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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.spectrumpharm.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 any time 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.fusilev.com, www.FUSILEV.com and www.sppirx.com will be deemed effective.

© 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.