Arzerra: 7 things you should know

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 21, 2023.

1. How it works

• Arzerra is a brand (trade) name for ofatumumab which may be used to treat certain patients with chronic lymphocytic leukemia (CLL).
• Arzerra works by targeting (binding to) the CD20 protein found on the surface of cancerous B cells (including those of CLL) and normal B lymphocytes. In conjunction with the immune system, Arzerra is thought to eliminate the cancerous CD20-positive B cells by two mechanisms: destroying the cancer cell through lysis (complement-dependent cytotoxicity) and by helping to release molecules from immune cells (like NK cells) that can enter and kill the cancer cell (this is called antibody-dependent, cell-mediated cytotoxicity).
• Arzerra belongs to the class of medicines known as CD20-directed cytolytic monoclonal antibodies. It may also just be called a monoclonal antibody.

2. Upsides

• May be used in combination with chlorambucil for untreated patients with CLL who cannot use fludarabine-based therapy.
• May also be given to those whose CLL has come back (relapsed) in combination with fludarabine and cyclophosphamide.
• Consider for extended treatment (maintenance) in patients with CLL who have had a complete or partial response after at least two lines of therapy for CLL.
• Consider for the treatment of patients with CLL who did not respond to previous treatment (refractory) to fludarabine and alemtuzumab.
• Administered by intravenous (IV) infusion by a healthcare provider usually on a cyclical dosing schedule You may need to use the medicine only during the first 1 or 2 weeks of each cycle.
• Poor kidney function does not affect Arzerra.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Low neutrophil counts, pneumonia, fever, cough, diarrhea, anemia, fatigue, shortness of breath, rash, nausea, bronchitis, and upper respiratory tract infections are the most common side effects, reported in 10% or more of people.
• May cause infusion reactions - symptoms may include bronchospasm, shortness of breath, swelling of the throat and fluid in the lungs, high or low blood pressure, pain, and other symptoms. Premedicate half an hour before the infusion 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.
• One infusion can take several hours to complete and you may need to take other medications before the infusion to reduce the risk of an infusion reaction occurring.
• May cause low levels of blood cells (cytopenias). Monitor blood counts at regular intervals.
• Intestinal obstruction has occurred in some patients receiving Arzerra.
• There is a risk of progressive multifocal leukoencephalopathy (PML) with Arzerra. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that often leads to death or severe disability. Monitor neurologic function and discontinue if PML is suspected.
• Reactivation of hepatitis B has been reported in people who have a current or prior hepatitis B virus (HBV) infection before initiating treatment with Arzerra. In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death. All patients should be tested for current or prior hepatitis B virus (HBV) infection before starting treatment. Do not give to people with an active HBV infection.
• Live vaccines are not recommended during treatment with Arzerra. Other vaccines may not work as well and may not fully protect you from disease.
• Safety and effectiveness have not been established in children.
• Using Arzerra during pregnancy could affect the immune system of the unborn baby. Tell your doctor if you are pregnant, planning a pregnancy, or if you become pregnant while using this medicine. Use effective birth control to prevent pregnancy while using Arzerra.
• It is not known whether Arzerra passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

4. Bottom Line

Arzerra may be used to treat certain types of chronic lymphocytic leukemia (CLL) in adults. It is given as an intravenous infusion by a healthcare provider and low neutrophil counts, upper respiratory tract infections, diarrhea, and fatigue are the most common side effects.

5. Tips

• Follow your healthcare provider's instructions and keep your appointments for your infusions. You may need to allow several hours for each infusion because premedication is usually given to reduce the risk of infusion reactions. Tell your doctor if you develop any signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of the infusion.
• Also tell your doctor if you develop bleeding, easy bruising, petechiae (red dots just under your skin), pallor (paleness), worsening weakness or fatigue, or signs of an infection including fever and cough, new neurological symptoms such as confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems.
• Arzerra can cause reactivation of hepatitis B infections and symptoms may include worsening fatigue or yellow discoloration of skin or eyes, new or worsening abdominal pain, or nausea.
• Keep all your appointments - you will need regular blood tests during treatment with Arzerra. Avoid getting vaccinated with liver vaccines. Arzerra may also limit the effectiveness of other vaccines.
• Arzerra can harm an unborn baby and you should take adequate precautions including using an effective contraceptive to make sure you don't get pregnant if you are a woman of childbearing age.. Tell your doctor right away if you inadvertently become pregnant. It is not known if Arzerra passes into human milk but talk to your doctor if you are breastfeeding.

6. Response and effectiveness

• In patients with CLL refractory to fludarabine and alemtuzumab, the investigator-determined overall response rate in patients with CLL refractory to fludarabine and alemtuzumab was 42% (99% CI: 26, 60) with a median duration of response of 6.5 months (95% CI: 5.8, 8.3). There were no complete responses. The median age was 64 years (range: 41 to 86 years), 75% were male, and 95% were White. The median number of prior therapies was 5; 93% received prior alkylating agents, 59% received prior rituximab, and all received prior fludarabine and alemtuzumab. Eighty-eight percent of patients received at least 8 infusions of Arzerra and 54% received 12 infusions.

7. Interactions

Medicines that interact with Arzerra may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Imbruvica. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Arzerra interacts with over 155 medicines; the majority of these interactions are considered moderate or major. Common medications that may interact with Imbruvica include:

• antipsychotics such as clozapine
• drugs that weaken the immune system such as cancer medications, steroids, and medicines to prevent organ transplant rejection
• vaccines

Note that this list is not all-inclusive and includes only common medications that may interact with Arzerra. You should refer to the prescribing information for Arzerra for a complete list of interactions.

References

• Arzerra Product label. October 2009. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Arzerra only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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