Nelarabine: uses, dosing, side effects & brands
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.
Key facts
- Drug class
- Nucleoside Metabolic Inhibitor
- Treats
- T-Cell Leukemia
- Available as
- Injectable
- Sold as
- 2 products — Arranon and Nelarabine
- Prescription?
- Prescription only
- Generic available?
- Yes
- Boxed warning
- Boxed warning
How nelarabine is dosed
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 ARRANON if the patient…
Nelarabine side effects
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…
Who shouldn’t take nelarabine
None. None. (4)
Nelarabine drug interactions
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 )
Every nelarabine product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
Nelarabine recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long nelarabine keeps
No nelarabine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does nelarabine expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about nelarabine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 768 reports naming nelarabine, and the FDA flagged 98% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia54 reports
- neurotoxicity52 reports
- peripheral sensory neuropathy49 reports
- myelopathy48 reports
- sepsis45 reports
- muscular weakness40 reports
- neuropathy peripheral40 reports
- neutropenia38 reports
Read these as a signal, not a rate. A report does not mean nelarabine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is nelarabine?
ARRANON (nelarabine) is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D -arabinofuranosylguanine (ara-G).
What kind of drug is nelarabine?
The FDA classifies nelarabine as a nucleoside metabolic inhibitor. Nucleoside metabolic inhibitors are fake DNA building blocks that fast-dividing cancer cells mistake for the real thing. Once inside, they get incorporated into the cell's DNA and also block enzymes such as ribonucleotide reductase, which together halt DNA copying and cause the cancer cell to die. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take nelarabine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run nelarabine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is nelarabine sold under?
We track 2 nelarabine-containing products in the U.S.: Arranon and Nelarabine. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does nelarabine come in?
Across the brands we track, nelarabine is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic nelarabine?
Yes. Our catalog lists 1 generic nelarabine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has nelarabine been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions nelarabine. The most recent: Nelarabine Injection (Feb 13, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Nelarabine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/nelarabine
- MLA
- “Nelarabine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/nelarabine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
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.
Read the full FDA label for nelarabine on DailyMed (NIH) ↗ — including its boxed warning in full.