Cetuximab Side Effects

Brand Names: Erbitux

Please note - some side effects for Cetuximab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Cetuximab - for the Consumer

Cetuximab

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 when using Cetuximab:

Changes in fingernails or toenails; constipation; cough; diarrhea; dry mouth; dry skin; eye redness or irritation; general body discomfort; headache; indigestion; mild acne; nausea; pain, swelling, or redness at the injection site; sore throat; stomach pain or upset; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems or shortness of breath; change in the amount of urine produced; chest pain; confusion; eye or eyelid redness, swelling, or irritation; fainting; fever, chills, or persistent sore throat; hoarseness; increased abnormal hair growth; mental or mood changes (eg, anxiety, depression); numbness of an arm or leg; peeling, redness, cracking, or oozing of the skin; severe or persistent acne; severe or persistent dizziness or headache; severe or persistent stomach pain, nausea, or vomiting; severe or persistent tiredness or weakness; sores on the lips or in the mouth; swelling of the hands, legs, or feet; trouble swallowing; vision changes; wheezing.

Side Effects by Body System

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 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.

General

General side effects have been reported including asthenia/malaise (73% in patients receiving cetuximab 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 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 fourty-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 with irinotecan.

Hematologic

Hematologic side effects including leukopenia (25%) and anemia (16%) have been reported in patients receiving cetuximab 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 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 (50% in patients receiving cetuximab with irinotecan), high alanine transaminase (43% in patients receiving cetuximab 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 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 with irinotecan).

Nervous system

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

Renal

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

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