Ovarian cancer — first-line (with cisplatin) and subsequent therapy for metastatic carcinoma; Breast cancer — adjuvant treatment of node-positive disease following standard doxorubicin-containing combination chemotherapy, and for treatment of metastatic disease after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy; Non-small cell lung cancer (NSCLC) — in combination with cisplatin for first-line treatment in patients who are not candidates for surgery or radiation; AIDS-related Kaposi sarcoma — second-line treatment.
Ovarian (first-line): 175 mg/m² IV over 3 hours, followed by cisplatin 75 mg/m², q3w
Ovarian (subsequent): 135 mg/m² or 175 mg/m² IV over 3 hours, q3w
Breast adjuvant: 175 mg/m² IV over 3 hours q3w × 4 cycles (after AC)
Breast metastatic: 175 mg/m² IV over 3 hours q3w
NSCLC: 135 mg/m² IV over 24 hours, followed by cisplatin 75 mg/m², q3w
Kaposi sarcoma: 135 mg/m² IV over 3 hours q3w, or 100 mg/m² IV over 3 hours q2w
Pre-medication (required): Dexamethasone 20 mg PO ~12 and 6 hours before, diphenhydramine 50 mg IV 30-60 min before, cimetidine 300 mg or ranitidine 50 mg IV 30-60 min before
Use non-PVC containers and administration sets (Cremophor EL leaches DEHP plasticizer)
Injection: 6 mg/mL, available in 5 mL (30 mg), 16.7 mL (100 mg), and 50 mL (300 mg) multi-dose vials. Contains Cremophor EL and dehydrated alcohol.
Hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil). Patients with solid tumors: baseline neutrophils <1,500/mm³. Patients with AIDS-related KS: baseline neutrophils <1,000/mm³.
Neutropenia (90%, Grade 4: 52%), alopecia (87%), peripheral neuropathy (60%), myalgia/arthralgia (60%), nausea/vomiting (52%), diarrhea (38%), mucositis (31%), hypotension (12%), bradycardia (29%), injection site reactions (13%), hypersensitivity (41% any grade)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Paclitaxel promotes polymerization of tubulin dimers into microtubules and stabilizes microtubules by preventing depolymerization. This abnormal stabilization results in inhibition of the normal dynamic reorganization of the microtubule network that is essential for interphase and mitotic cellular functions. Paclitaxel induces the formation of abnormal microtubule bundles throughout the cell cycle and multiple asters of microtubules during mitosis, leading to mitotic arrest at the metaphase-anaphase boundary, cell cycle arrest, and apoptosis.
Biphasic elimination. Half-life: alpha 0.27 hours, beta 6.4-20 hours (dose-dependent). Non-linear PK; disproportionate increase in Cmax and AUC with increasing dose. Protein binding: 89-98%. Metabolized by CYP2C8 (major) and CYP3A4. Primarily excreted in feces (biliary) with <10% in urine.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Taxol has FDA-approved indications across the following cancer types covered on PipelineEvidence: