Applies to panitumumab: intravenous solution.

Serious side effects of Panitumumab

Along with its needed effects, panitumumab 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 panitumumab:

More common

• Anxiety
• bloating or swelling of the face, arms, hands, lower legs, ankles, or feet
• chest pain
• chills
• confusion
• constipation
• convulsions
• cough
• decreased urination
• deep cracks, grooves, or lines in the skin
• diarrhea
• difficulty with swallowing
• discoloration of the fingernails or toenails
• drowsiness
• dry mouth, lips, or skin
• fainting
• fast or irregular heartbeat
• fever
• flushing or redness of the skin
• increased thirst
• itching, pain, and swelling of the eyelid
• itching, skin rash
• loosening of the fingernails
• loss of appetite
• muscle pain or cramps
• muscle spasms or twitching
• nausea
• rapid weight gain
• rapid, shallow breathing
• redness or soreness around the fingernails
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stomach pain
• sunken eyes
• swelling or inflammation of the mouth
• tearing of the eyes
• tingling of the hands or feet
• trembling
• troubled breathing
• unusual tiredness or weakness
• unusual weight gain or loss
• unusually warm skin
• vomiting

Less common

• Blurred vision
• burning, dry, or itching eyes
• discharge from the eyes or excessive tearing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• facial swelling
• headache
• hives
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sweating
• swelling of the eye, eyelid, or inner lining of the eyelid
• tightness in the chest

Rare

• Chest discomfort
• painful breathing
• quick, shallow breathing
• slight fever

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

For Healthcare Professionals

Applies to panitumumab: intravenous solution.

Dermatologic

Very common (10% or more): Erythema (66%), pruritus (58%), acneiform dermatitis (57%), rash (22%), skin fissures (20%), exfoliative rash (18%), alopecia (15%)

Common (1% to 10%): Dry skin, nail disorder, skin exfoliation, skin ulcer, pustular rash, popular rash, Palmar-plantar erythrodysesthesia syndrome

Postmarketing reports: Skin necrosis, life threatening and fatal bullous mucocutaneous disease^[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (25%), nausea (23%), diarrhea (21%), constipation (21%), vomiting (19%)

Common (1% to 10%): Stomatitis, mucosal inflammation, dry mouth^[Ref]

When used in combination with irinotecan, the incidence and severity of diarrhea is increased. In a study of 19 patients who received panitumumab in combination with irinotecan, 5-fluorouracil, and leucovorin, the incidence of grade 3 or 4 diarrhea was 58% and was fatal in one patient. The combination of panitumumab with leucovorin is not recommended.^[Ref]

Metabolic

Very common (10% or more): Anorexia (36%), hypomagnesemia (30%), hypokalemia (21%), weight loss (18%)

Common (1% to 10%): Dehydration

Frequency not reported: Hypocalcemia^[Ref]

Median magnesium levels decreased by 0.1 mmol/L. Hypomagnesemia (grade 3 or 4) requiring oral or IV electrolyte repletion occurred in 2% of patients. Hypomagnesemia occurred 6 weeks or longer after the initiation of panitumumab. In some patients, hypomagnesemia was associated with hypocalcemia. Patient's electrolytes should be monitored during and for eight weeks after the completion of panitumumab therapy. Patients should be periodically monitored for hypomagnesemia and accompanying hypocalcemia during the eight weeks after the completion of panitumumab therapy.^[Ref]

Respiratory

Very common (10% or more): Dyspnea (18%), cough (15%)

Common (1% to 10%): Epistaxis, pulmonary embolism

Uncommon (0.1% to 1%): Pulmonary fibrosis

Frequency not reported: Nasal dryness, interstitial lung disease (including fatal cases), lung infiltrates^[Ref]

Panitumumab should be permanently discontinued in patients developing interstitial lung disease, pneumonitis, or lung infiltrates.^[Ref]

Ocular

Common (1% to 10%): Growth of eyelashes, blepharitis, increased lacrimation, ocular hyperemia, dry eye, eye pruritus, eye irritation, conjunctivitis

Uncommon (0.1% to 1%): eyelid irritation, keratitis

Rare (less than 0.1%): Ulcerative keratitis^[Ref]

Hypersensitivity

Severe infusion reactions were identified as anaphylactic reaction, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with panitumumab, fatalities have occurred with other monoclonal antibody products. The infusion should be stopped if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, panitumumab may need to be permanently discontinued.^[Ref]

Common (1% to 10%): Hypersensitivity

Rare (less than 0.1%): Anaphylactic reaction, infusion reaction^[Ref]

Hematologic

Very common (10% or more): Anemia

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

Immunologic

Very common (10% or more): Paronychia (25%)

Common (1% to 10%): Pustular rash, cellulitis, folliculitis, localized infection

Uncommon (0.1% to 1%): Eye infection, eyelid infection

Postmarketing reports: Angioedema^[Ref]

Nervous system

Frequency not reported: Headache^[Ref]

Other

Very common (10% or more): Fatigue (26%), peripheral edema (12%)

Common (1% to 10%): Mucosal inflammation, pyrexia, chills^[Ref]

Renal

Frequency not reported: Acute renal failure (in patients who developed diarrhea and dehydration)^[Ref]