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Nelarabine (Arranon): Uses, Side Effects and Dosage

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Prescription (Rx) Boxed warning
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5 mg/mL
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Nelarabine

What is the most important information I should know about nelarabine injection?

Nelarabine injection may cause blood related adverse reactions. Your doctor will do blood tests regularly during treatment to monitor blood counts, including platelets.

Nelarabine injection may cause serious nervous system problems including:

  • extreme sleepiness
  • seizures
  • coma
  • numbness and tingling in the hands, fingers, feet, or toes (peripheral neuropathy)
  • weakness and paralysis

Call the doctor right away if you or your child has the following symptoms:

  • seizures
  • numbness and tingling in the hands, fingers, feet, or toes
  • problems with fine motor skills such as buttoning clothes
  • unsteadiness while walking
  • increased tripping while walking
  • weakness when getting out of a chair or walking upstairs

These symptoms may not go away even when treatment with nelarabine injection is stopped.

What is nelarabine injection?

Nelarabine injection is an anti-cancer medicine used to treat adults and children who have:

  • T-cell acute lymphoblastic leukemia (T-ALL)
  • T-cell lymphoblastic lymphoma (T-LBL)

What should you tell the doctor before you or your child starts nelarabine injection?

Tell the doctor about all health conditions you or your child have, including if you or your child:

  • have any nervous system problems.
  • have kidney problems.

  • are breastfeeding or plan to breastfeed. It is not known whether nelarabine passes through breast milk. You should not breastfeed during treatment with nelarabine injection.

  • are pregnant or plan to become pregnant. Nelarabine injection can harm your unborn baby. You should not become pregnant while you are taking nelarabine injection. You should use effective birth control to avoid getting pregnant. Talk with your doctor about your choices.
  • are male (including if you have had a vasectomy) with a sexual partner who is pregnant, think that they may be pregnant, or who could become pregnant. You should use condoms during sexual intercourse during treatment with nelarabine injection and for 3 months after last dose.

Tell the doctor about all the medicines you or your child take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

How is nelarabine injection given?

Nelarabine injection is an intravenous medicine. This means it is given through a tube in your vein.

What should you or your child avoid during treatment with nelarabine injection?

  • You or your child should not drive or operate dangerous machines. Nelarabine injection may cause sleepiness during and for several days after treatment.
  • You or your child should not receive vaccines made with live germs during treatment with nelarabine injection.

What are the possible side effects of nelarabine injection?

Nelarabine injection may cause serious nervous system problems. See “What is the most important information I should know about nelarabine injection?”

Nelarabine injection may also cause:

  • decreased blood counts such as low red blood cells, low white blood cells, and low platelets. Blood tests should be done regularly to check blood counts. Call the doctor right away if you or your child:
  • is more tired than usual, pale, or has trouble breathing
  • has a fever or other signs of an infection
  • bruises easy or has any unusual bleeding
  • stomach area problems such as nausea, vomiting, diarrhea, and constipation
  • headache
  • sleepiness
  • blurry eyesight

Call your doctor right away if you experience unexplained muscle pain, tenderness, or weakness while taking nelarabine injection. This is because on rare occasions, muscle problems can be serious.

These are not all the side effects associated with nelarabine injection. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General Advice about nelarabine injection.

This leaflet summarizes important information about nelarabine injection. If you have questions or problems, talk with your or your child’s doctor. You can ask your doctor or pharmacist for information about nelarabine injection that is written for healthcare providers.

For more information go to www.amneal.com or call 1-877-835-5472.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Amneal Oncology Pvt. Ltd.

Telangana 509301, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 12-2025-03

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 216346 · View the label on DailyMed

Revision date stated in the text: December 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Nelarabine

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Nucleoside Metabolic Inhibitor
Active ingredient Nelarabine 5 mg/mL
Dosage form Injection
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) AMNEAL
FDA approval ANDA 216346Abbreviated New Drug Application (ANDA) – generic drug Approved April 4, 2023
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Arranon with the same TE code
Manufacturers 13 labelers list this drug on DailyMed
Recalls
  • February 13, 2025: Class II recall: Failed Impurities/Degradation Specifications
  • February 13, 2025: Class II recall: Failed Impurities/Degradation Specifications
Packages (NDC)
Package
5 mg/mL – 50 ml in 1 vial, single-dose / 6 in 1 carton NDC 70121-1743-4
5 mg/mL – 50 ml in 1 vial, single-dose / 1 in 1 carton NDC 70121-1743-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.