FUSILEV® Homepage
This site is intended for U.S. Healthcare Professionals only

Spectrum Pharmaceuticals, Inc. Website Linking Policy

Spectrum Pharmaceuticals, Inc. ("Spectrum") ordinarily does not prohibit links to this website, provided that any such link does not improperly connote an endorsement by or affiliation with Spectrum, or otherwise adversely impact Spectrum, and pursuant to the terms below.

If you are interested in linking to this website or any other Spectrum owned websites, please notify Spectrum Pharmaceuticals by sending an e-mail to webmaster@sppirx.com. Include your name, your organization name, contact information (such as a phone number and/or e-mail address) as well as the URL of your site and a list of any URLs from which you intend to link to this site.

By linking to any page on the Spectrum websites, you hereby agree to be bound by the terms and conditions as set forth below:

Links may be text-based using the words: "FUSILEV®", "FUSILEV" , "Spectrum®", "Spectrum", or "Spectrum.com" the "Spectrum Marks". You may not use the FUSILEV® logo, Spectrum™ logo or any Spectrum logo as a link. By linking, you acknowledge and agree that, other than as set forth herein, all rights to the Spectrum Marks, other Spectrum marks, the content appearing on the Spectrum website and the design of the Spectrum website belong to Spectrum Pharmaceuticals, Inc. 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 Pharmaceuticals, Inc.

You may not create frames around any of the pages of the Spectrum™ websites or use other techniques that alter in any way the visual presentation or appearance of any of the Spectrum™ websites.

You must not misrepresent your relationship with any Spectrum™ product or Spectrum Pharmaceuticals, Inc. (or any Spectrum-owned business entity, Spectrum subsidiary, or Spectrum-affiliated business entity) or present false or misleading impressions about any Spectrum™ product or Spectrum Pharmaceuticals, Inc. (or any Spectrum-owned business entity, Spectrum subsidiary, or Spectrum-affiliated business entity). No links to any Spectrum™ website may be used in a manner that implies or suggests that Spectrum approves or endorses you, your website or your goods and services (in all cases, except as Spectrum may have agreed separately with you in writing).

Spectrum has no responsibility or liability for any content appearing on your website. You agree to indemnify and defend Spectrum against all claims arising out of or based upon your website.

No link(s) may appear on any page on your website or within any context containing content or materials that may be interpreted as libelous, obscene or criminal, or which infringes, otherwise violates, or advocates the infringement or other violation of, any third party rights.

Spectrum may at any time, in its sole discretion, without cause, terminate your right to link to any web pages of any Spectrum™ website. In such event, upon request, you agree to immediately remove all links to any Spectrum™ website and to cease using the Spectrum Marks.

Spectrum Pharmaceuticals, Inc., reserves the right to change this linking policy at any time. Changes will be posted on this page.

© 2014 Spectrum Pharmaceuticals, Inc. All rights reserved.

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.