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

 

ABRAXANE® Side Effects


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.

Understanding Safety Information About ABRAXANE®

The following side effects were reported in ABRAXANE clinical trials. Provided here is a description of these side effects and some helpful information.

Hair loss (alopecia)

Loss of eyebrows, eyelashes, pubic hair, and scalp hair can occur suddenly but usually occurs 14 to 21 days after you begin treatment. Your hair will grow back once the ABRAXANE treatment has ended.

  • Be gentle to your hair and scalp
  • Use low heat when using a hair dryer
  • Cut your hair short
  • Protect your scalp from the sun

Infections due to low white blood cell count (neutropenia)

White blood cells are among the body’s defenses against bacterial infections. ABRAXANE usually causes a brief drop in white blood cells, and you may be more susceptible to infection and fever. Between your treatment cycles, you will have blood tests to check your white blood cell counts.

  • Call your doctor if you experience a fever over 100.4°F or have any other early sign of an infection
  • Wash your hands often
  • Avoid crowds and people with colds
  • Immediately clean and protect cuts
  • Check with your doctor before getting immunization shots
  • Take a bath or shower daily using mild soap
  • Use lotion to prevent your skin from cracking

Numbness, tingling, or burning of hands and feet (sensory neuropathy)

These side effects, known as sensory neuropathy, occur often and usually improve without medication within a month of interrupting treatment (average 22 days for severe side effects).

  • Immediately tell your doctor about these side effects—your doctor may find it necessary to adjust the dose
  • Massage your hands and feet to stimulate nerves
  • Apply moisturizing cream/lotion to your hands and feet
  • Keep your body warm
  • Avoid activities in extreme weather
  • Avoid wearing tight footwear
  • Avoid standing for long periods of time and walk only short distances
  • Take extra precaution near fires, hot water, or other sources of heat
  • Avoid using an ice pack on any part of your body

Fatigue and weakness (asthenia)

Tiredness and weakness after treatment are known as asthenia. They usually do not require interrupting or modifying treatment.

  • Get proper rest
  • Take part in activities that relax you
  • Eat a well-balanced diet
  • Drink plenty of fluids
  • Perform light exercise daily

Joint and muscle pain

Soreness of the joints and muscles may occur shortly after treatment begins, but usually disappears within a few days.

  • Tell your doctor if you are experiencing any severe joint or muscle pain
  • Perform light exercise

Low red blood cell count (anemia)

Anemia occurs when there are not enough red blood cells in your blood. It may make you feel tired, appear pale, and experience shortness of breath. Contact your doctor if you experience any of these symptoms.

  • Talk to your doctor about medications that may increase your red blood cell count
  • Conserve energy by doing only the things that are most important to you
  • Take short naps throughout the day instead of one long nap
  • Perform light exercise
  • Get up slowly from lying or sitting positions to reduce dizziness
  • Eat small meals frequently throughout the day
  • Drink plenty of fluids

Mouth or lip sores (mucositis)

Mouth or lip sores may occur a few days after starting treatment. This side effect usually disappears within 1 week.

  • Use lip balm or another lip moisturizer
  • Use a soft toothbrush and brush your teeth after eating
  • Use mouthwash that does not contain alcohol
  • Frequently rinse your mouth with warm salt water
  • Avoid foods that might irritate your mouth, such as spicy foods, orange juice, and pretzels

Upset stomach and diarrhea

Nausea, vomiting, and/or diarrhea may occur following treatment. If you experience nausea or stomach upset, tell your doctor, because medicines can be given to reduce or eliminate these symptoms. Diarrhea will usually disappear without treatment; however, tell your doctor right away if you experience severe abdominal or stomach area pain and/or severe diarrhea.

  • Drink plenty of fluids slowly and frequently
  • Avoid drinking coffee, tea, and alcohol
  • Avoid sweets as well as fried, greasy, or spicy foods
  • Eat low-fiber foods such as eggs, potatoes, white bread, or creamed cereals
  • Avoid dairy products such as milk, cheese, or ice cream

Irritation at the injection site

You may experience discomfort, redness, swelling, inflammation, or a deep sore or break in the skin at the site of the injection.

  • Inform your doctor if you experience any irritation at the injection site

Low heart rate (bradycardia)

It is possible to experience a drop in your heart rate, but patients do not usually notice this change, which usually does not require treatment. You should tell your doctor if you have a history of heart disease.

Low blood pressure (hypotension)

If you experience dizziness, fainting, or shortness of breath, talk to your doctor.

  • Have your doctor check your blood pressure
  • Drink plenty of water
  • Exercise moderately to increase blood flow
  • Avoid heavy lifting
  • Elevate the head of your bed to improve blood circulation
  • Eat small meals frequently
  • Rest after meals to minimize dizziness
  • Avoid hot showers and baths
  • Rise slowly from sitting or lying positions

 

 

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 infection-fighting 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 treatment with ABRAXANE.

ABRAXANE contains albumin (human), 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, 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.

©2009 Abraxis BioScience, LLC.
All Rights Reserved. AB 1399 10/09

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 infection-fighting 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 treatment with ABRAXANE.

ABRAXANE contains albumin (human), 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, 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.

©2009 Abraxis BioScience, LLC.
All Rights Reserved. AB 1399   10/09
(Site updated 01/09)

Abraxis