ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(四)
tients with Hepatic Impairment MBC = Metastatic Breast Cancer; NSCLC = Non-Small Cell Lung Cancer.
a Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance.
b A dose increase to 260 mg/m2 for patients with metastatic breast cancer or 100 mg/m2 for patients with non-small cell lung cancer in subsequent courses should be considered if the patient tolerates the reduced dose for two cycles.
c Patients with bilirubin levels above the upper limit of normal were excluded from clinical trials for pancreatic or lung cancer.
SGOT (AST) Levels Bilirubin Levels ABRAXANE Dosea
MBC NSCLC c Pancreatic c
Adenocarcinoma
Mild < 10 x ULN AND > ULN to ≤ 1.5 x ULN 260 mg/m2 100 mg/m2 125 mg/m2
Moderate < 10 x ULN AND >1.5 to ≤ 3 x ULN 200 mg/m2 b 80 mg/m2 b not recommended
Severe < 10 x ULN AND > 3 to ≤ 5 x ULN 200 mg/m2 b 80 mg/m2 b not recommended
> 10 x ULN OR > 5 x ULN not recommended not recommended not recommended
2.5 Dose Reduction/Discontinuation Recommendations
Metastatic Breast Cancer
Patients who experience severe neutropenia (neutrophils less than 500 cells/mm3 for a week or longer) or severe sensory neuropathy during ABRAXANE therapy should have dosage reduced to 220 mg/m2 for subsequent courses of ABRAXANE. For recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m2. For Grade 3 sensory neuropathy hold treatment until resolution to Grade 1 or 2, followed by a dose reduction for all subsequent courses of ABRAXANE [see Contraindications (4), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)].
Non-Small Cell Lung Cancer
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 [see Contraindications (4),Warnings and Precautions (5.1) and Adverse Reactions (6.2)].
In patients who develop severe neutropenia or thrombocytopenia withhold treatment until counts recover to an absolute neutrophil count of at least 1500 cells/mm3 and platelet count of at least 100,000 cells/mm3 on Day 1 or to an absolute neutrophil count of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Days 8 or 15 of the cycle. Upon resumption of dosing, permanently reduce ABRAXANE and carboplatin doses as outlined in Table 2.
Withhold ABRAXANE for Grade 3-4 peripheral neuropathy. Resume ABRAXANE and carboplatin at reduced doses (see Table 2) when peripheral neuropathy improves to Grade 1 or completely resolves [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
Table 2: Permanent Dose Reductions for Hematologic and Neurologic Adverse Drug Reactions in NSCLC Adverse Drug Reaction Occurrence Weekly
ABRAXANE Dose
(mg/m2) Every 3-Week
Carboplatin Dose
(AUC mg•min/mL)
Neutropenic Fever (ANC less than 500/mm3 with fever >38°C)
OR
Delay of next cycle by more than 7 days for ANC less than 1500 |
