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About ARRANON
Indications [1]:
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.
The safety and efficacy of ARRANON were evaluated in two open-label, single-arm, multicenter studies.
Pediatric Study Design
- Patients 21 years of age and younger, who had relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)
- Eighty-four (84) patients, 39 of whom had received two or more prior induction regimens
- Treated with 650 mg/m²/day of ARRANON administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days
- Patients who experienced signs or symptoms of grade 2 or greater neurologic toxicity on therapy were to be discontinued from further therapy with ARRANON
Adult Study Design
- 39 treated patients, 28 who had T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) that had relapsed following or was refractory to at least two prior induction regimens
- ARRANON 1,500 mg/m² was administered intravenously over 2 hours on days 1, 3 and 5 repeated every 21 days
- Patients who experienced signs or symptoms of grade 2 or greater neurologic toxicity on therapy were to be discontinued from further therapy with ARRANON
Clinical Benefits of ARRANON [1]
- Induction of complete remission
– Pediatric CR+CR*=23% [9 of 39] (95% CI: 11%, 39%)
– Adult CR+CR*=21% [6 of 28] (95% CI: 8%, 41%)
– Effective in both relapsed and refractory disease
- Duration of CR+CR* (range in weeks)
– Pediatric: 3.3 to 9.3
– Adult: 4 to 195+
- May induce remission to allow for transplantation opportunity
CR=complete response defined as bone marrow blast counts ≤ 5%, no other evidence of disease, and full recovery of peripheral blood counts.
CR*=complete reponse without hematologic recovery.
Learn more about ARRANON, including:
Additional Important Safety Information
Drug Rationale
Mechanism of Action
Pharmacokinetics
Clinical Data and Efficacy
Dosage and Administration
Product Availability and Stability
For more information about acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL), visit the following pages on this site:
T-Cell Acute Lymphoblastic Leukemia (T-ALL)
T-Cell Lymphoblastic Lymphoma (T-LBL)
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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