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Arzerra (Ofatumumab) - Summary



  • Hepatitis B Virus Reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA®, in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnings and Precautions].
  • Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA [see Warnings and Precautions].


ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa.

Previously Untreated Chronic Lymphocytic Leukemia

ARZERRA (ofatumumab) is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies].

Refractory CLL

ARZERRA is indicated for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies].

See all Arzerra indications & dosage >>


Media Articles Related to Arzerra (Ofatumumab)

Genmab announces ofatumumab Phase III study in follicular lymphoma to be stopped following planned interim analysis
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.11.24]
Genmab A/S has announced that the Phase III study of single agent ofatumumab compared to single agent rituximab in patients with follicular non-Hodgkin's lymphoma (NHL) that has relapsed at least 6...

European Commission approves Blincyto for acute lymphoblastic leukemia
Source: Blood / Hematology News From Medical News Today [2015.11.25]
Amgen has announced that the European Commission (EC) has granted conditional marketing authorization for BLINCYTO® (blinatumomab) for the treatment of adults with Philadelphia...

Institute of Pediatrics achieved 80% survival in patients with leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.11.19]
Institute of Pediatrics attends between 800 and 1,200 thousand children with the disease per year; of which 365 are new cases.

Gene Editing Reverses Baby's Leukemia
Source: MedicineNet Leukemia Specialty [2015.11.09]
Title: Gene Editing Reverses Baby's Leukemia
Category: Health News
Created: 11/7/2015 12:00:00 AM
Last Editorial Review: 11/9/2015 12:00:00 AM

Social factors may impact young leukemia patients' survival
Source: Health Insurance / Medical Insurance News From Medical News Today [2015.09.14]
A new study reveals that insurance status, marital status, and county-level income may affect the chances of survival in young patients with acute myelogenous leukemia (AML).

more news >>

Published Studies Related to Arzerra (Ofatumumab)

Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase 2 study. [2014]
sclerosis (RRMS)... CONCLUSIONS: Ofatumumab (up to 700 mg) given 2 weeks apart was not associated

Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial. [2011]
arthritis (RA) patients despite methotrexate treatment... CONCLUSIONS: Ofatumumab significantly improved all clinical outcomes in

Ofatumumab, a human anti-CD20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomized, double-blind, placebo-controlled, phase I/II study. [2010.08]
OBJECTIVE: To investigate the safety and efficacy of ofatumumab, a novel human anti-CD20 monoclonal antibody (mAb), in patients with active rheumatoid arthritis (RA) whose disease did not respond to > or = 1 disease-modifying antirheumatic drug... CONCLUSION: Our findings indicate that ofatumumab, administered as 2 i.v. infusions of doses up to 1,000 mg, is clinically effective in patients with active RA.

Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. [2015]
have few treatment options... INTERPRETATION: Addition of ofatumumab to chlorambucil led to clinically

Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics. [2013]
objectives included characterizing pharmacokinetics and pharmacodynamics... CONCLUSION: Treatment of RA patients with SC ofatumumab doses of 30 mg or higher

more studies >>

Clinical Trials Related to Arzerra (Ofatumumab)

Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia [Recruiting]
This is a Phase II, single-arm study of ofatumumab investigating the safety of an accelerated infusion schedule of ofatumumab in patients who have received at least one prior therapy for CLL. The primary endpoint is to evaluate the number of subjects able to complete infusion number 3 (2000 mg) within 15 minutes of the planned time.

Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide for Refractory or Relapsed Aggressive B-Cell Lymphomas [Recruiting]
The Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of bendamustine, ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin's lymphoma whose disease has progressed or has recurred after prior chemotherapy. The Phase II part of the study will be a single-arm, open-label study in which all patients will receive combination bendamustine, ofatumumab, carboplatin and etoposide at the MTD dose defined in phase I. This study hopes to identify a life-prolonging therapy for patients with Non-Hodgkin's Lymphoma whose disease has progressed or has recurred after prior chemotherapy. The hypothesis is that the proposed combination of chemotherapy is well-tolerated and is efficacious for the treatment of relapsed/refractory aggressive B cell lymphomas.

Hyper CVAD Plus Ofatumumab in CD - 20 Positive Acute Lymphoblastic Leukemia (ALL) [Recruiting]
The goal of this clinical research study is to learn if ofatumumab combined with standard chemotherapy can help to control ALL. The safety of these drug combinations will also be studied.

Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma [Recruiting]
This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab (PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how safe these three drugs work together.

Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL) [Completed]
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR) to therapy and the secondary endpoints will assess the safety and tolerability of the regimen, the impact of the treatment on progression free, treatment free, overall survival, and pharmacokinetics of ofatumumab. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial prophylaxis.

more trials >>

Reports of Suspected Arzerra (Ofatumumab) Side Effects

Infusion Related Reaction (11)Neutropenia (11)Febrile Neutropenia (9)Diarrhoea (6)Pyrexia (5)Neuropathy Peripheral (5)Dyspnoea (5)Chills (4)Pneumonia (4)Lymphadenopathy (3)more >>

Page last updated: 2015-11-25

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