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Spectrum Pharmaceuticals, Inc. Website 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.

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Indications and Usage

FUSILEV is a folate analog indicated for:

  • Rescue after high-dose methotrexate therapy in osteosarcoma.
  • Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
  • Use in combination chemotherapy with 5-FU in the palliative treatment of patients with advanced metastatic colorectal cancer.

Limitations of Use

FUSILEV is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.

Important Safety Information

Contraindications

FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.

Warnings and Precautions

  • Due to Ca++ content, no more than 16 mL (160 mg) of levoleucovorin solution should be injected intravenously per minute.
  • FUSILEV enhances the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly d,l-leucovorin and 5-fluorouracil. When these drugs are administered concurrently in the palliative treatment of advanced colorectal cancer, the dosage of 5-FU must be lower than usually administered. Although the toxicities observed in patients treated with the combination of FUSILEV and 5-FU are qualitatively similar to those observed with 5-FU alone, gastrointestinal toxicities (particularly stomatitis and diarrhea) are observed more commonly and may be of greater severity and of prolonged duration in patients treated with the combination.
  • Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study.

Adverse Reactions

  • Allergic reactions were reported in patients receiving FUSILEV.
  • The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving FUSILEV in combination with 5-FU were diarrhea, nausea and stomatitis.
  • Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy.

Drug Interactions

FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.

FUSILEV adverse event profile

Adverse reactions (≥10% in either arm) in patients with advanced metastatic colorectal cancer

Adverse Reaction Levoleucovorin/5FU
n=318
d,l-Leucovorin/5FU
n=307
Adverse Event N (%) Grade 1–4 Grade 3–4 Grade 1–4 Grade 3–4
Gastrointestinal Disorders
Stomatitis 229 (72%) 37 (12%) 221 (72%) 44 (14%)
Diarrhea 222 (70%) 61 (19%) 201 (65%) 51 (17%)
Nausea 197 (62%) 25 (8%) 186 (61%) 26 (8%)
Vomiting 128 (40%) 17 (5%) 114 (37%) 18 (6%)
Abdominal Pain* 45 (14%) 10 (3%) 57 (19%) 10 (3%)
General Disorders
Asthenia/Fatigue/Malaise 91 (29%) 15 (5%) 99 (32%) 34 (11%)
Metabolism and Nutrition
Anorexia/Decreased Appetite 76 (24%) 13 (4%) 77 (25%) 5 (2%)
Skin Disorders
Dermatitis 91 (29%) 3 (1%) 86 (28%) 4 (1%)
Alopecia 83 (26%) 1 (0.3%) 87 (28%) 3 (1%)

* Includes abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal tenderness

ISI-0154-079600

Please click here to see full Prescribing Information for FUSILEV.

Reporting of Suspected Adverse Reactions

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.