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ARZERRA for:

Chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment and whose doctor has decided not to treat them with a chemotherapy drug called fludarabine

Important Safety Information, including Boxed WARNING

Treatment with ARZERRA may cause side effects, some of which are serious and life-threatening. Treatment with ARZERRA may cause hepatitis B virus (HBV) infection to reoccur, which may cause +

See full Important Safety Information



Approved Use:
 

ARZERRA is a prescription medication used with a chemotherapy drug called chlorambucil to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment and whose doctor has decided not to treat them with a chemotherapy drug called fludarabine.

When there are too many CLL cells in your blood, they may affect your body’s organs and your ability to fight infections. ARZERRA is not a cure for CLL, but it may help kill cancer cells.

This information is not meant to replace conversations with your health care team. If you have any questions regarding medical issues, please consult your doctor.

Chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment and whose doctor has decided not to treat them with a chemotherapy drug called fludarabine

About

ARZERRA is a prescription-only medicine called a monoclonal antibody. It is prescribed for patients who have CLL and have not been treated before and whose doctor has decided not to treat them with a chemotherapy drug called fludarabine. ARZERRA is given with chlorambucil, a type of medicine called an alkylator chemotherapy.

Dosing

How ARZERRA is given

ARZERRA is given by intravenous (IV) infusion; that is, through a needle placed in a vein in your arm. Before the treatment, you will be given 3 medicines to help decrease the chance of a possible reaction to the infusion. These medicines are a pain reliever, an antihistamine to reduce allergic reactions, and a steroid to reduce swelling and other symptoms of inflammation. Your health care provider will tell you where you will receive the treatment—for example, a hospital, clinic, or treatment facility. 

How often ARZERRA is given
Treatment with ARZERRA is scheduled in 28-day cycles. You will receive 2 infusions during the first cycle (300 mg on Day 1 and 1000 mg on Day 8). On Day 1 of the following cycles, you will receive a 1000-mg infusion for at least 3 cycles, until best response, or as many as 12 cycles. Your doctor will decide the number of treatment cycles you will receive, depending on how your CLL responds to the treatment.

How long is each infusion of ARZERRA?
Your first infusion of ARZERRA may last 5 hours or longer. The rest of your infusions may take 4 to 4.5 hours. Your health care provider will watch you carefully to see how your body reacts to ARZERRA. That will help him or her know how slowly you should receive your infusion. How long your entire treatment visit may take will depend on how your body reacts to the infusion.

Infusion schedule for
ARZERRA and chlorambucil

This is an example of an infusion schedule. Your
health care provider will decide what infusion
schedule is right for you

Possible Side Effects

Infusion reactions 

Treatment with ARZERRA may cause a side effect called an infusion reaction, which may be serious and may even lead to death in some people. Your doctor or nurse will stop your treatment so the infusion reaction can be treated. If you experience severe allergic reactions (anaphylaxis), your infusion will be stopped and you will not continue treatment with ARZERRA. If a reaction occurs, it is most likely to happen with the first 2 infusions and less likely with later infusions. Signs and symptoms of infusion reactions may include:

  • Fever
  • Chills
  • Rash
  • Hives
  • Chest pain
  • Back pain
  • Stomach pain
  • Swelling
  • Dizziness
  • Blurred vision
  • Drowsiness
  • Headache
  • Cough
  • Wheezing
  • Trouble breathing

 

Be sure to tell your health care provider or seek medical treatment right away if you have any of these symptoms while receiving, or within 24 hours after receiving, ARZERRA. To help decrease the chance of a possible infusion reaction, your health care provider will give you 3 types of medicine before your treatment. These medicines are a pain reliever, an antihistamine to reduce allergic reactions and a steroid to reduce swelling and other symptoms of inflammation. Even though you will receive these medicines, you may still have an infusion reaction.

Remember, your doctor and nurse(s) are trained to handle infusion reactions. If you feel anything unusual during or after your infusion, be sure to mention it right away. If you have an unusual reaction after you leave the infusion facility, call your doctor’s office immediately. 

Most common side effects with ARZERRA: 

  • Infusion reactions
  • Low white blood cell count
  • Pneumonia
  • Fever
  • Cough
  • Diarrhea
  • Low red blood cell count
  • Feeling tired
  • Shortness of breath
  • Rash
  • Nausea
  • Bronchitis
  • Upper respiratory tract infection

 

 

Tell your health care provider right away if you have any of the following serious side effects during or after treatment:

  • Fever
  • Chills
  • Rash
  • Cough
  • Breathing problems
  • Bleeding
  • Bruise easily
  • Small red or purple spots on the skin
  • Pale skin
  • Yellow-colored skin or eyes
  • Feeling tiredness or weakness that is
    worse than before
  • Confusion
  • Dizziness or loss of balance
  • Trouble talking
  • Trouble walking
  • Vision problems
  • New or worsening abdominal pain
    or nausea
  • Generally feeling much sicker
    than before

 

 

 

Other serious side effects:

Use of ARZERRA may cause:

  • Hepatitis B virus reactivation or infection
  • Progressive multifocal leukoencephalopathy, a potentially deadly brain disease 
  • Tumor lysis syndrome, a complication from cancer treatment that may cause damage to certain organs of the body, such as the heart and kidneys
  • Cytopenias, conditions that reduce the creation of blood cells 

These are not all of the possible side effects of ARZERRA. Tell your health care provider about any side effects you experience.

For more information about ARZERRA, speak to your health care provider.

Patient Assistance

Novartis Oncology is committed to helping patients who are living with cancer receive the medicines they need. Patient Assistance Now Oncology (PANO) offers quick and easy access to information about our wide range of resources.

You can get information about our PANO support programs in 2 ways:

  • Call 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making access to therapy as simple and convenient as possible; or

  • Visit our website at: www.OncologyAccessNow.com/patient

Important Safety Information, including Boxed WARNING.

Treatment with ARZERRA may cause side effects, some of which are serious and life-threatening.

  • Treatment with ARZERRA may cause hepatitis B virus (HBV) infection to reoccur, which may cause serious liver problems and death. Tell your doctor if you had HBV infection or are a carrier of HBV
  • Progressive multifocal leukoencephalopathy (PML) is a rare brain infection that can occur with treatment with ARZERRA. PML causes severe disability and can lead to death


Infusion reactions

Treatment with ARZERRA may cause a side effect called an infusion reaction, which may be serious and may even lead to death in some people. Your doctor or nurse will stop your treatment so the infusion reaction can be treated. If you experience severe allergic reactions (anaphylaxis), your infusion will be stopped and you will not continue treatment with ARZERRA.

Before your treatment with ARZERRA, your doctor or nurse will give you 3 types of medicines to help reduce the risk of an infusion reaction. These medicines are a steroid (to reduce swelling and other symptoms of inflammation), a pain reliever, and an antihistamine (to reduce allergic reactions).

Be sure to tell your doctor or nurse or seek medical treatment right away if you have any of these symptoms while receiving or within 24 hours after receiving ARZERRA: fever, chills, rash, hives, chest pain, back pain, stomach pain, swelling, dizziness, blurred vision, drowsiness, headache, cough, wheezing, or trouble breathing.

Hepatitis B

Tell your doctor if you had HBV infection or are a carrier of HBV.

Treatment with ARZERRA may cause the hepatitis B virus to become an active infection. This may cause serious liver problems and death. People with active liver disease due to hepatitis B should not receive ARZERRA.

If you are newly exposed to HBV during or following treatment with ARZERRA, you may experience serious liver problems and death.

Your doctor will do a blood test to check for HBV infection before starting treatment with ARZERRA. If you had HBV infection or are a carrier of HBV, your doctor will keep checking you during and several months after ARZERRA treatment to see if the HBV becomes an active infection. In some people HBV became an active infection at least 12 months after treatment with ARZERRA.

Call your doctor right away if you feel more tired than usual or notice a yellowing of your skin or eyes. These may be symptoms of hepatitis.

Progressive multifocal leukoencephalopathy (PML)

PML is a rare brain infection. It is a serious side effect that can happen with treatment. PML causes severe disability and can lead to death. Call your doctor right away if you notice new medical problems or problems that are getting worse, such as confusion, dizziness or loss of balance, difficulty talking or walking, or strength, vision or other problems that have lasted over several days. There is no known treatment, prevention, or cure for PML.

Tumor lysis syndrome (TLS)

TLS, including the need for a hospital stay, can occur with treatment with ARZERRA. TLS is caused by the breakdown of cancer cells, which then release their contents into the blood. This may lead to damage of certain organs of the body, such as the heart and kidneys. Your doctor may do a blood test to check you for TLS and may give you medicines before your treatment to help prevent TLS.

Low blood cell counts 

ARZERRA can cause low blood cell counts (white blood cells, platelets, and red blood cells). These low blood cell counts can be severe and, in some cases, lead to death. Low white blood cells counts, also called neutropenia, can happen during treatment. Neutropenia can occur 42 days or longer after the end of treatment. It may also last between 24 and 42 days after the last treatment dose. Your doctor will check your blood to see if you have low blood cell counts and need to be treated for them. Call your doctor right away if you have any bleeding, bruising, red or purple spots on your body, paleness, worsening weakness, tiredness, cough that will not go away, fever, chills, congestion, or any flu-like symptoms while receiving ARZERRA.

Common side effects with ARZERRA:

  • Infusion reactions
  • Low white blood cell count
  • Pneumonia
  • Fever  
  • Cough
  • Diarrhea
  • Low red blood cell count
  • Feeling tired
  • Shortness of breath
  • Rash
  • Nausea
  • Bronchitis
  • Upper respiratory tract infections


Infections

ARZERRA can increase your chances for getting infections. Some infections, such as pneumonia, bronchitis, and sepsis (a blood infection), can be serious, and in some cases, life-threatening. Call your doctor right away if you have a cough that will not go away, fever, chills, congestion, or any flu-like symptoms while receiving ARZERRA. These symptoms may be signs of a serious infection.

View full Prescribing Information, including Boxed WARNING, for ARZERRA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.