Erbitux is a brand-name injection prescribed for certain forms of colorectal and head and neck cancers. Erbitux contains the active ingredient cetuximab and belongs to the epidermal growth factor receptor (EGFR) inhibitor drug class.

Erbitux is approved by the Food and Drug Administration (FDA) to treat:

Erbitux may be used on its own or with other treatments, depending on the form of cancer being treated.

Drug details

The following list contains key information about Erbitux.

  • Drug form: liquid solution given by intravenous (IV) infusion (injection into a vein given over a period of time)
  • Generic or biosimilar available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2004

Erbitux has boxed warnings about the risks of serious and fatal infusion reactions and cardiac arrest and sudden death. A boxed warning is the most serious warning from the FDA. For details, see the “Erbitux precautions” section later in the article.

Erbitux is a biologic drug that is available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

Biologic drugs are made using living cells, whereas traditional drugs are made from chemicals. A generic drug is an exact copy of the active ingredient in a brand-name chemical medication. It’s not possible to make exact copies of biological drugs. Instead, biosimilars can sometimes be made. Like generics, these are considered to be as effective and safe as the original brand-name drug.

Generics and biosimilars usually cost less than brand-name drugs.

The Erbitux dosage your doctor prescribes will depend on several factors. These include:

  • the type of cancer you’re using Erbitux to treat
  • other treatments you are receiving with Erbitux
  • your body surface area in square meters (m2)
  • side effects you may have with Erbitux

The following information describes dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Erbitux comes as a liquid solution inside single-dose vials. It’s available in two strengths:

  • 100 milligrams (mg) in 50 millilitres (mL)
  • 200 mg in 100 mL

A healthcare professional will administer Erbitux by IV infusion. An IV infusion is an injection into a vein that’s given over a period of time. Erbitux infusions are usually given over 1 or 2 hours.

You’ll receive Erbitux in a hospital or infusion center.

Dosage for head and neck cancer

Erbitux is used to treat squamous cell carcinoma of the head and neck in adults. It may be used with radiation therapy, chemotherapy, or on its own, depending on your individual situation.

Your doctor will calculate your dose based on your body surface area in square meters (m2).

When used with radiation therapy:

  • The recommended first dose of Erbitux is 400 mg per m2, given over 2 hours. You’ll receive this dose 1 week before starting a course of radiation therapy.
  • You’ll usually receive radiation therapy once per week for 6 to 7 weeks. Before each dose of radiation therapy, you’ll receive a dose of Erbitux. Your Erbitux infusion should be completed 1 hour before you receive your radiation therapy.
  • The recommended dose of Erbitux before each weekly dose of radiation therapy is 250 mg per m2 given over 1 hour.

For example, if you have a body surface area of 1.8 m2, your first Erbitux dose will be 720 mg. After this, your Erbitux dose will be 450 mg once per week, given before your weekly dose of radiation therapy.

When used alone or with chemotherapy:

Your doctor may prescribe Erbitux weekly or every 2 weeks. If you receive Erbitux with chemotherapy, your Erbitux infusion should be completed 1 hour before you receive your chemotherapy.

  • If given weekly: The recommended first dose of Erbitux is 400 mg per m2, given over 2 hours. After this, the recommended dose is 250 mg per m2, given over 1 hour once per week. For example, if you have a body surface area of 1.8 m2, your first Erbitux dose will be 720 mg. After this, your Erbitux dose will be 450 mg once per week.
  • If given every 2 weeks: The recommended dose of Erbitux is 500 mg per m2, given over 2 hours every 2 weeks. For example, if you have a body surface area of 1.8 m2, your Erbitux dosage will be 900 mg once every 2 weeks.

Dosage for colorectal cancer

Erbitux is used to treat metastatic colorectal cancer in adults. It may be used alone, with chemotherapy, or with encorafenib (Braftovi), depending on your individual situation.

Your doctor will calculate your dose based on your body surface area in square meters (m2).

When used alone or with chemotherapy:

Your doctor may prescribe Erbitux weekly or every 2 weeks. If you receive Erbitux with chemotherapy, your Erbitux infusion should be completed 1 hour before you receive your chemotherapy.

  • If given weekly: The recommended first dose of Erbitux is 400 mg per m2 given over 2 hours. After this, the recommended dose is 250 mg per m2 given over 1 hour once per week. For example, if you have a body surface area of 1.8 m2, your first Erbitux dose will be 720 mg. After this, your Erbitux dose will be 450 mg once per week.
  • If given every 2 weeks: The recommended dose of Erbitux is 500 mg per m2 given over 2 hours every 2 weeks. For example, if you have a body surface area of 1.8 m2, your Erbitux dosage will be 900 mg once every 2 weeks.

When used with encorafenib (Braftovi):

You’ll typically receive a dose of Erbitux once per week. You’ll also usually take encorafenib by mouth once per day.

  • The recommended first dose of Erbitux is 400 mg per m2 given over 2 hours.
  • After this, the recommended dose is 250 mg per m2 given over 1 hour once per week.

For example, if you have a body surface area of 1.8 m2, your first Erbitux dose will be 720 mg. After this, your Erbitux dose will be 450 mg once per week.

About taking Erbitux

Below you’ll find information about key dosage issues.

  • If you miss a dose: If you miss an appointment to receive a dose of Erbitux, call your doctor’s office right away to reschedule.
  • Length of use: Erbitux is meant to be used as a long-term treatment. If you and your doctor determine that Erbitux is safe and effective for you, you’ll likely take it long term.
  • Length of time to work: Erbitux starts working to treat your cancer as soon as you start treatment, but you’re unlikely to notice it working. Your doctor will likely order tests or scans from time to time to check the medication is working for you.

Erbitux can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Erbitux. These lists do not include all possible side effects.

For more information about the possible side effects of Erbitux, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Erbitux, you can do so through MedWatch.

Mild side effects

The following list highlights some mild side effects of Erbitux. To learn about other mild side effects, talk with your doctor or pharmacist or view Erbitux’s prescribing information.

Mild side effects of Erbitux can include:

  • rash, including acne-like rash
  • skin dryness or cracking
  • itching
  • swelling of the base of the nails
  • headache
  • diarrhea
  • nausea and vomiting
  • abdominal pain
  • fatigue
  • reduced appetite
  • joint pain
  • fever
  • infections

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Erbitux aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • interstitial lung disease (inflammation and scarring in the lungs), which may include symptoms such as:
    • shortness of breath
    • new or worse cough
    • chest pain
  • severe skin reactions, which may include symptoms such as:
    • severe rash
    • skin infections
    • skin blistering or sores
    • skin peeling
  • electrolyte imbalance, such as low magnesium levels, which may cause symptoms such as:
    • nausea and vomiting
    • muscle cramps or twitching
    • weakness
  • serious and fatal infusion reactions*
  • cardiac arrest or sudden death*

* Erbitux has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Erbitux precautions” section below.

ALLERGIC REACTION

For some people, Erbitux injection can cause an allergic reaction.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Erbitux injection, your doctor may recommend taking a different medication instead.

The Food and Drug Administration (FDA) approves prescription drugs such as Erbitux to treat certain conditions. Erbitux may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Erbitux for head and neck cancer

Erbitux is FDA-approved to treat squamous cell carcinoma of the head and neck in adults. This type of cancer starts in squamous cells that line the soft tissue inside the mouth, throat, nose or sinuses.

Erbitux is approved to treat this type of cancer in certain situations. Specifically, it is approved for:

  • Cancer that is locally or regionally advanced (has spread into nearby tissues or lymph nodes). In this case, Erbitux is used with radiation therapy as a first treatment for the cancer.
  • Cancer that is metastatic (has spread to other parts of the body). In this case, Erbitux may be used with fluorouracil and platinum-based chemotherapy* as the first treatment for the cancer. It may also be used on its own if previous treatment with platinum-based chemotherapy hasn’t worked well enough.
  • Cancer that has come back after previous treatment. In this case, Erbitux may be used with fluorouracil and platinum-based chemotherapy* for cancer that is locally or regionally advanced. Or it may be used on its own if previous treatment with platinum-based chemotherapy hasn’t worked well enough.

Erbitux is a targeted cancer therapy. Targeted therapies block specific proteins or processes that help cancer cells grow and spread.

Erbitux helps shrink the cancer and increase the length of time you live without the cancer worsening.

* Examples of platinum-based chemotherapy drugs that may be used with Erbitux include cisplatin, carboplatin, and oxaliplatin.

Erbitux for colorectal cancer

Erbitux is FDA-approved to treat metastatic colorectal cancer in adults. This type of cancer started in the colon (large intestine) or rectum and has spread to other parts of the body, such as the liver or lungs.

Erbitux is approved to treat this type of cancer in certain situations. Specifically it is approved for:

  • Cancer with a certain mutation (abnormal change) in the BRAF gene called a BRAF V600E mutation. Your doctor will order a test to check the cancer cells for this mutation before prescribing Erbitux. For this form of colorectal cancer, Erbitux is used with a drug called encorafenib (Braftovi) after other treatments have been tried.
  • Cancer that has EGFR proteins and a “wildtype” (unmutated) form of the KRAS gene*. Your doctor will order tests to check the cancer cells for these features before prescribing Erbitux. For this form of colorectal cancer, Erbitux may be used in the following ways:
    • with irinotecan, fluorouracil, and leucovorin (a chemotherapy regimen called FOLFIRI) as a first treatment for the cancer
    • with irinotecan chemotherapy if irinotecan alone has not worked well enough
    • on its own if irinotecan and oxaliplatin chemotherapy has not worked well enough or irinotecan has caused bothersome side effects

Erbitux is a targeted cancer therapy. Targeted therapies block specific proteins or processes that help cancer cells grow and spread.

Erbitux helps to shrink the cancer and increase the length of time you live without the cancer getting worse.

* Erbitux is not FDA-approved for colorectal cancer that has a mutation in the KRAS gene or if test results for this mutation are not known. The drug will not work to treat colorectal cancer that has a mutation in the KRAS gene. It can also cause increased side effects in people with this form of colorectal cancer.

Erbitux and children

Erbitux is not FDA-approved for any use in children.

Erbitux is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer did not list any interactions in the drug’s prescribing information.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Erbitux.

Before starting Erbitux treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

As with all medications, the cost of Erbitux can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance:If you need financial support to pay for Erbitux or if you need help understanding your insurance coverage, help is available.

A program called Lilly Oncology Support is available for Erbitux. For more information and to find out if you’re eligible for support, call 866-472-8663 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Biosimilar version: Erbitux is a biologic (a drug made using living cells). It’s not available in a biosimilar form. Biosimilars are like generics for biologic drugs. Like generics, biosimilars tend to cost less than brand-name drugs.

To learn more about saving money on prescriptions, check out this article.

Erbitux is a targeted cancer therapy. Targeted therapies block specific proteins or processes that help cancer cells grow and spread. Other targeted therapies that can treat your cancer are available . Some may be a better fit for you than others.

If you’re interested in finding an alternative to Erbitux, talk with your doctor. They can tell you about other medications that may work well for you. Other targeted therapies that may be alternatives to Erbitux include:

  • bevacizumab (Avastin)
  • encorafenib (Braftovi)
  • panitumumab (Vectibix)
  • ramucirumab (Cyramza)
  • regorafenib (Stivarga)
  • ziv-aflibercept (Zaltrap)

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

Erbitux and pregnancy

You should not receive Erbitux during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving this medication. Your doctor may suggest birth control options to use during treatment with Erbitux.

Erbitux and fertility

Erbitux may reduce fertility in females. If you plan to have children, talk with your doctor about your options.

Erbitux and birth control

Erbitux is not a safe treatment during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Erbitux.

Note: Sex and gender exist on spectrums. Use of the term “female” and “male” in this article refers to sex assigned at birth.

For females using Erbitux

If you’re able to become pregnant, you should use birth control during Erbitux treatment and for 2 months after your last dose.

For males using Erbitux

The manufacturer of Erbitux does not give recommendations about birth control for males using Erbitux. If you are male and have a sexual partner who could become pregnant, talk with your doctor about your birth control needs.

Erbitux and breastfeeding

You should not breastfeed while receiving Erbitux. If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this medication. Your doctor may recommend other ways to feed your child during treatment with Erbitux.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Serious and fatal infusion reactions

Erbitux can cause serious infusion reactions that can sometimes be fatal. In clinical trials, serious infusion reactions were rare. These reactions are most likely to occur during or within several hours after receiving the first infusion of Erbitux.

Symptoms of a serious infusion reaction can include:

  • trouble breathing
  • dizziness
  • loss of consciousness
  • fever
  • chills
  • chest pain

You may have a higher risk of serious infusion reactions if you have an allergy to red meat or a history of tick bites. You may also have a higher risk if you have IgE antibodies against galactose-α-1,3-galactose (alpha-gal). Your doctor may test you for these antibodies before prescribing Erbitux.

What to do

To help prevent serious infusion reactions, your doctor will likely treat you with an intravenous antihistamine before administering your first dose of Erbitux.

A healthcare professional will monitor you for symptoms of a reaction during your infusion and for at least 1 hour afterward. Tell them right away if you have any of the symptoms listed above. If you have a reaction, they will give you medication to treat it. They may also slow down or stop your infusion until you recover. If you have a severe reaction, your doctor will likely permanently stop treatment with Erbitux.

Cardiac arrest or sudden death

Erbitux can cause cardiac arrest or sudden death in some people. In clinical trials, these side effects were rare.

Symptoms of a cardiac arrest can include:

  • loss of consciousness
  • dizziness
  • racing heartbeat
  • chest pain
  • shortness of breath
  • nausea, with or without vomiting

You may have a higher risk of cardiac arrest or sudden death if you have a history of heart disease, heart failure, or irregular heartbeats. Be sure to tell your doctor if you have had any problems with your heart before starting treatment with Erbitux.

You may also have a slightly higher risk of cardiac arrest or sudden death if you receive Erbitux with fluorouracil and platinum-based chemotherapy, such as cisplatin, oxaliplatin, or carboplatin.

Electrolyte disturbances such as low magnesium, potassium, or calcium levels can also raise your risk of heart problems.

What to do

If you have symptoms of cardiac arrest during Erbitux treatment, call 911 or your local emergency number right away.

If you have an electrolyte disturbance, your doctor will likely prescribe medication to correct it. Your doctor will monitor your electrolyte levels during treatment and for at least 8 weeks after stopping treatment with Erbitux.

Other precautions

Before taking Erbitux, discuss your health history with your doctor. Erbitux may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • breathing or lung conditions
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Erbitux, see the “Erbitux side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.