DRUG STUDY AND INFORMATION FORM Generic Name: Ofatumumab Trade Name: Arzerra Drug Class: Monoclonal Antibody

(Unarmed) Structure/Chemistry: Fully humanized antibody

Pharmacodynamics

Mechanism of Action: Binds to CD20 (expressed on B cells ranging from pre-B cells to plasma cells) on the major and minor extracellular loops of CD20, distinct from the site targeted by rituximab which promotes B-cell lysis.

Pharmacologic Effects: Binding of the drug results in B-cell lysis by antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.

Drug Resistance or Tolerance:

Pharmacokinetics

Absorption: Begin with small doses (300 mg), followed by higher doses (up to 2 g/week) for 7 weeks, followed by 2 g every four weeks for four additional doses. Slow rates of infusion are recommended for the initial dose and for the first 2 hours of each subsequent dose. Distribution:

Elimination:

Metabolism:

Adverse Side Effects/Toxicity: Immunosuppression, opportunistic infections, hypersensitivity reactions during antibody infusion, myelosuppression, which may be prolonged. May develop reactivation of viruses. Do not administer to patients with active Hepatitis B; closely monitor Hepatitis B carriers. Drug Interactions:

Therapeutic uses: Approved for CLL (chronic lymphocytic leukemia) after failure of fludarabine and alemtuzumab

Miscellaneous: Monoclonal antibodies with names ending in ximab have chimeric (mouse/human) antibodies while those with names ending in umab have fully humanized antibodies.