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References
- ARRANON [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2006.
- Gandhi et al. Compound GW506U78 in Refractory Hematologic Malignancies: Relationship between Cellular Pharmacokinetics and Clinical Response. J Clin Oncol. 1998;16(11):3607-3615.
- Data on file, GlaxoSmithKline.
- Kebriaei P et al. Acute Lymphoblastic Leukemia: diagnosis and classification. Best Practice and Research Clinical Hematology. 2003;15(4):597-621.
- National Cancer Institute, SEER Stat Fact Sheets. Available at: http://seer.cancer.gov/statfacts/html/alyl_print.html. Accessed November 8, 2006.
- American Cancer Society. Overview: Leukemia – Acute Lymphocytic (ALL): How Many People Get Acute Leukemia? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_
How_many_people_get_acute_leukemia_57.asp. Accessed November 8, 2006.
- Smith MA, Ries LA, Gurney JG, Ross JA. Leukemia. In: Ries LA, Smith MA, Gurney JG, et al, eds. Cancer incidence and survival among children and adolescents: United States SEER Program 1975-1995. Bethesda, Md: National Cancer Institute, SEER Program, 1999. NIH Pub. No. 99-4649;17-34.
- Randolph TR. Advances in acute lymphoblastic leukemia. Clin Lab Sci.
2004;17(4):235.
- Goldberg JM, Silverman LB, Levy DE, et al. Childhood T-cell acute lymphoblastic leukemia: the Dana-Farber Cancer Institute acute lymphoblastic leukemia consortium experience. J Clin Oncol. 2003;21:3616-3622.
- American Cancer Society. Detailed Guide: Leukemia – Acute Lymphocytic (ALL). Available at: http://www.cancer.org/docroot/CRI/content/
CRI_2_4_7x_CRC_Leukemia_Acute_Lymphocytic_PDF.asp. Accessed November 8, 2006.
- American Cancer Society. Detailed Guide: Leukemia – Children’s: Treatment of Children with Acute Lymphocytic Leukemia. Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_4X_
Treatment_of_Children_with_Acute_Lymphocytic_Leukemia_24.asp. Accessed November 8, 2006.
- Hoelzer D, Gökbuget N. Treatment of lymphoblastic lymphoma in adults. Best Practice and Research Clinical Hematology. 2003;15(4):713-728.
- American Cancer Society. Detailed Guide: Childhood Non-Hodgkin’s Lymphoma. Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_7x_
CRC_Non_Hodgkins_Lymphoma_in_Children_PDF.asp. Accessed November 8, 2006.
- American Cancer Society. Detailed Guide: Lymphoma, Non-Hodgkin’s. Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_7x_
CRC_Non_Hodgkins_Lymphoma_In_Adults_PDF.asp. Accessed November 8, 2006.
- National Cancer Institute. Adult Non-Hodgkin’s Lymphoma (PDQ®): Treatment. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/
adult-non-hodgkins/HealthProfessional/allpages. Accessed November 8, 2006.
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.
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