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LABELS · 4a616d65-765b-401c-abf3-8135df106493

DOXIL

Open original source → · Download preserved record

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
2026-03-10
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS • DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion and during and after treatment [see Warnings and Precautions (5.1) ] . • Serious, life-threatening, and fatal infusion-related reactions can occur with DOXIL liposomal infusion Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions [see Warnings and Precautions (5.2) ] . WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS See full prescribing information for complete boxed warning. • DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion, during treatment, and after treatment ( 5.1 ). • Serious, life-threatening, and fatal infusion‑related reactions can occur. Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions ( 5.2 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE DOXIL liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) • AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) • Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3 ) 1.1 Ovarian Cancer DOXIL liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi’s Sarcoma DOXIL liposomal infusion is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. 1.3 Multiple Myeloma DOXIL liposomal infusion, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
Full extracted label fields
application numbers
  1. NDA050718
boxed warning exact
  1. WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS • DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion and during and after treatment [see Warnings and Precautions (5.1) ] . • Serious, life-threatening, and fatal infusion-related reactions can occur with DOXIL liposomal infusion Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions [see Warnings and Precautions (5.2) ] . WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS See full prescribing information for complete boxed warning. • DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion, during treatment, and after treatment ( 5.1 ). • Serious, life-threatening, and fatal infusion‑related reactions can occur. Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions ( 5.2 ).
brand names
  1. DOXIL
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=917eddf9-1d3f-4abe-8c81-d33b066e5bae
generic names
  1. DOXORUBICIN HYDROCHLORIDE
id
4a616d65-765b-401c-abf3-8135df106493
indications and usage exact
  1. 1 INDICATIONS AND USAGE DOXIL liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) • AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) • Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3 ) 1.1 Ovarian Cancer DOXIL liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi’s Sarcoma DOXIL liposomal infusion is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. 1.3 Multiple Myeloma DOXIL liposomal infusion, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Baxter Healthcare Corporation
    matched search terms
    1. cancer
    2. sarcoma
    3. myeloma
    package ndcs
    1. 0338-9667-01
    2. 0338-9665-01
    product ndcs
    1. 0338-9665
    2. 0338-9667
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      meta
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      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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      spl effective date
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      spl effective time
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      substance names
      1. DOXORUBICIN HYDROCHLORIDE
      uniis
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      Drugs@FDA application source records
      1. application number
        NDA050718
        payload
        all indexed label documents
        1. Appl No
          050718
          Application Docs Date
          2004-11-01 00:00:00
          Application Docs ID
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          Application Docs Type ID
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          Submission No
          19
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          Application Docs Date
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          Application Docs ID
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          Application Docs Type ID
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          Application Docs ID
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          48
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        5. Appl No
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          Application Docs Date
          1999-06-28 00:00:00
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          6
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          050718
          Application Docs Date
          2007-05-29 00:00:00
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          39172
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          0
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          2
          Submission No
          28
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          050718
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          29
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        8. Appl No
          050718
          Application Docs Date
          2008-06-19 00:00:00
          Application Docs ID
          39174
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          33
          Submission Type
          SUPPL
        9. Appl No
          050718
          Application Docs Date
          2013-09-09 00:00:00
          Application Docs ID
          39175
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          45
          Submission Type
          SUPPL
        10. Appl No
          050718
          Application Docs Date
          2015-01-29 00:00:00
          Application Docs ID
          39176
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          46
          Submission Type
          SUPPL
        11. Appl No
          050718
          Application Docs Date
          2017-07-20 00:00:00
          Application Docs ID
          49020
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          0
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          2
          Submission No
          51
          Submission Type
          SUPPL
        12. Appl No
          050718
          Application Docs Date
          2019-08-13 00:00:00
          Application Docs ID
          59692
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          0
          Application Docs Type ID
          2
          Submission No
          55
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          Submission Status Date
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        2. Appl No
          050718
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submissions Public Notes
        3. Appl No
          050718
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          2019-08-12 00:00:00
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        4. Appl No
          050718
          Review Priority
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        5. Appl No
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          Review Priority
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        6. Appl No
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        7. Appl No
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        8. Appl No
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          050718
          Review Priority
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          Submissions Public Notes
        10. Appl No
          050718
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
          2013-08-30 00:00:00
          Submission Type
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          Submissions Public Notes
        11. Appl No
          050718
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submissions Public Notes
        12. Appl No
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          Review Priority
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          Submission No
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        latest approved submission date
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          Application Docs Date
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          Application Docs ID
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        Appl No
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        Appl Public Notes
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        Sponsor Name
        BAXTER HLTHCARE CORP
        openfda application present
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        products
        1. Active Ingredient
          DOXORUBICIN HYDROCHLORIDE
          Appl No
          050718
          Drug Name
          DOXIL (LIPOSOMAL)
          Form
          INJECTABLE, LIPOSOMAL;INJECTION
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          20MG/10ML (2MG/ML)
          marketing status
          1. Prescription
        2. Active Ingredient
          DOXORUBICIN HYDROCHLORIDE
          Appl No
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          Drug Name
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          Form
          INJECTABLE, LIPOSOMAL;INJECTION
          Product No
          002
          Reference Drug
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          Reference Standard
          0
          Strength
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          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 · indication intro context
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      1 INDICATIONS AND USAGE DOXIL liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) • AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) • Multiple
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            1 INDICATIONS AND USAGE DOXIL liposomal infusion is an anthracycline topoisomerase inhibitor indicated for:
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            1 INDICATIONS AND USAGE DOXIL liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) • AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) • Multiple Myeloma: In combination with bortezomib in patients who have not previo
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                  1 INDICATIONS AND USAGE DOXIL liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) • AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) • Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3 ) 1.1 Ovarian Cancer DOXIL liposomal infu
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                                        Preserved source evidence · Not medical advice