Generic Name and Formulations:
Nelarabine 250mg/50mL; soln for IV infusion.
Novartis Pharmaceuticals Corp
Indications for ARRANON:
T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) that is unresponsive or has relapsed after ≥2 chemotherapy regimens.
Give by IV infusion over 2hrs. 1500mg/m2 on days 1, 3, and 5; repeat every 21 days. In clinical trials, treatment was generally continued until there was evidence of disease progression, patient experienced unacceptable toxicity, patient became a candidate for bone marrow transplant, or patient no longer continued to benefit from treatment. See full labeling.
Give by IV infusion over 1hr. 650mg/m2 daily for 5 consecutive days; repeat every 21 days. In clinical trials, treatment was generally continued until there was evidence of disease progression, patient experienced unacceptable toxicity, patient became a candidate for bone marrow transplant, or patient no longer continued to benefit from treatment. See full labeling.
Neurologic adverse reactions.
Monitor closely for neurotoxicity; discontinue if ≥Grade 2 occurs. Prior or concurrent intrathecal chemotherapy or craniospinal irradiation (increased risk of neurotoxicity). May delay dosing if other toxicities occur (eg, hematologic toxicity). Monitor CBCs, platelet counts regularly, and for signs of infection. Moderate-to-severe renal or severe hepatic impairment; monitor. Ensure adequate hydration. Consider allopurinol for patients at risk for hyperuricemia. Elderly. Embryo-fetal toxicity. Use effective contraception during therapy and for 3 months (males) after last dose. Pregnancy; verify status prior to initiation. Nursing mothers: not recommended.
Avoid live vaccines in immunocompromised. Concomitant adenosine deaminase inhibitors (eg, pentostatin): not recommended.
Anemia, thrombocytopenia, neutropenia, nausea, vomiting, diarrhea, constipation, fatigue, pyrexia, cough, dyspnea, somnolence, dizziness, peripheral neuropathy, hypoesthesia, headache, paresthesia; tumor lysis syndrome (monitor).
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