ARZERRA® (ofatumumab)

Prescribing Information

Important Safety Information, including Boxed WARNING:

Approved Uses

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
With fludarabine and a chemotherapy drug called cyslopho...

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 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

Progressive multifocal leukoencephalopathy (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

Tumor lysis syndrome (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

Approved Uses

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
With fludarabine and a chemotherapy drug called cyslophosphammide for patients whose CLL has relaped (come back)
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

Please click here for full Prescribing Information, including Boxed WARNING, for ARZERRA.

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IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING AND APPROVED USES

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

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

Progressive multifocal leukoencephalopathy (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

Tumor lysis syndrome (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

APPROVED USES

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
With fludarabine and a chemotherapy drug called cyslophosphammide for patients whose CLL has relaped (come back)
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

Please see full Prescribing Information, including Boxed WARNING, for ARZERRA.

< Back To Site

About ARZERRA

ARZERRA is a prescription medicine called a monoclonal antibody. It is approved for:

Patients who have chronic lymphocytic leukemia (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
Use with fludarabine and a chemotherapy drug called cyslophosphammide for patients whose CLL has relaped (come back)
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)

After you have discussed your signs and symptoms, your doctor will want to take a complete medical history and perform a physical exam, with special attention to your lymph nodes and other parts of your body that may be affected. In order to confirm the diagnosis of CLL, you may be prescribed the following tests:

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

Why ARZERRA?

ARZERRA has shown to be an effective treatment option for a variety of patients with CLL:

Adults with CLL who have not yet been treated

For adults with CLL who have not yet been treated, ARZERRA has shown to be an effective treatment option. In one clinical trial, previously untreated patients who took ARZERRA plus chlorambucil, a type of chemotherapy, were compared with patients who only took chlorambucil. The results from this trial showed that:

Patients who took ARZERRA plus chlorambucil did not have their disease progress (advance) for a median of 22.4 months compared with a median 13.1 months for patients who only took chlorambucil
The majority of patients – 82.4% – treated with ARZERRA plus chlorambucil had their CLL respond to treatment, vs 68.6% of patients treated with just chlorambucil

Patients with relapsed CLL

For patients with relapsed CLL, ARZERRA has been shown to be an effective treatment option. In one clinical trial, patients who took ARZERRA plus two chemotherapy drugs, called fludarabine and cyclophosphamide (FC), were compared with patients who only took FC. The results from this trial showed that:

Patients who took ARZERRA plus FC did not have their disease progress (advance) for a median of 28.9 months compared with a median of 18.8 months for patients who only took FC
The majority of patients treated with ARZERRA plus FC – 84% – had their CLL respond to treatment, compared with 68% of patients treated with just FC

Patients with CLL that has responded to treatment, either partially or completely

For patients with CLL that has responded to treatment, either partially or completely, after having 2 or more different types of treatment, ARZERRA has shown be an effective form of follow-up treatment. In one clinical trial, patients who took ARZERRA alone as follow-up treatment were compared with those who had no follow-up treatment. The results from this trial showed that:

Patients who took ARZERRA did not have their disease progress (advance) for a median of 29.4 months compared with 15.2 months for patients who did not have follow-up treatment

Patients with CLL who have stopped responding to treatment with fludarabine and alemtuzumab

For patients with CLL who have stopped responding to treatment with a chemotherapy drug called fludarabine and another treatment called alemtuzumab, ARZERRA has shown be an effective treatment option. In one clinical trial, patients who stopped responding to fludarabine and alemtuzumab were treated with ARZERRA alone. The results from this trial showed that:

42% of patients given ARZERRA alone had their CLL respond to treatment

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 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 Schedules

Treatment with ARZERRA is scheduled as follows, based on your condition:

Adults with CLL who have not yet been treated

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.

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

Patients with relapsed 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 as many as 6 cycles. Your doctor will decide the number of treatment cycles you’ll receive, depending on how your CLL responds to the treatment.

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

Patients with CLL that has responded to treatment, either partially or completely

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.

Patients with CLL who have stopped responding to treatment with fludarabine and alemtuzumab

You will receive 300 mg on Day 1, then 1 week later, you will receive 2000 mg weekly for 7 doses. Four weeks later, you will receive 2000 mg every 4 weeks for 4 doses.

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

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

Most Common Side Effects

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
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.

In addition, click here to download the "What You Need to Know About ARZERRA" PDF booklet.

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

For Adults Who Have Chronic Lymphocytic Leukemia (CLL)

About ARZERRA

What is CLL?

Why ARZERRA?

Dosing

Infusion Schedules

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

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

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

Infusion Reactions

Most Common Side Effects

Other Serious Side Effects

Patient Assistance