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Spectrum Pharmaceuticals, Inc. Website Privacy Policy

This Privacy Policy applies to our data collection and use practices relating to our website located at www.sppirx.com. References in this Privacy Policy to "we," "us" or "our" refer to Spectrum Pharmaceuticals, Inc. ("Spectrum"). By using our website, you agree to the terms of this Privacy Policy and any modifications made to this Privacy Policy.

Please be aware that this Privacy Policy will not necessarily apply to information you may have provided or will provide to us in settings other than by or through our website.

Collection of Information

When you use our website, we collect personal information that you choose to provide voluntarily to us. For example, you may provide personal information on a customer feedback page. In addition, when you visit our website, you will be assigned a permanent "cookie" (a small text file) to be stored on your computer's hard drive. We may also collect certain technical information from your computer, including your Internet Protocol (IP) address, during your visit to our website. Some third party service providers may also use cookies on this website in connection with advertising or otherwise. We do not have access to or control over these third party cookies.

Use of Information

We use the information that we collect to communicate with you.

We may also use the personal information that we collect to provide you with details about promotions and services that we believe may be of interest to you, but we will only do so if you separately request, at the time of registration or at a later date, to receive these details. If you no longer wish to receive communications about such promotions and services, you may opt out at anytime by notifying us at optout@sppirx.com.

We use the aggregate statistical data that we collect to better serve you. For example, we use aggregate statistical data to identify the effectiveness of our promotional activities; and provide special savings offers, such as free samples, coupons, rebates and other promotions, to you.

Sharing of Information with Third Parties

We will not sell your personal information to third parties.

We may share your personal information with our subsidiaries, affiliates, agents, representatives and business partners for the limited purpose of providing services or information to us or our customers at our direction. We may also provide to third parties certain personal information that is necessary to fulfill an order you have placed with us, such as providing your name and address to a shipping carrier for delivery. We expect our agents and business partners to follow our privacy policies when using customer information provided by us. We are not responsible for any additional information that you provide directly to these third parties.

We may also disclose the aggregate statistical data that we collect to third parties in order to allow them to measure the effectiveness of programs and advertisements aimed at our customers.

Disclosure Of Information In Response To A Court Order Or In An Emergency

We will disclose information when compelled by a subpoena or court order, or when we believe, in our reasonable discretion, that such disclosure is warranted to cooperate with inquiries by law enforcement agencies or in emergencies where physical safety is at risk.

Contacting Us About Your Online Privacy

You may always contact us to remove or update personally identifiable information from our database by sending an e-mail to us at optout@sppirx.com. If you have any questions or comments about the way your personally identifiable information collected in via our website is used and handled, please e-mail us at listusage@sppirx.com.

Security

We have put into place physical, electronic and managerial procedures to safeguard and secure the information we collect about you. For example, we operate secure data networks protected by industry standard "firewalls" and password protection systems that are intended to keep unauthorized persons from accessing your personal information. Nevertheless, we cannot guarantee that unauthorized access or disclosure of your personal information will never occur.

Third Party Websites

As a convenience to our website visitors, this website may contain links to third-party web sites. Third party websites are not covered by this Privacy Policy and Spectrum will have no control over the information you enter or the cookies your browser accepts while on a third party's website. You should examine the terms of use and privacy policies of other website pages whenever you leave a Spectrum website. Spectrum is not responsible for the privacy practices or the content included on third party websites.

Amendment Or Modification Of This Privacy Statement

We reserve the right to amend this Privacy Policy at any time and only the current Privacy Policy, as set forth on our websites www.ZEVALIN.com and www.sppirx.com will be deemed effective.

© 2014 Spectrum Pharmaceuticals, Inc. All rights reserved.


Indications and Usage

ZEVALIN® is a CD20-directed radiotherapeutic antibody administered as part of the ZEVALIN therapeutic regimen indicated for the treatment of 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.

Important Safety Information

WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS
AND MUCOCUTANEOUS REACTIONS

Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. Discontinue rituximab and Y-90 ZEVALIN infusions in patients who develop severe infusion reactions.

Prolonged and Severe Cytopenias: Y-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Do not administer Y-90 ZEVALIN to patients with ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve.

Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen. Discontinue rituximab and Y-90 ZEVALIN infusions in patients experiencing severe cutaneous or mucocutaneous reactions.

Dosing: 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 radiolabeled ZEVALIN may result in secondary malignancies.

Myelodysplastic syndrome (MDS) and/or acute myelogenous leukemia (AML) were reported in 5.2% (11/211) of patients with relapsed or refractory NHL enrolled in clinical studies and 1.5% (8/535) of 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 treatment with the ZEVALIN therapeutic regimen; however, the cumulative incidence continues to increase.

Among 204 patients receiving Y-90-ZEVALIN following first-line chemotherapy, 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%, 7/204) were diagnosed with MDS/AML after receiving ZEVALIN, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years. Deaths due to second primary malignancy included 8 (3.9%) patients in the ZEVALIN arm compared to 3 (1.5%) patients in the control arm. Deaths due to MDS/AML included five (2.5%) patients in the ZEVALIN arm compared to no patients in the control arm.

Extravasation: Monitor for extravasation and terminate infusion if it occurs. Resume infusion in another limb.

Immunization: Do not administer live viral vaccines to patients who recently received ZEVALIN.

Radionuclide Precautions: During and after radiolabeling ZEVALIN with Y-90, minimize radiation exposure to patients and to medical personnel, consistent with institutional good radiation safety practices and patient management procedures.

Embryo-fetal Toxicity: May cause fetal harm if given during pregnancy.

Impairment of Fertility: There is a potential risk that the ZEVALIN therapeutic regimen could cause toxic effects on the male and female gonads. Effective contraceptive methods should be used during treatment and for up to 12 months following the ZEVALIN therapeutic regimen.

Nursing Mothers: Patients should be advised to discontinue nursing during and after ZEVALIN treatment.

Adverse Reactions: The most common adverse reactions of ZEVALIN are cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia. Common adverse reactions (≥10%) in clinical trials were: cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia. The most serious adverse reactions of ZEVALIN are prolonged and severe cytopenias (thrombocytopenia, anemia, lymphopenia, neutropenia) and secondary malignancies.

When administered following first-line chemotherapy, grade 3/4 adverse reactions of ZEVALIN include prolonged and severe cytopenias (thrombocytopenia [51%], neutropenia [41%], leukopenia [36%], lymphopenia [18%], and anemia [5%]) and secondary malignancies (12.7%). Cytopenias were more severe and more prolonged among eleven (5%) patients who received ZEVALIN after first-line fludarabine or a fludarabine-containing chemotherapy 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 (1%), bronchitis, catheter sepsis, diverticulitis, herpes zoster, influenza, lower respiratory tract infection, sinusitis, and upper respiratory tract infection.

Grade 3/4 adverse reactions of ZEVALIN in relapsed or refractory NHL patients include prolonged and severe cytopenias (thrombocytopenia [63%], neutropenia [60%], anemia [17%], and ecchymosis [<1%]) and secondary malignancies (5.2%). Serious infections occurred in 3% of patients (urinary tract infection, febrile neutropenia, sepsis, pneumonia, cellulitis, colitis, diarrhea, osteomyelitis, and upper respiratory tract infection). Life-threatening infections were reported in 2% of patients (sepsis, empyema, pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis).

Please click here to see the full Prescribing Information, including the BOXED WARNINGS, for ZEVALIN. Because the ZEVALIN therapeutic regimen includes the use of rituximab, please also consult Prescribing Information for rituximab (www.rituxan.com).

ISI-0154-079503

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