Erbitux Side Effects

Generic Name: cetuximab

Note: This document contains side effect information about cetuximab. Some of the dosage forms listed on this page may not apply to the brand name Erbitux.

Some side effects of Erbitux may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cetuximab: intravenous solution

Along with its needed effects, cetuximab (the active ingredient contained in Erbitux) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking cetuximab:

More common
  • Blemishes on the skin or pimples
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • chills
  • congestion
  • cough or hoarseness
  • deep cracks, grooves, or lines in the skin
  • difficult or labored breathing
  • dizziness
  • facial swelling
  • fever
  • headache
  • lower back or side pain
  • nausea
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • runny nose
  • severe dry skin
  • shortness of breath
  • skin rash
  • tender, swollen glands in the neck
  • tightness in the chest
  • tingling of the hands or feet
  • trouble with breathing on exertion
  • trouble with swallowing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • voice changes
  • vomiting
  • weakness
  • wheezing
Less common or rare
  • Anxiety
  • black, tarry stools
  • chest pain
  • confusion
  • decreased urination
  • dry mouth
  • fainting
  • fast heartbeat
  • increase in heart rate
  • lightheadedness
  • rapid, shallow breathing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sunken eyes
  • swollen glands
  • thirst
  • wrinkled skin

Some side effects of cetuximab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • burning, dry, or itching eyes
  • diarrhea
  • difficulty having a bowel movement (stool)
  • discharge from the eye
  • discoloration of the fingernails or toenails
  • discouragement
  • excessive tearing
  • feeling sad or empty
  • hair loss or thinning of the hair
  • heartburn
  • indigestion
  • irritability
  • itching skin
  • lack or loss of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • pain
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sleeplessness
  • stomach discomfort, upset, or pain
  • swelling or inflammation of the mouth
  • trouble concentrating
  • trouble sleeping
  • unable to sleep

For Healthcare Professionals

Applies to cetuximab: intravenous solution

Dermatologic

Severe acneform rash occurred in 1% to 17% of patients. Acneform rash usually developed within the first two weeks of therapy and resolved in a majority of the patients after cessation of treatment, although in nearly half, the event continued beyond 28 days. Patients receiving cetuximab (the active ingredient contained in Erbitux) should be monitored for dermatologic toxicities and infectious sequelae. Patients should be instructed to limit sun exposure during cetuximab therapy.

Dermatologic side effects including acneform rash (90% in patients on cetuximab monotherapy), alopecia (21% in patients on cetuximab with irinotecan), nail disorder (16% in patients on cetuximab monotherapy), skin disorder (15% in patients on cetuximab with irinotecan), pruritus (10%), skin drying, and fissuring, paronychial inflammation, and infectious sequelae (for example S. aureus sepsis, abscess formation, cellulitis, blepharitis, cheilitis) have been reported. Two cases of trichomegaly, one case of hypertrichosis of the chest, and one case of facial hypertrichosis have been reported. Postmarketing reports have included mucosal inflammation.

General

General side effects have been reported including asthenia/malaise (73% in patients receiving cetuximab (the active ingredient contained in Erbitux) with irinotecan), abdominal pain (45% in patients receiving cetuximab with irinotecan), fever (34% in patients receiving cetuximab with irinotecan), headache (25% in patients receiving cetuximab monotherapy), infusion reaction (25% in patients receiving cetuximab monotherapy), pain (23% in patients receiving cetuximab with irinotecan), infection (16% in patients receiving cetuximab with irinotecan), and back pain (16% in patients receiving cetuximab with irinotecan).

Cardiovascular

Although the etiology of these events is unknown, close monitoring of serum electrolytes, including serum magnesium, potassium, and calcium, during and after cetuximab (the active ingredient contained in Erbitux) therapy is recommended.

Cardiovascular side effects including cardiopulmonary arrest and/or sudden death have been reported in 2% of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and cetuximab as compared to none of the patients treated with radiation therapy alone. Fatal events occurred within one to forty-three days after the last cetuximab treatment.

Gastrointestinal

Gastrointestinal side effects including diarrhea (72%), nausea (55%), vomiting (41%), anorexia (36%), constipation (30%), stomatitis (26%), and dyspepsia (14%) have been reported in patients receiving cetuximab (the active ingredient contained in Erbitux) with irinotecan.

Hematologic

Hematologic side effects including leukopenia (25%) and anemia (16%) have been reported in patients receiving cetuximab (the active ingredient contained in Erbitux) with irinotecan. A case of tumor lysis syndrome has been reported following single agent cetuximab.

Respiratory

Respiratory side effects including dyspnea (23%) and increased cough (20%) have been reported in patients receiving cetuximab (the active ingredient contained in Erbitux) with irinotecan. Pulmonary embolus (1%) and interstitial lung disease (less than 0.5%) have also been reported. One of the cases of interstitial lung disease was a fatality.

Metabolic

Metabolic side effects including hypomagnesemia (up to 55%), high alanine transaminase (43% in patients receiving cetuximab (the active ingredient contained in Erbitux) with radiation), high aspartate transaminase (38% in patients receiving cetuximab with radiation), and high alkaline phosphatase (33% in patients receiving cetuximab with radiation), weight loss (21% in patients receiving cetuximab with irinotecan), peripheral edema (16% in patients receiving cetuximab with irinotecan), dehydration (15% in patients receiving cetuximab with irinotecan), and severe hypomagnesemia (10% to 15% in patients receiving cetuximab with irinotecan) have been reported.

The onset of electrolyte abnormalities has been reported to occur from days to months after initiation of cetuximab therapy. Electrolyte repletion was necessary in some patients and in severe cases, intravenous replacement was required. The exact time to resolution of electrolyte abnormalities is not known. Therefore monitoring is recommended after cetuximab treatment.

Other

The incidence of grade 3 or 4 late radiation toxicities were generally similar between the radiation therapy alone and the cetuximab (the active ingredient contained in Erbitux) plus radiation treatment groups.

Other side effects have included late radiation toxicities. The overall incidence of late radiation toxicities (any grade) was higher in cetuximab in combination with radiation therapy compared with radiation therapy alone. The following sites were affected: salivary glands (65% versus 56%), larynx (52% versus 36%), subcutaneous tissue (49% versus 45%), mucous membrane (48% versus 39%), esophagus (44% versus 35%), skin (42% versus 33%), brain (11% versus 9%), lung (11% versus 8%), spinal cord (4% versus 3%), and bone (4% versus 5%).

Ocular

Ocular side effects have been reported including conjunctivitis (14% in patients on cetuximab (the active ingredient contained in Erbitux) with irinotecan) and keratitis.

Nervous system

Nervous system side effects including insomnia (12%) and depression (10%) have been reported in patients receiving cetuximab (the active ingredient contained in Erbitux) with irinotecan.

Renal

Renal side effects including kidney failure (2%) have been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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