Paclitaxel: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Paclitaxel. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Febrile neutropenia | 90% |
| • alopecia | 87% |
| • nausea/vomiting | 18% |
| • injection site reaction | 13% |
| • mucositis | 13% |
| • hypersensitivity reactionf | 4% |
| • neurosensory toxicity | 3% |
| • cardio vascular events | 2% |
| • myalga/arthralgia | 2% |
| • neuromotor toxicity | 1% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin. Paclitaxel 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 receptornegative 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, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for p…
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