Applies to cetuximab: intravenous solution.

Serious side effects of Cetuximab

Along with its needed effects, cetuximab 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
• deep cracks, grooves, or lines in the skin
• difficult or labored breathing
• dizziness
• fever
• headache
• hoarseness
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• rapid weight gain
• runny nose
• severe dry skin
• 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

Less common

• 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
• thirst
• wrinkled skin

Incidence not known

• Blistering, peeling, or loosening of the skin
• cracked lips
• diarrhea
• difficulty in swallowing
• itching
• joint or muscle pain
• red, irritated eyes
• red skin lesions, often with a purple center
• stiff neck or back

Other side effects of Cetuximab

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

• Belching
• burning, dry, or itching eyes
• difficulty having a bowel movement
• 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
• 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

For Healthcare Professionals

Applies to cetuximab: intravenous solution.

Dermatologic

Very common (10% or more): Acneiform rash (90%), alopecia (21%), skin fissures (19%), nail disorder (16%), skin disorder (15%), acne (14%)

Common (1% to 10%): Pruritus

Very rare (less than 0.01%): Stevens-Johnson syndrome/toxic necrolysis

Frequency not reported: Superinfection of skin lesions

Postmarketing reports: Life-threatening/fatal bullous mucocutaneous disease^[Ref]

Cardiovascular

Common (1% to 10%): Cardiopulmonary arrest and/or sudden death

Uncommon (0.1% to 1%): Deep vein thrombosis^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (66%), nausea (55%), vomiting (41%), anorexia (36%), constipation (30%), stomatitis (26%), dyspepsia (14%), mucositis, dry mouth (12%)

Postmarketing reports: Mucosal inflammation^[Ref]

Hematologic

Very common (10% or more): Leukopenia (25%), anemia (16%)^[Ref]

Respiratory

Very common (10% or more): Dyspnea (49%), cough (30%)

Uncommon (0.1% to 1%): Pulmonary embolism, interstitial lung disease^[Ref]

Metabolic

Very common (10% or more): Hypomagnesemia (55%), sensory neuropathy (45%), weight loss (21%), peripheral edema (16%), dehydration (15%), severe hypomagnesemia (15%)

Common (1% to 10%): Hypocalcemia, anorexia^[Ref]

Other

Very common (10% or more): Asthenia (56%), fever (29%), chills (16%), taste disturbance (10%)

Common (1% to 10%): Fatigue

Frequency not reported: Late radiation toxicity^[Ref]

Ocular

Very common (10% or more): Conjunctivitis (14%)

Uncommon (0.1% to 1%): Blepharitis, keratitis^[Ref]

Nervous system

Very common (10% or more): Headache (19%)

Frequency not reported: Aseptic meningitis^[Ref]

Renal

Common (1% to 10%): Kidney failure^[Ref]

Hypersensitivity

Very common (10% or more): Mild or moderate infusion related reactions

Common (1% to 10%): Severe infusion related reactions (in some cases fatal)^[Ref]

Immunologic

Very common (10% or more): Infection (13%)

Frequency not reported: Immunogenicity^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (14%), back pain (16%)^[Ref]

Hepatic

Very common (10% or more): High alanine transaminase (43%), high aspartate transaminase (38%), high alkaline phosphatase (33%)^[Ref]

Psychiatric

Very common (10% or more): Insomnia (27%), confusion (18%), anxiety (14%), depression (14%)^[Ref]

Local

Very common (10% or more): Infusion reaction (e.g., chills, rigors, dyspnea, tachycardia, bronchospasm, chest tightness, swelling, urticaria, hypotension, flushing, rash, hypertension, nausea, angioedema, pain, sweating, tremors, shaking, drug fever, or other hypersensitivity reaction) (15%)^[Ref]