WHAT YOU NEED TO KNOW ABOUT ARZERRA

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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.

Be in the know about ARZERRA

You may have questions about ARZERRA. This website is designed to help you feel more informed and involved in your treatment with ARZERRA. This information does not replace speaking with your healthcare provider. You should always contact your healthcare provider if you have questions about your condition and treatment.

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 CLL cells.

Important Safety Information for ARZERRA

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). Even though you will receive these medicines, you may still have an infusion reaction.

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 treatment with ARZERRA 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.