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Paclitaxel

Prior to Initiation of Therapy

Qualified Physician/Equipped Facility

  • Paclitaxel 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.

Anaphylaxis/Hypersensitivity Reactions:

  • 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.
  • Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.

Contraindication in Low Neutrophil Counts

  • Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1000 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 paclitaxel.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • All patients must be premedicated with corticosteroids, diphenhydramine, and H2 antagonists
  • Perform frequent peripheral blood cell counts. Do not administer subsequent cycles until neutrophils recover to > 1500 cells/mm3 and platelets >100,000 cells/mm3.

Package Inserts

Paclitaxel

Additional Information

Updated January 2018