Basic Drug Info
Drug Name:Paclitaxel
Manufacturer:Bedford Laboratories
Other Info:

Paclitaxel could harm the fetus when given to a pregnant woman.

Women should avoid becoming pregnant while they are undergoing treatment with paclitaxel.

Tell your doctor if you become pregnant or plan to become pregnant while taking paclitaxel.Because studies have shown paclitaxel to be present in the breast milk of animals receiving the drug, it may be present in human breast milk as well.

Therefore, nursing a baby while taking paclitaxel is NOT recommended.This medicine was prescribed for your particular condition.

This summary does not include everything there is to know about paclitaxel.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet.

If you have questions or concerns, or want more information about paclitaxel, your doctor and pharmacist have the complete prescribing information upon which this guide is based.

You may want to read it and discuss it with your doctor.

Remember, no written summary can replace careful discussion with your doctor.This Patient Information Leaflet has been approved by the U.S.

Food and Drug Administration. Manufactured by:Manufactured for: Ben Venue Laboratories, Inc.Bedford LaboratoriesTM Bedford, OH 44146Bedford, OH 44146 February 2006PTXP05

Clinical Trials:

Indications and Usage

Paclitaxel is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary.

As firstline therapy, paclitaxel is indicated in combination with cisplatin.

Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.

In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors.

(See CLINICAL STUDIES: Breast Carcinoma.)Paclitaxel 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.Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.Paclitaxel is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.
Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Neoplasms -- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Neoplasm Metastasis -- The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Recurrent disease -- The return of signs and symptoms of cancer after a period of improvement.

Non-Small Cell Lung Carcinoma -- A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

AIDS with Kaposi's sarcoma -- The most aggressive form of Kaposi sarcoma. It presents in patients who are infected with the human immunodeficiency virus. It can affect the skin and internal organs.

Paclitaxel is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in polyoxyethylated castor oil.Paclitaxel should not be used in patients with solid tumors who have baseline neutrophil counts of <1500 cells/mm3 or in patients with AIDS-related Kaposi's sarcoma with baseline neutrophil counts of <1000 cells/mm3.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

solid tumor -- Cancer of body tissues other than blood, bone marrow, or the lymphatic system.

AIDS with Kaposi's sarcoma -- The most aggressive form of Kaposi sarcoma. It presents in patients who are infected with the human immunodeficiency virus. It can affect the skin and internal organs.


Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2% to 4% of patients receiving paclitaxel in clinical trials.

Fatal reactions have occurred in patients despite premedication.

All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists.

(See DOSAGE AND ADMINISTRATION.) Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose-limiting toxicity.

Neutrophil nadirs occurred at a median of 11 days.

Paclitaxel should not be administered to patients with baseline neutrophil counts of less than 1500 cells/mm3 (<1000 cells/mm3 for patients with KS).

Frequent monitoring of blood counts should be instituted during paclitaxel treatment.

Patients should not be re-treated with subsequent cycles of paclitaxel until neutrophils recover to a level >1500 cells/mm3 (>1000 cells/mm3 for patients with KS) and platelets recover to a level >100,000 cells/mm3.Severe conduction abnormalities have been documented in <1% of patients during paclitaxel therapy and in some cases requiring pacemaker placement.

If patients develop significant conduction abnormalities during paclitaxel infusion, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with paclitaxel.
Branded Drugs
The following US Branded drugs contain Paclitaxel



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