• Boxed Warning: infusion reactions              05/2014
• Indications and Usage (1)                             03/2015
• Dosage and Administration (2)                     05/2014
• Warnings and Precautions (5.2)                    03/2015

Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use:

• In combination with FOLFOX for first-line treatment. (1.1, 14.2)
• As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. (1.1, 14.1)
• Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown. (1.1, 2.1, 5.2, 12.1)

• Administer 6 mg/kg every 14 days as an intravenous infusion over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg). (2)
• Infusion Reactions: Reduce infusion rate by 50% for mild reactions; terminate the infusion for severe infusion reactions. (2.3, 5.4)
• Dermatologic Toxicity: Withhold or discontinue for severe or intolerable toxicity; reduce dose for recurrent, grade 3 toxicity. (2.3, 5.1)

• Single-use vials (20 mg/mL): 100 mg/5 mL, 200 mg/10 mL,
  400 mg/20 mL. (3)

• None

• Dermatologic and Soft Tissue Toxicity: Monitor for dermatologic and soft tissue toxicities and withhold or discontinue Vectibix for severe or life-threatening complications.  Limit sun exposure. (5.1, 5.7)
• Increased tumor progression, increased mortality, or lack of benefit in patients with RAS-mutant mCRC. (2.1, 5.2)
• Electrolyte Depletion/Monitoring: Monitor electrolytes and institute appropriate treatment. (5.3)
• Infusion Reactions: Terminate the infusion for severe infusion reactions. (5.4)
• Pulmonary Fibrosis/Interstitial Lung Disease (ILD): Permanently discontinue Vectibix in patients developing ILD. (5.6)
• Ocular Toxicities: Monitor for keratitis or ulcerative keratitis. Interrupt or discontinue Vectibix for acute or worsening keratitis. (5.8)

Most common adverse reactions (≥ 20%) of Vectibix as monotherapy are skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea. (6.1)

Most common adverse reactions (≥ 20%) in clinical trials of Vectibix in combination with FOLFOX chemotherapy are diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Pregnancy: Based on animal data, may cause fetal harm. (8.1) Physicians are encouraged to enroll pregnant patients in Amgen’s Pregnancy Surveillance Program by calling 1-800-772-6436
  (1-800-77-AMGEN). (8.1)

• Nursing Mothers: Discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother. (8.3)