DOSAGE & ADMINISTRATION: ABRAXANE + CARBOPLATIN

ABRAXANE (100 mg/m2) + carboplatin (AUC=6 mg•min/mL) - icon
  • Administer ABRAXANE intravenously at a dose of 100 mg/m2 over 30 minutes on a weekly schedule on Days 1, 8, and 15 of each 21-day cycle
  • Administer carboplatin intravenously on Day 1 of each 21-day cycle immediately after completion of ABRAXANE administration
Note: DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. ABRAXANE has different dosage and administration instructions from other paclitaxel products.
ABRAXANE is administered 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. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
  • Patients with a previous history of hypersensitivity to other taxanes should be closely monitored during initiation of ABRAXANE therapy
  • 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. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
  • Patients with a previous history of hypersensitivity to other taxanes should be closely monitored during initiation of ABRAXANE therapy
  • 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

    Median of 6 cycles (range: 1-31 cycles) in the Phase III trial. Median of 6 cycles (range: 1-31 cycles) in the Phase III trial.
    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
    The most common ARs resulting in permanent discontinuation of ABRAXANE were neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common ARs resulting in dose reduction of ABRAXANE were neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common ARs leading to withholding or delay of ABRAXANE were neutropenia (41%), thrombocytopenia (30%), and anemia (16%). The most common ARs resulting in permanent discontinuation of ABRAXANE were neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common ARs resulting in dose reduction of ABRAXANE were neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common ARs leading to withholding or delay of ABRAXANE were neutropenia (41%), thrombocytopenia (30%), and anemia (16%).
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  • 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
      >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
      >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
      OR
      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
      • 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 
      AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal.

      ABRAXANE dose

      ABRAXANE 100 mg/m2 vial NOT RECOMMENDED

      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:
      FIRST
      OCCURRENCE
      SECOND
      OCCURRENCE
      THIRD
      OCCURRENCE

      • 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 >38 °C
      OR
      • Delay of next cycle due to persistent neutropeniaa
        (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 >38 °C
      OR
      • Delay of next cycle due to persistent neutropeniaa
        (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 >38 °C
      OR
      • Delay of next cycle due to persistent neutropeniaa
        (nadir ANC <1500 cells/mm3)
      OR
      • Nadir ANC <500 cells/mm3 for >1 week

       

      ABRAXANE 75 mg/m2 + carboplatin AUC 4.5 mg•min/mL vial ABRAXANE 50 mg/m2 + carboplatin AUC 3 mg•min/mL vial ABRAXANE + carboplatin dose: 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced
        Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced
        Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grade 3-4 neutropenia
      • aMore than 7-day delay of 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:
      FIRST
      OCCURRENCE
      SECOND
      OCCURRENCE

      • 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 Grades 1-4 thrombocytopenia; 18% experienced Grades 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 Grades 1-4 thrombocytopenia; 18% experienced Grades 3-4 thrombocytopenia

      Nadir platelets <50,000 cells/mm3

      ABRAXANE 75 mg/m2 + carboplatin AUC 4.5 mg•min/mL vial ABRAXANE + carboplatin dose: DISCONTINUE TREATMENT

      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:
      FIRST
      OCCURRENCE
      SECOND
      OCCURRENCE
      THIRD
      OCCURRENCE

      • For Grades 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 Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
      • For Grades 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 Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
      • For Grades 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 Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm

      Severe sensory neuropathy
      (Grade 3 or 4)

      ABRAXANE 75 mg/m2 + carboplatin AUC 4.5 mg•min/mL vial ABRAXANE 50 mg/m2 + carboplatin AUC 3 mg•min/mL vial ABRAXANE + carboplatin dose: DISCONTINUE TREATMENT

      ILLUSTRATIVE PURPOSES ONLY
    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 >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
    OR
    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
    • 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 
    AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal.

    ABRAXANE dose

    ABRAXANE 100 mg/m2 vial NOT RECOMMENDED

    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.
    Recommendations for permanent dose modification in NSCLC patients with neutropenia
    MAKE A SELECTION:
    FIRST
    OCCURRENCE
    SECOND
    OCCURRENCE
    THIRD
    OCCURRENCE

    • 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 >38 °C
    OR
    • Delay of next cycle due to persistent neutropeniaa
      (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 >38 °C
    OR
    • Delay of next cycle due to persistent neutropeniaa
      (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 >38 °C
    OR
    • Delay of next cycle due to persistent neutropeniaa
      (nadir ANC <1500 cells/mm3)
    OR
    • Nadir ANC <500 cells/mm3 for >1 week

     

    ABRAXANE 75 mg/m2 + carboplatin AUC 4.5 mg•min/mL vial ABRAXANE 50 mg/m2 + carboplatin AUC 3 mg•min/mL vial ABRAXANE + carboplatin dose: 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced
      Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced
      Grades 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 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, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grade 3-4 neutropenia
    • aMore than 7-day delay of scheduled Day 1 dose of next cycle.
    Recommendations for permanent dose modification in NSCLC patients with thrombocytopenia
    MAKE A SELECTION:
    FIRST
    OCCURRENCE
    SECOND
    OCCURRENCE

    • 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 Grades 1-4 thrombocytopenia; 18% experienced Grades 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 Grades 1-4 thrombocytopenia; 18% experienced Grades 3-4 thrombocytopenia

    Nadir platelets <50,000 cells/mm3

    ABRAXANE 75 mg/m2 + carboplatin AUC 4.5 mg•min/mL vial ABRAXANE + carboplatin dose: DISCONTINUE TREATMENT

    ILLUSTRATIVE PURPOSES ONLY
    Recommendations for permanent dose modification in NSCLC patients with neurologic toxicity
    MAKE A SELECTION:
    FIRST
    OCCURRENCE
    SECOND
    OCCURRENCE
    THIRD
    OCCURRENCE

    • For Grades 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 Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
    • For Grades 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 Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
    • For Grades 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 Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm

    Severe sensory neuropathy
    (Grade 3 or 4)

    ABRAXANE 75 mg/m2 + carboplatin AUC 4.5 mg•min/mL vial ABRAXANE 50 mg/m2 + carboplatin AUC 3 mg•min/mL vial ABRAXANE + carboplatin dose: DISCONTINUE TREATMENT

    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 ABRAXANE 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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