregnancy. Use adequate birth control (in both males and females) during treatment and for 6 months following the last dose of Erbitux treatment.

Breastfeeding is not recommended during, and for 2 months following the last dose of Erbitux treatment.

Limit sun exposure by wearing sunscreen during, and for 2 months following the last dose of Erbitux treatment.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Erbitux there are no specific foods that you must exclude from your diet when receiving Erbitux.

• Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.
• Tell your doctor if you are pregnant or planning to become pregnant.
• Tell your doctor if you are breastfeeding or planning to breastfeed.
• Tell your doctor if you have heart problems.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Erbitux should not be used during pregnancy. Use adequate birth control (in both males and females) during treatment and for 6 months following the last dose of Erbitux treatment.

Tell your doctor if you are breastfeeding or plan to breastfeed. Erbitux may be excreted in human breast milk. It is not known if Erbitux will harm your nursing baby. Breastfeeding is not recommended during, and for 2 months following the last dose of Erbitux treatment.

Erbitux is a solution (liquid) to be infused (injected slowly) into a vein by a healtcare professional in a medical office or medical facility. It is usually given once a week for 6 to 7 weeks. If you miss an appointment to receive a dose of Erbitux, call your doctor right away.

Squamous Cell Carcinoma of the Head and Neck

Erbitux in combination with radiation therapy:

• The recommended initial dose is 400 mg/m² administered one week prior to initiation of a course of radiation therapy as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min).
• The recommended subsequent weekly dose (all other infusions) is 250 mg/m² infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6–7 weeks). Complete Erbitux administration 1 hour prior to radiation therapy.

Erbitux monotherapy:

• The recommended initial dose is 400 mg/m² administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min).
• The recommended subsequent weekly dose (all other infusions) is 250 mg/m² infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity.

Colorectal Cancer

• The recommended initial dose, either as monotherapy or in combination with irinotecan, is 400 mg/m² administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min).
• The recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan, is 250 mg/m² infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity.

Recommended Premedication:

Premedicate with an H1 antagonist (eg, 50 mg of diphenhydramine) intravenously 30–60 minutes prior to the first dose; premedication should be administered for subsequent Erbitux doses based upon clinical judgment and presence/severity of prior infusion reactions.

Erbitux is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, the dose is calculated based on body surface area, which is calculated using height and weight. Thus, too much of the drug could be given if a miscalculation is made.

Symptoms of an Erbitux overdose are difficult to predict as there have been no reports of an overdose. It is possible an overdose may result in an increased risk of the usual Erbitux side effects. However, a dose that was two and a half times the normal human dose was reported without any side effects

WARNING: Serious Infusion Reactions and Cardiopulmonary Arrest

Allergic Reaction

Severe allergic reactions due to Erbitux therapy have occurred in 42 of 1373 patients (3%) receiving Erbitux during clinical studies, resulting in death in less than 1 in 1000 patients. Symptoms can include trouble with breathing (including tightening of the airways, wheezing, or hoarseness), low blood pressure, shock, loss of consciousness, and/or heart attack. Most (90%) of the severe allergic reactions occurred with the first dose of Erbitux, although some patients experienced their first severe allergic reaction during a subsequent dose of Erbitux. Your doctor or nurse should watch you closely for these symptoms during treatment and may need to stop therapy in the event of an allergic reaction. Severe allergic reactions require that treatment with Erbitux be stopped immediately and not started again.

Heart Attack

Heart attack and/or sudden death occurred in 4 of 208 patients (2%) with head and neck cancer treated with radiation therapy and Erbitux, as compared to none of 212 patients treated with radiation therapy alone. Heart problems resulting in death and/or sudden death occurred in 7 of 219 patients (3%) with head and neck cancer treated with platinum-based chemotherapy with 5-fluorouracil and Erbitux compared to 4 of 215 patients (2%) treated with chemotherapy alone, based on a study conducted in Europe using European Erbitux. Notify your doctor if you have a history of any heart disease.