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Written By
P. Thirumal Reddy
B. Pharm

Reviewed By
Dr. Tejashwin Adiga
MBBS
Last updated : 30 Jul 2026 | 09:35 AM (IST)

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NELARABINE
Last updated on 30 Jul 2026 | 09:35 AM (IST)
NELARABINE
Background and Date of approval NELARABINE
Nelarabine is a nucleoside metabolic inhibitor medication that the Food and Drug Administration (FDA) approved on October 28, 2005. It is used to treat T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to or has relapsed after at least two chemotherapy regimens. Its approval is based on the induction of complete responses, though randomised trials showing increased survival have not been conducted.
Uses of NELARABINE
Nelarabine is used to treat T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to or has relapsed after at least two prior chemotherapy regimens. It is primarily indicated for patients with refractory or relapsed disease, aiming to induce complete remission.
How is NELARABINE administered?
Nelarabine will be administered by your healthcare professional in a hospital setting. It is important not to self-administer the medication, as it requires proper monitoring and administration by trained professionals to ensure safety and effectiveness.
Side Effects of NELARABINE
Side effects are unwanted symptoms caused by medicines. Although all drugs can cause side effects, not everyone experiences them.
Common side effects of Nelarabine:
- Decreased blood counts (low red blood cells, low white blood cells, low platelets)
- Fatigue or feeling more tired than usual
- Pale skin or difficulty breathing
- Fever or signs of infection
- Bruising easily or unusual bleeding
- Stomach issues such as nausea, vomiting, diarrhoea, and constipation
- Headache
- Sleepiness
- Blurry eyesight
Serious side effects of Nelarabine:
- Unexplained muscle pain, tenderness, or weakness (could be a sign of serious muscle problems)
Warnings
- Neurologic Adverse Reactions: You should monitor for signs of neurotoxicity, such as somnolence, confusion, convulsions, ataxia, paresthesias, and hypoesthesia. Severe reactions can include coma, status epilepticus, or Guillain-Barré-like syndrome.
- Hematologic Adverse Reactions: Be aware of risks like leukopenia, thrombocytopenia, anaemia, neutropenia, and febrile neutropenia. Regular blood count monitoring is essential.
- Pregnancy: Avoid using nelarabine if you are pregnant or planning to become pregnant, as it can harm the fetus, causing malformations and anomalies. Women should not become pregnant during treatment.
- Hyperuricemia: Administer intravenous hydration to manage the risk of tumour lysis syndrome and consider using allopurinol in patients at risk for hyperuricemia.
- Vaccinations: Avoid administering live vaccines to immunocompromised patients undergoing nelarabine treatment.
Precautions
Patients receiving nelarabine should be closely monitored for neurologic toxicity, including confusion or convulsions, as severe reactions like coma or Guillain-Barré syndrome may occur. Regular blood count checks are necessary to detect hematologic issues such as leukopenia or thrombocytopenia. Nelarabine should be avoided during pregnancy due to potential fetal harm, and live vaccines should not be given to immunocompromised patients on treatment.
Word of Advice
Follow your healthcare provider's instructions closely when receiving nelarabine, as it can cause serious side effects, including neurologic and hematologic issues. Attend all follow-up appointments for blood tests and monitoring. Tell your doctor if you're pregnant, planning to become pregnant, or breastfeeding, as nelarabine can harm the fetus. Avoid live vaccines during treatment and contact your doctor if you experience any unusual symptoms.
Frequently Asked Questions
Q1.
What is Nelarabine used for?
Nelarabine is used to treat T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to or has relapsed after at least two chemotherapy regimens.
Q2.
What is the classification of Nelarabine?
Nelarabine is classified as a nucleoside metabolic inhibitor. It is a chemotherapy drug that works by interfering with DNA synthesis in cancerous T-cells, leading to their death.
Q3.
When was nelarabine approved?
Nelarabine was approved by the U.S. Food and Drug Administration (FDA) on October 28, 2005. It was approved for the treatment of T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to or has relapsed after at least two prior chemotherapy regimens.
Q4.
How long does a nelarabine infusion take?
A nelarabine infusion typically takes about 1 hour to complete. However, the exact duration may vary depending on individual patient factors and the healthcare provider's instructions.
Q5.
Is Nelarabine a chemotherapy?
Yes, nelarabine is a chemotherapy drug. It works by targeting and killing cancerous T-cells in conditions like T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma.
References
1. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Nelarabine. [Updated 2020 May 1]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548515/
2. Boddu PC, Senapati J, Ravandi-Kashani F, Jabbour EJ, Jain N, Ayres M, Chen Y, Keating MJ, Kantarjian HM, Gandhi V, Kadia TM. A phase 1 study to evaluate the safety, pharmacology, and feasibility of continuous infusion nelarabine in patients with relapsed and/or refractory lymphoid malignancies.
https://pubmed.ncbi.nlm.nih.gov/36448227/
3. Kathpalia M, Mishra P, Bajpai R, Bhurani D, Agarwal N. Efficacy and safety of nelarabine in patients with relapsed or refractory T-cell acute lymphoblastic leukemia: a systematic review and meta-analysis. https://pubmed.ncbi.nlm.nih.gov/35727338/
4. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021877s005lbl.pdf
Disclaimer
The drug information on this page is not a substitute for medical advice, it is meant for educational purposes only. For further details consult your doctor about your medical condition to know if you are eligible to receive this treatment.






