Acrotech Biopharma, LLC. Terms of Use

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ZEVALIN Important Safety Information

Indications and Usage

ZEVALIN® (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that has three parts: two infusions of rituximab and one infusion 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 adult patients with:

Relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL)
Previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy

Patient Important Safety Information

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

The following section provides an overview of 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 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, 26 (12.7%) patients in the Zevalin arm developed a second primary malignancy compared to 14 (6.8%) of patients in the control arm. Seven 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.

Your doctor will monitor you for toxic effects to the blood, including development of MDS or AML.

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 the fetus. Please tell your doctor if you are pregnant or plan to become pregnant. If you are a male and your female partner is pregnant or plans to become pregnant please tell your doctor. You will need to use birth control during treatment and for a minimum of 12 months following ZEVALIN therapy.
Reproductive Organs: Based in its radioactivity, there is a potential risk that Zevalin therapeutic regimen could cause toxic effects on the male and female gonads. .
Lactation: Due to the potential for serious adverse reactions in a breastfeeding child from Zevalin, advice lactating women to avoid breastfeeding during treatment with Zevalin therapeutic regimen and for 6 months after the last dose.
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%]). 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%])). 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 see the accompanying 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.

ISI-ZEV-0317