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Arranon (Nelarabine): Uses, Side Effects and Dosage

Status:
Prescription (Rx) Boxed warning Facts
Strength:
5 mg/mL
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

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

What is the most important information I should know about ARRANON?

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

ARRANON 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 ARRANON is stopped.

What is ARRANON?

ARRANON 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 ARRANON?

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 ARRANON passes through breast milk. You should not breastfeed during treatment with ARRANON.

  • are pregnant or plan to become pregnant. ARRANON can harm your unborn baby. You should not become pregnant while you are taking ARRANON. 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 ARRANON and for 3 months after last dose.

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

How is ARRANON given?

ARRANON 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 ARRANON?

  • You or your child should not drive or operate dangerous machines. ARRANON 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 ARRANON.

What are the possible side effects of ARRANON?

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

ARRANON 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 ARRANON. This is because on rare occasions, muscle problems can be serious.

These are not all the side effects associated with ARRANON. 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 ARRANON

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

For more information go to www.sandoz.com or call 1-800-525-8747.

Manufactured by

FAREVA Unterach GmbH,

Mondseestraße 11

4866 Unterach am Attersee, Austria for

Sandoz Inc., Princeton, NJ 08540

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021877 · View the label on DailyMed

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

Drug information for Arranon

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) SANDOZ
FDA approval NDA 021877New Drug Application (NDA) Approved October 28, 2005
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Nelarabine with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
5 mg/mL – 50 ml in 1 vial / 1 in 1 carton NDC 66758-165-94

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.