Metastatic Breast Cancer Treatment Drug: ABRAXANE for Injectable Suspension


 

Frequently Asked Questions


Black Box Warning

ABRAXANE for Injectable Suspension 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?

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Important Safety Information & Boxed Warning

You should receive ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) under the care of a doctor who is trained to use cancer drugs. Because you may have side effects from your treatment, you should get this medicine in a clinic or hospital with doctors, nurses, and pharmacists who are trained to give cancer drugs.

ABRAXANE therapy should not be given to patients with metastatic breast cancer who have low blood counts. Low blood counts, especially low white blood cell counts, may make you more likely to get an infection. In order to check for low blood counts your doctor may need to take some blood to test your blood counts.

Note: ABRAXANE is paclitaxel made with the human blood protein albumin. This makes it behave differently in the body than regular paclitaxel. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL DRUGS.

Important Safety Information

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

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 (which in rare cases were severe), cardiovascular reactions, and injection site reactions were uncommon.

Sensory neuropathy (numbness, tingling, or burning in the hands and feet) 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.

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.

©2008 Abraxis BioScience, LLC.
and AstraZeneca Pharmaceuticals LP.
All Rights Reserved. AO 853/261222  4/08

ABRAXANE is marketed under a
co-promotion agreement between
Abraxis BioScience, LLC. and AstraZeneca.

Abraxis
AstraZeneca

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.

Important Safety Information & Boxed Warning

You should receive ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) under the care of a doctor who is trained to use cancer drugs. Because you may have side effects from your treatment, you should get this medicine in a clinic or hospital with doctors, nurses, and pharmacists who are trained to give cancer drugs.

ABRAXANE therapy should not be given to patients with metastatic breast cancer who have low blood counts. Low blood counts, especially low white blood cell counts, may make you more likely to get an infection. In order to check for low blood counts your doctor may need to take some blood to test your blood counts.

Note: ABRAXANE is paclitaxel made with the human blood protein albumin. This makes it behave differently in the body than regular paclitaxel. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL DRUGS.

Important Safety Information

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

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 (which in rare cases were severe), cardiovascular reactions, and injection site reactions were uncommon.

Sensory neuropathy (numbness, tingling, or burning in the hands and feet) 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.

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.

©2008 Abraxis BioScience, LLC. and AstraZeneca Pharmaceuticals LP. All Rights Reserved. AO 853/261222  4/08
(Site updated 2/07)

ABRAXANE is marketed under a co-promotion agreement between Abraxis BioScience, LLC. and AstraZeneca.

Abraxis
AstraZeneca

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.