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Follicular Non-Hodgkin's Lymphoma Patient StoriesSpectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

What is non-Hodgkin's lymphoma?

Dave S. ZEVALIN patient

Non-Hodgkin's lymphoma can occur at any age and is often identified by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of non-Hodgkin's lymphoma. These types can be divided into aggressive (fast-growing) and indolent (slow-growing) and they can be formed from either B-cells or T-cells. The most common type of non-Hodgkin’s lymphomas are B-cell lymphomas, which comprise 85% of all diagnoses.

Follicular lymphoma, one of the most common forms of lymphoma, is named after the rounded “follicles” seen when an affected lymph node is viewed under magnification. A slow-growing lymphoma that affects mainly older adults, follicular lymphoma (also known as “indolent” or “low-grade”) exhibits minor symptoms and often goes undetected until a swollen lymph node is identified.

Prognosis and treatment depend on the stage and type of disease. For patients diagnosed with follicular non-Hodgkin's lymphoma, you may wish to consult www.zevalin.com for more information on your disease and various treatment choices.

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.

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).

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 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).
  • Risk of Developing Myelodysplastic Syndrome, Leukemia, and Other Malignancies: The radiation dose resulting from therapeutic exposure to Y-90 ZEVALIN may result in secondary malignancies. 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.
  • 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 during treatment.
  • Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN treatment.
  • Your doctor will discuss precautions with you to minimize radiation exposure.
  • 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 a minimum of 12 months following ZEVALIN therapy.
  • Nursing: Patients should be advised to 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 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-1120-035603


Jan W., Columbus, OH

Jan W. ZEVALIN patient

"The summer of 1997 started as the happiest time of my life. I was close to retirement and looking forward to spending some quality time with my husband. What's more, my fondest wish - to become a grandmother - came true that June with the birth of my first grandson, Ian. But it's remarkable what a difference a month can make. In July, I was diagnosed with small cell follicular lymphoma."

Jan is an actual ZEVALIN patient.

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Dave S., Colorado Springs, CO

Dave S. ZEVALIN patient
"Like many other people with follicular lymphoma, my diagnosis came as a complete shock to me. As an avid hiker and outdoorsman, I'd always been physically active. In 2008, however, I began to feel some pain in my groin area. At the time, I thought it was just scar tissue from an old injury. But in November 2009, my doctor noticed a lump on my neck during my yearly physical and scheduled me for a biopsy in a few weeks' time. It was then that he first mentioned lymphoma as a possibility."

Dave is an actual ZEVALIN patient.

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For complete safety information, please see the full Prescribing Information for ZEVALIN, including BOXED WARNINGS, for ZEVALIN on www.zevalin.com. Because the ZEVALIN therapeutic regimen includes the use of rituximab, please also consult prescribing information for rituximab at (www.rituxan.com). Additional information may also be found on this web site or by speaking with your health care provider.


Laura T, Glencoe, IL

Laura T. ZEVALIN patient

"When I was diagnosed with follicular lymphoma several years ago, my life could not have been going any better. I was living in Chicago. I had a great job and lots of friends. I was also in the best physical shape of my life, running three miles every other day. One day, though, a co-worker commented that my neck looked really swollen. Even though I felt completely fine, I made an appointment with an internist just to be safe."

Laura is an actual ZEVALIN patient.

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Michael W., Chicago, IL

Mike W. ZEVALIN patient

"My experience with follicular lymphoma began in the fall of 2005, when I observed a small-sized bump in my right groin. I thought it was a sports injury and didn't think much more about it. But on Thanksgiving Day, I noticed that the bump appeared to have grown. At first, I thought perhaps it was a hernia, so I went to a hernia specialist to get it checked out. As it turned out, that mysterious bump was actually a swollen lymph node. The doctor recommended I get a biopsy."

Michael is an actual ZEVALIN patient.

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