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Please visit www.abraxane.com
FDA Approval
Abraxane® is an innovative therapy that has been approved by the
United States Food and Drug Administration (FDA) for the treatment
of patients with breast cancer, after failure of combination chemotherapy
for metastatic disease or relapse within 6 months of adjuvant chemotherapy,
with prior therapy including an anthracycline unless clinically contraindicated.
Safety
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.
WARNING
ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE.
Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. |
Please see Warnings, Precautions and Contraindications in
the Product Information.
 Abraxane
Prescribing information (252k .pdf)
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