Erbitux is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Erbitux is used to treat cancers of the colon and rectum. It is also used to treat head and neck cancer.

Erbitux is often used in combination with other cancer medicines or radiation treatment.

Erbitux is often used in combination with other cancer medications and/or radiation treatments.

Before receiving Erbitux, tell your doctor if you have heart rhythm problems, congestive heart failure, breathing problems, coronary artery disease, or low levels of potassium or magnesium in your blood.

Side effects may occur when Erbitux is injected into your vein. Tell your caregiver right away if you feel dizzy, feverish, itchy, or short of breath during the infusion.

Cetuximab has caused life-threatening side effects in a small number of patients. Your caregivers will watch you closely after you receive each Erbitux dose.

Avoid exposure to sunlight or tanning beds while you are receiving this medicine and for at least 2 months after your treatment ends. Erbitux can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Erbitux can have long lasting effects on your body. You may need frequent medical tests for a short time after you stop using this medicine.

Before taking this medicine

You should not use Erbitux if you are allergic to cetuximab or to mouse protein.

To make sure Erbitux is safe for you, tell your doctor if you have ever had:

• heart rhythm problems;

• lung disease or a breathing disorder;

• congestive heart failure;

• coronary artery disease (clogged arteries); or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Tell your doctor if you are allergic to red meat, or if you've ever been bitten by a tick. If so, you may be more likely to have certain reactions during or shortly after injection of this medicine.

Cetuximab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using Erbitux and for at least 2 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using Erbitux, and for at least 2 months after your last dose.

Erbitux is given as an infusion into a vein. A healthcare provider will give you this injection.

Erbitux must be given slowly, and the infusion can take up to 2 hours to complete. You may be given other medications to help prevent serious side effects or allergic reaction.

Erbitux is often used in combination with other cancer medications and/or radiation treatments. You may receive another cancer medicine 1 hour after your Erbitux infusion.

Cetuximab has caused life-threatening side effects in a small number of patients. After each Erbitux infusion, your caregivers will watch you closely to make sure you do not have any serious side effects.

Erbitux is usually given until your body no longer responds to the medication. Follow your doctor's dosing instructions very carefully.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Erbitux can have long-lasting effects on your body. You may need medical tests for at least 8 weeks after your last dose.

Usual Adult Dose for Colorectal Cancer:

As a Single-Agent or in Combination with Irinotecan or FOLFIRI (irinotecan, fluorouracil, leucovorin)
-Administer weekly or biweekly as below; complete cetuximab administration 1 hour prior to irinotecan or FOLFIRI; continue treatment until disease progression or unacceptable toxicity
WEEKLY: Initial Dose: 400 mg/m2 IV over 120 minutes; Maintenance Dose: 250 mg/m2 IV over 60 minutes once a week
BIWEEKLY: 500 mg/m2 IV over 120 minutes every 2 weeks

In Combination with Encorafenib:
Initial Dose: 400 mg/m2 IV over 120 minutes
Maintenance Dose: 250 mg/m2 IV over 60 minutes once a week until disease progression or unacceptable toxicity

Comments:
-Patient selection for treatment requires testing for presence of K-Ras or BRAF V600E mutations; information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics
-This drug is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown
-Premedicate with an H1 antagonist IV 30 to 60 minutes prior to the first dose or subsequent doses as deemed necessary.
-Dose modifications may be necessary for adverse reactions (See Dosage Adjustment Section)

Uses: Colorectal Cancer:
For the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test:
--In combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment
--In combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy
--As a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
For the treatment of mCRC in combination with encorafenib for patients with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy

Usual Adult Dose for Head and Neck Cancer:

In Combination with Radiation Therapy: Complete IV administration 1 hour prior to radiation therapy
-Initial dose: 400 mg/m2 IV over 120 minutes administered 1 week prior to initiating a course of radiation therapy
-Maintenance dose: 250 mg/m2 IV over 60 minutes once a week for the duration of radiation therapy (6 to 7 weeks)

As a Single-Agent or In Combination with Platinum-Based Therapy and Fluorouracil:
-Administer weekly or biweekly as below; complete cetuximab administration 1 hour prior to platinum-based therapy with fluorouracil; continue treatment until disease progression or unacceptable toxicity
WEEKLY: Initial dose: 400 mg/m2 IV over 120 minutes; Maintenance dose: 250 mg/m2 IV over 60 minutes once a week
BIWEEKLY: 500 mg/m2 IV over 120 minutes every 2 weeks

Comments:
-Premedicate with an H1 antagonist IV 30 to 60 minutes prior to the first dose or subsequent doses as deemed necessary.
-Dose modifications may be necessary for adverse reactions (See Dosage Adjustment Section).

Uses: Squamous Cell Carcinoma of the Head and Neck (SCCHN):
-In combination with radiation therapy for the initial treatment of locally or regionally advanced SCCHN
-In combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN
-As a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed

You should not use Erbitux if you are allergic to cetuximab or to mouse protein.

To make sure Erbitux is safe for you, tell your doctor if you have ever had:

• heart rhythm problems;

• lung disease or a breathing disorder;

• congestive heart failure;

• coronary artery disease (clogged arteries); or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Tell your doctor if you are allergic to red meat, or if you've ever been bitten by a tick. If so, you may be more likely to have certain reactions during or shortly after injection of this medicine.

Cetuximab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using Erbitux and for at least 2 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using Erbitux, and for at least 2 months after your last dose.

Call your doctor for instructions if you miss an appointment for your Erbitux infusion.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Cetuximab could make you sunburn more easily. Avoid sunlight or tanning beds while you are receiving Erbitux and for at least 2 months after your treatment ends. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to Erbitux (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the infusion or several hours afterward. Tell your caregiver right away if you feel short of breath, itchy, nauseated, weak or dizzy, or if you have chest pain, wheezing, noisy breathing, or a hoarse voice.

Call your doctor at once if you have:

• eye pain or redness, puffy eyelids, drainage or crusting in your eyes, vision problems, or increased sensitivity to light;

• a new or worsening cough, chest pain, or shortness of breath;

• an acne-like skin rash or any severe skin rash;

• redness or crusting around your hair follicles;

• redness, warmth, or puffiness under your skin;

• slow heartbeats, weak pulse, fainting, slow breathing (breathing may stop);

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or

• signs of an electrolyte imbalance - increased thirst or urination, constipation, muscle pain or weakness, leg cramps, numbness or tingling, feeling jittery, irregular heartbeats, fluttering in your chest, or a choking feeling.

Common Erbitux side effects may include:

• itching or rash;

• changes in your fingernails or toenails;

• dry, cracked, or swollen skin;

• headache;

• diarrhea; or

• infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with cetuximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.