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Paclitaxel (Taxol)
( PACK-lih- tax-el)
Pregnancy Category: D Taxol (Rx)

Classification: Antineoplastic, miscellaneous

See Also: See also Antineoplastic Agents .

Action/Kinetics: Naturally occurring antineoplastic agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. The stabilization results in the inhibition of the normal dynamic reorganization of the microtubule network that is required for vital interphase and mitotic cellular functions. Also induces abnormal ``bundles'' of microtubules throughout the cell cycle and multiple esters of microtubules during mitosis. Following IV administration, there is a biphasic decline in plasma levels. The initial rapid decline is due to distribution to the peripheral compartment and significant elimination, whereas the second phase is due, in part, to a slow efflux of the drug from the peripheral compartment. Metabolized by the liver with small amounts of unchanged drug excreted in the urine.

Uses: Metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. With cisplatin to treat advanced ovarian cancer. Breast cancer after combination chemotherapy has failed or there has been relapse within 6 months of adjuvant chemotherapy (prior therapy must have included an anthracycline unless contraindicated). Adjuvant treatment of node-positive breast cancer after a course of standard combination chemotherapy containing doxorubicin. Second-line treatment of AIDS-related Kaposi's sarcoma. With cisplatin as first-line treatment of non-small-cell lung cancer in those who are not candidates for potentially curative surgery or radiation. Investigational: Alone or in combination with other chemotherapeutic drugs for advanced head and neck cancer, previously untreated extensive-stage small-cell lung cancer, adenocarcinoma of the upper GI tract, hormone-refractory prostate cancer, advanced non-small-cell lung cancer, and leukemias.

Contraindications: Hypersensitivity to paclitaxel, in those with a hypersensitivity to products containing polyoxymethylated castor oil (Cremophor EL), clients with a baseline neutropenia below 1,500 cells/mm 3, and those with AIDS-related Kaposi's sarcoma with baseline neutrophil counts below 1,000 cells/mm 3. Lactation.

Special Concerns: Use with caution in clients with impaired hepatic function. Safety and efficacy have not been determined in children.

Side Effects: Hypersensitivity reactions: Severe symptoms usually occur during the first hour of therapy and occur during both the first or second course of therapy despite premedication. Severe symptoms include dyspnea, angioedema hypotension, or generalized urticaria all of which require immediate cessation of the drug and aggressive treatment therapy. Symptoms not requiring treatment include milder dyspnea, flushing, skin reactions, hypotension, or tachycardia. Hematologic: Neutropenia and leukopenia (common), thrombocytopenia, anemia, infections, bleeding, packed cell transfusions, platelet transfusions. CV: Bradycardia and hypotension (including during the infusion), hypertension, severe CV events (including asymptomatic VT, bigeminy, syncope, complete AV block) abnormal ECG (including nonspecific repolarization abnormalities, sinus tachycardia, premature beats). Musculoskeletal: Peripheral neuropathy (including mild paresthesia), myalgia, arthralgia. GI: N&V, diarrhea, mucositis. Miscellaneous: Alopecia, fever associated with severe neutropenia; infections of the urinary tract and upper respiratory tract as well as sepsis due to neutropenia.

Laboratory Test Alterations: Bilirubin, alkaline phosphatase, ALT, AST.

Overdose Management: Symptoms: Bone marrow suppression peripheral neurotoxicity, mucositis. Accidental inhalation may cause dyspnea, chest pain, burning eyes, sore throat, and nausea. Treatment: Treat symptomatically.

Drug Interactions: Cisplatin / More profound myelosuppression when paclitaxel was given after cisplatin than when paclitaxel was given before cisplatin, due to a 1/3 decrease in paclitaxel clearance Doxorubicin / Levels of doxorubicin and doxorubicinol Ketoconazole / Inhibition of metabolism of paclitaxel by ketoconazole

How Supplied: Injection: 6 mg/mL

?IV Infusion Metastatic carcinoma of the ovary.
Adults: 135 mg/m 2 given IV over 3 hr q 3 weeks after failure of first-line or subsequent chemotherapy.
Advanced ovarian cancer.
Paclitaxel, 135 mg/m 2, followed by cisplatin, 75 mg/m 2 over 24 hr, once q 3 weeks.
Metastatic breast cancer.
Adults: 175 mg/m 2 given IV over 3 hr q 3 weeks after failure of chemotherapy for metastatic disease or relapse after 6 months of adjuvant chemotherapy.
AIDS-related Kaposi's sarcoma.
135 mg/m 2 given IV over 3 hr q 3 weeks or 100 mg/m 2 given IV over 3 hr q 2 weeks.

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