Abraxane

• •
  Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm³

  [see Contraindications (4)].
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  Monitor for neutropenia, which may be severe and result in infection or sepsis

  [see Warnings and Precautions (5.1, 5.3)].
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  Perform frequent complete blood cell counts on all patients receiving ABRAXANE

  [see Warnings and Precautions (5.1, 5.3)].

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.
• •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.
• •Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

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  Do not substitute ABRAXANE for other paclitaxel products.
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  Extravasation
  : Closely monitor the infusion site for extravasation and infiltration.
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  Metastatic Breast Cancer (MBC)
  : Recommended dosage of ABRAXANE is 260 mg/m² intravenously over 30 minutes every 3 weeks.
• •
  Non-Small Cell Lung Cancer (NSCLC)
  : Recommended dosage of ABRAXANE is 100 mg/m² intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after ABRAXANE.
• •
  Adenocarcinoma of the Pancreas
  : Recommended dosage of ABRAXANE is 125 mg/m² intravenously over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle; administer gemcitabine on Days 1, 8, and 15 of each 28-day cycle immediately after ABRAXANE.
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  Use in Patients with Hepatic Impairment:
  ABRAXANE is not recommended for use in patients with AST > 10 × ULN; or bilirubin > 5 × ULN or with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. For MBC or NSCLC, reduce starting dose in patients with moderate to severe hepatic impairment.
• •
  Dose Reductions for Adverse Reactions
  : Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicities.

For injectable suspension, for intravenous use: white to yellow, sterile lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution.

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  Lactation
  : Advise not to breastfeed.