Vectibix- Monoclonal antibody for colorectal cancer

Company:

Amgen

Pharmacologic class:

Human epidermal growth factor receptor (EGFR) inhibitor

Active ingredient:

Panitumumab 20 mg/mL; solution for IV infusion after dilution; preservative-free.

Indication:

EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Pharmacology:

Panitumumab is a recombinant, human immunoglobulin G2 kappa monoclonal antibody that binds to EGFR on both normal and tumor cells. It competitively inhibits the binding of ligands to EGFR, therefore preventing ligand-induced receptor auto-phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, internalization of the EGFR, and decreased pro-inflammatory cytokine and vascular growth factor production.

Clinical trials:

Panitumumab was evaluated in a study involving 463 patients with EGFR-expressing, metastatic colorectal cancer.

Patients were randomized 1:1 to receive panitumumab plus best supportive care (BSC) or BSC alone until investigator-determined disease progression. Upon investigator-determined disease progression, patients on BSC alone were eligible to receive panitumumab in an optional trial. Based upon independent review committee determination of disease progression, a statistically significant prolongation in progression-free survival (PFS) was seen in patients receiving panitumumab compared with those receiving BSC alone. The mean PFS was 96 days for the panitumumab group and 60 days for the BSC-alone group. Of the 232 patients given BSC alone, 75% of patients crossed over to receive panitumumab; the median time to cross over was 8.4 weeks.

Currently, there are no data available to show an improvement in disease-related symptoms or increased survival. Adults: 6 mg/kg by IV infusion over 60 minutes once every 14 days until disease progression detected. Doses >1,000 mg: infuse over 90 minutes. Infusion reactions or dermatologic toxicity: see literature.

Children:

Not recommended.

Precautions:

Test for EGFR protein expression. Withhold or discontinue therapy if severe dermatologic toxicities occur; monitor for infection. Interstitial pneumonia, pulmonary fibrosis; discontinue if interstitial lung disease, pneumonitis, or lung infiltrates develop. Limit sun exposure. Monitor magnesium and calcium levels during and for eight weeks after completing therapy. May impair fertility in women; use effective contraception during treatment and for six months following last dose. Pregnancy (Cat. C). Nursing mothers: not recommended; discontinue during therapy and for two months after last dose.

Interactions:

Concomitant irinotecan, bolus 5-fluorouracil, and leucovorin (IFL): not recommended.

Adverse reactions:

Skin rash, paronychia, photosensitivity, electrolyte depletion (e.g., hypomagnesemia, hypocalcemia), nausea, diarrhea, abdominal pain, constipation, fatigue; severe dermatologic toxicities with possible infection (may be fatal), infusion reactions (stop therapy if severe; may need to permanently discontinue: see literature), pulmonary fibrosis.

How supplied:

Single-use vial (5 mL, 10 mL, 20 mL)—1.

For more information, call 800.77.AMGEN.

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