Important Safety Information
Clolar® should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. View additional Important Safety Information.

Privacy Policy

Genzyme Corporation (“Genzyme”), a subsidiary of Sanofi, respects individual privacy and is committed to protecting personally identifiable information in conformity with applicable legal and ethical standards.

This Privacy Policy and Notice of Information Practices sets forth Genzyme’s practices regarding the collection, use and disclosure of information that you may provide through this site. Please read this entire Privacy Policy before using this site or submitting information to Genzyme through this site.

By using this site and whenever you submit information through this site to Genzyme, you agree with the terms of Genzyme’s Privacy Policy and Notice of Information Practices written below.

Privacy Policy and Notice of Information Practices

Information Genzyme Collects

Personally Identifiable Information

Genzyme only collects personally identifiable information, such as your name, address, telephone number or email address, when you voluntarily submit it to Genzyme.

Cookies and Other Non-Personally Identifiable Information

We collect information about your usage of our site through cookies and similar technology. There are two types of cookies: session cookies (non persistent cookies) and persistent cookies. Session cookies temporarily store non-personally identifiable information about your visit to our website in your computer’s memory. The cookie is deleted as soon as you close your browser. Persistent or permanent cookies will uniquely identify your browser and will permanently save in your computer’s memory information requested by the website.

On some of our websites, we also use pixels, or transparent GIF files. These GIF files are provided by our ad management partner, DoubleClick. These files enable DoubleClick to recognize a unique cookie on your Web browser, which in turn enables us to learn which advertisements bring users to our website. The cookie was placed by us, or by another advertiser who works with DoubleClick.

With both cookies and transparent GIF files, the information that we collect and share is anonymous and not personally identifiable. It does not contain your name, address, telephone number, or email address.

We also track the total number of visitors to our website, the number of visitors to each page of the website, and the domain names of our visitors’ Internet service providers.  On certain Genzyme websites, we may also ask users that have opted to receive information to complete a survey.  No personally identifiable information is gathered in any of these processes.

How Genzyme Uses This Information

Personally Identifiable Information

This information may be used by Genzyme personnel or agents of Genzyme to obtain more information, to improve this site, or to provide you with information that you have requested or additional information which Genzyme believes may be of interest to you.

Genzyme does not sell any of your personally identifiable information for marketing or advertising purposes.

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We use other non-personally identifiable information, including information obtained through surveys, to improve this site.

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Genzyme, or in some cases its agents, may store the personally identifiable data collected via this site in an electronic database. Genzyme and its agents may also exchange such data with each other or with you over the internet or over intranet systems for the purposes of processing the data, mailing information to you in response to your request, or otherwise carrying out the services described above.  We may also release your personally identifiable data in response to a court order, subpoena, search warrant, or applicable law or regulation.

While Genzyme makes every reasonable effort to protect the personally identifiable data collected through its websites, please be aware that there is always some risk involved when submitting data over the Internet. We cannot guarantee that our website is 100% safe from illegal tampering or “hacking.” Any data transmitted over the Internet may be at risk; however, once it is received at Genzyme and entered into its database, it has the same protection that Genzyme extends to its own confidential information.

Your Information Choices

Personally Identifiable Information

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As a reminder to you when exchanging emails, any email that you send or receive on your employer’s email system may be the property of your employer. Consequently, your employer may have the ability to review your personal information sent via email.

Please note that although we attempt to adhere to requests to remove personal data from our records, it may not be possible to remove all copies depending on the manner in which the information was submitted to us.  In addition, we reserve the right not remove or amend information provided to us regarding an adverse drug effect and information is otherwise required to be retained by law.

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For more information about how to opt out of Doubleclick, go to http://www.google.com/privacy_ads.html.  Users always have the option of declining to participate in any survey they receive from Genzyme.

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As a convenience to our visitors, our sites currently contain links to a number of other (non-Genzyme) sites that we believe may offer useful information. The privacy policy presented here does not apply to those sites. You should contact these sites directly for information on their privacy policies, confidentiality agreements, and data collection/distribution procedures.

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Children’s Policy

Our websites are not intended or designed to attract children under the age of 13. We do not collect personal information from any person we actually know is a child under the age of 13.

Privacy Policy Updates

Any changes to this Privacy Policy will be posted on this page.  If a change to this Privacy Policy results in a materially different use of your personally identifiable information provided prior to the date of the change, you may opt out of such use by providing notice to Genzyme.

This privacy policy only applies to websites linked to it.  A different privacy policy may apply to other Genzyme websites you visit. 

This privacy policy was last updated 9/21/2011.

 

Indication

Clolar is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

Important Safety Information

Warnings and Precautions:

  • Clolar should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.

Hematologic Toxicity

  • Monitor complete blood counts and platelet counts during Clolar therapy.
  • Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose dependent. Severe bone marrow suppression, including neutropenia, anemia, and thrombocytopenia, has been observed in patients treated with Clolar. At initiation of treatment, most patients in the clinical studies had hematological impairment as a manifestation of leukemia.
  • Because of the pre-existing immunocompromised condition of these patients and prolonged neutropenia that can result from treatment with Clolar, patients are at increased risk for severe opportunistic infections.

Infections

  • The use of Clolar is likely to increase the risk of infection, including severe sepsis, as a result of bone marrow suppression. Monitor patients for signs and symptoms of infection and treat promptly.

Hyperuricemia (Tumor Lysis)

  • Administration of Clolar may result in a rapid reduction in peripheral leukemia cells. Evaluate and monitor patients undergoing treatment for signs and symptoms of tumor lysis syndrome. Provide intravenous infusion fluids throughout the five days of Clolar administration to reduce the effects of tumor lysis and other adverse events. Administer allopurinol if hyperuricemia (tumor lysis) is expected.

Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome

  • Evaluate and monitor patients undergoing treatment with Clolar for signs and symptoms of cytokine release (e.g., tachypnea, tachycardia, hypotension, pulmonary edema) that could develop into systemic inflammatory response syndrome (SIRS), capillary leak syndrome and organ dysfunction.
  • Discontinue Clolar immediately in the event of clinically significant signs or symptoms of SIRS or capillary leak syndrome, either of which can be fatal, and consider use of steroids, diuretics, and albumin. Re-institute Clolar when the patient is stable, generally with a 25% dose reduction. The use of prophylactic steroids may be of benefit in preventing signs and symptoms of cytokine release.

Hepatic Enzymes

  • Hepato-biliary enzyme elevations were frequently observed in pediatric patients during treatment with Clolar. Some patients discontinued treatment due to hepatic enzyme abnormalities.
  • Hepatic and Renal Impairment
  • Clolar has not been studied in patients with hepatic or renal dysfunction. Its use in such patients should be undertaken only with the greatest caution.
  • Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2). Severe hepatotoxic events have been reported in an ongoing Phase 1/2 combination study of clofarabine in pediatric patients with relapsed or refractory acute leukemia.

Use in Pregnancy

  • Clolar can cause fetal harm when administered to a pregnant woman. Intravenous doses of clofarabine in rats and rabbits administered during organogenesis caused an increase in resorptions, malformations, and variations. Women of childbearing potential should be advised to avoid becoming pregnant while receiving Clolar.

Nursing Mothers

  • Female patients should be advised to avoid breast-feeding during treatment with Clolar.

Incidence of Treatment Emergent Laboratory Abnormalities

ParameterAny gradeGrade 3 or higher
Anemia 83% 75%
Leukopenia 88% 88%
Lymphopenia 82% 82%
Neutropenia 64% 64%
Thrombocytopenia 81% 80%
Elevated creatinine 50% 8%
Elevated SGOT 74% 36%
Elevated SGPT 81% 43%
Elevated total bilirubin 45% 13%

Adverse Reactions:

  • Most common adverse reactions with Clolar® were nausea (73%), vomiting (78%), diarrhea (56%), febrile neutropenia (55%), headache (43%), rash (38%), pruritus (43%), pyrexia (39%), fatigue (34%), palmar-plantar erythrodysesthesia syndrome (16%), anxiety (21%), flushing (19%), and mucosal inflammation (16%).

For more information, please consult the full Prescribing Information(PDF).