Erbitux

DRUG DESCRIPTION

Erbitux (cetuximab) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). Cetuximab is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab is produced in mammalian (murine myeloma) cell culture.

Erbitux is a sterile, clear, colorless liquid of pH 7.0 to 7.4, which may contain a small amount of easily visible, white, amorphous cetuximab particulates. Erbitux is supplied at a concentration of 2 mg/mL in either 100 mg (50 mL) or 200 mg (100 mL), single-use vials. Cetuximab is formulated in a solution with no preservatives, which contains 8.48 mg/mL sodium chloride, 1.88 mg/mL sodium phosphate dibasic heptahydrate, 0.41 mg/mL sodium phosphate monobasic monohydrate, and Water for Injection, USP.

What are the possible side effects of cetuximab (Erbitux)?

Some people receiving a cetuximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel short of breath, weak or dizzy, nauseated, itchy, or have wheezing, noisy breathing, or a hoarse voice during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

    ...

Read All Potential Side Effects and See Pictures of Erbitux

What are the precautions when taking cetuximab (Erbitux)?

Before receiving cetuximab, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, radiation therapy, heart disease (e.g., coronary artery disease, congestive heart failure, arrhythmias).

This medication may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged...

Read All Potential Precautions of Erbitux


Erbitux Consumer (continued)

SIDE EFFECTS: (see also Warning section)

Nausea, vomiting, constipation, diarrhea, headache, stomachache, backache, fever/chills, trouble sleeping, weight loss, fatigue, drowsiness, eye redness/itching, nail changes, and dry skin may occur. Nausea and vomiting can be quite severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

An acne-like rash may occur. Depending on how severe this rash is, your doctor may delay your cetuximab treatment, lower your dose, treat the rash with antibiotics, or stop treatment with cetuximab to decrease this potentially serious side effect.

Tell your doctor immediately if any of these unlikely but serious side effects occur: confusion, depression, swelling of hands/feet/lower legs, dehydration, serious infection (e.g., high fever, chills, persistent sore throat), change in amount of urine, severe dizziness, fast/slow/irregular heartbeat.

Rarely, very serious lung problems may occur. Seek immediate medical attention if you develop: trouble breathing.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving cetuximab, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, radiation therapy, heart disease (e.g., coronary artery disease, congestive heart failure, arrhythmias).

This medication may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps during treatment and for 2 months after your last treatment with cetuximab. Use a sunscreen and wear protective clothing when outdoors.

This medication may harm an unborn baby. This medication is not recommended for use during pregnancy. Both males and females using this drug must avoid becoming pregnant or causing pregnancy. Therefore, both males and females using this drug must use at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while using this medication and for 6 months after treatment is ended. Consult your doctor for information on reliable birth control. If you or your partner becomes pregnant while using this drug or during the 6 months after the last treatment, tell both of your doctors immediately.

Based on information from related drugs, cetuximab may pass into breast milk. Because of potential harm to the infant, breast-feeding is not recommended while using cetuximab and for 2 months after the end of treatment. Consult your doctor before breast-feeding.


Erbitux Patient Information Including Side Effects

Brand Names: Erbitux

Generic Name: cetuximab (Pronunciation: se TUX i mab)

  • What is cetuximab (Erbitux)?
  • What are the possible side effects of cetuximab (Erbitux)?
  • What is the most important information I should know about cetuximab (Erbitux)?
  • What should I discuss with my healthcare provider before I receive cetuximab (Erbitux)?
  • How is cetuximab given (Erbitux)?
  • What happens if I miss a dose (Erbitux)?
  • What happens if I overdose (Erbitux)?
  • What should I avoid while receiving cetuximab (Erbitux)?
  • What other drugs will affect cetuximab (Erbitux)?
  • Where can I get more information?

What is cetuximab (Erbitux)?

Cetuximab is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

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

Cetuximab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of cetuximab (Erbitux)?

Some people receiving a cetuximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel short of breath, weak or dizzy, nauseated, itchy, or have wheezing, noisy breathing, or a hoarse voice during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • an acne-like skin rash or any severe skin rash;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding;
  • urinating more or less than usual;
  • hot dry skin with weakness or dizziness;
  • confusion; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • dry, cracked, or swollen skin;
  • changes in your fingernails or toenails;
  • headache;
  • nausea, vomiting, stomach pain, loss of appetite;
  • diarrhea, constipation;
  • dry mouth, trouble swallowing;
  • cough or sore throat;
  • weight loss; or
  • weakness.

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.

What is the most important information I should know about cetuximab (Erbitux)?

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

Before receiving cetuximab, tell your doctor if you have heart rhythm problems, congestive heart failure, breathing problems, or coronary artery disease. Tell your doctor if you are also being treated with cisplatin (Platinol).

After you receive this medicine, your doctor will need to watch you for about an hour. This is to make sure you do not have any serious side effects from the medicine.

Some people receiving a cetuximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel short of breath, weak or dizzy, nauseated, itchy, or have wheezing, noisy breathing, or a hoarse voice during the injection.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor. You may need to have blood tests for several weeks after your cetuximab treatment has ended.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds) while you are receiving cetuximab and for at least 2 months after your treatment ends. Cetuximab can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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