WARNING HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, includi…+
*Based on in vitro data.
In this video, watch Steven Rosen, MD, present the approval history of ARZERRA® (ofatumumab) and review its mechanism of action in CLL.
1. Arzerra [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016.
2. Church AK et al. Clin Exp Immunol. 2015; 183(1):90-101.
3. Shimada K et al. Br J Haematol. 2014;166(3):455-457.
4. Barth MJ et al. Clin Cancer Res. 2015; 21(19):4391-4397.
INDICATIONS for ARZERRA® (ofatumumab)
IMPORTANT SAFETY INFORMATION for ARZERRA® (ofatumumab)
Hepatitis B Virus Reactivation
Progressive Multifocal Leukoencephalopathy
Tumor Lysis Syndrome
Most Common Adverse Reactions
*Assessed by a blinded Independent Review Committee (IRC) using the International Workshop on Chronic Lymphocytic Leukemia updated National Cancer Institute–sponsored Working Group (NCI-WG) guidelines (1996).1
The efficacy of ARZERRA was studied in a single-arm, multicenter trial of 154 patients with CLL refractory to fludarabine and alemtuzumab (n=59).1
CI=confidence interval; CLL=chronic lymphocytic leukemia; FA=fludarabine and alemtuzumab.
Reference: 1. Arzerra [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016.