Information Collection and Use
Spectrum may collect non-personally identifiable information about how you use this Web Site using analysis technologies. These analysis technologies may be provided by third parties. Information that might be collected using these technologies includes, for example, the pages you visit on this Web Site, the paths you take within this Web Site, and the length of time that you spend on this Web Site. We use this information in the aggregate in order to better understand how to improve the quality of this Web Site.
As is common among Internet site operators, the operator of this Web Site maintains Web server logs. Web servers automatically identify your computer by its IP address and collect that information in its Web server logs. An IP address is a number that is automatically assigned to your computer by your Internet service provider whenever you log onto the World Wide Web or “surf” the Internet. The Spectrum Web server log collect statistical data that is generated by your computer when it visits this Web Site, such as the type of Web browser and operating system used to access this Web Site, the domain name of your Internet service provider, the date and time you access this Web Site, and the pages you visit. This Web Site uses this non-personally identifying Web server log information for a variety of purposes. Some of these purposes include: system administration; examination of overall traffic trends on this Web Site; troubleshooting; and the collection of broad demographic information about users of this Web Site. No personally identifiable information is contained in these Web server logs. The log files may be purged periodically, in our discretion, to maximize space on the server. In addition to the purposes described above, any information we collect may also be used for analytics purposes (e.g., evaluating site usage patterns, assessing throughput) so that we can gauge the effectiveness of our programs and improve the usefulness of information presented to users. Spectrum is the owner of all information collected on this website.
Use of Information
We may collect personally identifying information that you affirmatively provide to us, including, without limitation, your name, address, telephone number, and/or e-mail address and, if you are a physician, your specialty and certain generic patient and practice information.
From time to time, we may use this information to better understand your needs and how we can improve our products and services. When you voluntarily give us your personal contact information, we may use this information to contact you directly.
We may also disclose the aggregate statistical data that we collect to third parties in order to allow them to measure the effectiveness of our programs and advertisements.
Comments, e-mails, suggestions, or other communications sent by you to us are deemed to be
non-confidential (except with regard to personally identifying information included therein), and we are free to use or distribute them in any way without compensation to the author, sender, or any other party.
We might also merge the information collected through off-line sources with data collected through our Web Site into the same database.
Security of Data Stored by Spectrum
Spectrum and its third-party providers may employ procedural and technological security measures, consistent with industry practice. Such measures are reasonably designed to protect your personally identifiable information from loss, misuse, unauthorized access, disclosure, alteration or destruction of the information under our direct control. While we make reasonable efforts to ensure the integrity and security of our network and systems, we cannot guarantee that our security measures will prevent third parties from illegally obtaining this information. However, you provide your information to us at your own risk. We cannot guarantee that your data will not be lost, accessed without authorization, disclosed, altered, or destroyed. You should consider any communication that you transmit to Spectrum (such as personally identifiable or other data, questions or answers, comments, or suggestions) as non-confidential and agree that Spectrum shall not be liable or responsible if any information about you is intercepted and used by an unintended recipient.
Sharing and Disclosure
We will also disclose your personally identifiable information if we reasonably believe we are required to do so by law, regulation, legal process, or other government authority (such as reporting safety information to the Food and Drug Administration); to investigate fraud; to protect your safety or the safety of others; or when we have reason to believe that disclosing this information is necessary to protect our rights or the rights of a third party who may be harmed by your activities.
This Web Site is not intended for or designed to attract children under the age of 18. Spectrum uses reasonable efforts and does not knowingly collect, use, or disclose personally identifiable information from children under the age of 18 years old without the consent of a parent or guardian.
We do not disclose your personal information to third parties for the third parties’ direct marketing purposes, as governed by California Civil Code 1798.83.
Access or Correction of Your Personally Identifying Information; Opt Out from Receiving Communications
You may always contact us to remove or update personally identifiable information from our database. To request a copy of your personally identifiable information stored by Spectrum, please send an e-mail containing your request to firstname.lastname@example.org. You must provide your full name, e-mail address, and any other information reasonably requested by Spectrum. You may then correct or delete such information using the procedures specified in the e-mail message.
In addition, if you no longer wish to receive communications from us, you may opt out at any time by notifying us at email@example.com.
Indications and Usage
KHAPZORYTM is a folate analog indicated for:
- Rescue after high-dose methotrexate therapy in patients with osteosarcoma.
- Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination.
- Treatment of patients with metastatic colorectal cancer in combination with fluorouracil.
Limitations of Use
KHAPZORY is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.
Important Safety Information
- KHAPZORY is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid, or folinic acid.
Warnings and Precautions
- Increased gastrointestinal toxicities with fluorouracil: Gastrointestinal toxicities, including stomatitis and diarrhea, occur more commonly and may be of greater severity and of prolonged duration. Deaths from severe enterocolitis, diarrhea, and dehydration have occurred in elderly patients receiving weekly d,l-leucovorin and fluorouracil. Do not initiate or continue therapy with KHAPZORY and fluorouracil in patients with symptoms of gastrointestinal toxicity until those symptoms have resolved. Monitor patients with diarrhea until it has resolved as rapid deterioration leading to death can occur.
- Drug interaction with trimethoprim-sulfamethoxazole: Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis jiroveci pneumonia in patients with HIV infection increased treatment failure and morbidity.
- The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue were stomatitis (38%) and vomiting (38%).
- The most common adverse reactions (>50%) in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer were stomatitis (72%), diarrhea (70%), and nausea (62%).
Leucovorin products increase the toxicity of fluorouracil.
Use in Specific Populations
Levoleucovorin is administered in combination with methotrexate or fluorouracil, which can cause embryo-fetal harm. Refer to methotrexate and fluorouracil prescribing information for additional information.
Please click here to see full Prescribing Information for KHAPZORY.
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.