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Uses

What is Arzerra used for?

Arzerra (ofatumumab) is commonly used to treat certain people with chronic lymphocytic leukemia (CLL).

Arzerra may also be used for other conditions as determined by your health care provider.

How does Arzerra work (mechanism of action)?

Arzerra attaches to a protein called CD20. This protein is found on certain cells in your immune system, called B cells, which play a role in chronic lymphocytic leukemia (CLL). Once Arzerra binds to these B cells, it tells your immune system to target and destroy them. This helps lower the number of cancer cells in your body.

How is Arzerra supplied (dosage forms)?

Brands and other names

  • Arzerra

Dosage forms and strengths

Arzerra is available in an injectable form that is given by a health care provider.

How should I store Arzerra?

Arzerra is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Arzerra?

The most common side effects of Arzerra are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Infusion reactions (see below)
  • Blood disorders (see below)
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Lung infections, including bronchitis or pneumonia
  • Fever
  • Cough or shortness of breath
  • Diarrhea or nausea
  • Tiredness
  • Rash

There may be other side effects of Arzerra that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Arzerra?

While less common, the most serious side effects of Arzerra are described below, along with what to do if they happen.

Severe Allergic Reactions. Arzerra may cause allergic reactions, which can be serious. Stop using Arzerra and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infusion Reactions. Arzerra can cause reactions that can be serious when it is given to you. Your infusion may need to be slowed or stopped if you have these reactions. These reactions are more likely with your first couple of infusions. They can happen up to 24 hours after your infusion. Tell your health care provider right away if you have any of the following symptoms during or after your infusion.

  • Fever or chills
  • Joint or muscle pain
  • Redness of your face and neck
  • Trouble breathing
  • Pain in your chest, back, or stomach
  • Rash or hives
  • Nausea or vomiting
  • Fainting or lightheadedness

Progressive Multifocal Leukoencephalopathy (PML). People using Arzerra may get a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop using Arzerra and call your health care provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • Trouble walking or speaking
  • Facial drooping
  • Vision problems
  • Confusion or thinking, memory, or personality changes
  • Dizziness
  • Weakness on one side of your body that gets worse
  • Seizures

Tumor Lysis Syndrome. Arzerra can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while receiving Arzerra and to keep all appointments for blood work so your health care provider can see how your body is responding to Arzerra. Your health care provider may give you medicine to reduce your risk of this happening. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while using Arzerra.

  • Nausea and vomiting
  • Weakness
  • Swelling or fluid retention
  • Shortness of breath
  • Muscle cramps
  • Seizures

Hepatitis B Infection or Reactivation. Some people who use Arzerra have had hepatitis B. If you have the hepatitis B virus in your body or have had hepatitis B in the past, Arzerra could make the virus active again. This can happen up to one year after your last dose of Arzerra. Keep all appointments for blood work before starting Arzerra and during treatment. Call your health care provider right away if you have any of the following symptoms of hepatitis.

  • Unusual tiredness
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Nausea, vomiting, or loss of appetite
  • Dark-colored pee
  • Fever or chills
  • Pain in your side
  • Stool (poop) that is clay-colored

Blood Disorders. Arzerra can cause blood disorders, such as anemia, which is when you have low levels of red blood cells, agranulocytosis, low platelet levels (thrombocytopenia), and low white blood cell levels (leukopenia or neutropenia). These disorders can sometimes happen several weeks after your last dose of Arzerra. Stop using Arzerra and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Cough or shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infections
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Warnings & Precautions

Who should not use Arzerra?

Allergies to Ingredients. People who are allergic to any of the following should not use Arzerra.

  • Arzerra
  • Ofatumumab
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Arzerra.

What should I know about Arzerra before using it?

Arzerra is usually given into a vein as an IV infusion by a health care provider in a hospital or clinic.

Your health care provider will likely give you medicine before you get Arzerra to lower your risk of side effects. These medicines often include the following.

  • Acetaminophen (Tylenol), which is a medicine used for pain or fever
  • A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions
  • An antihistamine, such as chlorpheniramine or diphenhydramine (Benadryl), which is a medicine commonly used to treat allergy symptoms

Your health care provider will likely order lab tests before and while you are using Arzerra to make sure it is working and to watch for certain side effects. Keep all appointments, including those for lab tests, while you are using Arzerra.

People aged 65 or older can be at a greater risk of some side effects from Arzerra. Talk to your health care provider about your risks if you are in this age group.

What should I tell my health care provider before using Arzerra?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Arzerra is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Current or past hepatitis B infection
  • High white blood cell levels

Vaccines. Talk to your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Arzerra. Tell your health care provider about any vaccines you have recently received or have scheduled.

Pregnancy. Arzerra may cause certain immune cell levels to be low in your baby. Tell your health care provider if you are pregnant or plan to become pregnant. If you use Arzerra while you are pregnant, let your baby’s health care provider know. Your baby may need to delay getting certain vaccines until their immune cell levels return to normal.

Breastfeeding. It is not known if Arzerra passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Arzerra while breastfeeding.

How can I get more information about Arzerra?

For more information about Arzerra, you can visit the drugmaker’s website at www.novartis.com/us-en/patients-and-caregivers or call them at 888-NOW-NOVA (888-669-6682).

Interactions

Does Arzerra interact with foods or drinks?

There are no known interactions between Arzerra and foods or drinks.

It is unknown if drinking alcohol will affect Arzerra, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Arzerra interact with other medicines (drug interactions)?

Arzerra may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Arzerra?

If you or someone else has used too much Arzerra, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Arzerra?

Arzerra is usually given by a health care provider in a hospital. Your health care provider will make sure you are receiving Arzerra as scheduled.

If you miss an appointment to get your Arzerra dose, call to make another appointment as soon as possible.

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