ARRANON (nelarabine) injection

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T-Cell Acute Lymphoblastic Leukemia (T-ALL) T-Cell Acute Lymphoblastic Leukemia (T-ALL)

Web Resources

The following is a list of Web sites that offer additional information on acute lymphoblastic leukemia (ALL).

American Cancer Society
Telephone: 1-800-ACS-2345 (1-800-227-2345)
Internet: www.cancer.org

Leukemia & Lymphoma Society
Telephone: 1-800-955-4572
Internet: www.lls.org

Association of Cancer Online Resources
Telephone: 1-212-226-5525
Internet: www.acor.org

National Bone Marrow Transplant Link
Telephone: 1-800-LINK-BMT (1-800-546-5268)
Internet: www.nbmtlink.org

National Cancer Institute
Telephone: 1-800-4-CANCER (1-800-422-6237)
Internet: www.cancer.gov

National Marrow Donor Program
Telephone: 1-800-MARROW-2 (1-800-627-7692)
Internet: www.marrow.org

Candlelighters Childhood Cancer Foundation
Telephone: 1-800-366-2223
Internet: www.candlelighters.org

Childhood Leukemia Foundation
Telephone: 1-888-CLF-7109 (1-888-253-7109)
Internet: www.clf4kids.com

CureSearch National Childhood Cancer Foundation
Telephone: 1-800-458-6223
Internet: www.curesearch.org

Disclaimer

The ARRANON.com Web site contains links to third-party Web sites on the Internet. These links are provided as a service to individuals interested in more information. These sites are not part of this GlaxoSmithKline (GSK) Web site. The content and materials in these third-party Web sites are not produced or endorsed by GSK and may refer to uses of our products that are not recommended by GSK.

Indication

ARRANON is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy 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

ARRANON® (nelarabine) injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous use only.

Neurologic Events: Severe neurologic events have been reported with the use of ARRANON. These events have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.

Full recovery from these events has not always occurred with cessation of therapy with ARRANON. Close monitoring for neurologic events is strongly recommended, and ARRANON should be discontinued for neurologic events of NCI Common Toxicity Criteria grade 2 or greater.

In clinical studies of ARRANON, hematologic toxicity was the most common grade 3 (moderate) or 4 (severe) adverse event. For a complete list and incidence of adverse events: pediatric patients; adult patients. Hematologic toxicity included neutropenia, thrombocytopenia, anemia, febrile neutropenia, or neutropenia with infection.

Other common toxicities included laboratory abnormalities including increased transaminases, gastrointestinal toxicity, fatigue, and asthenia.

Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation may be at increased risk for neurologic adverse events.

Women of child-bearing potential should be advised to avoid becoming pregnant while receiving treatment with ARRANON.

Appropriate measures (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) must be taken to prevent hyperuricemia of tumor lysis syndrome.

Nursing should be discontinued in women who are receiving therapy with ARRANON.

Because the risk of adverse reactions to this drug may be greater in patients with severe renal impairment (CLcr <30 mL/min), these patients should be closely monitored for toxicities when treated with ARRANON.

Because the risk of adverse reactions to this drug may be greater in patients with severe hepatic impairment (bilirubin >3.0 mg/dL), these patients should be closely monitored for toxicities when treated with ARRANON.

Prescribing Information for ARRANON  |  Important Safety Information | Patient Information Leaflet

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