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LABELS · a7f31acd-4120-420a-ab5d-10415866e41a

DECNUPAZ

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
2026-05-27
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) DECNUPAZ can cause hepatotoxicity, including severe or fatal hepatic VOD (also known as sinusoidal obstruction syndrome) [see Warnings and Precautions ( 5.1 )] . Closely monitor patients for signs and symptoms of VOD including elevations in liver tests, hepatomegaly (which may be painful), rapid weight gain, and ascites [see Warnings and Precautions ( 5.1 )] . Monitor liver tests, including ALT, AST, and total bilirubin, prior to each dose of DECNUPAZ [see Warnings and Precautions ( 5.1 )] . Delay DECNUPAZ dosage for liver test elevation. Permanently discontinue DECNUPAZ for patients who experience VOD [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) See full prescribing information for complete boxed warning. VOD, a severe form of hepatotoxicity, has been reported in patients with BPDCN treated with DECNUPAZ, including severe or fatal hepatic VOD. ( 5.1 ) Closely monitor for signs and symptoms of VOD. Monitor liver tests and total bilirubin prior to each dose. ( 5.1 ) Discontinue DECNUPAZ for patients who experience VOD. ( 2.4 , 5.1 )

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ( 1 )
Full extracted label fields
application numbers
  1. BLA761460
boxed warning exact
  1. WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) DECNUPAZ can cause hepatotoxicity, including severe or fatal hepatic VOD (also known as sinusoidal obstruction syndrome) [see Warnings and Precautions ( 5.1 )] . Closely monitor patients for signs and symptoms of VOD including elevations in liver tests, hepatomegaly (which may be painful), rapid weight gain, and ascites [see Warnings and Precautions ( 5.1 )] . Monitor liver tests, including ALT, AST, and total bilirubin, prior to each dose of DECNUPAZ [see Warnings and Precautions ( 5.1 )] . Delay DECNUPAZ dosage for liver test elevation. Permanently discontinue DECNUPAZ for patients who experience VOD [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) See full prescribing information for complete boxed warning. VOD, a severe form of hepatotoxicity, has been reported in patients with BPDCN treated with DECNUPAZ, including severe or fatal hepatic VOD. ( 5.1 ) Closely monitor for signs and symptoms of VOD. Monitor liver tests and total bilirubin prior to each dose. ( 5.1 ) Discontinue DECNUPAZ for patients who experience VOD. ( 2.4 , 5.1 )
brand names
  1. DECNUPAZ
current indication status
not_reconciled
dailymed set url
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generic names
  1. PIVEKIMAB SUNIRINE-PVZY
id
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indications and usage exact
  1. 1. INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ( 1 )
indications and usage tables exact
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    1. AbbVie Inc.
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    1. neoplasm
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    1. 0074-0282-02
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    1. HUMAN PRESCRIPTION DRUG
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        products
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          PIVEKIMAB SUNIRINE-PVZY
          Appl No
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          Drug Name
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          Form
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          Product No
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          Reference Drug
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          Reference Standard
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          Strength
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          marketing status
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      Source passages and status connections

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      1. INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent c
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            1. INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ( 1 )
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                INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
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                1. INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ( 1 )
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                    ic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ( 1 )
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                          Preserved source evidence · Not medical advice