Paclitaxel Recall

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Questions & Answers

Side Effects & Adverse 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 (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 1,500 cells/mm3 (<1,000 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 >1,500 cells/mm3 (>1,000 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.

Pregnancy: Paclitaxel can cause fetal harm when administered to a pregnant woman. Administration of paclitaxel during the period of organogenesis to rabbits at doses of 3 mg/kg/day (about 0.2 the daily maximum recommended human dose on a mg/m2 basis) caused embryo- and fetotoxicity, as indicated by intrauterine mortality, increased resorptions, and increased fetal deaths. Maternal toxicity was also observed at this dose. No teratogenic effects were observed at 1 mg/kg/day (about 1/15 the daily maximum recommended human dose on a mg/m2 basis); teratogenic potential could not be assessed at higher doses due to extensive fetal mortality.

There are no adequate and well-controlled studies in pregnant women. If paclitaxel injection, USP is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Paclitaxel Injection, USP is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin.

Paclitaxel Injection, USP 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 Injection, USP 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 Injection, USP, 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 Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.


There is currently no drug history available for this drug.

Other Information

Paclitaxel injection, USP is a clear colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, 527 mg of polyoxyl 35 castor oil, NF1 and 49.7% (v/v) dehydrated alcohol, USP.

Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is (5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S) -N-benzoyl-3-phenylisoserine.

Paclitaxel has the following structural formula:

                         image of structure  

Paclitaxel is a white to off-white crystalline powder with the molecular formula C47H51NO14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 °C to 217 °C.

Polyxoxyl 35 castor oil, NF is further purified before use by a process developed by Dabur Research Foundation (Patent Pending).

Paclitaxel Manufacturers

  • App Pharmaceuticals, Llc
    Paclitaxel Injection, Solution [App Pharmaceuticals, Llc]
  • Sandoz Inc.
    Paclitaxel Injection, Solution [Sandoz Inc.]
  • Onco Therapies Limited
    Paclitaxel Injection [Onco Therapies Limited ]
  • Pfizer Laboratories Div Pfizer Inc.
    Paclitaxel Injection [Pfizer Laboratories Div Pfizer Inc.]
  • Sagent Pharmaceuticals
    Paclitaxel Injection, Solution [Sagent Pharmaceuticals]
  • Teva Parenteral Medicines, Inc.
    Paclitaxel Injection, Solution [Teva Parenteral Medicines, Inc.]
  • Wg Critical Care, Llc
    Paclitaxel Injection [Wg Critical Care, Llc]
  • Hospira Worldwide, Inc.
    Paclitaxel Injection, Solution [Hospira Worldwide, Inc.]
  • Mylan Institutional Llc
    Paclitaxel Injection [Mylan Institutional Llc ]
  • Fresenius Kabi Usa, Llc
    Paclitaxel Injection, Solution [Fresenius Kabi Usa, Llc]

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