Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) refractory to fludarabine and alemtuzumab

INN:

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

FDA

Class:

CD20 MAb

R/R

PI: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/arzerra.pdf 

1. Approved Labelling

Arzerra (ofatumumab) is indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) refractory to fludarabine and alemtuzumab.

2. Treatment Regimen

  • Dilute and administer as an intravenous infusion. Do not administer as an intravenous push or bolus
  • Recommended dose and schedule is 12 doses administered as follows:
    • 300 mg initial dose, followed 1 week later by
    • 2,000 mg weekly for 7 doses, followed 4 weeks later by
    • 2,000 mg every 4 weeks for 4 doses

Infusions

  • Infusion 1 (300-mg dose): Initiate infusion at a rate of 3.6 mg/hour (12 mL/hour).
  • Infusion 2 (2,000-mg dose): Initiate infusion at a rate of 24 mg/hour (12 mL/hour).
  • Infusions 3 through 12 (2,000-mg doses): Initiate infusion at a rate of 50 mg/hour (25 mL/hour).

Premedicate with oral acetaminophen, oral or intravenous antihistamine, and intravenous corticosteroid

3. AE/Warnings

Please see section 5 of the PI

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