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Important Safety Information and BOXED WARNINGS
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Indications and Usage

ZEVALIN® (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that has three parts: two treatments of rituximab and one treatment of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the amount of B-cells in your blood and Y-90 ZEVALIN is given to treat your non-Hodgkin’s lymphoma (NHL).

The ZEVALIN therapeutic regimen is used to treat patients with:

  • Recurring, low-grade or follicular B-cell NHL, after other anticancer drugs are no longer working.
  • Newly diagnosed follicular NHL following a response to initial anticancer therapy.

What Is the Most Important Safety Information I Should Know About ZEVALIN Treatment?

The following section provides an overview of the most important safety information you should know about ZEVALIN, including side effects. Not all of the safety information about ZEVALIN treatment is included here. For complete safety information, please click here to see the full prescribing information for ZEVALIN. Additional information may also be found on this Web site or by speaking with your health care provider. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide (www.rituxan.com).

The ZEVALIN treatment can cause serious side effects including:

  • Serious Infusion Reactions: Rituximab, alone or as part of the ZEVALIN treatment, may cause serious infusion reactions. Deaths have occurred within 24 hours of rituximab infusion, an important component of the ZEVALIN treatment. Tell your doctor or infusion nurse or get medical treatment right away if you develop fever or chills, a rash, itching, dizziness, swelling of your hands, feet or face, throat irritation or trouble breathing during or after receiving the ZEVALIN treatment.
  • Extended and Severe Decreases in Your Blood Counts (Cytopenias): Your doctor will monitor your blood counts after receiving the ZEVALIN treatment. Decreased blood counts can occur late and continue for more than 12 weeks after receiving ZEVALIN. Tell your doctor if you have a fever, feel too tired to do daily activities, feel weak, develop bruises, have unusual bleeding or notice blood in your urine or stool.
  • Severe Skin or Mucous Membrane Reactions: If you experience any reactions related to your skin or mucous membranes (e.g. mouth, nose), your infusion of rituximab and Y-90 ZEVALIN should be discontinued.

Dosing Warning: The dose of Y-90 ZEVALIN should not exceed 32.0 mCi (1184 MBq).

Additional Safety Information:

  • Leukemia and Myelodysplastic Syndrome (MDS): Among 204 patients who received Y-90 ZEVALIN, following anticancer therapy, 2 patients (1%) were diagnosed with Acute Myelogenous Leukemia (a type of cancer of the blood, AML) within 3 years of receiving ZEVALIN treatment.  MDS (another type of cancer in the bone marrow) and/or AML were reported in 5.2% (11/211) of patients with recurring non-Hodgkin’s lymphoma (NHL) in clinical studies, and 1.5% (8/535) of all patients included in the expanded-access trial, with median follow-up of 6.5 and 4.4 years, respectively. Among the 19 reported cases, the median time to diagnosis of MDS or AML was 1.9 years following the ZEVALIN therapy; however, the total incidence continues to increase.
  • ZEVALIN therapy may cause harm to an unborn baby, please tell your doctor if you are pregnant or plan to become pregnant.
  • ZEVALIN may leak from your vein or infusion site. Your doctor will monitor you during treatment and will stop the infusion and switch to another vein, if this occurs during treatment.
  • Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN treatment.
  • Your doctor will need to monitor your blood weekly to watch for dropping blood counts and platelet counts.
  • Your doctor will discuss precautions with you to minimize radiation exposure.
  • Creutzfeldt-Jakob Disease (CJD): CJD is a form of brain damage that leads to rapid decrease of mental function and movement. The ZEVALIN therapeutic regimen contains a protein made from human blood. Based on effective donor screening and product manufacturing processes, ZEVALIN carries a very low risk for transmission of viral diseases. The risk for getting CJD is also very low. No cases of transmission of viral diseases or CJD have ever been identified.
  • Impairment of Fertility: There is a risk that ZEVALIN therapy will affect the male and female reproductive organs. Use birth control during treatment and for up to 12 months following ZEVALIN therapy.
  • Nursing: Patients should be advised to discontinue nursing during and after ZEVALIN treatment.

Adverse Reactions (Side Effects):

  • The most common adverse reactions of ZEVALIN are: decreases in blood counts, tiredness, abdominal (stomach) pain, nausea (upset stomach), inflammation of the nose and upper throat, weakness, diarrhea, cough, and fever. Common adverse reactions (≥40%) in clinical trials were: low neutrophil count (a type of white blood cell), decrease in number of white blood cells, decrease in platelets, decrease in red blood cells or hemoglobin, infection, lack of body strength and energy, muscles and bones symptoms, and stomach and intestinal symptoms.
  • The most serious adverse reactions of ZEVALIN are prolonged and severe reduction in the number of blood counts and secondary cancers.
  • When administered following initial anticancer therapy, grade 3/4 adverse reactions of ZEVALIN include prolonged and severe decrease in blood counts (decrease in platelets [51%], decrease in neutrophils [41%], decrease in white blood cells [36%], decrease in lymphocytes [18%], and decrease in red blood cells or hemoglobin [5%]), and secondary cancers. Reductions in blood cells were more severe and more prolonged among eleven (5%) patients who received ZEVALIN after first-line fludarabine or a fludarabine-containing anticancer regimen as compared to patients receiving non–fludarabine-containing regimens. Grade 3/4 infections occurred in 8% of ZEVALIN-treated patients and in 2% of controls and included neutropenic sepsis (fever and infection due to decrease in the number of neutrophils [1%]), bronchitis, catheter sepsis (bacterial infection in the blood related to catheter), diverticulitis (inflammation in the intestines), shingles or blistering skin rash caused from herpes virus reactivation, flu, lower air passage infection, sinusitis (swelling of the sinuses), and upper air passage infection.
  • Grade 3/4 adverse reactions of ZEVALIN in recurring NHL patients include prolonged and severe reduction of blood cells (decrease in platelets [63%], decrease in neutrophils [60%], decrease in red blood cells or hemoglobin [17%], and ecchymosis (small blue or purple patch on the skin or mucous membrane [<1%])) and secondary cancers. Serious infections occurred in 3% of patients (urinary tract infection, febrile neutropenia, sepsis, pneumonia, cellulitis (type of skin infection), colitis (swelling of the large intestine), diarrhea, osteomyelitis (bone infection), and upper-air passage infection). Life-threatening infections were reported in 2% of patients (sepsis, empyema (collection of pus), pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis (bile duct infection)).

Please click here to see the full Prescribing Information, including BOXED WARNINGS, for ZEVALIN. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide (www.rituxan.com).

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.