Paclitaxel (Taxol)

General information

Class/mechanism: Taxane, promotes assembly of microtubules, stablizes microtubules, preventing depolymerization. Paclitaxel interferes with the normal dynamic reorganization of microtubules that is necessary for regular interphase/mitosis processes. It also leads to creation of abnormal bundles of microtubules. Paclitaxel is highly lipophilic/insoluble in water and needs to be dissolved in Cremophor EL (polyoxyethylated castor oil), which may cause hypersensitivity infusion reactions.
Route: IV
Extravasation: irritant (usually), vesicant (rare)

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Aggressive Non-Hodgkin lymphoma
• Basal cell and squamous cell skin cancer
• Bladder cancer
• Breast cancer
• Cervical cancer
• Esophageal cancer
• Head and neck cancer
• Melanoma
• Non-small cell lung cancer
• Ovarian cancer
• Penile cancer
• Prostate cancer
• Sarcoma
• Small cell lung cancer
• Testicular cancer
• Thymoma
• Unknown primary
• Uterine cancer

Patient drug information

• Paclitaxel (Taxol) package insert PDF pages 50-53
• Paclitaxel (Taxol) patient drug information (Chemocare)
• Paclitaxel (Taxol) patient drug information (UpToDate)

History of changes in FDA indication

• 12/29/1992: Initial FDA approval (label is not available)
• 4/9/1998 (earliest label available on Drugs @ FDA): Indicated for:

1. First-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Taxol is indicated in combination with cisplatin.
2. The treatment of breast cancer after failure of combination therapy for metastatic disease or relapsed within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
3. The second-line treatment of AIDS-related Kaposi's sarcoma.

• 6/30/1998: New indication added: 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.
• 10/25/1999: New indication for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.

Also known as

Synonyms
Abitaxel	Altaxel	Anzatax	Anzatec	APO-Paclitaxel	Asotax	Betaxel	Bristaxol
Britaxol	Clitaxel	Cytax	Daburex	Dalys	Drifen	Ebetaxel	Formoxol
Genaxol	Genetaxyl	Gros	Ifaxol	Intaxel	LEP-ETU	LI PU SU	Magytax
Medixel	Mitotax	Neotacs	Neotaxan	Neotaxl	Ofoxel	Oncotaxel	Onxol
Paclitax	Paclitaxel	Paclitaxel-GRY	Paclitaxel APS	Paclitaxel Comp	Paclitaxel Delta Farma	Paclitaxel Ebewe	Paclitaxel Hexal
Paclitaxel Lens	Paclitaxel Mayne	Paclitaxel Microsules	Paclitaxel Servycal	Paclitaxin	Pacliteva	Pacxel	Padexol
Paklitaxfil	Panataxel	Parexel	Paxene	Paxenor	Paxus	Petaxel	Phyxol
Poltaxel	Praxel	Ribotax	Sindaxel	Taclipaxol	Tarvexol	Taxocris	Taxodiol
Taxol	Taxol Semi-Synthetic	Taxomedac	Taycovit	TE SU	Teva-Paclitaxel	Unitaxel	Yewtaxan
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