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

 

Frequently Asked Questions


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.

How does ABRAXANE® differ from some other cancer treatments?

How does ABRAXANE work?

Do I need to be premedicated prior to the ABRAXANE infusion to prevent hypersensitivity reactions?

Are there serious side effects associated with ABRAXANE?

What are other important side effects associated with ABRAXANE?

How is ABRAXANE administered and dosed?

Are there instances when my treatment will be interrupted?

Is there anything I can do to minimize the risk of sensory neuropathy?

What can I do to reduce the risk of infections?

Can I take ABRAXANE if I am pregnant or nursing?

What if I want to become pregnant in the future?

When should I consult my doctor or nurse?

How can I get the most from my treatment?

How do I know if ABRAXANE is right for me?

Back to top

Q: How does ABRAXANE differ from some other cancer treatments?

A: One of the most important differences between ABRAXANE and solvent-based paclitaxel (Taxol® Injection) 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.

Back to top

Q: How does ABRAXANE work?

A: Paclitaxel is the active agent in ABRAXANE. It is a potent anticancer drug that stops cancer cells from growing and dividing by interfering with certain cell structures and killing the cancer cells. Paclitaxel can slow tumor growth or temporarily stop tumor growth altogether.

Solvent-based paclitaxel (Taxol® Injection) contains chemicals that are needed to dissolve the drug before it can be injected into the bloodstream. These solvents can cause side effects; therefore, patients usually need to take additional medications before they receive paclitaxel to reduce the risk of getting these solvent-related side effects.

ABRAXANE offers a different approach for treating metastatic breast cancer with paclitaxel because it uses an albumin formulation to deliver paclitaxel.

Because ABRAXANE does not contain solvents, there is a reduced risk of certain hypersensitivity-related side effects, so additional medications, such as steroids and antihistamines, are not necessary.

Back to top

Q: Do I need to be premedicated prior to the ABRAXANE infusion to prevent hypersensitivity reactions?

A: No. Treatment with ABRAXANE does not require premedication with steroids, antihistamines, or other medications to prevent solvent-related hypersensitivity reactions.

Back to top

Q: Are there serious side effects associated with ABRAXANE?

A: While ABRAXANE does not have solvent-related toxicities, ABRAXANE is associated with side effects, some of which may be serious. These side effects may be caused by ABRAXANE or other medications you may be taking, or may be a consequence of the cancer itself.

  • One of the more important side effects associated with chemotherapy is neutropenia, which is a decrease in the number of infection-fighting white blood cells (neutrophils).  Normal levels range from approximately 1,500 cells/mm3 to 1,800 cells/mm3 (but vary according to several factors, such as age and race). If levels fall below 500 cells/mm3, your risk of developing an infection increases and treatment may be interrupted. To avoid the risk of serious infection and fever, your doctor will monitor your absolute neutrophil count (ANC) during therapy.
  • 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. Discuss with your doctor how ABRAXANE may affect fertility. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk.
  • In the randomized metastatic breast cancer study, the most important adverse events included lower white and red blood cell counts, infections, tingling and numbness, nausea, vomiting, diarrhea, muscle and joint aches, and mouth sores. Other adverse reactions included weakness, visual disturbances, fluid retention, hair loss, and liver and kidney dysfunction. Low platelet counts, allergic reactions, cardiovascular reactions, and injection site reactions were uncommon.
  • Sensory neuropathy can occur with ABRAXANE and other paclitaxel medications. Severe sensory neuropathy can improve with proper management, as prescribed by your doctor. You should tell your nurse or doctor if you experience numbness, tingling, or burning in your hands or feet while taking ABRAXANE.
  • Please talk to your doctor or nurse if you have questions regarding the potential side effects of ABRAXANE therapy. You may want to review the Product Information, including Warnings, Precautions, and Contraindications.

Back to top

Q: What are other important side effects associated with ABRAXANE?

A: Side effects were reported in ABRAXANE clinical trials. For a list of side effects, click here to go to the safety information section.

Back to top

Q: How is ABRAXANE administered and dosed?

A: ABRAXANE is given via an intravenous infusion. The infusions are generally given at an outpatient clinic and take 30 minutes—less time than solvent-based paclitaxel (Taxol® Injection), which may take as long as 3 hours. Your doctor will determine the correct dose and schedule for you.

Back to top

Q: Are there instances when my treatment will be interrupted?

A: Your doctor may find it necessary to interrupt or reduce the dose of your ABRAXANE treatment if certain side effects, such as sensory neuropathy or neutropenia, occur.

Back to top

Q: Is there anything I can do to minimize the risk of sensory neuropathy?

A: Sensory neuropathy is a known side effect of paclitaxel therapy. Sensory neuropathy can be resolved with proper management, so it is very important that you inform your doctor or nurse of any side effects you experience relating to sensory neuropathy, such as numbness, tingling, or burning in the hands and feet.

Back to top

Q: What can I do to reduce the risk of infections?

A: While undergoing cancer treatment, you are more prone to infections. Talk to your doctor about special precautions you may want to take to reduce your risk.

Back to top

Q: Can I take ABRAXANE if I am pregnant or nursing?

A: Women should avoid becoming pregnant while they are undergoing ABRAXANE therapy. It is important that you tell your doctor if you become pregnant or plan to become pregnant while taking ABRAXANE. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in your milk.

Back to top

Q: What if I want to become pregnant in the future?

A: You should discuss the long-term effects of ABRAXANE on fertility with your doctor.

Back to top

Q: When should I consult my doctor or nurse?

A: You should consult your doctor or nurse any time you have a question or concern about your treatment. You should also consult your health care team if you experience any physical changes.

Back to top

Q: How can I get the most from my treatment?

A: Your doctor has designed a treatment plan that takes into account your individual needs. In order to get the most out of treatment, it is important that you follow this plan as closely as possible. It is also important to:

  • Receive every dose of ABRAXANE. Alert your doctor immediately if you have to miss a dose.
  • Establish and maintain healthy lifestyle habits, including good nutrition, getting plenty of rest, and exercising.
  • Become familiar with your body and be aware of what is "normal" for you.
  • Trust your instincts and seek medical attention when unusual changes occur.
  • Be persistent in communicating your concerns to your doctors and do not give up until you are satisfied that your concerns are adequately addressed.
  • Know that you have a say in all aspects of your care.

Back to top

Q: How do I know if ABRAXANE is right for me?

A: Talk to your doctor to find out if ABRAXANE is right for you.

Back to top

 

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.

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