INDICATIONS AND USAGE（适应症）

Metastatic Colorectal Cancer

Vectibix is indicated for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC):

As first-line therapy in combination with FOLFOX.

As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

Limitation of Use:  Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.

DOSAGE（服用剂量）

Prior to initiation of treatment with Vectibix, assess RAS mutational status in colorectal tumors and confirm the absence of a RAS mutation in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of both KRAS and NRAS.

Recommended Dose

The recommended dose of Vectibix is 6 mg/kg, administered as an intravenous infusion over 60 minutes, every 14 days. If the first infusion is tolerated, administer subsequent infusions over 30 to 60 minutes. Administer doses higher than 1000 mg over 90 minutes.

Appropriate medical resources for the treatment of severe infusion reactions should be available during Vectibix infusions.

ADVERSE REACTIONS（不良反应）

Dermatologic and Soft Tissue Toxicity

Increased Tumor Progression, Increased Mortality, or Lack of Benefit in RAS-Mutant mCRC

Electrolyte Depletion/Monitoring

Infusion Reactions

Acute Renal Failure in Combination with Chemotherapy

Pulmonary Fibrosis/Interstitial Lung Disease (ILD)

Photosensitivity

Ocular Toxicities

Increased Mortality and Toxicity with Vectibix in combination with Bevacizumab and Chemotherapy

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/e0fa4bca-f245-4d92-ae29-b0c630a315c2/spl-doc?hl=Panitumumab

Vectibixinformation