Vectibix Side Effects

Generic Name: panitumumab

Please note - some side effects for Vectibix 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 Vectibix - for the Consumer

Vectibix

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 Vectibix:

Constipation; diarrhea; eyelash growth; mild acne; mild dryness, itching, or redness of the skin; nausea; stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest congestion or tightness; chest pain; cough; increased tearing; irritation, pain, redness, or swelling of the eye or eyelid; irritation, redness, swelling, or sores in or around the mouth; moderate to severe skin changes (eg, blistered, cracking, peeling, swollen, or painful skin; moderate to severe acne; moderate to severe redness or itching); pain, redness, or swelling at the injection site; pain, redness, or swelling near the nailbed; severe or persistent diarrhea, nausea, or vomiting; shortness of breath; signs of infection (eg, chills, fever, sore throat); swelling of the ankles, feet, or hands; vision changes; wheezing.

Vectibix Side Effects - for the Professional

Vectibix

Most common adverse reactions (≥ 20%) are skin toxicities (ie, erythema, acneiform/dermatitis, pruritus, exfoliation, rash, and fissures), paronychia, hypomagnesemia, fatigue, abdominal pain, nausea, diarrhea, and constipation. (6)

Side Effects by Body System

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.

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