ARRANON nelarabine

Get an overview of ARRANON (nelarabine injection), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in ARRANON can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as ARRANON.

Drug Basics

Brand Name: ARRANON

Generic Name: NELARABINE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: INJECTION

Data Current As Of: 2018-10-05

indications & usage

ARRANON is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

drug interactions

Administration of nelarabine in combination with adenosine deaminase inhibitors, such as pentostatin, is not recommended [see Clinical Pharmacology (12.3)].

patient counseling information

Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information. However, inform the patients of the following:

  • Since patients receiving nelarabine therapy may experience somnolence, they should be cautioned about operating hazardous machinery, including automobiles.
  • Patients should be instructed to contact their physician if they experience new or worsening symptoms of peripheral neuropathy (see Boxed Warning, Warnings and Precautions (5.1), Dosage and Administration (2.3)]. These signs and symptoms include: tingling or numbness in fingers, hands, toes, or feet; difficulty with the fine motor coordination tasks such as buttoning clothing; unsteadiness while walking; weakness arising from a low chair; weakness in climbing stairs; increased tripping while walking over uneven surfaces.
  • Patients should be instructed that seizures have been known to occur in patients who receive nelarabine. If a seizure occurs, the physician administering ARRANON should be promptly informed.
  • Patients who develop fever or signs of infection while on therapy should notify their physician promptly.
  • Patients should be advised to use effective contraceptive measures to prevent pregnancy and to avoid breastfeeding during treatment with ARRANON.

ARRANON is a registered trademark of the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2014, the GSK group of companies. All rights reserved.

ARR:3PI

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

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PATIENT INFORMATION LEAFLET

ARRANON® (AIR-ra-non)

(nelarabine) Injection

Read the Patient Information that comes with ARRANON before you or your child starts treatment with ARRANON. Read the information you get each time before each treatment with ARRANON. There may be new information. This information does not take the place of talking with the doctor about your or your child’s medical condition or treatment. Talk to your or your child’s doctor, if you have any questions.

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

ARRANON may cause serious nervous system problems including:

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 up stairs

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-cell lymphoblastic lymphoma

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 may harm an unborn baby. You should use effective birth control to avoid getting pregnant. Talk with your doctor about your choices.

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.
  • 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 or it is available at www.GSK.com.

ARRANON is a registered trademark of the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2014, the GSK group of companies. All rights reserved.

December 2014

ARR:3PIL

PRINCIPAL DISPLAY PANEL

NDC 00707-4401-06

ARRANON®

(nelarabine) Injection

For I.V. Infusion Only

250 mg / 50 mL

(5 mg / mL)

Rx only

Six 50-mL Vials

Made in England

©2015, the GSK group of companies.

  •  10000000131765 Rev. 2/15

Arranon spl graphic 02.jpg

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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