ABRAXANE IS ADMINISTERED WEEKLY OVER 30 MINUTES
GENERALLY WITHOUT THE NEED FOR STEROID PRETREATMENT

Premedication may be needed in patients who have had a prior hypersensitivity reaction to ABRAXANE
  • Severe hypersensitivity reactions with fatal outcome have been reported with ABRAXANE. Do not re-challenge
  • Severe hypersensitivity reactions with fatal outcome have been reported with ABRAXANE.
    Do not re-challenge

Administer ABRAXANE intravenously at
a dose of 100 mg/m2

Administer ABRAXANE intravenously at a dose of
100 mg/m2

Advanced Non-Small Cell Lung Cancer (NSCLC) 100 and 6 milligram ABRAXANE dosing bottles - small - icon Advanced Non-Small Cell Lung Cancer (NSCLC) 100 and 6 milligram ABRAXANE dosing bottles - small - icon
ILLUSTRATIVE PURPOSES ONLY

The recommended ABRAXANE schedule is weekly dosing

The recommended ABRAXANE schedule is weekly dosing

Advanced Non-Small Cell Lung Cancer (NSCLC) recommened dosing schedule is weekly - icon Advanced Non-Small Cell Lung Cancer (NSCLC) recommened dosing schedule is weekly - icon
  • Administer ABRAXANE on Days 1, 8, and 15 of each 21-day cycle
  • Administer carboplatin on Day 1 of each 21-day cycle

ABRAXANE is administered
over 30 minutes

ABRAXANE is administered
over 30 minutes

Advanced Non-Small Cell Lung Cancer (NSCLC) dosing is administered over 30 minutes- icon Advanced Non-Small Cell Lung Cancer (NSCLC) dosing is administered over 30 minutes- icon

Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

  • Duration and Dosing in the Phase III Trial

    MEDIAN NUMBER OF TREATMENT CYCLES IN THE PHASE III PIVOTAL TRIAL OF ABRAXANE + CARBOPLATIN

    MEDIAN NUMBER OF TREATMENT CYCLES IN THE PHASE III PIVOTAL TRIAL OF ABRAXANE + CARBOPLATIN

    Advanced Non-Small Cell Lung Cancer (NSCLC) 6 Median dosing cycles - icon Advanced Non-Small Cell Lung Cancer (NSCLC) 6 Median dosing cycles - icon
    Patients in the study were treated until disease progression or development of unacceptable toxicity. 

    DOSE ADJUSTMENTS
    OBSERVED IN THE PHASE III PIVOTAL TRIAL

    DOSE ADJUSTMENTS
    OBSERVED IN THE PHASE III PIVOTAL TRIAL

    Adverse reactions were assessed in 514 patients treated with ABRAXANE + carboplatin
    Advanced Non-Small Cell Lung Cancer (NSCLC) dose modifications observed in Phase III trial Advanced Non-Small Cell Lung Cancer (NSCLC) dose modifications observed in Phase III trial
    CLOSE THE TAB
  • Dose Modifications
    PLEASE SELECT A DOSE MODIFICATION BELOW:
    • Hepatic

      START WITH THE RIGHT DOSE OF ABRAXANE IN PATIENTS
      WITH HEPATIC IMPAIRMENT

      START WITH THE RIGHT DOSE OF ABRAXANE IN PATIENTS
      WITH HEPATIC IMPAIRMENT

      Recommendations for starting dose in patients with hepatic impairment
      SGOT (AST) LEVELS
      <10 x ULN
      AND
      BILIRUBIN LEVELS
      >1.5 TO ≤3 x ULN
      SGOT (AST) LEVELS
      <10 x ULN
      AND
      BILIRUBIN LEVELS
      >ULN TO ≤1.5 x ULN
      SGOT (AST) LEVELS <10 x ULN
      AND
      BILIRUBIN LEVELS >1.5 TO ≤3 x ULN
      SGOT (AST) LEVELS
      <10 x ULN
      AND
      BILIRUBIN LEVELS
      >1.5 TO ≤3 x ULN
      SGOT (AST) LEVELS <10 x ULN
      AND
      BILIRUBIN LEVELS >3 TO ≤5 x ULN
      SGOT (AST) LEVELS
      <10 x ULN
      AND
      BILIRUBIN LEVELS
      >3 TO ≤5 x ULN
      SGOT (AST) LEVELS
      >10 x ULN
      AND
      BILIRUBIN LEVELS >5 x ULN
      SGOT (AST) LEVELS
      >10 x ULN
      OR
      BILIRUBIN LEVELS
      >5 x ULN

      Mild

      • No dose adjustment is necessary for patients with mild hepatic impairment
      • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
      • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer 
      • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance
      • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer 
      • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

      Moderate

      • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN 
      • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer 
      • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

      Severe

      • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN 
      • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer 
      • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

      Very Severe

      • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN 
      • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer 
      ULN=upper limit of normal.

      ABRAXANE dose

      Advanced Non-Small Cell Lung Cancer (NSCLC) 100 Milligram dosing bottle icon Advanced Non-Small Cell Lung Cancer (NSCLC) 80 Milligram dosing bottle icon Advanced Non-Small Cell Lung Cancer (NSCLC) 80 Milligram dosing bottle icon Not recommended icon - green

      ILLUSTRATIVE PURPOSES ONLY

      • aA dose increase to 100 mg/m2 in subsequent courses should be considered if the patient tolerates the reduced dose for 2 cycles.
    • Neutropenia

      DOSING FOR YOUR PATIENTS
      WHO EXPERIENCE HEMATOLOGIC TOXICITIES

      DOSING FOR YOUR PATIENTS
      WHO EXPERIENCE HEMATOLOGIC TOXICITIES

      Recommendations for permanent dose modification in NSCLC patients with neutropenia
      MAKE A SELECTION:

      • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
      • Nadir ANC <500 cells/mm3 with neutropenic fever >38OC
      OR
      • Delay of next cycle due to persistent neutropenia* (nadir ANC <1500 cells/mm3)
      OR
      • Nadir ANC <500 cells/mm3 for >1 week
      • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
      • Nadir ANC <500 cells/mm3 with neutropenic fever >38OC
      OR
      • Delay of next cycle due to persistent neutropenia*
        (nadir ANC <1500 cells/mm3)
      OR
      • Nadir ANC <500 cells/mm3 for >1 week
      • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
      • Nadir ANC <500 cells/mm3 with neutropenic fever >38OC
      OR
      • Delay of next cycle due to persistent neutropenia*
        (nadir ANC <1500 cells/mm3)
      OR
      • Nadir ANC <500 cells/mm3 for >1 week

       

      Advanced Non-Small Cell Lung Cancer (NSCLC) 75 and 4.5 milligram dosing bottle icons --- non-small cell lung cancer dosing bottles 75 + 4.5 Advanced Non-Small Cell Lung Cancer (NSCLC) 50 and 3 milligram ABRAXANE dosing bottle icons non-small cell lung cancer dosing bottles 50 + 3 ABRAXANE discontinue treatment dosing bottles - icon --- non-small cell lung cancer dosing bottles discontinue treatment

      ILLUSTRATIVE PURPOSES ONLY

      • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
      • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
      • In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced
        Grade 3-4 neutropenia
      • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
      • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
      • In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced Grade 3-4 neutropenia
      • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
      • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
      • In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced
        Grade 3-4 neutropenia
      • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
      • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
      • In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced Grade 3-4 neutropenia
      • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
      • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
      • In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced
        Grade 3-4 neutropenia
      • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
      • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
      • In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced Grade 3-4 neutropenia
      • *Maximum of 7 days post-scheduled Day 1 dose of next cycle.
    • Thrombocytopenia

      DOSING FOR YOUR PATIENTS
      WHO EXPERIENCE HEMATOLOGIC TOXICITIES

      DOSING FOR YOUR PATIENTS
      WHO EXPERIENCE HEMATOLOGIC TOXICITIES

      Recommendations for permanent dose modification in NSCLC patients with thrombocytopenia
      MAKE A SELECTION:

      • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
      • Prior to permanent dose reduction, withhold treatment until platelet count recovery to ≥100,000 cells/mm3 on Day 1 or ≥50,000 cells/mm3 on Days 8 or 15 of the cycle
      • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
      • In the phase III ABRAXANE NSCLC clinical trial, 68% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 thrombocytopenia; 18% experienced Grade 3-4 thrombocytopenia
      • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
      • Prior to permanent dose reduction, withhold treatment until platelet count recovery to ≥100,000 cells/mm3 on Day 1 or ≥50,000 cells/mm3 on Days 8 or 15 of the cycle
      • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
      • In the phase III ABRAXANE NSCLC clinical trial, 68% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 thrombocytopenia; 18% experienced Grade 3-4 thrombocytopenia

      Nadir platelets <50,000 cells/mm3

      Advanced Non-Small Cell Lung Cancer (NSCLC) 75 and 4.5 milligram dosing bottle icons ABRAXANE discontinue treatment dosing bottles - icon

      ILLUSTRATIVE PURPOSES ONLY

    • Neurologic

      DOSING FOR YOUR PATIENTS
      WHO EXPERIENCE NEUROLOGIC TOXICITIES

      DOSING FOR YOUR PATIENTS
      WHO EXPERIENCE NEUROLOGIC TOXICITIES

      Recommendations for permanent dose modification in NSCLC patients with neurologic toxicity
      MAKE A SELECTION:

      • For Grade 3-4 peripheral neuropathy, withhold treatment until resolution to ≤Grade 1
        • Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
      • In the phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 peripheral neuropathy; 3% experienced Grade 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
      • For Grade 3-4 peripheral neuropathy, withhold treatment until resolution to ≤Grade 1
        • Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
      • In the phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 peripheral neuropathy; 3% experienced Grade 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
      • For Grade 3-4 peripheral neuropathy, withhold treatment until resolution to ≤Grade 1
        • Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
      • In the phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 peripheral neuropathy; 3% experienced Grade 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm

      Severe sensory neuropathy
      (Grade 3 or 4)

      Advanced Non-Small Cell Lung Cancer (NSCLC) 75 and 4.5 milligram dosing bottle icons Advanced Non-Small Cell Lung Cancer (NSCLC) 50 and 3 milligram ABRAXANE dosing bottle icons ABRAXANE discontinue treatment dosing bottles - icon

      ILLUSTRATIVE PURPOSES ONLY

    CLOSE THE TAB
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Additional Information for Readers Provided by Celgene Corporation

The clinical trial described in this article served as the
basis for the approval for ABRXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.

Please see Important Safety Information and Prescribing Information, including Boxed WARNING.

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