Arzerra
Generic Name: ofatumumab
Date of Approval: October 26, 2009
Company: GlaxoSmithKline
Treatment for: Chronic Lymphocytic Leukemia
FDA Approves Arzerra
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The U.S. Food and Drug Administration has approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia.
Highlights of Arzerra Prescribing Information
These highlights do not include all the information needed to use Arzerra safely and effectively. See full prescribing information for Arzerra.
Indications and Usage
Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. The effectiveness of Arzerra is based on the demonstration of durable objective responses. No data demonstrate an improvement in disease related symptoms or increased survival with Arzerra.
Dosage and Administration
- Dilute and administer as an intravenous infusion. Do not administer as an intravenous push or bolus.
- Recommended dose and schedule is 12 doses administered as follows:
- 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.
- Premedicate with oral acetaminophen, oral or intravenous antihistamine, and intravenous corticosteroid.
Dosage Forms and Strengths
100 mg/5 mL single-use vial.
CONTRAINDICATIONS
None.
Warnings and Precautions
- Infusion Reactions: Premedicate with an intravenous corticosteroid (as appropriate), an oral analgesic, and an oral or intravenous antihistamine. Monitor patients closely during infusions. Interrupt infusion if infusion reactions occur.
- Cytopenias: Monitor blood counts at regular intervals for neutropenia and thrombocytopenia.
- Progressive Multifocal Leukoencephalopathy (PML): Monitor neurologic function and discontinue Arzerra if PML is suspected.
- Hepatitis B Reactivation: Screen high-risk patients. Discontinue Arzerra in patients who develop viral hepatitis or reactivation of viral hepatitis.
Arzerra Side Effects
Most common adverse reactions (≥10%) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections.
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use In Specific Populations
- Pregnancy: Based on animal data, may cause fetal harm.
- Nursing mothers: Published data suggest that consumption of breast milk does not result in substantial absorption of maternal antibodies into circulation.
Patient Counseling Information
Advise patients to contact a healthcare professional for any of the following:
- Signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion
- Bleeding, easy bruising, petechiae, pallor, worsening weakness, or fatigue
- Signs of infections including fever and cough
- New neurological symptoms such as confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems
- Symptoms of hepatitis including worsening fatigue or yellow discoloration of skin or eyes
- New or worsening abdominal pain or nausea
- Pregnancy or nursing
Advise patients of the need for:
- Periodic monitoring for blood counts
- Avoiding vaccination with live viral vaccines
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