Panitumumab Side Effects

Some side effects of panitumumab 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 panitumumab: intravenous solution

Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fever, chills, or trouble breathing during the injection.

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

Some of the side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.

Call your doctor at once if you have a serious side effect such as:

• acne, dryness, peeling, cracking, bleeding, oozing, pus, or any other signs of skin infection;

• swelling or infection around your fingernails or toenails.

• vision changes;

• sudden chest pain or discomfort, wheezing, dry cough or hack, feeling short of breath on exertion;

• feeling weak or tired, loss of appetite, rapid weight loss;

• swelling in your face, hands, ankles, or feet;

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• white patches or sores inside your mouth or on your lips;

• drowsiness, restless feeling, confusion, muscle stiffness, fast or uneven heart rate;

• redness, swelling, or irritation of your eyes or eyelids; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of panitumumab may include:

• nausea, vomiting, stomach pain;

• diarrhea or constipation; or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to panitumumab: intravenous solution

Dermatologic

Dermatologic side effects including all skin/integument toxicity (90%), erythema (65%), acneiform dermatitis (57%), pruritus (57%), skin exfoliation (25%), paronychia (25%), rash (22%), skin fissures (20%), acne (13%), dry skin (10%), nail disorders (9%), and growth of eyelashes (6%) have been reported.

Dermatologic toxicities related to the panitumumab blockade of EGF binding and subsequent inhibition of EGFR-mediated signaling were severe in 16% of patients with metastatic colorectal cancer receiving panitumumab. Subsequent to the development of severe dermatologic toxicities infectious complications including sepsis, septic death, and abscesses requiring incisions and drainage were reported.

Animal studies have reported dermatologic findings, including dermatitis, pustule formation, exfoliative rash, and deaths secondary to bacterial infection and sepsis.

General

General side effects including fatigue (26%) and general deterioration (11%) have been reported.

Gastrointestinal

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.

Gastrointestinal side effects including abdominal pain (25%), nausea (23%), diarrhea (21%), constipation (21%), vomiting (19%), stomatitis (7%), and mucosal inflammation (6%) have been reported.

Metabolic

Metabolic side effects including hypomagnesemia (39%) and peripheral edema (12%) have been reported.

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.

Respiratory

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

Respiratory side effects including cough (14%), pulmonary embolism, and pulmonary fibrosis (reported in less than 1%) have been reported.

Ocular

Ocular side effects (15%) have been reported.

Hypersensitivity

Hypersensitivity side effects have been reported. Four percent of patients have experienced an infusion reaction and 1% of those were severe.

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.

Cardiovascular

Cardiovascular side effects including angioedema have been reported.

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