BRAND NAMES
 MECHANISM OF ACTION
This is a human antibody against CD20 antigen, a hydrophobic transmembrane protein located on pre-B, mature B lymphocytes and on B-cell CLL. It is a fully human antibody that interacts with CD20 in a different binding site with respect to Rituximab. The CD20 molecule is expressed on normal B lymphocytes (pre–B- to mature B-lymphocyte) and on B-cell chronic lymphocytic leukemia.
Ofatumumab interacts with CD20 and triggers antibody-dependent cell mediated cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC).
- In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
- For the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.
- Dilute and administer as an intravenous infusion. Do not administer subcutaneously or as an intravenous push or bolus.
- Previously untreated CLL 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.
- 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.
- Administer where facilities to adequately monitor and treat infusion reactions are available.
- Premedicate with acetaminophen, antihistamine, and corticosteroid.
 WARNINGS AND PRECAUTIONS
- Infusion Reactions: Premedicate with corticosteroid, acetaminophen, and an antihistamine. Monitor patients during infusions. Interrupt infusion if infusion reactions occur.
- Tumor Lysis Syndrome: Anticipate TLS in high-risk patients; premedicate with anti-hyperuricemics and hydration.
- Cytopenias: Neutropenia, anemia, and thrombocytopenia occur. Late-onset and prolonged neutropenia can also occur. Monitor complete blood counts at regular intervals.
- Hepatitis B Virus Reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including Ofatumumab, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
- Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including Ofatumumab.
 PREGNANCY AND LACTATION
- Pregnancy Category C (US): Based on animal data, may cause fetal harm.
- Nursing Mothers: Published data suggest that consumption of breast milk
 SIDE EFFECTS
Previously Untreated CLL: Common adverse reactions (≥10%) were infusion reactions and neutropenia.
Refractory CLL: Common adverse reactions (≥10%) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections.