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LABELS · 1aaa2d67-c709-f01c-026d-0eaa8f47c5d1

IVRA

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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
2025-09-04
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY and LEUKEMOGENICITY Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )] . Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] . Melphalan produces chromosomal aberrations in vitro and in vivo . IVRA should be considered potentially leukemogenic in humans [see Warnings and Precautions ( 5.5 )]. WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY and LEUKEMOGENICITY See full prescribing information for complete boxed warning. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters ( 5.1 ). Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions ( 5.4 ). Melphalan produces chromosomal aberrations in vitro and in vivo. IVRA should be considered potentially leukemogenic in humans ( 5.5 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. ( 1 )
Full extracted label fields
application numbers
  1. NDA217110
boxed warning exact
  1. WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY and LEUKEMOGENICITY Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )] . Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] . Melphalan produces chromosomal aberrations in vitro and in vivo . IVRA should be considered potentially leukemogenic in humans [see Warnings and Precautions ( 5.5 )]. WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY and LEUKEMOGENICITY See full prescribing information for complete boxed warning. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters ( 5.1 ). Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions ( 5.4 ). Melphalan produces chromosomal aberrations in vitro and in vivo. IVRA should be considered potentially leukemogenic in humans ( 5.5 ).
brand names
  1. IVRA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c23e868a-dc62-2181-5099-76c9226602b2
generic names
  1. MELPHALAN HCL
id
1aaa2d67-c709-f01c-026d-0eaa8f47c5d1
indications and usage exact
  1. 1 INDICATIONS AND USAGE Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. ( 1 )
indications and usage tables exact
    is original packager
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    1. Apotex Corp
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    1. myeloma
    package ndcs
    1. 60505-6414-1
    product ndcs
    1. 60505-6414
    product types
    1. HUMAN PRESCRIPTION DRUG
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      1. MELPHALAN HYDROCHLORIDE
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      Drugs@FDA application source records
      1. application number
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        payload
        all indexed label documents
        1. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Date
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          Application Docs ID
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          Submission No
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        all submission records
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          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submissions Public Notes
        2. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submissions Public Notes
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        approval interpretation
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        latest label selection rule
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        latest posted label documents
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          Application Docs Date
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          Application Docs ID
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          Application Docs Title
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        official application record
        Appl No
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        Appl Public Notes
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        Sponsor Name
        APOTEX
        openfda application present
        true
        products
        1. Active Ingredient
          MELPHALAN HYDROCHLORIDE
          Appl No
          217110
          Drug Name
          IVRA
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 90MG BASE/ML (EQ 90MG BASE/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.

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      1 INDICATIONS AND USAGE Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. ( 1 )
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            1 INDICATIONS AND USAGE Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
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            1 INDICATIONS AND USAGE Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. ( 1 )
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                IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
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                th multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. ( 1 )
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                      Preserved source evidence · Not medical advice