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LABELS · 599caf4c-5f89-41b2-b3df-35f740593d7f

CARMUSTINE

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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
2026-04-09
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for Injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections, [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration (2.1) ] . Do not administer a repeat course of Carmustine for Injection until blood counts recover. Pulmonary Toxicity Carmustine for Injection causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg /m 2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] . WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY See full prescribing information for complete boxed warning • Suppression of marrow function, notably thrombocytopenia and leukopenia, is the most common and severe of the toxic effects of Carmustine for Injection. Monitor blood counts. (5, 6). • Pulmonary toxicity from Carmustine for Injection appears to be dose related. Patients receiving greater than 1400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less (5, 6).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Carmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 ) Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. Multiple myeloma in combination with prednisone. Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.
Full extracted label fields
application numbers
  1. NDA017422
boxed warning exact
  1. WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for Injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections, [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration (2.1) ] . Do not administer a repeat course of Carmustine for Injection until blood counts recover. Pulmonary Toxicity Carmustine for Injection causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg /m 2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] . WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY See full prescribing information for complete boxed warning • Suppression of marrow function, notably thrombocytopenia and leukopenia, is the most common and severe of the toxic effects of Carmustine for Injection. Monitor blood counts. (5, 6). • Pulmonary toxicity from Carmustine for Injection appears to be dose related. Patients receiving greater than 1400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less (5, 6).
brand names
  1. CARMUSTINE
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9b47082-32ee-4abb-a7b2-52292894d3f8
generic names
  1. CARMUSTINE
id
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indications and usage exact
  1. 1 INDICATIONS AND USAGE Carmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 ) Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. Multiple myeloma in combination with prednisone. Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
    matched search terms
    1. lymphoma
    2. lymphomas
    3. myeloma
    4. tumors
    5. glioma
    6. glioblastoma
    package ndcs
    1. 23155-790-41
    2. 23155-789-31
    3. 23155-788-31
    product ndcs
    1. 23155-790
    product types
    1. HUMAN PRESCRIPTION DRUG
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              NDA017422
              payload
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              1. Appl No
                017422
                Application Docs Date
                2007-08-21 00:00:00
                Application Docs ID
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                Application Docs Type ID
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                Submission No
                37
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              2. Appl No
                017422
                Application Docs Date
                2011-03-14 00:00:00
                Application Docs ID
                33262
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                38
                Submission Type
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              3. Appl No
                017422
                Application Docs Date
                2011-08-12 00:00:00
                Application Docs ID
                33263
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                42
                Submission Type
                SUPPL
              4. Appl No
                017422
                Application Docs Date
                2013-10-22 00:00:00
                Application Docs ID
                33264
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                46
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              5. Appl No
                017422
                Application Docs Date
                2016-06-17 00:00:00
                Application Docs ID
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                0
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                2
                Submission No
                50
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                017422
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                Application Docs ID
                47723
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                0
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                Submission No
                62
                Submission Status
                AP
                Submission Status Date
                2021-04-30 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                55
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              3. Appl No
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                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission Status
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                Submission Status Date
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                Submissions Public Notes
              4. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                49
                Submission Status
                AP
                Submission Status Date
                2015-11-25 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                47
                Submission Status
                AP
                Submission Status Date
                2014-06-13 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
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                Submission Status
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                Submissions Public Notes
              7. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
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                Submission Status
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                Submissions Public Notes
              8. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                42
                Submission Status
                AP
                Submission Status Date
                2011-08-11 00:00:00
                Submission Type
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                Submissions Public Notes
              9. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                38
                Submission Status
                AP
                Submission Status Date
                2011-03-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                017422
                Review Priority
                N/A
                Submission Class Code ID
                4
                Submission No
                37
                Submission Status
                AP
                Submission Status Date
                2007-08-17 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                36
                Submission Status
                AP
                Submission Status Date
                2005-10-20 00:00:00
                Submission Type
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                Submissions Public Notes
              12. Appl No
                017422
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                35
                Submission Status
                AP
                Submission Status Date
                2003-02-27 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA017422
              approval interpretation
              Application linkage and approved submission are not indication-level current approval verification
              current indication status
              not_reconciled
              has approved submission record
              true
              latest approved submission date
              2021-04-30
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              latest posted label documents
              1. Appl No
                017422
                Application Docs Date
                2017-03-27 00:00:00
                Application Docs ID
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                Application Docs Title
                0
                Application Docs Type ID
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                Submission No
                55
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              official application record
              Appl No
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              Sponsor Name
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              openfda application present
              true
              products
              1. Active Ingredient
                CARMUSTINE
                Appl No
                017422
                Drug Name
                BICNU
                Form
                INJECTABLE;INJECTION
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                100MG/VIAL
                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
            application numbers
            1. NDA017422
            brand names
            1. CARMUSTINE
            classification reasons
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            exact text
            1 INDICATIONS AND USAGE Carmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 ) Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. Multiple myeloma in combination with prednisone. Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. Relapsed or refractory Non-Hodgkin's lymphomas in combination with
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                1 INDICATIONS AND USAGE Carmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 ) Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
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                            Preserved source evidence · Not medical advice