ARRANON:
an option in the fight against relapsed and refractory
T-ALL (T-Cell Acute Lymphoblastic Leukemia) and T-LBL (T-Cell Lymphoblastic Lymphoma)
affecting children and adults
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 2 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.
WARNING[1]
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.
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IMPORTANT SAFETY INFORMATION[1]
In clinical studies of ARRANON, hematologic toxicity was the most common grade 3 (moderate) or 4 (severe) adverse event. Hematologic toxicity in pediatric patients included neutropenia (grade 3: 17%; grade 4+: 62%), thrombocytopenia (grade 3: 27%; grade 4+: 32%), anemia (grade 3: 45%; grade 4+: 10%), and leukopenia (grade 3: 14%; grade 4+: 7%). Hematologic toxicity in adult patients included anemia (grade 3: 20%; grade 4+: 14%), thrombocytopenia (grade 3: 37%; grade 4+: 22%), and neutropenia (grade 3: 14%; grade 4+: 49%).
Of the nonhematologic adverse events in the pediatric patients, the most frequent (>10%) events reported (all grades) were headache (17%), peripheral neurologic disorder (any event; 12%), increased transaminase levels (12%), decreased blood potassium (11%), decreased blood albumin (10%), increased blood bilirubin (10%), and vomiting (10%). For a complete list and incidence of adverse events, see complete Prescribing Information.
Other common toxicities reported (>10%) in the adult patients (all grades) included fatigue (50%), pyrexia (23%), asthenia (17%), peripheral edema (15%), myalgia (13%), edema (11%), pain (11%); gastrointestinal (GI) disorders such as nausea (41%), diarrhea (22%), vomiting (22%), constipation (21%); respiratory disorders such as cough (25%), dyspnea (20%), plural effusion (10%); and nervous system disorders such as somnolence (23%), dizziness (21%), peripheral neurologic disorder (any event; 21%), hypoesthesia (17%), headache (15%), and paresthesia (15%). For a complete list and incidence of adverse events, see complete Prescribing Information.
Neurotoxicity is the dose-limiting toxicity of nelarabine (ARRANON). Patients undergoing therapy with ARRANON should be closely observed for signs and symptoms of neurologic toxicity. Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation may be at increased risk for neurologic adverse events.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ARRANON.
Nursing should be discontinued in women who are receiving therapy with ARRANON.
Appropriate measures (eg, hydration, urine alkalinization, and prophylaxis with allopurinol) must be taken to prevent hyperuricemia of tumor lysis syndrome.
Because the risk of adverse reaction 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 reaction 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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Prescribing Information for ARRANON | Important Safety Information| Patient Information Leaflet
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Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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