Generic Name: cetuximab (se-TUX-i-mab)
Brand Name: Erbitux
Serious and sometimes fatal infusion reactions have occurred in patients while receiving Erbitux. Most of the reactions have occurred during the first dose. Symptoms may include trouble breathing or swallowing; unusual hoarseness; wheezing; hives; itching; fever; chills; severe dizziness, headache, or light-headedness; fainting; fast heartbeat; flushing; loss of consciousness; sudden, severe nausea or vomiting; swelling of the mouth, face, lips, or tongue; chest, jaw, or arm pain; tremors; unusual sweating; or chest tightness. Tell your doctor right away if you experience any of these symptoms or other unusual effects during or after an infusion.
Heart attack and/or sudden death have rarely occurred in patients who receive Erbitux along with radiation or certain other chemotherapy medicines to treat certain types of cancer of the head and neck. Be sure to tell your doctor if you have a history of heart blood vessel problems or other heart problems (eg, heart failure, irregular heartbeat). Lab tests, including blood electrolytes, may be performed while you use Erbitux and for a period of time after you finish Erbitux. Be sure to keep all doctor and lab appointments.
Erbitux is used for:
Treating certain types of head, neck, and colorectal cancer. Erbitux may be used alone or along with radiation treatments or other medicines. It may also be used for other conditions as determined by your doctor.
Erbitux is a monoclonal antibody. It works by blocking a certain growth factor. This helps to reduce the growth and survival of certain types of cancer cells.
Do NOT use Erbitux if:
- you are allergic to any ingredient in Erbitux
- you are using Erbitux to treat colorectal cancer and you have a certain type of gene mutation (K-RAS)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Erbitux:
Some medical conditions may interact with Erbitux. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances (eg, mouse proteins)
- if you have lung or breathing problems (eg, interstitial lung disease, pulmonary fibrosis), abnormal blood electrolyte levels (eg, calcium, magnesium, potassium), or a respiratory tract infection
- if you have a history of blood vessel problems (eg, in the heart) or heart problems (eg, heart failure, irregular heartbeat)
- if you are having radiation therapy or other types of chemotherapy (eg, cisplatin)
Some MEDICINES MAY INTERACT with Erbitux. However, no specific interactions with Erbitux are known at this time.
Ask your health care provider if Erbitux may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Erbitux:
Use Erbitux as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Erbitux is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Erbitux at home, a health care provider will teach you how to use it. Be sure you understand how to use Erbitux. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Erbitux should be a clear and colorless solution that may contain a very small amount of clear to white particles. Do not use Erbitux if it contains a large amount of particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not shake or dilute Erbitux.
- Your doctor may give you another medicine (eg, an antihistamine, such as diphenhydramine) before you receive Erbitux to help reduce the risk of an infusion reaction. Your health care provider will monitor you for an infusion reaction while you receive Erbitux and for at least 1 hour after receiving your dose. Discuss any questions or concerns with your doctor.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Erbitux, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Erbitux.
Important safety information:
- Erbitux may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Erbitux with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Erbitux may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Erbitux. If you must be outside for more than a short time, use a sunscreen or wear protective clothing while you use Erbitux and for 2 months after your last dose.
- If nausea, loss of appetite, vomiting, or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions on how to lessen these effects.
- Erbitux may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection, such as fever, sore throat, rash, or chills.
- Men who take Erbitux should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Erbitux and for 6 months after you stop taking it.
- Women who are able to become pregnant should use effective birth control while using Erbitux and for at least 6 months after the last dose. If you have questions about effective birth control, talk with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Erbitux. Talk with your doctor before you receive any vaccine.
- Lab tests, including blood electrolytes, may be performed while you use Erbitux and for 8 weeks after you stop using it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Erbitux should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Erbitux can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Erbitux while you are pregnant. It is not known if Erbitux is found in breast milk. Do not breast-feed while using Erbitux or for 60 days after your last dose.
Possible side effects of Erbitux:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Changes in fingernails or toenails; constipation; diarrhea; dry mouth; dry skin; hair loss; headache; indigestion; joint pain; loss of appetite; mild acne; mild sore throat; nausea; stomach upset; taste changes; tiredness; trouble sleeping; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; burning, numbness, or tingling; chest, jaw, or arm pain; confusion; coughing up blood; decreased urination; eye or eyelid pain, redness, swelling, or irritation; fainting; fever, chills, or persistent sore throat; mental or mood changes (eg, anxiety, depression); moderate to severe skin changes (eg, blistered, cracking, peeling, swollen, or painful skin; moderate to severe redness or itching; oozing of the skin); muscle pain, weakness, or cramping; new or worsening lung or breathing problems (eg, cough, shortness of breath); pain, redness, or swelling at the injection site or near the nailbed; severe headache; severe or persistent acne; sores on the lips or in the mouth; stiff neck; sudden, severe nausea or vomiting; swelling of the hands, legs, or feet; symptoms of low blood magnesium levels (eg, irregular heartbeat; muscle aches or spasms; seizures; sluggishness; tremor; unusual loss of appetite, nausea, vomiting, or weakness); unusual sweating; very dry mouth or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Erbitux is usually handled and stored by a health care provider. If you are using Erbitux at home, store Erbitux as directed by your pharmacist or health care provider. Keep Erbitux out of the reach of children and away from pets.
- If you have any questions about Erbitux, please talk with your doctor, pharmacist, or other health care provider.
- Erbitux is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Erbitux or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Erbitux. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Erbitux. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Erbitux.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.