Paclitaxel

TAXOL

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Pronunciation: pak-li-TAX-el

Paclitaxel ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Paclitaxel ballicule

Paclitaxel TAXOL / PTX mascot mnemonic cartoon — Visual mnemonic: Paclitaxel mascot
**“Pac attacks all (dividing cells)”**

What it isTaxane chemotherapy that stabilizes microtubules and arrests mitosis; used across breast, ovarian, lung, and other cancers.

Why this oneAlbumin-bound paclitaxel avoids the Cremophor vehicle and its premedication burden.

What limits itBone-marrow suppression and cumulative peripheral neuropathy limit treatment; solvent-based infusion can cause severe hypersensitivity.

Paclitaxel molecular structure (skeletal formula) — Molecular structure: Paclitaxel

FDA-approved for

cancer (1992)

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Legacy pregnancy categoryD

Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Experienced chemotherapy physician; anaphylaxis/severe hypersensitivity (fatal despite premedication) — premedicate all, no rechallenge; do not give if baseline ANC <1,500 cells/mm3 (solid tumors) or <1,000 (AIDS-related KS); frequent blood counts

FDA dosing	Population	Start	Target	Max
Ovarian carcinoma — first-line (+ cisplatin)	Adults	175 mg/m2 IV over 3 h then cisplatin 75 mg/m2, OR 135 mg/m2 IV over 24 h then cisplatin 75 mg/m2; q3wk	Same	Undefined
Ovarian carcinoma — previously treated	Adults	135 or 175 mg/m2 IV over 3 h q3wk	Same	Undefined
Breast cancer — adjuvant, node-positive (after doxorubicin-containing combination)	Adults	175 mg/m2 IV over 3 h q3wk x4 courses	Same	Undefined
Breast cancer — metastatic after failure of combination chemo or relapse within 6 months of adjuvant	Adults	175 mg/m2 IV over 3 h q3wk	Same	Undefined
NSCLC — first-line (+ cisplatin), not candidates for curative surgery/radiation	Adults	135 mg/m2 IV over 24 h then cisplatin 75 mg/m2; q3wk	Same	Undefined
AIDS-related Kaposi sarcoma — second-line	Adults	135 mg/m2 IV over 3 h q3wk OR 100 mg/m2 IV over 3 h q2wk	Same (q2wk schedule less toxic)	Undefined

Renal Undefined (effect of renal dysfunction not investigated)

Hepatic First course (mg/m2) — 24-h infusion: transaminase <2x ULN & bili ≤1.5 mg/dL → 135; 2 to <10x & ≤1.5 → 100; <10x & 1.6–7.5 mg/dL → 50; ≥10x or >7.5 → not recommended. 3-h infusion: <10x ULN & bili ≤1.25x ULN → 175; 1.26–2.0x → 135; 2.01–5.0x → 90; ≥10x or >5.0x → not recommended

Instructions

Premedicate all: dexamethasone 20 mg PO ≈12 and 6 h before; diphenhydramine 50 mg IV and cimetidine 300 mg or ranitidine 50 mg IV 30–60 min before (advanced HIV/KS: dexamethasone 10 mg PO)
Dilute in 0.9% NaCl, D5W, D5/NS or D5 Ringer's to 0.3–1.2 mg/mL; stable up to 27 hours at ambient temperature
Use glass/polypropylene/polyolefin containers and polyethylene-lined (non-PVC) sets; in-line filter ≤0.22 micron
Do not use spiked dispensing-pin devices (stopper collapse)
Repeat courses only when ANC ≥1,500 and platelets ≥100,000 cells/mm3 (KS: ANC ≥1,000)
Reduce subsequent doses 20% after severe neutropenia (<500 cells/mm3 for ≥1 week) or severe peripheral neuropathy
Monitor infusion site for extravasation; frequent vital signs in first hour

Available strengths

inj 6 mg/mL

Contraindications

History of hypersensitivity to paclitaxel or other drugs formulated in Polyoxyl 35 Castor Oil
Solid tumors with baseline neutrophils <1,500 cells/mm3; AIDS-related KS with baseline neutrophils <1,000 cells/mm3

Cautions

Anaphylaxis/severe hypersensitivity — premedicate; no rechallenge
Bone marrow suppression (neutropenia, dose-limiting)
Severe cardiac conduction abnormalities
Embryo-fetal toxicity
PVC/DEHP leaching — non-PVC containers, in-line filter
CYP2C8/CYP3A4 interactions; more myelosuppression if given after cisplatin; may raise doxorubicin levels
Hypotension, bradycardia, hypertension during infusion
Peripheral neuropathy
Alcohol content (CNS effects)
Hepatic impairment — increased myelotoxicity
Injection site reactions / extravasation, recall

Adverse reactions

Neutropenia
Leukopenia
Anemia
Infections
Hypersensitivity reaction
Abnormal ECG
Peripheral neuropathy
Myalgia/arthralgia
Nausea and vomiting
Diarrhea
Mucositis
Alopecia

Pregnancy Can cause fetal harm (embryo-fetotoxic in rabbits); advise women of childbearing potential to avoid pregnancy

Lactation Unknown if excreted in human milk (higher in rat milk than plasma); discontinue nursing during therapy

Cost

Paclitaxel (TAXOL)

Strength		#/mo	generic $/unit	CostPlus
6 mg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Paclitaxel is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2002

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Memory aids: interaction avatars

CYP2C8 substrate

P-gp substrate (sensitive)

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Self-check

Paclitaxel: What does albumin-bound paclitaxel avoid?
The Cremophor vehicle.
Paclitaxel: Which cumulative neurologic toxicity limits treatment?
Peripheral neuropathy.