ARZERRA Premedication in the First-Line Treatment of CLL1

Patients Should Receive the Following Premedication 30 Minutes to 2 Hours Prior to Each Infusion of ARZERRA for Previously Untreated CLL

Recommended Infusion Rates for ARZERRA in Previously Untreated CLL1

  • In the absence of severe infusion-related reactions after the second infusion, the rate of infusion may be increased every 30 minutes
  • Do not exceed the infusion rates in the table above

Management of Infusion-Related Reactions1

    ARZERRA therapy has been associated with infusion reactions. These may result in temporary interruption or withdrawal of treatment.
  • Premedication is administered prior to initiation of the infusion to reduce the risk of infusion reactions
  • Appropriate clinical interventions in the case of infusion reactions are at the discretion of the treating physician
  • Infusion rate modification due to the infusion-related ADRs
    • Infusion reactions following ARZERRA administration occur most frequently on the first infusion and tend to decrease with subsequent infusions
    • Infusion reactions can include anaphylactoid events, bronchospasm, cardiac events, chills/rigors, cough, cytokine release syndrome, diarrhea, dyspnea, fatigue, flushing, hypertension, hypotension, nausea, pain, pulmonary edema, pruritus, pyrexia, rash, and urticaria. In rare cases, these reactions lead to death
    • If any infusion reactions are observed, interrupt the infusion and restart at slower infusion rates according to the guidelines specified below. In cases of severe infusion reaction, the infusion of ARZERRA must be interrupted immediately and symptomatic treatment instituted

Infusion Rate Modifications for IRRs1

  • Interrupt infusion for IRRs of any severity. Treatment can be resumed at the discretion of the treating physician. The following infusion rate modifications can be used as a guide
  • If the IRR resolves or remains grade ≤2, resume infusion with the following modifications according to the initial grade of the IRR:
aRestart the infusion at 12 mL/hour if the infusion rate has not been increased from the starting rate of 12 mL/hour.
CLL, chronic lymphocytic leukemia; IRR, infusion-related reaction.

View information on the storage, preparation, and dilution of ARZERRA.

Reference: 1. Arzerra® (ofatumumab) summary of product characteristics. West Sussex, UK; Novartis Europharm Limited; 2016.