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 ![]()
FDA-approved dose and schedule for ABRAXANE in metastatic breast cancer:
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FDA-approved dose and schedule for ABRAXANE in metastatic breast cancer:
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- Dose Modifications:
Hepatic ImpairmentDOSE MODIFICATIONS
FOR PATIENTS WITH HEPATIC IMPAIRMENTRecommendations for starting dose in patients with hepatic impairmentSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
> ULN TO ≤1.5 x ULNSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
> ULN TO ≤1.5 x ULNSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
>ULN TO ≤1.5 x ULNSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
>1.5 TO ≤3 x ULNSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
>3 TO ≤5 x ULNSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
>3 TO ≤5 x ULNSGOT (AST) LEVELS
<10 x ULNORBILIRUBIN LEVELS >5 x ULNSGOT (AST) LEVELS
>10 x ULNORBILIRUBIN LEVELS
>5 x ULNMild
- 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
ABRAXANE dose
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.
- Dose Modifications:
NeuropathyDOSING FOR YOUR PATIENTS
WHO EXPERIENCE SENSORY NEUROPATHYABRAXANE dose-modification schedule for neuropathyMild 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
ILLUSTRATIVE
PURPOSES ONLY - Dose Modifications:
NeutropeniaDOSING FOR YOUR PATIENTS
WHO EXPERIENCE NEUTROPENIAABRAXANE dose-modification schedule for neutropeniaMild 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
ILLUSTRATIVE
PURPOSES ONLY