Clinical Information
Gen. Code and Des.
67553 ofatumumab INTRAVEN VIAL 1000 MG/50
GCN and Des.
30137 ofatumumab INTRAVEN VIAL 1000 MG/50
Strength
1000MG
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
13301 ofatumumab 679818598
Inactive Ingredients
2551 polysorbates 9005645
3785 edetic acid 60004
756 sodium acetate 127093
These highlights do not include all the information needed to use ARZERRA safely and effectively. See full prescribing information for ARZERRA.
ARZERRA® (ofatumumab) injection, for intravenous use
Initial U.S. Approval: 2009
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
See full prescribing information for complete boxed warning.
Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. (5.2)
Progressive Multifocal Leukoencephalopathy (PML) resulting in death. (5.4)
RECENT MAJOR CHANGES
Indications and Usage, Extended Treatment in CLL (1)
1/2016
Indications and Usage, Relapsed CLL (1)
8/2016
Dosage and Administration, Recommended Dosage Regimen (2.1)
1/2016
Dosage and Administration, Administration (2.2)
8/2016
Dosage and Administration, Pre-medication (2.4)
1/2016
INDICATIONS AND USAGE
ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of chronic lymphocytic leukemia (CLL) (1):
in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL.
for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
DOSAGE AND ADMINISTRATION
Dilute and administer as an intravenous infusion. Do not administer subcutaneously or as an intravenous push or bolus. (2.1)
Previously untreated CLL in combination with chlorambucil recommended dosage and schedule is:
300 mg on Day 1 followed by 1,000 mg on Day 8 (Cycle 1)
1,000 mg on Day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles. (2.1)
Relapsed CLL in combination with fludarabine and cyclophosphamide recommended dosage and schedule is:
300 mg on Day 1 followed by 1,000 mg on Day 8 (Cycle 1)
1,000 mg on Day 1 of subsequent 28-day cycles for a maximum of 6 cycles (2.1)
Extended treatment in CLL recommended dosage and schedule is:
300 mg on Day 1 followed by
1,000 mg 1 week later on Day 8, followed by
1,000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years. (2.1)
Refractory CLL recommended dosage and schedule is:
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. (2.1)
Administer where facilities to adequately monitor and treat infusion reactions are available. (2.2)
Pre-medicate with acetaminophen, antihistamine, and corticosteroid. (2.4)
DOSAGE FORMS AND STRENGTHS
100 mg/5 mL single-use vial for intravenous infusion. (3)
1,000 mg/50 mL single-use vial for intravenous infusion. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Infusion Reactions: Pre-medicate with corticosteroid, acetaminophen, and an antihistamine. Monitor patients during infusions. Interrupt infusion if infusion reactions occur. (2.3, 2.4, 5.1)
Tumor Lysis Syndrome: Anticipate TLS in high-risk patients; pre-medicate with anti-hyperuricemics and hydration. (5.5)
Cytopenias: Neutropenia, anemia, and thrombocytopenia occur. Late-onset and prolonged neutropenia can also occur. Monitor complete blood counts at regular intervals. (5.6)
ADVERSE REACTIONS
Previously Untreated CLL: Common adverse reactions (≥10%) were infusion reactions and neutropenia. (6)
Relapsed CLL: Common adverse reactions (>10%) were infusion reactions, neutropenia, leukopenia and febrile neutropenia. (6)
Extended Treatment in CLL: Common adverse reactions (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection. (6)
Refractory CLL: Common adverse reactions (≥10%) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause fetal B-cell depletion. (8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 8/2016
