LABELS · d1c7770f-7099-4ad3-84e2-20e638cb224e

ABRAXANE

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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: 2022-10-31
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: SEVERE MYELOSUPPRESSION • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. • Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. • Perform frequent complete blood cell counts on all patients receiving ABRAXANE [see Warnings and Precautions (5.1 , 5.3) ]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) • Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) • Perform frequent complete blood cell counts on all patients receiving ABRAXANE. ( 5.1 , 5.3 )

Indications and usage: exact source text

1 INDICATIONS AND USAGE ABRAXANE is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) • Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 ) 1.1 Metastatic Breast Cancer ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 1.2 Non-Small Cell Lung Cancer ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. 1.3 Adenocarcinoma of the Pancreas ABRAXANE is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Full extracted label fields

application numbers

NDA021660

boxed warning exact

WARNING: SEVERE MYELOSUPPRESSION • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. • Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. • Perform frequent complete blood cell counts on all patients receiving ABRAXANE [see Warnings and Precautions (5.1 , 5.3) ]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) • Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) • Perform frequent complete blood cell counts on all patients receiving ABRAXANE. ( 5.1 , 5.3 )

brand names

ABRAXANE

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24d10449-2936-4cd3-b7db-a7683db721e4

generic names

PACLITAXEL

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indications and usage exact

1 INDICATIONS AND USAGE ABRAXANE is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) • Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 ) 1.1 Metastatic Breast Cancer ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 1.2 Non-Small Cell Lung Cancer ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. 1.3 Adenocarcinoma of the Pancreas ABRAXANE is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

indications and usage tables exact

is original packager

true

manufacturer names

Abraxis BioScience, LLC

matched search terms

cancer

package ndcs

68817-134-50

product ndcs

68817-134

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration ( 2.1 , 2.7 ) 8/2020 Contraindications ( 4 ) 8/2020 Warnings and Precautions ( 5.1 , 5.2 ) 8/2020

record type

complete_spl_indications_section_candidate

routes

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rxcuis

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source batch

file

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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

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brand names

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Passage 2 · unclassified context

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use intent

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Passage 3 · risk or warning

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exact text: microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiat
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exact text: failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation ther
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Preserved source evidence · Not medical advice