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Indication:

ARZERRA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not responded to fludarabine and alemtuzumab or whose cancer has come back within 6 months of treatment with these medications. ARZERRA is prescribed by doctors when these treatments no longer work. 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.

Infusion reactions
Treatment with ARZERRA may cause a side effect called an infusion reaction, which may be serious in some people. Your doctor or nurse may stop your treatment so the infusion reaction can be treated.

Before your treatment with ARZERRA, your doctor or nurse will give you 3 types of medicines to help manage possible infusion reactions. These medicines are a steroid (to reduce swelling and other symptoms of inflammation), a pain reliever, and an antihistamine (to reduce inflammatory 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, swelling, dizziness, blurred vision, drowsiness, headache, cough, wheezing or have trouble breathing.

Low blood cell counts
ARZERRA can cause low blood cell counts (white blood cells and platelets). These low blood cell counts can be severe and, in some cases, life-threatening. Your doctor will check your blood to see if you have low blood cell counts and need to be treated for them.

Progressive multifocal leukoencephalopathy (PML)
PML is a rare brain infection. It is a serious side effect that can happen with treatment. PML usually causes death or severe disability. 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, strength, vision or other problems that have lasted over several days. There is no known treatment, prevention, or cure for PML.

Hepatitis B
Tell your doctor if you had hepatitis B virus or are a carrier of hepatitis B virus.

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.

Also, patients newly exposed to hepatitis B virus following treatment with ARZERRA may experience serious liver problems and death.

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.

Bowel problems
Serious stomach area and bowel problems, including intestinal blockage, have been reported with ARZERRA. Call your doctor right away if you have any stomach area pain during treatment with ARZERRA.

Common side effects with ARZERRA:

  • 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.