ABRAXANE® for Injectable Suspension
(paclitaxel protein-bound particles for injectable suspension)
The following is a Brief Summary; refer to full Prescribing Information for
complete product information.
1 INDICATIONS AND USAGE
1.1 Metastatic Breast Cancer
ABRAXANE is indicated for the treatment of breast cancer after failure
of combination chemotherapy for metastatic disease or relapse within
6 months of adjuvant chemotherapy. Prior therapy should have included
an anthracycline unless clinically contraindicated.
1.2 Non-Small Cell Lung Cancer
ABRAXANE is indicated for the first-line treatment of locally advanced or
metastatic non-small cell lung cancer, in combination with carboplatin, in
patients who are not candidates for curative surgery or radiation therapy.
1.3 Adenocarcinoma of the Pancreas
ABRAXANE is indicated for the first-line treatment of patients with
metastatic adenocarcinoma of the pancreas, in combination with
2 DOSAGE AND ADMINISTRATION
2.1 Metastatic Breast Cancer
After failure of combination chemotherapy for metastatic breast cancer
or relapse within 6 months of adjuvant chemotherapy, the recommended
regimen for ABRAXANE is 260 mg/m2 administered intravenously over
30 minutes every 3 weeks.
2. 2 Non-Small Cell Lung Cancer
The recommended dose of ABRAXANE is 100 mg/m2 administered as an
intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day
cycle. Administer carboplatin on Day 1 of each 21 day cycle immediately
after ABRAXANE [see Clinical Studies ( 14. 2)].
2. 3 Adenocarcinoma of the Pancreas
The recommended dose of ABRAXANE is 125 mg/m2 administered as an
intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each
28-day cycle. Administer gemcitabine immediately after ABRAXANE on
Days 1, 8 and 15 of each 28-day cycle [see Clinical Studies( 14. 3)].
2. 4 Dosage in Patients with Hepatic Impairment
No dose adjustment is necessary for patients with mild hepatic
impairment. Patients with moderate and severe hepatic impairment
treated with ABRAXANE may be at increased risk of toxicities known to
paclitaxel. Withhold ABRAXANE if AST > 10 x ULN or bilirubin > 5 x ULN.
Recommendations for dosage adjustment for the first course of therapy
are shown in Table 1.
For metastatic breast cancer, the dose of ABRAXANE can be increased
from 130 mg/m2 up to 200 mg/m2 in patients with severe hepatic
impairment in subsequent cycles based on individual tolerance.
For non-small cell lung cancer, reduce the dose of ABRAXANE to 50 mg/m2
in patients with severe hepatic impairment. In subsequent cycles, the dose
of ABRAXANE may be increased to 75 mg/m2 as tolerated.
Monitor patients closely [see Warnings and Precautions ( 5. 6), Use in
Specific Populations ( 8. 6) and Clinical Pharmacology ( 12. 3)].
Table 1: Recommendations for Starting Dose in Patients with
SGOT (AST) Bilirubin ABRAXANE Dosea
MBC NSCLCc Pancreaticc Adenocarcinoma
Mild < 10 x ULN AND > ULN to 260 mg/m2 100 mg/m2 125 mg/m2
≤ 1.25 x ULN
Moderate < 10 x ULN AND 1.26 to 200 mg/m2 75 mg/m2 not
2 x ULN recommended
Severe < 10 x ULN AND 2.01 to 130 mg/m2 b 50 mg/m2 not
5 x ULN recommended
> 10 x ULN OR > 5 x ULN not not not
recommended recommended recommended
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
b A dose increase to 200 mg/m2 in subsequent courses should be considered
based on individual tolerance.
c Patients with bilirubin levels above the upper limit of normal were excluded
from clinical trials for pancreatic or lung cancer.
2. 5 Dose Reduction/Discontinuation Recommendations
Metastatic Breast Cancer
Patients who experience severe neutropenia (neutrophil <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
Weekly Every 3-Week
Adverse Drug Reaction Occurrence ABRAXANE Dose Carboplatin Dose
(mg/m2) (AUC mg•min/mL)
Neutropenic Fever (ANC
less than 500/mm3 First 75 4. 5
with fever > 38°C)
Delay of next cycle by
more than 7 days for ANC Second 50 3
less than 1500/mm3
ANC less than 500/mm3 Third Discontinue Treatment
for more than 7 days
Platelet count less than First 75 4. 5
50,000/mm3 Second Discontinue Treatment
Severe sensory First 75 4. 5
Neuropathy – Second 50 3
Grade 3 or 4 Third Discontinue Treatment
• Do not administer ABRAXANE therapy to patients who have baseline
neutrophil counts of less than 1,500 cells/mm3. In order to monitor the
occurrence of bone marrow suppression, primarily neutropenia, which
may be severe and result in infection, it is recommended that frequent
peripheral blood cell counts be performed on all patients receiving
ABRAXANE [see Contraindications ( 4), Warnings and Precautions ( 5.1)
and Adverse Reactions ( 6.1, 6. 2, 6. 3)].
• Note: An albumin form of paclitaxel may substantially affect a drug’s
functional properties relative to those of drug in solution. DO NOT
SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.