Ofatumumab
Generic Name: ofatumumab
Brand Names:
Arzerra
11 DESCRIPTION ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa. The antibody was generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line (NS0) using standard mammalian cell cultivation and purification technologies. ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate for intravenous administration.
Overview
11 DESCRIPTION ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa. The antibody was generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line (NS0) using standard mammalian cell cultivation and purification technologies. ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate for intravenous administration.
Uses
1 INDICATIONS AND USAGE Chronic Lymphocytic Leukemia (CLL) ARZERRA (ofatumumab) is indicated: in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)] in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)] for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)] for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)] ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of ch...
Dosage
2 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.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Infusion Reactions [see Warnings and Precautions (5.1)] Hepatitis B Virus Reactivation [see Warnings and Precautions (5.2)] Hepatitis B Virus Infection [see Warnings and Precautions (5.3)] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.4)] Tumor Lysis Syndrome [see Warnings and Precautions (5.5)] Cytopenias [see Warnings and Precautions (5.6)] 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.
Warnings
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) 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 (5.2)] . 5 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. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary ARZERRA may cause fetal B-cell depletion based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1)] . There are no data on ARZERRA use in pregnant women to inform a drug-associated risk. However, there are clinical considerations [see Clinical Considerations] .
Storage
Store ARZERRA refrigerated between 2° to 8°C (36° to 46°F). Do not freeze. Vials should be protected from light.
Frequently Asked Questions
What is Ofatumumab used for?▼
1 INDICATIONS AND USAGE Chronic Lymphocytic Leukemia (CLL) ARZERRA (ofatumumab) is indicated: in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)] in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)] for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)] for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)] ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of ch...
What are the side effects of Ofatumumab?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Infusion Reactions [see Warnings and Precautions (5.1)] Hepatitis B Virus Reactivation [see Warnings and Precautions (5.2)] Hepatitis B Virus Infection [see Warnings and Precautions (5.3)] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.4)] Tumor Lysis Syndrome [see Warnings and Precautions (5.5)] Cytopenias [see Warnings and Precautions (5.6)] 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.
Can I take Ofatumumab during pregnancy?▼
8.1 Pregnancy Risk Summary ARZERRA may cause fetal B-cell depletion based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1)] . There are no data on ARZERRA use in pregnant women to inform a drug-associated risk. However, there are clinical considerations [see Clinical Considerations] .
What are the important warnings for Ofatumumab?▼
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) 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 (5.2)] . 5 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. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.