Support, Resources, and Downloads
Talking to your doctor
It’s important to have clear discussions with your doctor as you plan treatment. Here are some things to consider when entering a discussion:
- Ensure it’s a two-way conversation—doctors need to know what is important to you to help advise the best-fit treatment for your disease
- Take plenty of notes, and if you have questions—don’t hesitate to ask them
- If you don’t understand something the doctor is saying, ask for a simpler explanation
Preparing for an appointment with your doctor
To ready yourself for your appointment, you may want to:
- Write down questions you’d like to ask, and bring a notebook (or an audio recorder) with you to record your doctor’s answers
- Ask a family member or friend to accompany you for support, and to ask any questions you may not think of
Questions to ask your doctor
Your doctor will attempt to answer any questions you have about ZEVALIN treatment. Here are some examples of questions you may want to ask:
General information related to you
- What characterizes a typical ZEVALIN candidate?
- Are there reasons I may qualify for ZEVALIN treatment?
General information about your doctor
- Do you have experience with ZEVALIN?
- Have you ever referred a patient for ZEVALIN treatment? If not, is there someone I can talk to who has?
- Would you consider ZEVALIN if you had follicular lymphoma?
Treatment with ZEVALIN
- Who will be part of my treatment team, and what does each member do?
- Where do you refer patients for ZEVALIN treatment?
- How long will it take to complete a full course of ZEVALIN treatment?
- What are the short-term side effects of ZEVALIN?
- Are there any long-term side effects of ZEVALIN I should be aware of?
- Who should I contact with questions or concerns during my ZEVALIN treatment?
After ZEVALIN treatment
- What follow-up tests do I need, and how often will I need them?
- When will I come back to see you after ZEVALIN treatment?
Response to ZEVALIN
- For a patient like me, what are the expected responses to ZEVALIN treatment?
- How effective is ZEVALIN in comparison to rituximab alone in relapsed/refractory patients?
What if your doctor is not familiar with ZEVALIN?
If your doctor has no prior experience with ZEVALIN, we can help you find a doctor who does. You can find and connect with an oncologist in your area who has prescribed ZEVALIN before by visiting the Find a ZEVALIN Oncologist page.
Most doctors will be very helpful and supportive if you express interest in speaking with a colleague of theirs who has firsthand experience prescribing ZEVALIN.
If your doctor doesn’t have the answers you need, you or your doctor can contact Spectrum Pharmaceuticals for more information at:
What should you tell your doctor before ZEVALIN treatment?
Tell your doctor about all of your medical conditions, especially if you1:
- Had a severe infusion reaction to rituximab in the past
- Are taking any medications that increase your risk of bleeding, such as aspirin or warfarin
- Have, or have recently had, an infection
- Have recently received a vaccination, or are scheduled to be vaccinated (It is recommended you do not receive a live vaccine for 12 months after receiving ZEVALIN treatment)
- Are pregnant or planning to become pregnant. The ZEVALIN therapeutic regimen may cause harm to an unborn child. Use effective birth control during treatment and for at least one year after
- Are breastfeeding. It is not known if the different parts of the ZEVALIN therapeutic regimen pass into human breast milk. A decision should be made to discontinue breastfeeding or not to treat with the ZEVALIN therapeutic regimen
Tell your doctor about all substances you are currently taking, including prescription and nonprescription medications, vitamins or herbal supplements.
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.
1. ZEVALIN [consumer brief summary]. Irvine, CA: Spectrum Pharmaceuticals, Inc.