Arranon (nelarabine)

The optimal duration of treatment in adult or pediatric patients has not been clearly established. In clinical trials, treatment generally was continued until evidence of disease progression, unacceptable toxicity, bone marrow transplantation, or lack of clinical benefit was observed or until patients became candidates for bone marrow transplantation.

Nelarabine should be discontinued in patients experiencing neurotoxicity of NCI Common Toxicity Criteria grade 2 or greater. (See Neurotoxicity under Warnings/Precautions: Warnings, in Cautions.) Dosage may be delayed for other toxicity (e.g., hematologic toxicity).

Nelarabine is administered by IV infusion over 2 hours in adults and over 1 hour in children. Nelarabine injection should not be diluted prior to administration. The appropriate dose of nelarabine should be withdrawn from the required number of vials and transferred into empty polyvinylchloride (PVC) infusion bags or glass containers prior to administration. The drug should be inspected visually for particulate matter and discoloration prior to administration.

Appropriate measures (e.g., administration of IV fluids, allopurinol, and alkalinization of urine) should be taken to prevent hyperuricemia of tumor lysis syndrome. (See Tumor Lysis Syndrome under Warnings/Precautions: Warnings, in Cautions.)

The usual precautions for handling and preparing solutions of cytotoxic drugs should be observed when preparing or administering nelarabine.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to nelarabine or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in 5% or more of adults receiving nelarabine include anemia, thrombocytopenia, neutropenia, febrile neutropenia, somnolence, dizziness, peripheral neurologic disorders, peripheral neuropathy, peripheral motor neuropathy, peripheral sensory neuropathy, hypoesthesia, headache, paresthesia, ataxia, depressed level of consciousness, tremor, fatigue, pyrexia, asthenia, confusion, insomnia, depression, muscular weakness, myalgia, arthralgia, back pain, extremity pain, abnormal gait, nausea, diarrhea, vomiting, constipation, abdominal pain, anorexia, stomatitis, abdominal distension, sinus tachycardia, peripheral edema, edema, pain, rigors, chest pain, noncardiac chest pain, infection, pneumonia, sinusitis, increased serum AST concentrations, dehydration, hyperglycemia, cough, dyspnea, pleural effusion, epistaxis, exertional dyspnea, wheezing, petechiae, and hypotension.

Adverse effects reported in 5% or more of pediatric patients receiving nelarabine include anemia, neutropenia, thrombocytopenia, leukopenia, headache, peripheral neurologic disorders, peripheral neuropathy, peripheral sensory neuropathy, somnolence, hypoesthesia, seizures, increased serum transaminase concentrations, hyperbilirubinemia, hypoalbuminemia, hypokalemia, hypocalcemia, increased serum creatinine concentrations, hypoglycemia, hypomagnesemia, vomiting, asthenia, and infection.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy for treatment of relapsed or refractory T-cell ALL and T-cell lymphoblastic lymphoma have been established in patients 2.5-21 years of age. (See Pediatric Patients under Acute Lymphocytic Leukemia: Acute T-cell Leukemia, in Uses.)

Category D. (See Users Guide.) (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Not known whether nelarabine or ara-G is distributed into human milk; discontinue nursing during nelarabine therapy.

Experience in those 65 years of age and older insufficient to determine whether they respond differently from younger adults. Incidence of adverse neurologic effects appears to increase with increasing age, especially in those 65 years of age and older. Renal impairment, which occurs more commonly in geriatric patients, may result in reduced clearance of ara-G.