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
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
- Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN
- 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
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
- 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
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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