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DELIVER THE DIFFERENCE OF AN ALBUMIN-BOUND PACLITAXEL

ABRAXANE is an albumin-bound nanoparticle formulation

  • ABRAXANE has different pharmacokinetic (PK) properties than paclitaxel
See the PK profile of ABRAXANE
ABRAXANE is an albumin-bound nanoparticle formulation

A TRIAL REFLECTIVE OF THE PATIENTS TYPICALLY SEEN IN YOUR PRACTICE

The first Phase III trial for 1L mPC based on a real-world population3

MPACT is the largest multinational trial (861 patients) in the mPC setting

151 community and academic centers worldwide; 63% of patients treated in a community setting; Broad range of PS; No upper age limit 151 community and academic centers worldwide; 63% of patients treated in a community setting; Broad range of PS; No upper age limit
Broad range of PS in MPACT: Proportion of patients by KPS No upper age limit No upper age limit

Study Design

The multinational, randomized, Phase III MPACT study compared ABRAXANE + gemcitabine vs gemcitabine alone as first-line treatment in 861 patients with mPC with normal bilirubin and no prior chemotherapy in the metastatic setting. Primary endpoint was OS. ABRAXANE(125 mg/m2) + gemcitabine (1000 mg/m2) was given QW3/4. In the gemcitabine arm, gemcitabine (1000 mg/m2) was given QW7/8 then QW3/4.

1L=first-line; ECOG=Eastern Cooperative Oncology Group; KPS=Karnofsky Performance Status; MPACT=Metastatic Pancreatic Adenocarcinoma Clinical Trial; mPC=metastatic pancreatic cancer; OS=overall survival; PS=performance status; QW3/4=weekly for 3 of 4 weeks; QW7/8=weekly for 7 of 8 weeks.

UNDERSTANDING THE RELATION BETWEEN
PERFORMANCE STATUS MEASUREMENTS5-7

Karnofsky Performance Status (KPS) Eastern Cooperative Oncology Group Performance Status (ECOG PS) Karnofsky Performance Status (KPS); Eastern Cooperative Oncology Group Performance Status (ECOG PS)

This proposed conversion scale was constructed empirically from a sample of patients (n=1385) with advanced cancer, including different tumor types. Both KPS and ECOG PS were determined by 7 physicians for each patient. This conversion scale had the highest rate of agreement (75%) observed among all possible scales.7

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PATIENTS WERE WELL BALANCED
BETWEEN TREATMENT ARMS3

Patients were well balanced between treatment arms Patients were well balanced between treatment arms

ULN=upper limit of normal.

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Watch. Dr. Kim Discusses the Largest Multinational Phase III Study

WATCH
Dr. Kim Discusses the Largest Multinational Phase III Study

EFFICACY THAT DELIVERS

Only ABRAXANE + gemcitabine is proven to significantly improve OS across a broad range of patients3,a
Only ABRAXANE + gemcitabine is proven to significantly improve OS across a broad range of patients3

Patient performance status ranged from ECOG 0-2, with no upper age limit (age range: 27-86 years).3

Stratified using Cox proportional hazard model.

Based on a stratified log-rank test (stratified by geographic region, KPS, and presence of liver metastasis).

RESPONSE MATTERS:
ORR ASSESSED BY INDEPENDENT REVIEW

ABRAXANE (125 mg/m2 QW3/4) + gemcitabine more than tripled ORR vs gemcitabine alone
Response Matters: ORR assessed by independent review CLOSE THE TAB

ABRAXANE + GEMCITABINE
SIGNIFICANTLY IMPROVED PFSa

49% increase in median PFS with ABRAXANE (125 mg/m2 QW3/4) + gemcitabine compared with gemcitabine alone3
Abraxane + gemcitabine signficantly improved PFSa

Based on independent radiological reviewer assessment.

Stratified using Cox proportional hazard model.

Based on a stratified log-rank test (stratified by geographic region, KPS, and presence of liver metastasis).

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Watch. Dr. Kim Discusses the Largest Multinational Phase III Study

WATCH
Dr. Kim Discusses the Largest Multinational Phase III Study

GREATER THAN 1-YEAR SURVIVAL BENEFIT FOR THE FITTEST PATIENTS
(ECOG PS 0)8

Post-hoc analysis of survival by performance status

Post-hoc analysis of survival by performance status Post-hoc analysis of survival by performance status

ECOG PS 0 to 1 (KPS 90-100)

9.7 months (n=248; 95% CI: 8.71-10.91) with ABRAXANE + gemcitabine vs 7.9 months (n=268; 95% CI: 6.97-9.03) with gemcitabine (HR=0.75 [95% CI: 0.62-0.92])

ECOG PS 1 to 2 (KPS 70-80)

7.6 months (n=179; 95% CI: 6.44-8.38) with ABRAXANE + gemcitabine vs 4.3 months (n=161; 95% CI: 3.81-5.72) with gemcitabine (HR=0.61 [95% CI: 0.48-0.78])

Analysis limitations: An exploratory analysis should not be interpreted to determine a treatment difference between arms in these selected subgroups because of insufficient sample size and a higher probability of making a false-positive finding.

Watch. Dr. Kim Discusses the Largest Multinational Phase III Study

WATCH
Dr. Kim Discusses the Largest Multinational Phase III Study

DOSING THAT DELIVERS

A well-established regimen for your patients
Dosing that delivers
  • Starting dose of 125 mg/m2
  • Administer ABRAXANE, followed by gemcitabine 1000 mg/m2, on Days 1, 8, and 15 of each 28-day cycle
  • 30- to 40-minute IV infusion

NOTE: DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.
ABRAXANE has different dosage and administration instructions from other paclitaxel products.

A WELL-DEFINED DOSE MODIFICATION SCHEDULE

Dose level reductions for patients with mPC
Dose level reductions for patients with mPC Dose level reductions for patients with mPC

In the MPACT study4

  • 41% of patients had at least one ABRAXANE dose reduction
  • 71% of patients had at least one ABRAXANE dose withheld or delayed

STARTING DOSE FOR PATIENTS
WITH HEPATIC IMPAIRMENT

Starting dose for patients with heptic impairement
  • Patients with bilirubin levels above the ULN were excluded from the MPACT study (central lab ULN in the MPACT study was 1.5 mg/dL)

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

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UNDERSTANDING TIMING OF DOSE MODIFICATIONS
DURING ABRAXANE + GEMCITABINE THERAPY9

Understanding timing of dose modications during Abraxane + gemcitabine therapy Understanding timing of dose modications during Abraxane + gemcitabine therapy

First 2 cycles.

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THE APPROVED STARTING DOSE OF 125 mg/m2

Percentage of ABRAXANE patients receiving 125 mg/m2 at the start of each treatment cycle9,a

Percentage of Abraxane patients receiving 125 mg/m<sup>2</sup> at the start of each treatment cycle Percentage of Abraxane patients receiving 125 mg/m<sup>2</sup> at the start of each treatment cycle
  • Median duration of treatment: 3.9 months (range 0.1 to 21.9 months)3

Within the MPACT study there were also dose modifications to the gemcitabine dose within the ABRAXANE + gemcitabine arm. Those modifications are not shown here.

Cycle 1=8 weeks; subsequent cycles=4 weeks each.

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VIEW
Dose Modifications for Severe Hematologic, Neurologic, Cutaneous, or Gastrointestinal Toxicity
Download now. Quick reference card for dosing schedule and dose modifcations

DOWNLOAD NOW
Quick-reference Card for Dosing Schedule and Dose Modifications
Watch Dr. Kim Presents the Dosing and Schedule Recommendation for ABRAXANE + Gemcitabine

WATCH
Dr. Kim Presents the Dosing and Schedule Recommendation for
ABRAXANE + Gemcitabine

A PREFERRED 1L REGIMEN OPTION (CATEGORY 1 RECOMMENDATION)10

A preferred 1L regimen option (category 1 recommendation) A preferred 1L regimen option (category 1 recommendation)

Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.10

Good performance status for this regimen (AG) is defined as KPS ≥70, so some patients with an ECOG score of 2 may be eligible to receive this regimen (AG).10

According to the NCCN Chemotherapy Order Templates: Peer-reviewed statements of consensus of its authors derived from the NCCN Guidelines®.

The albumin-bound paclitaxel (ABRAXANE) Phase III MPACT study enrolled patients with KPS ≥70.10
Good performance status is defined as ECOG 0-1, with good biliary drainage and adequate nutritional intake, and ECOG 0-2 if considering gemcitabine + albumin-bound paclitaxel.10
Please refer to the NCCN Guidelines for pancreatic cancer for a complete list of recommended treatment options.
AG=ABRAXANE + gemcitabine.

NCCN Category 1

DOWNLOAD NOW
Summary of NCCN Guidelines®: Albumin-bound Paclitaxel (ABRAXANE) + Gemcitabine as a Preferred First-Line Regimen

A WELL-ESTABLISHED SAFETY PROFILE

Most common ARs (≥20%) with a ≥5% higher incidence for ABRAXANE + gemcitabine arm

Most common ARs (≥20%) with a ≥5% higher incidence for ABRAXANE + gemcitabine arm Most common ARs (≥20%) with a ≥5% higher incidence for ABRAXANE + gemcitabine arm
  • ABRAXANE + gemcitabine had the same incidence of death due to adverse reactions compared to gemcitabine alone (4% of patients in each arm)4
  • Disease progression was the most common reason for treatment discontinuation4
  • The most common ARs resulting in permanent discontinuation of ABRAXANE were:
    8% peripheral neuropathy | 4% fatigue | 2% thrombocytopenia

A WELL-ESTABLISHED SAFETY PROFILE

Higher incidence (≥5% for all grade toxicity or ≥2% Grade 3 or higher toxicity) in the ABRAXANE + gemcitabine arm

Higher incidence (≥5% for all grade toxicity or ≥2% Grade 3 or higher toxicity) in the ABRAXANE + gemcitabine arm

MedDRA=Medical Dictionary for Regulatory Activities.

405 patients assessed in ABRAXANE + gemcitabine–treated group.

388 patients assessed in gemcitabine-treated group.

404 patients assessed in ABRAXANE + gemcitabine–treated group.

Neutrophil growth factors were administered to 26% of patients in the ABRAXANE + gemcitabine group.

Peripheral neuropathy is defined by the MedDRA v15.0 Standardized MedDRA Query (broad scope).

Urinary tract infections includes the preferred terms of: urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, and urinary tract infection enterococcal.

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A WELL-ESTABLISHED SAFETY PROFILE

Most common serious ARs (with a ≥1% higher incidence) for ABRAXANE + gemcitabine arm

A well-established safety profileA well-established safety profile CLOSE THE TAB
Download now. Quick reference card for dosing schedule and dose modifcations

DOWNLOAD NOW
Quick-reference Card for Dosing Schedule and Dose Modifications
Watch Dr. Kim Presents the Dosing and Schedule Recommdation for ABRAXANE + Gemcitabine

WATCH
Dr. Kim Reviews the Well-Established Safety Profile of ABRAXANE Based on the Phase III Study

PERIPHERAL NEUROPATHY IN THE MPACT STUDY

Peripheral Neuropathy
  • 54% of patients experienced peripheral neuropathy of any grade (227/421)
  • In the 17% of patients who experienced Grade 3 peripheral neuropathy (70/421), 44% (n=31) resumed ABRAXANE at a reduced dose
    • The median time to first occurrence of Grade 3 peripheral neuropathy in the ABRAXANE arm was 140 days
    • The median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days after withholding dose
  • 8% of patients who received ABRAXANE + gemcitabine permanently discontinued ABRAXANE due to peripheral neuropathy

APPROPRIATE DOSE MODIFICATIONS FOR PERIPHERAL NEUROPATHY

Assessing the severity of peripheral neuropathy is key to determining dose modifications

Grade 1 or 2 Grade 1 or 2 Grade >=3 Grade >=3

DOSE LEVEL REDUCTIONS

Dose level reductions Dose level reductions CLOSE THE TAB

CLEARLY DEFINED DOSE MODIFICATIONS FOR OTHER ARs

Clearly defined dose modifcations for other ARs Clearly defined dose modifcations for other ARs

ANC=absolute neutrophil count.

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Download now. Quick reference card for dosing schedule and dose modifcations

DOWNLOAD NOW
Quick-reference Card for Dosing Schedule and Dose Modifications

UNDERSTANDING HEMATOLOGIC ARs
WITH ABRAXANE + GEMCITABINE

Understanding hematologic Ars with Abraxane + gemcitabine Understanding hematologic Ars with Abraxane + gemcitabine

26% of ABRAXANE + gemcitabine patients received granulocyte colony stimulating factor (G-CSF).

APPROPRIATE DOSE MODIFICATIONS FOR HEMATOLOGIC ARs

Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15

Day 1

Assess whether to begin or delay treatment cycle (based on CBC prior to dosing on Day 1)

  • Patients must have ANC ≥1500 cells/mm3 and platelet counts ≥100,000 cells/mm3 to initiate a cycle
  • If counts are not at these levels, delay the start of the cycle until recovery

The recommended starting dose of ABRAXANE is 125 mg/m2

Adjust treatment as necessary within the cycle based on ANC and platelet counts

(determined via CBC prior to dosing on Days 8 and 15)

Day 8 adjust tretament as necessary within the cycle based on ANC and platelet counts Day 8 adjust tretament as necessary within the cycle based on ANC and platelet counts
Day 15

Treatment adjustments at Day 15 depend upon action taken at Day 8
SELECT ACTION TAKEN ON DAY 8 ABOVE TO SEE APPROPRIATE DOSE MODIFICATIONS FOR DAY 15

If Grade 3 or 4 febrile neutropenia occurs, withhold ABRAXANE and gemcitabine until fever resolves and ANC ≥1500; resume at next lower dose level.

CBC=complete blood count.

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DOSE LEVEL REDUCTIONS

Dose level reductions Dose level reductions CLOSE THE TAB
Download now. Quick reference card for dosing schedule and dose modifcations

DOWNLOAD NOW
Quick-reference Dosing Card, including Dose Modifications for Hematologic ARs
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. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-1703. 4. Data on file. Bristol-Myers Squibb Company. 5. Karnofsky DA, Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. In: MacLeod CM, ed. Evaluation of Chemotherapeutic Agents in Cancer. New York, NY: Columbia University Press; 1949:191-205. 6. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655. 7. Ma C, Bandukwala S, Burman D, et al. Interconversion of three measures of performance status: an empirical analysis. Eur J Cancer. 2010;46(18):3175-3183. 8. Tabernero J, Chiorean EG, Infante JR, et al. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015;20(2):143-150. 9. Scheithauer W, Ramanathan RK, Moore M, et al. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016;7(3):469-478. 10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma V.1.2021. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed October 23, 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. 11. National Comprehensive Cancer Network, Inc. Chemotherapy Order Template Pancreatic Adenocarcinoma: Gemcitabine/Albumin-bound Paclitaxel. Updated August 17, 2016. Accessed May 9, 2017.

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

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2013-US-2200013 10/22

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References: 1. Paclitaxel. Package insert. Hospira, Inc; 2018. 2. Taxotere. Package insert. Sanofi-Aventis U.S. LLC; 2020. 3. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-1703. 4. Data on file. Bristol-Myers Squibb Company. 5. Karnofsky DA, Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. In: MacLeod CM, ed. Evaluation of Chemotherapeutic Agents in Cancer. New York, NY: Columbia University Press; 1949:191-205. 6. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655. 7. Ma C, Bandukwala S, Burman D, et al. Interconversion of three measures of performance status: an empirical analysis. Eur J Cancer. 2010;46(18):3175-3183. 8. Tabernero J, Chiorean EG, Infante JR, et al. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015;20(2):143-150. 9. Scheithauer W, Ramanathan RK, Moore M, et al. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016;7(3):469-478. 10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma V.1.2021. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed October 23, 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. 11. National Comprehensive Cancer Network, Inc. Chemotherapy Order Template Pancreatic Adenocarcinoma: Gemcitabine/Albumin-bound Paclitaxel. Updated August 17, 2016. Accessed May 9, 2017.