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WHEN IS CHEMOTHERAPY AN APPROPRIATE TREATMENT CHOICE
IN HER2-NEGATIVE METASTATIC BREAST CANCER (MBC)?3,4

  • Triple negative breast cancer (TNBC)
  • Hormone receptor (HR) + and hormone refractory/resistant disease
  • Visceral metastases
When selecting chemotherapy in patients with MBC, what characteristics or poor prognostic factors are considered?
Treatment Considerations and Indicators of Poor Prognosis Treatment Considerations and Indicators of Poor Prognosis

ECOG=Eastern Cooperative Oncology Group.

Chart Symbol

Learn More: ABRAXANE’s Phase III Trial Designed to Assess Response Rates
in MBC Patients, Including Those With Poor Prognostic Factors

PATIENTS WHO HAVE MBC WITH VISCERAL AND MULTIPLE
METASTASES OFTEN HAVE LESS FAVORABLE OUTCOMES

There is lower median survival time for patients who develop visceral metastases vs nonvisceral metastases5,a
Patients who have MBC with visceral and multiple metastases often have less favorable outcomes Patients who have MBC with visceral and multiple metastases often have less favorable outcomes
  • A retrospective database analysis of 111 women at a single center in Canada between 2005 and 2007 found that about 67%-73% of patients with metastatic breast cancer (MBC) developed visceral metastases.19 A retrospective analysis of 6 clinical studies between 1983 and 2001 (N=640) found that in 57%-74% of patients, visceral metastases developed as the dominant metastatic site9
  • Further studies demonstrate that up to 85% of patients will develop visceral metastases at some point in the course of their disease7,20-22
  • Visceral metastases are associated with more aggressive MBC compared with nonvisceral metastases; patients tend to have worse outcomes5
The number of metastatic sites is associated with more aggressive MBCa
  • The presence of multiple metastatic lesions or sites is associated with poor prognosis in patients with MBC6
  • Patients with MBC who present metastases at ≥3 sites are likely to have a comparatively less favorable outcome than those with ≤2 metastatic sites8

Univariate survival analysis from a retrospective database of 346 patients diagnosed with MBC after first recurrence between 1970 and 1991.
All patients had undergone surgery for primary breast cancer and may have received radiation, hormonal therapy, and/or chemotherapy for metastatic disease.5

THERE IS LOWER MEDIAN SURVIVAL TIME FOR PATIENTS WITH INCREASING NUMBER OF METASTATIC SITES6,a

Univariate survival analysis of 1430 patients from 8 consecutive prospective trials conducted between 1977 and 1992 of anthracycline-based first-line chemotherapy in MBC. Univariate survival analysis of 1430 patients from 8 consecutive prospective trials conducted between 1977 and 1992 of anthracycline-based first-line chemotherapy in MBC.

Univariate survival analysis of 1430 patients from 8 consecutive prospective trials conducted between 1977 and 1992 of anthracycline-based first-line chemotherapy in MBC.

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Learn More: Majority of Patients From ABRAXANE MBC Phase III Trial Had Multiple and Visceral Metastases

Learn More: Majority of Patients From ABRAXANE MBC Phase III Trial
Had Multiple and Visceral Metastases

BASELINE PATIENT CHARACTERISTICS IN THE ABRAXANE PHASE III STUDY

Baseline patient characteristics in the Abraxane Phase III study Baseline patient characteristics in the Abraxane Phase III study

Study design

Multicenter, 1:1 randomized, Phase III study comparing ABRAXANE 260 mg/m2 IV Q3W with paclitaxel injection 175 mg/m2 IV Q3W in 460 patients with MBC. The primary efficacy endpoint was recTLRR. recTLRR was based on independent radiologic assessment of target lesions reconciled with investigator-reported responses for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy. The secondary endpoints were time to disease progression and overall survival.

IV=intravenously; PS=performance status; Q3W=every 3 weeks; recTLRR=reconciled target lesion response rate.

PHASE III RIGOROUS TUMOR RESPONSE ENDPOINT: recTLRR

  • The primary efficacy endpoint: reconciled target lesion response rate (recTLRR)
    • recTLRR was based on independent radiologic assessment of tumor responses
    • recTLRR was reconciled with investigator-reported responses for the first 6 cycles of therapy
  • Secondary efficacy endpoints included time to disease progression and overall survival, among other measures24
  • An exploratory analysis was conducted for overall survival to evaluate the subgroup of patients receiving ABRAXANE as second-line or later therapy

Patients who completed 6 cycles of ABRAXANE therapy and did not progress were able to continue treatment at the investigator's discretion.24

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RECOMMENDATIONS FOR METASTATIC BREAST CANCER PATIENTS WITH VISCERAL METASTASES

The predominance of visceral metastases in the Phase III study is consistent with the National Comprehensive Cancer Network® (NCCN®) recommended* patient population for albumin-bound paclitaxel (ABRAXANE).3

NCCN Guidelines® (V.6.2020) recommend albumin-bound paclitaxel as Category 2A.

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chart symbol

Learn More: ABRAXANE Delivered Almost Double the Response Rates vs
Paclitaxel Injection in MBC

WHEN RESPONSE RATES MATTER, CHOOSE ABRAXANE

Primary endpoint was response rate in ITT population based on reconciled investigator and independent radiologic assessments of target lesions through cycle 6 (recTLRR)a ABRAXANE 260 mg/m2 IV Q3W vs paclitaxel injection 175 mg/m2 IV Q3W

Primary endpoint was response rate in ITT population based on reconciled investigator and independent radiologic assessments of target lesions through cycle 6 (recTLRR)a ABRAXANE 260 mg/m2 IV Q3W vs paclitaxel injection 175 mg/m2 IV Q3W Primary endpoint was response rate in ITT population based on reconciled investigator and independent radiologic assessments of target lesions through cycle 6 (recTLRR)a ABRAXANE 260 mg/m2 IV Q3W vs paclitaxel injection 175 mg/m2 IV Q3W

ITT=intent-to-treat.

recTLRR was the prospectively defined, protocol-specific endpoint, based on independent radiologic assessment of tumor responses reconciled with investigator responses (which also included clinical information) for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy.

From Cochran-Mantel-Haenszel test stratified by first-line vs > first-line therapy.

IN RELAPSED OR REFRACTORY METASTATIC BREAST CANCER,
RESPONSE RATES ARE AN IMPORTANT MEASURE

recTLRR: ABRAXANE vs paclitaxel injection for patients who failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy (indicated population)

Prior therapy included an anthracycline unless clinically contraindicated. Prior therapy included an anthracycline unless clinically contraindicated.

Prior therapy included an anthracycline unless clinically contraindicated.

MEDIAN TIME TO FIRST CONFIRMED RECONCILED RESPONSE WITH ABRAXANE (EXPLORATORY ENDPOINT FOR ITT)24,a

Median time to first confirmed reconciled response with Abraxane (exploratory endpoint for ITT) Median time to first confirmed reconciled response with Abraxane (exploratory endpoint for ITT)

Analysis Limitations: Time to first reconciled response was an exploratory endpoint that was not powered to determine a treatment difference.

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Median OS

Compare Median Overall Survival (OS) Data: ABRAXANE vs Paclitaxel Injection

MEDIAN OVERALL SURVIVAL DATA:
ABRAXANE VS PACLITAXEL INJECTION23

ITT population: No statistically significant difference between ABRAXANE vs paclitaxel injection; Post-hoc analysis in patients who received at least one prior chemotherapy for metastatic disease ITT population: No statistically significant difference between ABRAXANE vs paclitaxel injection; Post-hoc analysis in patients who received at least one prior chemotherapy for metastatic disease

Median overall survival was measured in weeks and converted to months (assuming 4.348125 weeks in 1 Gregorian month).

Analysis Limitations: A post-hoc exploratory analysis should not be interpreted to determine a treatment difference between arms in this selected subgroup because of potential selection bias, insufficient sample size, and a higher probability of making a false positive finding.

OBSERVED SAFETY PROFILE
MOST COMMON ADVERSE EVENTS IN >20% OF PATIENTS

Observed safety profile most common adverse events in >20% of patients Observed safety profile most common adverse events in >20% of patients

AST=aspartate aminotransferase; ECG=electrocardiogram;
SGOT=serum glutamic-oxaloacetic transaminase.

Paclitaxel injection patients received premedication.

Severe events are defined as at least Grade 3 toxicity.

OBSERVED SAFETY PROFILE
ADVERSE EVENTS IN A PHASE III CLINICAL TRIAL

Frequencya of important treatment-emergent adverse events in the randomized study of an every-3-week schedule

 

Frequencya of important treatment-emergent adverse events in the randomized study of an every-3-week schedule

PERCENTAGE OF PATIENTS
ABRAXANE 260 mg/m2 over 30 min (n=229)
Paclitaxel injection 175 mg/m2 over 3 hb (n=225)
HEMATOLOGIC    
BONE MARROW    
Neutropenia    
<2.0 x 109/L 80 82
<0.5 x 109/L (Grade 4) 9 22
Thrombocytopenia    
<100 x 109/L 23
<50 x 109/L (Grade ≥3) <1 <1
Anemia    
<11 g/dL 33 25
<8 g/dL (Grade ≥3) 1<1
Infections 24 20
Febrile Neutropenia 2 1
Neutropenic Sepsis <1 <1
Bleeding 2 2
NONHEMATOLOGIC    
HYPERSENSITIVITY REACTIONc    
All 4 12
Severed 0 2
CARDIOVASCULAR    
Vital Sign Changes During Administration    
Bradycardia <1 <1
Hypotension 5 5
Severe Cardiovascular Eventsd 3 4
ABNORMAL ECG    
All Patients 60 52
Patients With Normal Baseline 35 30
RESPIRATORY    
Cough 7 6
Dyspnea 12 9
SENSORY NEUROPATHY    
Any Symptoms 71 56
Severe Symptomsd 10 2
MYALGIA/ARTHRALGIA    
Any Symptoms 44 49
Severe Symptomsd 8 4
ASTHENIA    
Any Symptoms 47 39
Severe Symptomsd 8 3
FLUID RETENTION/EDEMA    
Any Symptoms 10 8
Severe Symptomsd 0 <1
GASTROINTESTINAL    
Nausea    
Any Symptoms 30 22
Severe Symptomsd 3 <1
Vomiting    
Any Symptoms 18 10
Severe Symptomsd 4 1
Diarrhea    
Any Symptoms 27 15
Severe Symptomsd <1 1
Mucositis    
Any Symptoms 7 6
Severe Symptomsd <1 0
ALOPECIA 90 94
HEPATIC (PATIENTS WITH NORMAL BASELINE)    
Bilirubin Elevations 7 7
Alkaline Phosphatase Elevations 36 31
AST (SGOT) Elevations 39 32
INJECTION-SITE REACTION <1 1

NCI=National Cancer Institute.

Based on worst grade by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.

Paclitaxel injection patients received premedication.

Includes treatment-related events related to hypersensitivity (eg, flushing, dyspnea, chest pain, hypotension) that began on a day of dosing.

Severe events are defined as at least Grade 3 toxicity.

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Patient and Healthcare Resources

Download the “Preparing for My Treatment” Brochure: Help Your
Patients With MBC Get Ready for Their Medical Appointments

UNDERSTANDING AND ADDRESSING NEUROPATHY
ABRAXANE PHASE III MBC TRIAL

71% of 229 patients who received ABRAXANE developed Grades 1-3 sensory neuropathy (no Grade 4 was reported)

ABRAXANE® for metastatic breast cancer (MBC) - Grade 3 neuropathy from the phase III trial: 10% of patients developed Grade 3 neuropathy, 22 days median time to documented improvement for 14 of the 24 patients with Grade 3 neuropathy. Of the 10 patients without documented improvement, 4 discontinued due to peripheral neuropathy. 42% of patients resumed ABRAXANE® at a reduced dose - chart ABRAXANE® for metastatic breast cancer (MBC) - Grade 3 neuropathy from the phase III trial: 10% of patients developed Grade 3 neuropathy, 22 days median time to documented improvement for 14 of the 24 patients with Grade 3 neuropathy. Of the 10 patients without documented improvement, 4 discontinued due to peripheral neuropathy. 42% of patients resumed ABRAXANE® at a reduced dose - chart
  • The frequency and severity of sensory neuropathy increased with cumulative doses of ABRAXANE
    • 3% of patients (7/229) discontinued treatment with ABRAXANE due to sensory neuropathy
  • Only 1 incident of motor neuropathy (Grade 2) was observed in either arm of the controlled trial
Learn about dose modifications for treatment-related Neuropathy

Learn About Dose Modifications for Treatment-related Neuropathy

UNDERSTANDING AND ADDRESSING NEUTROPENIA
ABRAXANE PHASE III MBC TRIAL

ABRAXANE® for metastatic breast cancer (MBC) incidences of neutropenia from the phase III trial: Grade 1-4 ABRAXANE® (80%) vs paclitaxel (82%), Grade 4 ABRAXANE® (9%) vs paclitaxel 22%, febrile neutropenia ABRAXANE® (2%) vs paclitaxel (1%). 34% of patients receiving ABRAXANE® experienced Grade 3-4 neutropenia - chart ABRAXANE® for metastatic breast cancer (MBC) incidences of neutropenia from the phase III trial: Grade 1-4 ABRAXANE® (80%) vs paclitaxel (82%), Grade 4 ABRAXANE® (9%) vs paclitaxel 22%, febrile neutropenia ABRAXANE® (2%) vs paclitaxel (1%). 34% of patients receiving ABRAXANE® experienced Grade 3-4 neutropenia - chart
Learn about dose modifications for treatment-related Neutropenia

Learn About Dose Modifications For Treatment-related Neutropenia

UNDERSTANDING DURATION AND DOSING
ABRAXANE PHASE III MBC TRIAL

Patients treated with ABRAXANE received a median of 6 cycles of therapy

The primary endpoint, recTLRR, was the evaluation of reponses achieved in the first 6 cycles of therapy
  • The primary endpoint, recTLRR, was the evaluation of responses achieved in the first 6 cycles of therapy

FDA-approved dose and schedule for ABRAXANE in metastatic breast cancer:

  • Administer intravenously at a dose of 260 mg/m2
  • Recommended schedule is once every 3 weeks
  • Administer over 30 minutes
  • Premedication to prevent hypersensitivity reactions is generally not needed prior to the administration of ABRAXANE. Premedication may be needed in patients who have had prior hypersensitivity reactions to ABRAXANE. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
Watch the ABRAXANE
Reconstitution Video

DOSE MODIFICATIONS
FOR 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
> 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
>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
  • 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

ABRAXANE 260 mg/m2 dose illustration ABRAXANE 200 mg/m2 dose illustration ABRAXANE 200 mg/m2 dose illustration Not Recommended ABRAXANE dosing icon

ILLUSTRATIVE PURPOSES ONLY

A dose increase to 260 mg/m2 in subsequent courses should be considered if the patient tolerates the reduced dose for 2 cycles.

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DOSING FOR YOUR PATIENTS
WHO EXPERIENCE SENSORY NEUROPATHY

ABRAXANE dose-modification schedule for neuropathy

MILD TO MODERATE

SEVERE

RECURRENT

Mild 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
  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN

ABRAXANE dose

ABRAXANE 260 mg/m2 dose illustration ABRAXANE 220 mg/m2 dose illustration ABRAXANE 180 mg/m2 dosing illustration

ILLUSTRATIVE PURPOSES ONLY

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DOSING FOR YOUR PATIENTS
WHO EXPERIENCE NEUTROPENIA

ABRAXANE dose-modification schedule for neutropenia

MILD TO MODERATE

SEVERE

RECURRENT

Mild 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
  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN

ABRAXANE dose

ABRAXANE 260 mg/m2 dose illustration ABRAXANE 220 mg/m2 dosing illustration ABRAXANE 180 mg/m2 dosing illustration

ILLUSTRATIVE PURPOSES ONLY

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THE MAJORITY OF PATIENTS IN BOTH ARMS HAD POOR PROGNOSTIC FACTORS

  • 79%
    had visceral metastases
  • 76%
    >3 sites of metastases

ABRAXANE ALMOST DOUBLED THE RESPONSE RATE (recTLRR) VS PACLITAXEL IN THE ITT POPULATION

ABRAXANE almost doubled the response rate (recTLRR) vs paclitaxel in the ITT population ABRAXANE almost doubled the response rate (recTLRR) vs paclitaxel in the ITT population
  • Indication population:
    15.5% (n=20/129 [95% CI: 9.26%-21.75%]) vs
    8.4% (n=12/143 [95% CI: 3.85%-12.94%])

From Cochran-Mantel-Haenszel test stratified by first-line vs > first-line therapy.

MEDIAN OVERALL SURVIVAL23

ITT: No significant difference in OS between treatments; ≥ One prior therapy: Post-hoc exploratory analysis ITT: No significant difference in OS between treatments; ≥ One prior therapy: Post-hoc exploratory analysis

Analysis Limitations: A post-hoc exploratory analysis should not be interpreted to determine a treatment difference between arms in this selected subgroup because of potential selection bias, insufficient sample size, and a higher probability of making a false positive finding.

Median overall survival was measured in weeks and converted to months (assuming 4.348125 weeks in 1 Gregorian month).

MOST COMMON AEs (≥20%)

  • Alopecia
  • Neutropenia
  • Sensory Neuropathy
  • Abnormal ECG
  • Fatigue/Asthenia
  • Myalgia/Arthralgia
  • AST Elevations
  • Alkaline Phosphatase Elevations
  • Anemia
  • Nausea
  • Infections
  • Diarrhea

Study design

Multicenter, 1:1 randomized, Phase III study comparing ABRAXANE 260 mg/m2 IV Q3W with paclitaxel injection 175 mg/m2 IV Q3W in 460 patients with MBC. The primary efficacy endpoint was recTLRR. recTLRR was based on independent radiologic assessment of target lesions reconciled with investigator-reported responses for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy. The secondary endpoints were time to disease progression and overall survival.

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FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING PATIENT
INFORMATION

IMPORTANT SAFETY INFORMATION & INDICATIONS

WARNING — SEVERE MYELOSUPPRESSION

  • Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3
  • Monitor for neutropenia, which may be severe and result in infection or sepsis. Perform frequent complete blood cell counts on all patients receiving ABRAXANE

CONTRAINDICATIONS

  • Baseline neutrophil counts of <1500 cells/mm3
  • A history of severe hypersensitivity reactions to ABRAXANE

WARNINGS AND PRECAUTIONS

Severe Myelosuppression

  • Severe myelosuppression (primarily neutropenia) is dose-dependent and a dose-limiting toxicity of ABRAXANE. In clinical studies, Grade 3-4 neutropenia occurred in 34% of patients with metastatic breast cancer (MBC), 47% of patients with non–small cell lung cancer (NSCLC), and 38% of patients with pancreatic cancer
  • Monitor for severe neutropenia and thrombocytopenia by performing complete blood cell counts frequently, including prior to dosing on Day 1 (for MBC) and Days 1, 8, and 15 (for NSCLC and for pancreatic cancer)
  • Do not administer ABRAXANE to patients with baseline absolute neutrophil counts (ANC) of less than 1500 cells/mm3
  • In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in subsequent courses in patients with either MBC or NSCLC
  • In patients with MBC, resume treatment with every-3-week cycles of ABRAXANE after ANC recovers to a level >1500 cells/mm3 and platelets recover to a level >100,000 cells/mm3
  • In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly ABRAXANE and every-3-week carboplatin after ANC recovers to at least 1500 cells/mm3 and platelet count of at least 100,000 cells/mm3 on Day 1 or to an ANC of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Days 8 or 15 of the cycle
  • In patients with adenocarcinoma of the pancreas, withhold ABRAXANE and gemcitabine if the ANC is less than 500 cells/mm3 or platelets are less than 50,000 cells/mm3 and delay initiation of the next cycle if the ANC is less than 1500 cells/mm3 or platelet count is less than 100,000 cells/mm3 on Day 1 of the cycle. Resume treatment with appropriate dose reduction if recommended

Severe Neuropathy

  • Sensory neuropathy is dose- and schedule-dependent
  • If ≥ Grade 3 sensory neuropathy develops, withhold ABRAXANE treatment until resolution to Grade 1 or 2 for MBC or until resolution to ≤ Grade 1 for NSCLC and pancreatic cancer followed by a dose reduction for all subsequent courses of ABRAXANE

Sepsis

  • Sepsis occurred in 5% of patients with or without neutropenia who received ABRAXANE in combination with gemcitabine
  • Biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis
  • If a patient becomes febrile (regardless of ANC), initiate treatment with broad-spectrum antibiotics
  • For febrile neutropenia, interrupt ABRAXANE and gemcitabine until fever resolves and ANC ≥1500 cells/mm3, then resume treatment at reduced dose levels

Pneumonitis

  • Pneumonitis, including some cases that were fatal, occurred in 4% of patients receiving ABRAXANE in combination with gemcitabine
  • Monitor patients for signs and symptoms and interrupt ABRAXANE and gemcitabine during evaluation of suspected pneumonitis
  • Permanently discontinue treatment with ABRAXANE and gemcitabine upon making a diagnosis of pneumonitis

Severe Hypersensitivity

  • Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, have been reported
  • Do not rechallenge patients who experience a severe hypersensitivity reaction to ABRAXANE with this drug
  • Cross-hypersensitivity between ABRAXANE and other taxane products has been reported and may include severe reactions such as anaphylaxis. Closely monitor patients with a previous history of hypersensitivity reaction to ABRAXANE with this drug

Use in Patients With Hepatic Impairment

  • The exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment. Closely monitor patients with hepatic impairment for severe myelosuppression
  • ABRAXANE is not recommended in patients who have a total bilirubin >5 x ULN or AST >10 x ULN
  • For MBC and NSCLC, the starting dose should be reduced for patients with moderate or severe hepatic impairment
  • For pancreatic adenocarcinoma, ABRAXANE is not recommended for patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN and AST ≤10 x ULN)

Albumin (Human)

  • ABRAXANE contains albumin (human), a derivative of human blood

Embryo-Fetal Toxicity

  • Based on mechanism of action and findings in animals, ABRAXANE can cause fetal harm when administered to a pregnant woman
  • Advise females of reproductive potential of the potential risk to a fetus
  • Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with ABRAXANE and for at least six months after the last dose of ABRAXANE
  • Advise male patients with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with ABRAXANE and for at least three months after the last dose of ABRAXANE

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

  • The most common adverse reactions (≥20%) with single-agent use of ABRAXANE vs paclitaxel injection in the MBC study are alopecia (90%, 94%), neutropenia (all cases 80%, 82%; severe 9%, 22%), sensory neuropathy (any symptoms 71%, 56%; severe 10%, 2%), abnormal ECG (all patients 60%, 52%; patients with normal baseline 35%, 30%), fatigue/asthenia (any 47%, 39%; severe 8%, 3%), myalgia/arthralgia (any 44%, 49%; severe 8%, 4%), AST elevation (any 39%, 32%), alkaline phosphatase elevation (any 36%, 31%), anemia (any 33%, 25%; severe 1%, <1%), nausea (any 30%, 22%; severe 3%, <1%), diarrhea (any 27%, 15%; severe <1%, 1%), and infections (24%, 20%), respectively
  • Sensory neuropathy was the cause of ABRAXANE discontinuation in 7/229 (3%) patients
  • Other adverse reactions of note with the use of ABRAXANE vs paclitaxel injection included vomiting (any 18%, 10%; severe 4%, 1%), fluid retention (any 10%, 8%; severe 0%, <1%), mucositis (any 7%, 6%; severe <1%, 0%), hepatic dysfunction (elevations in bilirubin 7%, 7%), hypersensitivity reactions (any 4%, 12%; severe 0%, 2%), thrombocytopenia (any 2%, 3%; severe <1%, <1%), neutropenic sepsis (<1%, <1%), and injection site reactions (<1%, 1%), respectively. Dehydration and pyrexia were also reported
  • Renal dysfunction (any 11%, severe 1%) was reported in patients treated with ABRAXANE (n=229)
  • In all ABRAXANE-treated patients (n=366), ocular/visual disturbances were reported (any 13%; severe 1%)
  • Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients and included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension
  • Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported

Non-Small Cell Lung Cancer (NSCLC) Study

  • The most common adverse reactions (≥20%) of ABRAXANE in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue
  • The most common serious adverse reactions of ABRAXANE in combination with carboplatin for NSCLC are anemia (4%) and pneumonia (3%)
  • The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%)
  • The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (24%), thrombocytopenia (13%), and anemia (6%)
  • The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%)
  • The following common (≥10% incidence) adverse reactions were observed at a similar incidence in ABRAXANE plus carboplatin–treated and paclitaxel injection plus carboplatin–treated patients: alopecia (56%), nausea (27%), fatigue (25%), decreased appetite (17%), asthenia (16%), constipation (16%), diarrhea (15%), vomiting (12%), dyspnea (12%), and rash (10%); incidence rates are for the ABRAXANE plus carboplatin treatment group
  • Adverse reactions with a difference of ≥2%, Grade 3 or higher, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (28%, 7%), neutropenia (47%, 58%), thrombocytopenia (18%, 9%), and peripheral neuropathy (3%, 12%), respectively
  • Adverse reactions with a difference of ≥5%, Grades 1-4, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (98%, 91%), thrombocytopenia (68%, 55%), peripheral neuropathy (48%, 64%), edema peripheral (10%, 4%), epistaxis (7%, 2%), arthralgia (13%, 25%), and myalgia (10%, 19%), respectively
  • Neutropenia (all grades) was reported in 85% of patients who received ABRAXANE and carboplatin vs 83% of patients who received paclitaxel injection and carboplatin

Pancreatic Adenocarcinoma Study

  • Among the most common (≥20%) adverse reactions in the phase III study, those with a ≥5% higher incidence in the ABRAXANE/gemcitabine group compared with the gemcitabine group are neutropenia (73%, 58%), fatigue (59%, 46%), peripheral neuropathy (54%, 13%), nausea (54%, 48%), alopecia (50%, 5%), peripheral edema (46%, 30%), diarrhea (44%, 24%), pyrexia (41%, 28%), vomiting (36%, 28%), decreased appetite (36%, 26%), rash (30%, 11%), and dehydration (21%, 11%)
  • Of these most common adverse reactions, those with a ≥2% higher incidence of Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared with the gemcitabine group, respectively, are neutropenia (38%, 27%), fatigue (18%, 9%), peripheral neuropathy (17%, 1%), nausea (6%, 3%), diarrhea (6%, 1%), pyrexia (3%, 1%), vomiting (6%, 4%), decreased appetite (5%, 2%), and dehydration (7%, 2%)
  • Thrombocytopenia (all grades) was reported in 74% of patients in the ABRAXANE/gemcitabine group vs 70% of patients in the gemcitabine group
  • The most common serious adverse reactions of ABRAXANE (with a ≥1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%), and vomiting (4%)
  • The most common adverse reactions resulting in permanent discontinuation of ABRAXANE were peripheral neuropathy (8%), fatigue (4%), and thrombocytopenia (2%)
  • The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (10%) and peripheral neuropathy (6%)
  • The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%), and diarrhea (5%)
  • Other selected adverse reactions with a ≥5% higher incidence for all-grade toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group, respectively, are asthenia (19%, 13%), mucositis (10%, 4%), dysgeusia (16%, 8%), headache (14%, 9%), hypokalemia (12%, 7%), cough (17%, 7%), epistaxis (15%, 3%), urinary tract infection (11%, 5%), pain in extremity (11%, 6%), arthralgia (11%, 3%), myalgia (10%, 4%), and depression (12%, 6%)
  • Other selected adverse reactions with a ≥2% higher incidence for Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group are thrombocytopenia (13%, 9%), asthenia (7%, 4%), and hypokalemia (4%, 1%)

Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations

  • Severe and sometimes fatal hypersensitivity reactions. Cross-hypersensitivity between ABRAXANE and other taxanes has been reported
  • Congestive heart failure, left ventricular dysfunction, and atrioventricular block. Most patients were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history
  • Extravasation. Closely monitor the ABRAXANE infusion site for possible infiltration during drug administration

DRUG INTERACTIONS

  • Caution should be exercised when administering ABRAXANE concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4

USE IN SPECIFIC POPULATIONS

Pregnancy

  • Based on the mechanism of action and findings in animals, ABRAXANE can cause fetal harm when administered to a pregnant woman. Advise females of the potential risk to a fetus and to avoid becoming pregnant while receiving ABRAXANE

Lactation

  • Paclitaxel and/or its metabolites were excreted into the milk of lactating rats. Nursing must be discontinued when receiving treatment with ABRAXANE and for two weeks after the last dose

Females and Males of Reproductive Potential

  • Based on animal studies and mechanism of action, ABRAXANE can cause fetal harm when administered to a pregnant woman
  • Verify the pregnancy status of females of reproductive potential prior to starting treatment with ABRAXANE
  • Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with and for at least six months after the last dose of ABRAXANE [see Warnings and Precautions]
  • Advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with ABRAXANE and for at least three months after the last dose of ABRAXANE [see Warnings and Precautions]
  • Based on findings in animals, ABRAXANE may impair fertility in females and males of reproductive potential

Pediatric

  • The safety and effectiveness of ABRAXANE in pediatric patients have not been established

Geriatric

  • A higher incidence of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema was found in patients 65 years or older who received ABRAXANE for MBC in a pooled analysis of clinical studies
  • Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients ≥65 years of age treated with ABRAXANE and carboplatin in NSCLC
  • Diarrhea, decreased appetite, dehydration, and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old who received ABRAXANE and gemcitabine in adenocarcinoma of the pancreas

Renal Impairment

  • There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 mL/min)

DOSAGE AND ADMINISTRATION

  • DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS
  • Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicity

INDICATIONS

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.

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.

ABRAXANE® is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Please see full Prescribing Information, including Boxed WARNING.

References: 1. Paclitaxel. Package insert. Hospira, Inc; 2018. 2. Taxotere. Package insert. Sanofi-Aventis U.S. LLC; 2020. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 15, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Cardoso F, Costa A, Norton L, et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol. 2014;25(10):1871-1888. 5. Chang J, Clark GM, Allred DC, Mohsin S, Chamness G, Elledge RM. Survival of patients with metastatic breast carcinoma: importance of prognostic markers of the primary tumor. Cancer. 2003;97(3):545-553. 6. Pierga JY, Robain M, Jouve M, et al. Response to chemotherapy is a major parameter-influencing long-term survival of metastatic breast cancer patients. Ann Oncol. 2001;12(2):231-237. 7. Sledge GW, Neuberg D, Bernardo P, et al. Phase Ill trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol. 2003;21(14):588-592. 8. Jung SY, Rosenzweig M, Sereika SM, Linkov F, Brufsky A, Weissfeld JL. Factors associated with mortality after breast cancer metastasis. Cancer Causes Control. 2012;23(1):103-112. 9. Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005;104(8):1742-1750. 10. Lobbezoo DJA, van Kampen RJW, Voogd AC, et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res Treat. 2013;141(3):507-514. 11. Yamamoto N, Watanabe T, Katsumata N, et al. Construction and validation of a practical prognostic index for patients with metastatic breast cancer. J Clin Oncol. 1998;16(7):2401-2408. 12. Thientosapol ES, Tran TT, Della-Fiorentina SA, et al. Survival times of women with metastatic breast cancer starting first-line chemotherapy in routine clinical practice versus contemporary randomised trials. Intern Med J. 2013;43(8):883-888. 13. Harris LN, Broadwater G, Lin NU, et al. Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Res. 2006;8(6):R66. 14. Chung M, Chang HR, Bland KI, Wanebo HJ. Younger women with breast carcinoma have a poorer prognosis than older women. Cancer. 1996;77(1):97-103. 15. Clark GM, Sledge GW Jr, Osborne CK, McGuire WL. Survival from first recurrence: relative importance of prognostic factors in 1,015 breast cancer patients. J Clin Oncol. 1987;5(1):55-61. 16. Azim HA Jr, Michiels S, Bedard PL, et al. Elucidating prognosis and biology of breast cancer arising in young women using gene expression profiling. Clin Cancer Res. 2012;18(5):1341-1351. 17. DeSantis CE, Fedewa SA, Sauer A, Kramer JL, Jemal A. Breast cancer statistics, 2015: convergence of incidence rates between black and white women. CA Cancer J Clin. 2016;66(1):31-42. 18. American Cancer Society. Cancer Facts & Figures for African Americans 2018. Atlanta, GA: American Cancer Society, 2018. 19. Samiee S, Berardi P, Bouganim N, et al. Excision of the primary tumour in patients with metastatic breast cancer: a clinical dilemma. Curr Oncol. 2012;19(4):e270-e279. 20. Wallwiener M, Hartkopf AD, Baccelli I, et al. The prognostic impact of circulating tumor cells in subtypes of metastatic breast cancer. Breast Cancer Res Treat. 2013;137(2):503-510. 21. Loibl S, Doering G, Müller L, et al. Multicenter phase II study with weekly bendamustine and paclitaxel as first- or later-line therapy in patients with metastatic breast cancer: RiTa II trial. Breast Care (Basel). 2011;6(6):457-461. 22. Villanueva C, Chaigneau L, Dufresne A, et al. Phase II trial of paclitaxel and uracil-tegafur in metastatic breast cancer. TEGATAX trial. Breast. 2011;20(4):329-333. 23. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase Ill trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil–based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794-7803. 24. Data on file. Bristol-Myers Squibb Company.

This website is intended for U.S. residents 18 years of age or older.

ABRAXANE® is a registered trademark of Abraxis BioScience, LLC. Abraxis BioScience, LLC is a wholly owned subsidiary of Bristol-Myers Squibb Company.

Access Support® is a registered trademark of Bristol-Myers Squibb Company.

© 2022 Bristol-Myers Squibb Company.

2013-US-2200013 10/22

2013-US-2300003 02/23

References: 1. Paclitaxel. Package insert. Hospira, Inc; 2018. 2. Taxotere. Package insert. Sanofi-Aventis U.S. LLC; 2020. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 15, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Cardoso F, Costa A, Norton L, et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol. 2014;25(10):1871-1888. 5. Chang J, Clark GM, Allred DC, Mohsin S, Chamness G, Elledge RM. Survival of patients with metastatic breast carcinoma: importance of prognostic markers of the primary tumor. Cancer. 2003;97(3):545-553. 6. Pierga JY, Robain M, Jouve M, et al. Response to chemotherapy is a major parameter-influencing long-term survival of metastatic breast cancer patients. Ann Oncol. 2001;12(2):231-237. 7. Sledge GW, Neuberg D, Bernardo P, et al. Phase Ill trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol. 2003;21(14):588-592. 8. Jung SY, Rosenzweig M, Sereika SM, Linkov F, Brufsky A, Weissfeld JL. Factors associated with mortality after breast cancer metastasis. Cancer Causes Control. 2012;23(1):103-112. 9. Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005;104(8):1742-1750. 10. Lobbezoo DJA, van Kampen RJW, Voogd AC, et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res Treat. 2013;141(3):507-514. 11. Yamamoto N, Watanabe T, Katsumata N, et al. Construction and validation of a practical prognostic index for patients with metastatic breast cancer. J Clin Oncol. 1998;16(7):2401-2408. 12. Thientosapol ES, Tran TT, Della-Fiorentina SA, et al. Survival times of women with metastatic breast cancer starting first-line chemotherapy in routine clinical practice versus contemporary randomised trials. Intern Med J. 2013;43(8):883-888. 13. Harris LN, Broadwater G, Lin NU, et al. Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Res. 2006;8(6):R66. 14. Chung M, Chang HR, Bland KI, Wanebo HJ. Younger women with breast carcinoma have a poorer prognosis than older women. Cancer. 1996;77(1):97-103. 15. Clark GM, Sledge GW Jr, Osborne CK, McGuire WL. Survival from first recurrence: relative importance of prognostic factors in 1,015 breast cancer patients. J Clin Oncol. 1987;5(1):55-61. 16. Azim HA Jr, Michiels S, Bedard PL, et al. Elucidating prognosis and biology of breast cancer arising in young women using gene expression profiling. Clin Cancer Res. 2012;18(5):1341-1351. 17. DeSantis CE, Fedewa SA, Sauer A, Kramer JL, Jemal A. Breast cancer statistics, 2015: convergence of incidence rates between black and white women. CA Cancer J Clin. 2016;66(1):31-42. 18. American Cancer Society. Cancer Facts & Figures for African Americans 2018. Atlanta, GA: American Cancer Society, 2018. 19. Samiee S, Berardi P, Bouganim N, et al. Excision of the primary tumour in patients with metastatic breast cancer: a clinical dilemma. Curr Oncol. 2012;19(4):e270-e279. 20. Wallwiener M, Hartkopf AD, Baccelli I, et al. The prognostic impact of circulating tumor cells in subtypes of metastatic breast cancer. Breast Cancer Res Treat. 2013;137(2):503-510. 21. Loibl S, Doering G, Müller L, et al. Multicenter phase II study with weekly bendamustine and paclitaxel as first- or later-line therapy in patients with metastatic breast cancer: RiTa II trial. Breast Care (Basel). 2011;6(6):457-461. 22. Villanueva C, Chaigneau L, Dufresne A, et al. Phase II trial of paclitaxel and uracil-tegafur in metastatic breast cancer. TEGATAX trial. Breast. 2011;20(4):329-333. 23. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase Ill trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil–based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794-7803. 24. Data on file. Bristol-Myers Squibb Company.