UNDERSTANDING DURATION AND DOSING
ABRAXANE PHASE III MBC TRIAL

UNDERSTANDING
DURATION AND DOSING ABRAXANE PHASE III MBC TRIAL

Patients treated with ABRAXANE received a median of 6 cycles of therapy

Metastatic breast cancer (MBC) 6 median dosing cycles (range: 1-18 cycles) - icon
  • The primary endpoint, recTLRR, was the evaluation of responses achieved in the first 6 cycles of therapy

FDA-approved dose and schedule for ABRAXANE in metastatic breast cancer:

  • Administer intravenously at a dose of 260 mg/m2
  • Recommended schedule is once every 3 weeks
  • Administer over 30 minutes
  • Premedication to prevent hypersensitivity reactions is generally not needed prior to the administration of ABRAXANE. Premedication may be needed in patients who have had prior hypersensitivity reactions to ABRAXANE. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
Watch the ABRAXANE Reconstitution Video

FDA-approved dose and schedule for ABRAXANE in metastatic breast cancer:

  • Administer intravenously at a dose of 260 mg/m2
  • Recommended schedule is once every 3 weeks
  • Administer over 30 minutes
  • Premedication to prevent hypersensitivity reactions is generally not needed prior to the administration of ABRAXANE. Premedication may be needed in patients who have had prior hypersensitivity reactions to ABRAXANE. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
Watch the ABRAXANE Reconstitution Video
  • Dose Modifications:
    Hepatic Impairment

    DOSE MODIFICATIONS 
    FOR PATIENTS WITH HEPATIC IMPAIRMENT

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

    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
    • 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
    • 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
    • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

     

    • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
    ULN=upper limit of normal.

    ABRAXANE dose

    ABRAXANE® for metastatic breast cancer (MBC) 260 milligrams/m2 bottle - icon https://www.abraxanepro.com/wp-content/uploads/2016/10/200-mg-dosing-bottle-icon.gif https://www.abraxanepro.com/wp-content/uploads/2018/01/not-recommended-dosing-bottle-icon.png

    ILLUSTRATIVE
    PURPOSES ONLY

    • aA dose increase to 260 mg/m2 in subsequent courses should be considered if the patient tolerates the reduced dose for 2 cycles.
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  • Dose Modifications:
    Neuropathy

    DOSING FOR YOUR PATIENTS
    WHO EXPERIENCE SENSORY NEUROPATHY

    ABRAXANE dose-modification schedule for neuropathy
    MILD TO MODERATE
    SEVERE
    RECURRENT

    Mild to Moderate

    The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose modification

    • In the phase III ABRAXANE MBC clinical trial, sensory neuropathy with any symptoms occurred in 71% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; sensory neuropathy with severe symptoms (defined as ≥Grade 3 toxicity) occurred in 10% of patients receiving ABRAXANE

    Severe

    If ≥Grade 3 sensory neuropathy develops, hold until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE

    • In the phase III ABRAXANE MBC clinical trial, sensory neuropathy with any symptoms occurred in 71% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; sensory neuropathy with severe symptoms (defined as ≥Grade 3 toxicity) occurred in 10% of patients receiving ABRAXANE

    Recurrent

    If severe (≥Grade 3) neuropathy is recurrent, hold treatment until resolution to Grade 1 or 2, then reduce dose from 220 mg/m2 to 180 mg/m2 for all subsequent courses

    • In the phase III ABRAXANE MBC clinical trial, sensory neuropathy with any symptoms occurred in 71% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; sensory neuropathy with severe symptoms (defined as ≥Grade 3 toxicity) occurred in 10% of patients receiving ABRAXANE

    ABRAXANE dose

    ABRAXANE® for metastatic breast cancer (MBC) 260 milligrams/m2 bottle - icon ABRAXANE® for metastatic breast cancer (MBC) hold or resume at 220 milligrams/m2 dosing bottle - icon ABRAXANE® for metastatic breast cancer (MBC) 180 milligrams/m2 bottle - icon

    ILLUSTRATIVE
    PURPOSES ONLY
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  • Dose Modifications:
    Neutropenia

    DOSING FOR YOUR PATIENTS
    WHO EXPERIENCE NEUTROPENIA

    ABRAXANE dose-modification schedule for neutropenia
    MILD TO MODERATE
    SEVERE
    RECURRENT

    Mild to Moderate

    • If neutropenia is mild or moderate (Grade 1 or 2), no dose reduction is needed
    • ABRAXANE has a dose-reduction schedule for patients who experience severe neutropenia
    • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1
    • In the phase III ABRAXANE MBC clinical trial, neutropenia (<2.0 x 109/L) occurred in 80% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; neutropenia (<0.5 x 109/L) occurred in 9% of patients receiving ABRAXANE

    Severe

    • If neutropenia is severe (neutrophils <500 cells/mm3 for 7 days or longer), reduce dose from 260 mg/m2 to 220 mg/m2 for subsequent courses
    • ABRAXANE has a dose-reduction schedule for patients who experience severe neutropenia
    • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1
    • In the phase III ABRAXANE MBC clinical trial, neutropenia (<2.0 x 109/L) occurred in 80% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; neutropenia (<0.5 x 109/L) occurred in 9% of patients receiving ABRAXANE

    Recurrent

    • If severe neutropenia is recurrent, reduce dose from 220 mg/m2 to 180 mg/m2 for subsequent courses
    • ABRAXANE has a dose-reduction schedule for patients who experience severe neutropenia
    • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1
    • In the phase III ABRAXANE MBC clinical trial, neutropenia (<2.0 x 109/L) occurred in 80% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; neutropenia (<0.5 x 109/L) occurred in 9% of patients receiving ABRAXANE

    ABRAXANE dose

    ABRAXANE® for metastatic breast cancer (MBC) 260 milligrams/m2 bottle - icon ABRAXANE® for metastatic breast cancer (MBC) 220 milligrams/m2 bottle - icon ABRAXANE® for metastatic breast cancer (MBC) 180 milligrams/m2 bottle - icon

    ILLUSTRATIVE
    PURPOSES ONLY
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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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