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Abraxane (Paclitaxel) - Summary

 

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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.  

 

ABRAXANE SUMMARY

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albumin-bound)

ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. ABRAXANE is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel and approximately 900 mg of human albumin. Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. ABRAXANE is free of solvents. The active agent in ABRAXANE® is paclitaxel, a natural product with antitumor activity. Paclitaxel is obtained from Taxus media.

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles 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.

ABRAXANE NEWS HIGHLIGHTS

Media Articles Related to Abraxane (Paclitaxel)

Paclitaxel Plus Chemo Improves Outcomes in Early Breast Cancer
Source: MedicineNet cyclophosphamide Specialty [2008.05.28]

Gemcitabine Plus Paclitaxel Increases Survival in Metastatic Breast Cancer
Source: Medscape Pharmacotherapy Headlines [2004.06.10]

Boston Scientific Completes Clinical Trial Enrollment For Third-Generation Drug-Eluting Stent
Source: Cardiovascular / Cardiology News From Medical News Today [2008.10.09]

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Published Studies Related to Abraxane (Paclitaxel)

Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. [2008.07.01]

Randomized phase 3 trial of Fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer. [2008.06.04]

Phase III study of valspodar (PSC 833) combined with paclitaxel and carboplatin compared with paclitaxel and carboplatin alone in patients with stage IV or suboptimally debulked stage III epithelial ovarian cancer or primary peritoneal cancer. [2008.06.01]

Safety and efficacy of overlapping sirolimus-eluting versus paclitaxel-eluting stents. [2008.06]

The safety and efficacy of a paclitaxel-eluting wrap for preventing peripheral bypass graft stenosis: a 2-year controlled randomized prospective clinical study. [2008.06]

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Clinical Trials Related to Abraxane (Paclitaxel)

Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and TaxolŽ Pharmacokinetics in Patients With Advanced Cancer [Active, not recruiting]

Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer [Active, not recruiting]

Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis [Active, not recruiting]

Study of Dose-Dense Adriamycin Plus Cytoxan (AC) Followed by Either Abraxane or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer [Active, not recruiting]

Therapy With Abraxane and 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) for Patients With Breast Cancer [Active, not recruiting]

more>>

Page last updated: 2008-10-09

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