ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(五)
/mm3
OR
ANC less than 500/mm3 for more than 7 days First 75 4.5
Second 50 3
Third Discontinue Treatment
Platelet count less than 50,000/mm3 First 75 4.5
Second Discontinue Treatment
Severe sensory Neuropathy – Grade 3 or 4 First 75 4.5
Second 50 3
Third Discontinue Treatment
Adenocarcinoma of the Pancreas
Dose level reductions for patients with adenocarcinoma of the pancreas, as referenced in Tables 4 and 5, are provided in Table 3.
Table 3: Dose Level Reductions for Patients with Adenocarcinoma of the Pancreas Dose Level ABRAXANE (mg/m2) Gemcitabine (mg/m2)
Full dose 125 1000
1st dose reduction 100 800
2nd dose reduction 75 600
If additional dose reduction required Discontinue Discontinue
Recommended dose modifications for neutropenia and thrombocytopenia for patients with adenocarcinoma of the pancreas are provided in Table 4.
Table 4: Dose Recommendation and Modifications for Neutropenia and/or Thrombocytopenia at the Start of a Cycle or within a Cycle for Patients with Adenocarcinoma of the Pancreas ANC = Absolute Neutrophil Count
Cycle
Day ANC (cells/mm3) Platelet count (cells/mm3) ABRAXANE / Gemcitabine
Day 1 < 1500 OR < 100,000 Delay doses until recovery
Day 8 500 to < 1000 OR 50,000 to < 75,000 Reduce 1 dose level
< 500 OR < 50,000 Withhold doses
Day 15: If Day 8 doses were reduced or given without modification:
500 to < 1000 OR 50,000 to < 75,000 Reduce 1 dose level from Day 8
< 500 OR < 50,000 Withhold doses
Day 15: If Day 8 doses were withheld:
≥ 1000 OR ≥ 75,000 Reduce 1 dose level from Day 1
500 to < 1000 OR 50,000 to < 75,000 Reduce 2 dose levels from Day 1
< 500 OR < 50,000 Withhold doses
Recommended dose modifications for other adverse drug reactions in patients with adenocarcinoma of the pancreas are provided in Table 5.
Table 5: Dose Modifications for Other Adverse Drug Reactions in Patients with Adenocarcinoma of the Pancreas Adverse Drug Reaction ABRAXANE Gemcitabine
Febrile Neutropenia:
Grade 3 or 4 Withhold until fever resolves and ANC ≥ 1500; resume at next lower dose level
Peripheral Neuropathy:
Grade 3 or 4 Withhold until improves to ≤ Grade 1;
resume at next lower dose level No dose reduction
Cutaneous Toxicity:
Grade 2 or 3 Reduce to next lower dose lev |
