"The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
HER2 is a protein involved in normal cell growth. It is foun"...
- Patient Information:
Details with Side Effects
(paclitaxel protein-bound particles for injectable suspension) (albumin-bound)
Read this Patient Information before you start receiving ABRAXANE and before each infusion. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is ABRAXANE?
ABRAXANE is a prescription medicine used to treat:
- advanced breast cancer in people who have already received certain other medicines for their cancer.
- advanced non-small cell lung cancer, in combination with carboplatin in people who cannot be treated with surgery or radiation.
- and advanced pancreatic cancer, when used in combination with gemcitabine as the first medicine for advanced pancreatic cancer.
It is not known if ABRAXANE is safe or effective in children.
Who should not receive ABRAXANE?
Do not receive ABRAXANE if:
- your white blood cell count is below 1,500 cells/ mm³.
- you have had a severe allergic reaction to ABRAXANE.
What should I tell my doctor before receiving ABRAXANE?
Before you receive ABRAXANE, tell your doctor if you:
- have liver or kidney problems.
- have any other medical conditions.
- are a man planning to father a child. You should not father a child during your treatment with ABRAXANE. ABRAXANE can harm the unborn baby of your partner. Talk to your doctor if this is a concern to you.
- are pregnant or plan to become pregnant. ABRAXANE can harm your unborn baby. You should not become pregnant while receiving ABRAXANE. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving ABRAXANE.
- are breastfeeding or plan to breastfeed. It is not known if ABRAXANE passes into your breast milk. You and your doctor should decide if you will receive ABRAXANE or breastfeed.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list to show your doctor and pharmacist when you get a new medicine.
How will I receive ABRAXANE?
- Your doctor will prescribe ABRAXANE in an amount that is right for you.
- Premedication to prevent allergic reactions is generally not needed to receive ABRAXANE. Premedication may be needed if you have had an allergic reaction to ABRAXANE. In case of severe allergic reaction, ABRAXANE should not be used again.
- ABRAXANE will be given to you by intravenous infusion into your vein.
- Your doctor should do regular blood tests while you receive ABRAXANE.
What are the possible side effects of ABRAXANE?
ABRAXANE may cause serious side effects, including:
- decreased blood cell counts. ABRAXANE can cause a severe decrease in neutrophils (a type of white blood cells important in fighting against bacterial infections) and platelets (important for clotting and to control bleeding). Your doctor will check your blood cell count during your treatment with ABRAXANE and after you have stopped your treatment.
- numbness, tingling, pain, or weakness in your hands or feet (neuropathy).
- severe infection (sepsis). If you receive ABRAXANE in combination with gemcitabine, infections can be severe and lead to death. Tell your doctor right away if you have a fever (temperature of greater than 100.4° F) or develop signs of infection.
- lung or breathing problems. If you receive Abraxane in combination with gemcitabine, lung or breathing problems may be severe and can lead to death. Tell your doctor right away if you have a sudden onset of persistent dry cough or shortness of breath.
- allergic reactions. Allergic reactions to ABRAXANE may be severe and can lead to death.
The most common side effects of ABRAXANE include:
- hair loss
- numbness, tingling, pain, or weakness in the hands or feet
- abnormal heart beat
- joint and muscle pain
- changes in your liver function tests
- low red blood cell count (anemia). Red blood cells carry oxygen to your body tissues. Tell your doctor if you feel weak, tired or short of breath.
- nausea and vomiting
- infections. If you have a fever (temperature of greater than 100.4° F) or other signs of infection, tell your doctor right away.
- Loss of body fluid (dehydration)
- Swelling in the hands or feet
These are not all the possible side effects of ABRAXANE. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ABRAXANE.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
This Patient Information leaflet summarizes the important information about ABRAXANE. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about ABRAXANE that is written for health professionals.
For more information, call 1-888-423-5436.
What are the ingredients in ABRAXANE?
Active ingredient: paclitaxel (bound to human albumin).
Other ingredient: human albumin (containing sodium caprylate and sodium acetyltryptophanate).
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 9/19/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Abraxane Information
Abraxane - User Reviews
Abraxane User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find support and advances in treatment.