Frequently Asked Questions

How is ZEVALIN different from other treatments?

ZEVALIN is different from other non-Hodgkin’s follicular lymphoma (FL) treatments in many ways:

  • It is a short-course treatment that is delivered over 7–9 days
  • ZEVALIN combines immunotherapy and radiotherapy. It delivers radiation to targeted and neighboring cells
  • ZEVALIN is not a chemotherapy treatment
  • ZEVALIN is typically administered in an outpatient setting
  • Clinical trials in the relapsedRelapse
    The return of signs and symptoms of cancer after improvement.
    setting have shown that ZEVALIN delivers more measurable responses than if FL is treated with rituximab alone

How is ZEVALIN given?

ZEVALIN is delivered in a single injection over 10 minutes, and is preceded by two rituximabRituximab
A drug used to treat certain types of B-cell non-Hodgkin’s lymphoma. Rituximab binds to a protein called CD20, which is found on B-cells, and may destroy cancer cells. It is a type of monoclonal antibody.
infusions. The treatment takes 7–9 days.

How is ZEVALIN Delivered?

Who administers ZEVALIN treatment?

Because ZEVALIN treatment involves multiple steps, you will be treated by a coordinated team of health care professionals who specialize in specific steps of your treatment.

An oncology nurse will likely administer your rituximab infusions, and a member of the radiation oncology or nuclear medicine team will administer your ZEVALIN injection.

How do I prepare for treatment with ZEVALIN?

Generally, you do not need to make any special preparations prior to treatment. You can continue with your normal daily activities and your regular diet. You may also wear regular clothing to receive treatment. Talk to your doctor before treatment—he or she may have recommendations for you to follow.

Where will I go to receive ZEVALIN?

On an outpatient basis, you may receive treatment at a nuclear medicine or radiation oncology facility. These facilities have special licenses and equipment to safely give treatments that involve radiation.

What safety precautions should I take after the radioactive component of ZEVALIN treatment is given?

Because ZEVALIN uses a different type of radiation than external beam radiation, you do not have to avoid contact with others after treatment. Your doctor will advise you on radiation safety precautions you should take.

What are the most common side effects of ZEVALIN?

The most common side effects of ZEVALIN are:1

  • Decreased blood counts
  • Fatigue
  • Stomach pain
  • Nausea
  • Weakness
  • Diarrhea
  • Cough
  • Fever
  • Nose and upper throat irritation
If you experience any of the above side effects, please discuss them with your doctor. Your doctor can also give you more information on ZEVALIN side effects. Since it is part of the ZEVALIN treatment, you should ask your doctor about rituximab side effects.

What follow-up is needed after completing ZEVALIN treatment?

After you receive treatment with ZEVALIN, you will have weekly blood tests until your blood counts return to normal or as long as your doctor thinks it is necessary. Some patients may need more frequent testing. These blood tests are performed to check for potential side effects. Your doctor or nurse will speak with you about the details of your follow-up.

Where can I talk to other patients who have received ZEVALIN?

Organizations such as the Lymphoma Research Foundation and The Leukemia & Lymphoma Society have programs that can put you in touch with other lymphoma patients, including patients in your local area who have received treatment for FL. Both organizations offer nationwide support programs where patients can share their experiences and find emotional support and encouragement. For contact information for these and other organizations, visit our Patient Resources page.

How can I get more information about ZEVALIN?

If you have questions or want more information, talk with your doctor or contact Spectrum Pharmaceuticals:

Indications and Usage

ZEVALIN® (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that has three parts: two infusions of rituximab and one injection of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the number 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:

  • Low-grade or follicular B-cell NHL that has relapsed during or after treatment with other anticancer drugs.
  • Newly diagnosed follicular NHL following a response to initial anticancer therapy.

Patient Important Safety Information

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 see the accompanying full prescribing information for ZEVALIN. Additional information may also be found on the ZEVALIN Website (www.ZEVALIN.com) 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).

WARNING: ZEVALIN TREATMENT CAN CAUSE SERIOUS SIDE EFFECTS:

  • 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 or pinpoint red or purple spots on your skin, 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:

  • Risk of Developing Myelodysplastic Syndrome, Leukemia and Other Malignancies (Cancers): The radiation dose resulting from therapeutic exposure to Y-90 ZEVALIN may result in secondary malignancies.

    Myelodysplastic syndrome (MDS; a type of pre-cancerous bone marrow abnormality) and/or Acute Myelogenous Leukemia (AML, a type of cancer of the blood) were reported in 5.2% (11/211) of patients treated with Y-90 ZEVALIN for relapsed or refractory 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.

    Among 204 newly diagnosed patients who received Y-90 ZEVALIN, following complete or partial response to initial anticancer therapy, 7 patients (3.4%) were diagnosed with MDS/AML after receiving ZEVALIN treatment, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years. Deaths due to secondary new malignancies occurred in 8 (3.9%) patients treated with ZEVALIN compared to 3 (1.5%) patients in the control arm of the study. Deaths due to MDS or AML occurred in 5 (2.5%) patients treated with ZEVALIN compared to no patients in the control arm.

  • Infusion Site Leakage: 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.
  • Immunization: Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN treatment.
  • Precautions During and After Administration: Your doctor will discuss precautions with you to minimize radiation exposure.
  • Potential for Birth Defects: ZEVALIN therapy may cause harm to an unborn baby, please tell your doctor if you are pregnant or plan to become pregnant.
  • Reproductive Organs: There is a risk that ZEVALIN therapy will affect the male and female reproductive organs. Use birth control during treatment and for a minimum of 12 months following ZEVALIN therapy.
  • Nursing Mothers: Discontinue nursing during and after ZEVALIN treatment.
  • Adverse Reactions (Side Effects): The most common adverse reactions (≥10%) in clinical trials with ZEVALIN were: decreases in blood counts, tiredness, inflammation of the nose and upper throat, nausea (upset stomach), abdominal (stomach) pain, weakness, cough, diarrhea, and fever. 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 (a type of white blood cell) [41%], decrease in total white blood cells [36%], decrease in lymphocytes [18%], and decrease in red blood cells or hemoglobin [5%]), and secondary cancers (12.7%). Reductions in blood cells were more severe and more prolonged among 11 (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 (5.2%). 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 in a cavity in the body), pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis (bile duct infection)).

Please click here to see the full Prescribing Information, including the 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.

ISI-1120-035604

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Reference:

1. ZEVALIN [consumer brief summary]. Irvine, CA: Spectrum Pharmaceuticals, Inc.