Class: Biological Therapy

Generic Name: Ofatumumab
Trade Name: Arzerra®

For which conditions is this drug approved?Arzerra is approved in combination with the chemotherapy drug Leukeran® (chlorambucil) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) who are not eligible for fludarabine-based therapy (such asFludara®). Arzerra is also approved for the treatment of patients with CLL that is resistant (refractory) to Fludara and Campath® (alemtuzumab).

What is the mechanism of action? Arzerra binds specifically to the protein CD20, which is found on the surfaces of B cells, including cancerous B cells. By binding to CD20, Arzerra triggers the immune system to recognize and destroy the B cells.

How is Arzerra typically given (administered)?Arzerra is given as an intravenous injection. Recommended dosing and schedule differs for patients with previously untreated CLL and those with refractory CLL.

How are patients typically monitored?

  • Patients with a history of hepatitis B infection (based on a blood test) should be monitored and my need treatment if hepatitis B occurs.
  • Blood counts should be taken periodically.

What are the common (occur in 30% or more of patients) side effects of treatment with Arzerra?

  • Infusion reactions
  • Leukopenia (decrease in the number of white blood cells)
  • Neutropenia (low neutrophil counts, a type of blood cell that fights infection)
  • Lymphopenia (low levels of lymphocytes)

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Arzerra?

  • Pneumonia
  • Fever 

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Follow your dosing schedule, as prescribed by your doctor.

Are there any special precautions patients should be aware of before starting treatment?

  • It is not well understood how Arzerra might affect an unborn baby or whether it’s secreted in breast milk. Therefore, women who are pregnant and/or nursing or may become pregnant should discuss potential risks with their doctor.
  • Avoid vaccination with live viral vaccines (such vaccine for measles, mumps, rubella, chickenpox, influenza as a nasal spray)

When should patients notify their physician?

  • Signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion
  • Symptoms of hepatitis including worsening fatigue or yellow discoloration of skin or eyes
  • New neurological symptoms such as confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems
  • Bleeding, easy bruising, petechiae (small round spots on the skin that are the result of bleeding under the skin), pallor (pale skin), worsening weakness, or fatigue
  • Signs of infections including fever and cough
  • Pregnant or nursing

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.