Spectrum Pharmaceuticals, Inc. Terms of Use

The information provided on this Spectrum Pharmaceuticals, Inc. Website is for general informational and educational use only and is subject to the following terms and conditions. By accessing and using this website, you acknowledge and accept, without limitation or qualification, this Terms of Use Agreement. If you do not wish to be bound by this agreement, you may not access or use any materials on this website.

1. Scope of Use. Spectrum Pharmaceuticals, Inc. ("Spectrum") maintains this website for your personal information and education. The information, documents and related graphics are available for your personal use, provided that the materials are not modified in any way and all copyright and other proprietary notices contained on the provided materials are maintained. This website and all its contents are intended to comply with United States laws that it may be subject to and Spectrum makes no representation that the information is appropriate for use in locations outside of the United States. Other countries may have laws, regulatory requirements, and medical practices that differ from those in the U.S. Those who access this site from other locations do so on their own initiative and are responsible to comply with applicable local laws and regulations. Any offer, product, or service available through this website is void where prohibited.

2. Intellectual Property. Images and materials displayed on this website are subject to intellectual property laws. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark, or copyright owned by Spectrum or any third party. Except as expressly provided herein, no use of any Spectrum intellectual property rights may be made without prior written consent of Spectrum. In addition, Spectrum neither warrants nor represents that the use of images or materials from this website will not infringe the rights of third parties not owned by or affiliated with Spectrum.

3. Medical Information. The medical information provided on this website is for educational and informational purposes only and not meant to be a substitute for advice offered by a physician or other healthcare professional. If medical advice or services are desired, please consult your physician or health care provider.

4. Non-Confidential Information. Any oral, written or electronic response or communication established with Spectrum by any user of this website shall be deemed as non-confidential. Spectrum shall not have any obligations of any kind with respect to such information and shall be free to use any ideas, concepts, know-how or techniques contained in such communication without restriction for any purpose whatsoever. The sender of such information is fully responsible for its content, including, without limitation, its accuracy and truthfulness and its non-infringement of another party's proprietary rights.

5. Forward-Looking Statements. This website may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the beliefs of Spectrum's management as well as assumptions made by and information currently available to Spectrum's management. Readers should not put undue reliance on these forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Spectrum's actual results may differ materially from the results projected in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in the documents and reports filed by the Spectrum from time to time with the Securities and Exchange Commission, specifically the most recent Form 10-K and 10-Q.

6. Disclaimer of Warranties. While Spectrum uses reasonable efforts to include accurate and up-to-date information in this site, we make no warranties or representations of any kind as to the accuracy, currency or completeness of the information provided. We assume neither responsibility for any errors or omissions in the content of this site nor any liability to update the information contained in this site. Spectrum provides this information "as is" and disclaims all warranties of any kind, both express and implied, including, but not limited to, merchantability, fitness for a particular purpose, or non-infringement. Please note that some jurisdictions do not allow the exclusion of implied warranties, so the above disclaimer may not apply to you.

7. Limitations of Liability. Use of this site is at the user's own risk. Neither Spectrum nor any other party involved in the creating, producing, or delivering the website is liable for any direct, incidental, consequential, indirect or punitive damages arising out of access to or use of this website and/or the information provided, regardless of whether Spectrum has been advised as the possibility of such damages.

8. Third Party Websites and Links. This site may contain references or links to other websites maintained by third parties not under Spectrum's control. Such references or links are provided merely for convenience and Spectrum makes no representations or warranties of any kind with respect to any third party site. The inclusion of the reference or link does not imply endorsement of the site and Spectrum is not liable for any damages or injuries of any kind arising from such content or information.

9. Governing Law. This Terms of Use Agreement and your use of this website shall be governed by the laws of the United States and the State of California without regard to its conflicts of law provisions. Any legal action or proceeding arising from or relating to your access or use of this website shall be brought exclusively in a federal or state court of proper jurisdiction in the State of California.

10. Modifications. Spectrum Pharmaceuticals reserves the right to revise the terms and conditions of this agreement at any time without notice and such changes will be deemed effective upon posting. Continued use of the website following posting of an amended Terms of Use will indicate acceptance of such changes and therefore, this agreement should be reviewed periodically.

© 2014 Spectrum Pharmaceuticals, Inc. All rights reserved.

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.

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 (www.rituxan.com).

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 arm.

  • 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 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 the 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-1120-035604

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