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Information about Necitumumab

Necitumumab is a human monoclonal antibody to the epidermal growth factor (EGF) receptor and is an anti-angiogenesis agent used in the therapy of advanced non-small cell lung cancer. 

Liver safety of Necitumumab

Necitumumab has not been linked to serum enzyme elevations during therapy or to idiosyncratic acute liver injury

Mechanism of action of Necitumumab

Necitumumab (ne" si toom' ue mab) is a recombinant human monoclonal IgG1 antibody to the epidermal growth factor (EGF) receptor.  The engagement of EGF with its receptors results in activation of cellular pathways that promote cell growth and angiogenesis.  EGF receptors are often overexpressed in cancer cells, particularly squamous non-small cell lung cancer.  Inhibition of EGF receptor signaling decreases cell growth and proliferation and decreases formation of new blood vessels, which plays an important role in growth and spread of cancer cells.  When used in combination with other antineoplastic agents, necitumumab was shown to extend recurrence-free survival in several forms of advanced cancer. 

FDA approval information for Necitumumab

Necitumumab was approved in the United States in 2015 for use in metastatic squamous, non-small cell lung cancer as a part of combination therapy with gemcitabine and cisplatin. 

Dosage and administration for Necitumumab

Necitumumab is available in solution in single use vials of 800 mg in 50 mL (16 mg/mL) under the brand name Portrazza.  The typical dose is 800 mg given intravenously over at least 60 minutes on days 1 and 8 of each 3-week cycle.  It is typically given in combination with other antineoplastic agents, most commonly with gemcitabine and cisplatin. 

Side effects of Necitumumab

Common adverse events include rash and hypomagnesemia, but when combined with other agents, diarrhea, fatigue, anorexia, epistasis, neutropenia, and stomatitis are frequent.  Uncommon, but potentially severe adverse events include arterial and venous thromboembolic events, cardiopulmonary arrest, marked hypomagnesemia, severe infusion reactions and embryofetal toxicity.

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