Nelarabine is a nucleoside metabolic inhibitor sold in the U.S. under 2 brand and generic names, for t-cell leukemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Arranon (application NDA021877). Other nelarabine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Adult Dose : 1,500 mg/m 2 administered by intravenous infusion over 2 hours on Days 1, 3, and 5 repeated every 21 days. ( 2.1 ) • Pediatric Dose : 650 mg/m 2 administered by intravenous infusion over 1 hour daily for 5 consecutive days repeated every 21 days. ( 2.1 ) • Discontinue treatment for neurologic reactions greater than or equal to Grade 2. ( 2.2 ) • Dosage may be delayed for hematologic reactions. ( 2.2 ) • Take measures to prevent hyperuricemia. ( 2.4 ) 2.1 Recommended Dosage This product is for intravenous use only. Adult Dosage : The recommended adult dose of ARRANON is 1,500 mg/m 2 administered by intravenous infusion over 2 hours on Days 1, 3, and 5 repeated every 21 days. Administer ARRANON undiluted. Pediatric Dosage : The recommended pediatric dose of ARRANON is 650 mg/m 2 administered by intravenous infusion over 1 hour daily for 5 consecutive days repeated every 21 days. Administer ARRANON undiluted. The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for hematopoietic stem cell transplantation (HSCT), or the patient no longer continued to benefit from treatment. 2.2 Dosage Modification Discontinue…
The following clinically-significant adverse reactions are discussed in greater detail in other sections of the label: • Neurologic [see Boxed Warning, Warnings and Precautions (5.1)] • Hematologic [see Warnings and Precautions (5.2)] • Tumor Lysis Syndrome [see Warnings and Precautions (5.4)] • Effects on Ability to Drive and Use Machines [see Warnings and Precautions (5.6)] The most common (≥ 20%) adverse reactions were: • Adult : anemia, thrombocytopenia, neutropenia, nausea, diarrhea, vomiting, constipation, fatigue, pyrexia, cough, and dyspnea. ( 6.1 ) • Pediatric : anemia, neutropenia, thrombocytopenia, and leukopenia. ( 6.1 ) The most common (> 10%) neurological adverse reactions were: • Adult : somnolence, dizziness, peripheral neurologic disorders, hypoesthesia, headache, and paresthesia. ( 6.1 ) • Pediatric : headache and peripheral neurologic disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory T-ALL and T-LBL ARRANON was studied in 459 patients in Phase I and…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None. None. (4)
Administration of ARRANON in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended [see Clinical Pharmacology (12.3)] . Administration in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended. ( 7 , 12.3 )
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