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
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.
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.