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ARZERRA for:

Adults who have Chronic Lymphocytic Leukemia (CLL) and have not been treated before; continued follow-up treatment of patients whose extent of cancer has decreased (partial response) or whose signs of cancer have completely disappeared (complete response) after being treated with at least two lines of therapy for their recurrent or progressive CLL; patients whose CLL is refractory (stopped responding) to treatment with fludarabine and alemtuzumab

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

  • Alone for continued follow-up treatment of patients whose extent of cancer had decreased (partial response) or whose signs of cancer have completely disappeared (complete response) after being treated with at least two lines of therapy for their recurrent or progressive CLL

  • Alone to treat patients with CLL whose disease is refractory to treatment with fludarabine and a monoclonal antibody called alemtuzumab

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 reduce the number of 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.

Adults who have Chronic Lymphocytic Leukemia (CLL) and have not been treated before; continued follow-up treatment of patients whose extent of cancer has decreased (partial response) or whose signs of cancer have completely disappeared (complete response) after being treated with at least two lines of therapy for their recurrent or progressive CLL; patients whose CLL is refractory (stopped responding) to treatment with fludarabine and alemtuzumab

About ARZERRA

ARZERRA is a prescription medicine called a monoclonal antibody. It is approved 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
  • The continued follow-up treatment of patients who are in complete response (whose signs of cancer have disappeared) or partial response (whose extent of cancer has decreased) after being treated with at least two lines of therapy for their recurrent or progressive CLL
  • Patients whose CLL is refractory (stopped responding) to treatment with fludarabine and alemtuzumab

What is CLL?

Definition

Leukemia is a type of cancer that starts in the bone marrow from white blood cells called lymphocytes. CLL is a chronic disease whereby leukemia cells accumulate slowly over time and may spread from the bone marrow to the blood and other parts of the body (lymph nodes, spleen, and liver).

Symptoms and Diagnosis

Some patients do not have any symptoms when they are initially diagnosed with CLL, but the following are some symptoms that may indicate CLL:

  • Weakness
  • Tiredness
  • Weight loss
  • Fever
  • Night sweats
  • Lumps under the skin (which could be enlarged lymph nodes)
  • Feeling full even after a very small meal, or feeling pain in the belly (which could be due to an enlarged spleen and/or liver)

In order to confirm the diagnosis of CLL after you have discussed your signs and symptoms with your doctor, the following tests may be prescribed to you:

  • A complete medical history
  • A physical exam, with special attention to your lymph nodes and other parts of your body that may be affected
  • Blood tests to measure the different types of cells in the blood (blood cell count) and determine whether any cells look abnormal
  • Flow cytometry to detect certain substances on or in cells (markers), and identify what types of cells they are and if they are cancer cells
  • Bone marrow tests (bone marrow aspiration and biopsy) to determine the extent of the disease and how advanced it is
  • Genetic tests (examination of chromosomes) to determine whether there are any chromosome changes
  • Lymph node biopsy is rarely used to diagnose CLL, but it could be used when the lymph nodes have grown very large to see if the disease has changed (transformation)
  • Lumbar puncture (or spinal tap) to examine the fluid surrounding the brain and spinal cord if your doctor suspects that cancer cells have spread to these areas
  • Imaging tests, such as computed tomography scan, magnetic resonance imaging, and ultrasound, to see how far the cancer has spread or if you are responding to the treatment you were given

Treatment Approaches

  • If you have not been previously treated for chronic lymphocytic leukemia (CLL), you may live for years without treatment, but you may eventually need to be treated if your disease progresses or if you have bothersome symptoms. Your doctor will discuss with you which treatment option may benefit you based on your age, general health, and history and conditions
  • If you have received previous therapy and your disease stopped responding to ARZERRA or your CLL came back, your doctor may prescribe different treatment regimens than the ones you received initially. If your response to the first treatment lasted at least a few years, your doctor may decide to use the same treatment again
  • If you have responded to previous therapy (some or all of the signs and symptoms of your cancer have disappeared, although cancer may still be in your body), your doctor may decide to give you continued follow-up therapy to slow the progression of your disease

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 as follows, based on your condition:

  • If you have not been previously treated for CLL: Your treatment will be 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’ll receive, depending on how your CLL responds to the treatment
  • If are to receive continued follow-up treatment with ARZERRA: You will receive 300 mg on Day 1 and 1000 mg on Day 8. You will then receive 1000 mg 7 weeks later and every 8 weeks for a maximum of 2 years. Your doctor will decide the number of treatment cycles you’ll receive, depending on how your CLL responds to the treatment
  • If your CLL is refractory to fludarabine and alemtuzumab: You will receive 300 mg on Day 1, then 1 week later, you will receive 2000 mg weekly for 7 doses. 4 weeks later, you will receive 2000 mg every 4 weeks for 4 doses 

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.

Infusion schedule for continued 
follow-up treatment with ARZERRA

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

Infusion schedule for ARZERRA for CLL 
refractory to fludarabine and alemtuzumab

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

ARZERRA® (ofatumumab) Indications

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
  • Alone for continued follow-up treatment of patients whose extent of cancer has decreased (partial response) or whose signs of cancer have completely disappeared (complete response) after being treated with at least two lines of therapy for their recurrent or progressive CLL
  • Alone to treat patients with CLL whose disease has stopped responding (refractory) to treatment with fludarabine and a monoclonal antibody called alemtuzumab

IMPORTANT SAFETY INFORMATION ABOUT ARZERRA® (ofatumumab)

  • 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 lead to death in some people
  • 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. If you experience an infusion reaction, 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

Be sure to tell your doctor or nurse or seek medical treatment right away if you experience any of the following 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 hepatitis B virus (HBV) infection or are a carrier of HBV
  • Treatment with ARZERRA may cause the HBV to become an active infection. This may cause serious liver problems and death. People with active liver disease due to HBV 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 perform 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 HBV

Progressive Multifocal Leukoencephalopathy (PML)

  • PML is a rare brain infection. It is a serious side effect that may happen with treatment. PML causes severe disability and may 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, may 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, 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 may cause low blood cell counts (white blood cells, platelets, and red blood cells). These low blood cell counts may be severe and, in some cases, lead to death. Low white blood cell count, also called neutropenia, may happen during treatment or even weeks later. 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 may increase your chances for developing infections. Some infections, such as pneumonia, bronchitis, and sepsis (a blood infection), may 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

Immunizations

  • Avoid receiving a type of vaccination called a live viral vaccine while being treated with ARZERRA

 

Please see accompanying 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.