Comparative Pharmacology
Head-to-head clinical analysis: ARZERRA versus RAXIBACUMAB.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ARZERRA versus RAXIBACUMAB.
ARZERRA vs RAXIBACUMAB
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Ofatumumab is a fully human monoclonal antibody that binds specifically to the CD20 molecule on B lymphocytes, resulting in complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) of CD20+ cells.
Raxibacumab is a monoclonal antibody that binds to the protective antigen (PA) component of Bacillus anthracis toxins, preventing PA from binding to host cell receptors and thereby inhibiting the intracellular entry of lethal factor and edema factor. This neutralizes the lethal and edema toxins, reducing pathogenicity.
ARZERRA (ofatumumab) for chronic lymphocytic leukemia (CLL): Initial dose 300 mg IV, then 1 week later 2000 mg IV weekly for 6 doses, then 2000 mg IV every 4 weeks for up to 4 additional doses. For relapsed CLL: 300 mg IV followed by 1000 mg IV on day 8, then 1000 mg IV on day 15 and day 22 of cycle 1, then 1000 mg IV on day 1 of cycles 2-6 (28-day cycles). Premedicate with acetaminophen, antihistamine, and corticosteroid.
Single intravenous dose of 40 mg/kg administered over 30 minutes.
None Documented
None Documented
Mean terminal elimination half-life after first dose is approximately 14 days (range 7–21 days) and increases with repeated dosing due to target-mediated clearance saturation; at steady state, half-life is ~24 days.
Terminal elimination half-life approximately 12-24 hours (mean ~18 hours) in patients with normal renal function; half-life extends in renal impairment.
Arzerra (ofatumumab) is eliminated primarily via the reticuloendothelial system and catabolism; renal excretion is minimal (<1% of dose as intact antibody). Biliary/fecal excretion has not been characterized, but as a monoclonal antibody, it is not significantly excreted in urine or feces.
Primarily renal excretion as intact protein; >90% of administered dose recovered in urine over 48 hours.
Category C
Category C
Antineoplastic, Monoclonal Antibody
Monoclonal Antibody