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
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
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
- 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
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)).
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
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.
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