ARRANON（nelarabine）injection
nelarabine - Drug Summary
CLASSES
Purine Analogs
BOXED WARNING
Chemotherapy, driving or operating machinery, geriatric, neurological disease, peripheral neuropathy, radiation therapy, seizures
Patients should be closely monitored for signs and symptoms of neurological disease toxicity during nelarabine therapy. Severe neurologic events have been reported during nelarabine therapy such as altered mental status, severe somnolence, CNS effects including seizures, peripheral neuropathies ranging from numbness and paresthesias to motor weakness and paralysis, demyelination, and ascending peripheral neuropathies similar to Guillain-Barre syndrome. Full recovery from these events has not always occurred with nelarabine cessation. Patients previously treated with or concurrently receiving intrathecal chemotherapy or previously treated with craniospinal radiation therapy may be at increased risk for neurologic adverse events. If patients develop neurotoxicity consistent with National Cancer Institute (NCI) Common Toxicity Criteria grade 2 or greater, nelarabine therapy should be discontinued. Patients should contact their healthcare provider if they experience new or worsening peripheral neuropathy. As nelarabine may cause somnolence, patients should be cautioned about driving or operating machinery during nelarabine therapy. Geriatric patients (> 65 years) may experience an increased incidence of neurologic toxicities.
DEA CLASS
Rx
DESCRIPTION
Pro-drug of the purine analog deoxyguanosine analogue 9-ß-Darabinofuranosylguanine (ara-G); approved for treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma that has not responded to or has relapsed after treatment with at least two chemotherapy regimens.
COMMON BRAND NAMES
Arranon
HOW SUPPLIED
Arranon/Nelarabine Intravenous Inj Sol: 1mL, 5mg
DOSAGE & INDICATIONS
For the treatment of T-cell leukemia/lymphoma.
For the treatment of T-cell leukemia/lymphoma in patients at first relapse or with refractory disease†.
Intravenous dosage
Adults
1.5 grams/m2 IV over 2 hours on days 1, 3, and 5 (repeated after day 22—29 if residual disease was detected following a bone marrow biopsy) has been studied. Nelarabine produced an overall response rate of 55% (complete remission (CR) + CR without complete hematologic recovery rate, 36%), a median overall survival (OS) of 19.8 weeks, and a 1-year OS rate of 36% in a subpopulation of 11 adult patients in a multicenter phase II study. Patients who achieved a CR could receive 2 additional cycles of consolidation therapy with nelarabine in this study.
Infants >= 2 months, Children, and Adolescents
650 mg/m2/day IV over 1 hour for 5 days repeated every 3 weeks has been studied. Nelarabine led to an overall response rate (ORR) of 55% (complete remission rate, 48%) in 33 pediatric patients in a multicenter, 4-arm, phase II trial.
For the treatment of T-cell leukemia/lymphoma in patients who have not responded to or have relapsed following treatment with at least 2 chemotherapy regimens.
Intravenous dosage
Adults
1500 mg/m2 IV over 2 hours on days 1, 3, and 5 repeated every 21 days led to complete response (CR) (<= 5% bone marrow blasts, no other evidence of disease, and full hematologic recovery) plus CR without hematologic recovery rate of 21% in 28 adult patients. The duration of CR (with and without hematologic recovery) wa |
