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Arzerra Generic Name & Formulations
Legal Class
Rx
General Description
Ofatumumab 20mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
CD20-directed cytolytic monoclonal antibody.
How Supplied
Single-use vial (5mL)—3; (50mL)—1
Manufacturer
Generic Availability
NO
Arzerra Indications
Indications
In combination with chlorambucil in previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. Extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. Treatment of CLL refractory to fludarabine and alemtuzumab.
Arzerra Dosage and Administration
Adult
Premedicate with acetaminophen (oral), antihistamine (oral or IV), corticosteroid (IV) 30mins to 2hrs prior to each infusion. Give by IV infusion (rate varies with dose and during infusion); see full labeling. Previously untreated: initially 300mg on Day 1, then 1 week later by 1000mg on Day 8 (Cycle 1), followed by 1000mg on Day 1 of subsequent 28-day cycles for at least 3 cycles until best response or max 12 cycles. Extended treatment: initially 300mg on Day 1, then by 1000mg 1 week later on Day 8, followed by 1000mg 7 weeks later and every 8 weeks thereafter for up to max 2 years. Refractory: initially 300mg on Day 1, then 1 week later by 2000mg weekly for 7 doses, followed 4 weeks later by 2000mg every 4 weeks for 4 doses. Dose modification for infusion reactions: see full labeling.
Children
Not established.
Arzerra Contraindications
Not Applicable
Arzerra Boxed Warnings
Boxed Warning
Hepatitis B virus reactivation. Progressive multifocal leukoencephalopathy.
Arzerra Warnings/Precautions
Warnings/Precautions
Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Monitor CBCs at regular intervals during and after therapy, increase frequency if Grade 3/4 cytopenias develop. Monitor for new onset of or changes in pre-existing neurological signs/symptoms; discontinue and evaluate if progressive multifocal leukoencephalopathy (PML) is suspected. Increased risk of tumor lysis syndrome (TLS) in high tumor burden and/or high circulating lymphocytes; consider prophylaxis with anti-hyperuricemics and hydration beginning 12–24hrs prior to infusion. Pregnancy (Cat.C). Nursing mothers.
Arzerra Pharmacokinetics
See Literature
Arzerra Interactions
Interactions
Avoid vaccination with live viral vaccines.
Arzerra Adverse Reactions
Adverse Reactions
Neutropenia, thrombocytopenia, anemia, pneumonia, pyrexia, cough, fatigue, dyspnea, rash, nausea, diarrhea, bronchitis, upper respiratory tract infections; infusion reactions (eg, bronchospasm; laryngeal, pulmonary, or angioedema; flushing, hyper- or hypotension, syncope, cardiac ischemia, back or abdominal pain, fever, urticaria) (interrupt, adjust infusion rate and monitor; permanently discontinue if anaphylaxis occurs), PML, infections (eg, sepsis), hepatotoxicity, TLS.
Arzerra Clinical Trials
See Literature
Arzerra Note
Not Applicable
Arzerra Patient Counseling
See Literature
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