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Arranon (Nelarabine) - Summary

 

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WARNING

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.

 

ARRANON SUMMARY

ARRANON®
(nelarabine)
Injection
FOR INTRAVENOUS USE

ARRANON (nelarabine) is a pro-drug of the cytotoxic deoxyguanosine analogue, 9-β- D -arabinofuranosylguanine (ara-G).

ARRANON is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma 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.

ARRANON NEWS HIGHLIGHTS

Published Studies Related to Arranon (Nelarabine)

Phase I trial of nelarabine in indolent leukemias. [2008.03.01]

Nelarabine. [2008]

Three new drugs for acute lymphoblastic leukemia: nelarabine, clofarabine, and forodesine. [2007.12]

Nelarabine: a novel purine antimetabolite antineoplastic agent. [2007.09]

Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801. [2007.06.15]

more>>

Clinical Trials Related to Arranon (Nelarabine)

Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma [Recruiting]

506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL) [Recruiting]

Hyper-CVAD Plus Nelarabine in Untreated T-ALL/Lymphoblastic Lymphoma [Recruiting]

506U78 in Treating Patients With Refractory Hematologic Cancer [Active, not recruiting]

506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-Cell Lymphoma [Completed]

more>>

Page last updated: 2008-08-10

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