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Panitumumab

Dermatologic Toxicity; Infusion Reactions

Dermatologic Toxicity

  • Dermatologic toxicitiesoccured in 89% of patients and were severe (NCI-CTC grade 3 or higher) in 12% of patients receiving panitumumab monotherapy. [See Dosage and Administration; Warnings and Precautions; and Adverse Reactions]

Infusion Reactions

  • Severe infusion reactions occurred with the administration of panitumumab in approximately 1% of the patients.
  • Fatal infusion reactions occurred in postmarketing experience. [See Dosage and Administration; Warnings and Precautions; and Adverse Reactions]

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

Dermatological Toxicities

  • Clinical manifestations in clinical trials included, but were not limited to, dermatitis aceniform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Severe dermatologic toxicities were complicated by infection including sepsis, septic death, and abscesses requiring incisions and drainage.
  • Withhold or discontinue panitumumab for severe or life theratening dermatologic toxicity.
  • Monitor for inflammatory or infectious sequelae in patients with severe dermatologic toxicities.

Infusion Reactions

  • Clinical manifestations have included anaphylactoid reactions, bronchospasm, and hypotension.
  • Severe Infusion Reaction: Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue panitumumab. (See DOSAGE AND ADMINISTRATION)
  • Mild or Moderate Infusion Reaction (grade 1 or 2):  Reduce infusion rate by 50% in patients experiencing mild or moderate infusion reaction for the duration of that infusion.

Patient Counseling Information

Package Inserts

Panitumumab

Additional Information

Updated January 2018