Metastatic Breast Cancer Treatment Drug: ABRAXANE for Injectable Suspension
For US Residents Only
ABRAXANE for Injectable Suspension
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Benefits of ABRAXANE®


Black Box Warning

ABRAXANE is a prescription medicine used to treat breast cancer that has spread to other parts of the body after treatment with certain other medicines has not worked.

ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) 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 has some important benefits compared to solvent-based paclitaxel (Taxol® Injection) in terms of efficacy (tumor response), the lack of medications needed to help prevent solvent-related hypersensitivity reactions, and the time it takes for an infusion.

Patients showed nearly double the response to
ABRAXANE in a clinical trial compared to solvent-based paclitaxel.1

A study comparing ABRAXANE with solvent-based paclitaxel in women with metastatic breast cancer showed that ABRAXANE was more effective than solvent-based paclitaxel. In the clinical trial, the tumor response rate was nearly double for patients who received ABRAXANE compared to those who received solvent-based paclitaxel. ABRAXANE is solvent-free, which allowed a higher dose of tumor-fighting paclitaxel to be administered in the clinical study.

  • The overall response rate with ABRAXANE for all study patients was 21.5% compared to 11.1% with solvent-based paclitaxel
  • The overall response rate with ABRAXANE for study patients who failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy was 15.5% compared to 8.4% with solvent-based paclitaxel

No premedication required to
prevent solvent-related hypersensitivity

One of the most important differences between ABRAXANE and solvent-based paclitaxel is the lack of solvents. These solvents can cause side effects such as difficulty breathing, hives, swollen eyes and lips, a flushed face, and severe allergic reactions (hypersensitivity reactions), which is why patients also need to be pretreated with steroids and antihistamines. Because ABRAXANE does not contain solvents, patients treated with ABRAXANE do not need to be pretreated with these medications.

Severe allergic reactions to ABRAXANE, although rare, can occur. Contact your doctor if you experience any signs of an allergic reaction.

Infusion time is significantly shorter with ABRAXANE

ABRAXANE is administered in only 30 minutes, while solvent-based paclitaxel can take up to 3 hours. This gives you more time away from the clinic.

 

To learn more about the benefits of ABRAXANE, talk to your doctor.

 

WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) should be given under the care of a doctor experienced with cancer therapy in a health care facility that is capable of managing possible complications.

ABRAXANE should not be given to patients who have dangerously low white blood counts because of the risk for serious infections. Frequent blood tests are used to check white blood cell count during therapy with ABRAXANE.

An albumin form of paclitaxel may behave differently in the body than other paclitaxel medications. ABRAXANE SHOULD NOT BE SUBSTITUTED FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

IMPORTANT SAFETY INFORMATION

One of the more important side effects associated with chemotherapy is a decrease in the number of infectionfighting white blood cells (neutrophils) called "neutropenia". ABRAXANE should not be given to patients with dangerously low white blood cell counts because of the risk for serious infections. Your doctor will schedule blood tests to check your white blood cell count (absolute neutrophil count [ANC]) during therapy with ABRAXANE. Tell your doctor if you have a fever or notice any other signs of an infection.

Women should avoid becoming pregnant while being treated with ABRAXANE. Tell your doctor if you are pregnant, if you become pregnant, or you plan to become pregnant while taking ABRAXANE. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk. Men should be advised not to father a child while receiving ABRAXANE.

ABRAXANE contains albumin a derivative of human blood.

The most important side effects have included hair loss, infections due to low white blood cell count, numbness, tingling or burning in the hands or feet, fatigue and weakness, low red blood cell count, mouth or lip sores, joint and muscle pain, stomach upset and diarrhea, heart and blood vessel (cardiovascular) effects and irritation at the injection site.

Numbness, tingling, or burning in the hands and feet (neuropathy) occurs with ABRAXANE and other paclitaxel medications. Be sure to tell your doctor if you experience these symptoms. Your doctor may interrupt treatment and restart at a lower dose after symptoms improve.

Other side effects have included blurred vision or eye irritation, fluid retention, liver and kidney dysfunction, low platelet counts, dehydration, fever and allergic reactions (which in rare cases were severe). Tell your doctor about any side effects that bother you.

Your ability to drive and use machines may be limited by side effects such as: fatigue, lethargy and malaise.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

1. ABRAXANE [prescribing information]. Bridgewater, NJ: Abraxis BioScience, LLC; September 2009.

The information on this site is intended for US residents only.

ABRAXANE is a registered
trademark of Abraxis BioScience, LLC.

All Abraxis BioScience, LLC.
corporate names, names of services,
and names of products referred to herein
are trade names, service marks, and/or
trademarks that are owned by or licensed
to Abraxis BioScience, its divisions or its
affiliates, unless otherwise noted.

©2010 Abraxis BioScience, LLC.
All Rights Reserved. AB 1650 05/10

Abraxis

WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) should be given under the care of a doctor experienced with cancer therapy in a health care facility that is capable of managing possible complications.

ABRAXANE should not be given to patients who have dangerously low white blood counts because of the risk for serious infections. Frequent blood tests are used to check white blood cell count during therapy with ABRAXANE.

An albumin form of paclitaxel may behave differently in the body than other paclitaxel medications. ABRAXANE SHOULD NOT BE SUBSTITUTED FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

IMPORTANT SAFETY INFORMATION

One of the more important side effects associated with chemotherapy is a decrease in the number of infectionfighting white blood cells (neutrophils) called "neutropenia". ABRAXANE should not be given to patients with dangerously low white blood cell counts because of the risk for serious infections. Your doctor will schedule blood tests to check your white blood cell count (absolute neutrophil count [ANC]) during therapy with ABRAXANE. Tell your doctor if you have a fever or notice any other signs of an infection.

Women should avoid becoming pregnant while being treated with ABRAXANE. Tell your doctor if you are pregnant, if you become pregnant, or you plan to become pregnant while taking ABRAXANE. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk. Men should be advised not to father a child while receiving ABRAXANE.

ABRAXANE contains albumin a derivative of human blood.

The most important side effects have included hair loss, infections due to low white blood cell count, numbness, tingling or burning in the hands or feet, fatigue and weakness, low red blood cell count, mouth or lip sores, joint and muscle pain, stomach upset and diarrhea, heart and blood vessel (cardiovascular) effects and irritation at the injection site.

Numbness, tingling, or burning in the hands and feet (neuropathy) occurs with ABRAXANE and other paclitaxel medications. Be sure to tell your doctor if you experience these symptoms. Your doctor may interrupt treatment and restart at a lower dose after symptoms improve.

Other side effects have included blurred vision or eye irritation, fluid retention, liver and kidney dysfunction, low platelet counts, dehydration, fever and allergic reactions (which in rare cases were severe). Tell your doctor about any side effects that bother you.

Your ability to drive and use machines may be limited by side effects such as: fatigue, lethargy and malaise.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

The information on this site is intended for US residents only.

ABRAXANE is a registered trademark of Abraxis BioScience, LLC. Abraxis Oncology® is a division of Abraxis BioScience, LLC.

All Abraxis BioScience, LLC. corporate names, names of services, and names of products referred to herein are trade names, service marks, and/or trademarks that are owned by or licensed to Abraxis BioScience, its divisions or its affiliates, unless otherwise noted.

©2010 Abraxis BioScience, LLC.
All Rights Reserved. AB 1650   05/10
(Site updated 01/09)

Abraxis