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LABELS · 0015d51c-784c-4f0d-938c-6c81decd5903

Arranon

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-03-31
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: NEUROLOGIC ADVERSE REACTIONS Severe neurologic adverse reactions have been reported with the use of ARRANON ® . These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome [see Warnings and Precautions (5.1)]. Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Monitor frequently for signs and symptoms of neurologic toxicity during treatment with ARRANON. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater [see Warnings and Precautions (5.1)]. WARNING: NEUROLOGIC ADVERSE REACTIONS See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of ARRANON. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome. ( 5.1 ) Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Monitor frequently for signs and symptoms of neurologic toxicity. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ( 1 )
Full extracted label fields
application numbers
  1. NDA021877
boxed warning exact
  1. WARNING: NEUROLOGIC ADVERSE REACTIONS Severe neurologic adverse reactions have been reported with the use of ARRANON ® . These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome [see Warnings and Precautions (5.1)]. Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Monitor frequently for signs and symptoms of neurologic toxicity during treatment with ARRANON. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater [see Warnings and Precautions (5.1)]. WARNING: NEUROLOGIC ADVERSE REACTIONS See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of ARRANON. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome. ( 5.1 ) Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Monitor frequently for signs and symptoms of neurologic toxicity. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater. ( 5.1 )
brand names
  1. Arranon
current indication status
not_reconciled
dailymed set url
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generic names
  1. NELARABINE
id
0015d51c-784c-4f0d-938c-6c81decd5903
indications and usage exact
  1. 1 INDICATIONS AND USAGE ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ( 1 )
indications and usage tables exact
    is original packager
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    manufacturer names
    1. Sandoz Inc
    matched search terms
    1. lymphoma
    2. leukemia
    package ndcs
    1. 66758-165-94
    product ndcs
    1. 66758-165
    product types
    1. HUMAN PRESCRIPTION DRUG
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        payload
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        8. Appl No
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          Application Docs ID
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          Submission No
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          STANDARD
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        4. Appl No
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          STANDARD
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        8. Appl No
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          STANDARD
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          Submission No
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          STANDARD
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          Submission Status Date
          2025-03-11 00:00:00
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        approval interpretation
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        openfda application present
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        products
        1. Active Ingredient
          NELARABINE
          Appl No
          021877
          Drug Name
          ARRANON
          Form
          INJECTABLE;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          250MG/50ML (5MG/ML)
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
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      1 INDICATIONS AND USAGE ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric p
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          1 INDICATIONS AND USAGE ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.
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          -cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ( 1 )
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                    Preserved source evidence · Not medical advice