Paclitaxel (Monograph)

Brand names: Abraxane, Onxol, formerly available as Taxol
Drug class: Antineoplastic Agents
- Antimitotic Agents
- Antimicrotubule Agents
VA class: AN900
Chemical name: [2aR-[2aα,4β,4aβ,6β,9α(αR*,βS*),11α,1-2α,12aα,12bα]]-β-(Benzoylamino)-α-hydroxybenzenepropanoic acid 6, 12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a-,12b-dodecahydro-4, 11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz [1,2-b]oxet -9-yl ester
Molecular formula: C₄₇H₅₁NO₁₄
CAS number: 33069-62-4

Medically reviewed by Drugs.com on Jul 17, 2023. Written by ASHP.

Warning

Conventional paclitaxel: Anaphylaxis and severe hypersensitivity reactions (dyspnea and hypotension requiring treatment, angioedema, and/or generalized urticaria) reported.¹ Fatal reactions reported despite premedication.¹ Administer premedication (corticosteroids, diphenhydramine, histamine H₂-receptor antagonists) to all patients.¹ Do not administer paclitaxel to patients with a history of severe hypersensitivity reactions to the drug.¹
Paclitaxel should not be administered to patients with solid tumors with baseline ANC <1500/mm³ or to patients with AIDS-related Kaposi’s sarcoma with baseline ANC <1000/mm³.¹ ³⁵⁴ Monitor blood cell counts frequently.¹ ³⁵⁴
Albumin-bound paclitaxel differs from conventional paclitaxel; do not substitute albumin-bound paclitaxel for conventional paclitaxel or vice versa.³⁵⁴
Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹ Adequate diagnostic and treatment facilities should be readily available to manage complications.¹

Introduction

Antineoplastic agent; natural or semisynthetic diterpene from the bark of the Western (Pacific) yew (Taxus brevifolia) or needles and twigs of Taxus baccata.¹ ² ³ ⁴ ⁶ ⁷ ²⁰ ²² ⁷¹ ¹⁸³

Uses for Paclitaxel

Ovarian Cancer

Conventional paclitaxel: Treatment of advanced carcinoma of the ovary.¹ ²⁴ ²⁶ ²⁸ ²⁹ ¹²² ¹²⁴ ¹²⁹ ¹³⁰ ¹³¹ ¹³² ¹³⁴ ¹³⁵ ¹³⁶ ¹⁷⁸ ¹⁸³ ¹⁸⁴ ²³⁹ ²⁴⁰ ²⁴¹ ²⁴² ²⁴⁹ Used as first-line therapy with carboplatin or cisplatin; this regimen is considered the treatment of choice for primary therapy of advanced ovarian cancer.¹²² ¹³³ ¹³⁴ ¹³⁵ ¹³⁶ ¹⁷⁸ Used alone or in combination therapy as second-line (salvage) therapy or subsequent therapy in patients with advanced ovarian epithelial cancer.¹ ¹²⁴ ¹³⁴ ²⁴¹ ²⁴² ²⁴⁷ ³⁰² ³⁰³

Combined therapy with IV paclitaxel, intraperitoneal cisplatin, and intraperitoneal paclitaxel^{† [off-label]}: Use is recommended (accepted) for the initial adjuvant treatment of optimally debulked stage III epithelial ovarian cancer in patients with good performance status (Gynecologic Oncology Group [GOG] performance status of 0–2).¹⁰⁰⁰¹ ¹⁰⁰¹²

Breast Cancer

Conventional paclitaxel: Adjuvant therapy in patients with evidence of axillary node tumor involvement; administered sequentially to standard doxorubicin-containing combination therapy.¹ ¹²² ²¹⁵

Conventional paclitaxel: Treatment of breast cancer in patients who have metastatic disease refractory to combination chemotherapy or who have experienced relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline antineoplastic agent (e.g., doxorubicin) unless clinically contraindicated.¹ ³⁶ ³⁷ ⁴² ⁴³ ⁴⁵ ⁴⁶ ¹²² ²¹⁵ ³⁵²

Conventional paclitaxel: Treatment of breast cancer in combination with trastuzumab for tumors that overexpress the HER2 protein.¹²² ²¹⁵ ²⁴⁴ ³⁰⁷ ³⁰⁸

Albumin-bound paclitaxel: Used alone for the treatment of breast cancer in patients who have metastatic disease refractory to conventional combination chemotherapy or who have experienced relapse within 6 months of adjuvant therapy; prior therapy should have included an anthracycline antineoplastic agent (e.g., doxorubicin) unless clinically contraindicated.²¹⁵ ³⁵⁴ ³⁵⁵

Non-small Cell Lung Cancer (NSCLC)

Conventional paclitaxel: First-line treatment of advanced NSCLC in combination with carboplatin or cisplatin in patients for whom potentially curative surgery and/or radiation therapy are not possible.¹ ¹²² ²¹⁷ ²⁹¹

Albumin-bound paclitaxel: First-line treatment of advanced NSCLC in combination with carboplatin in patients for whom potentially curative surgery or radiation therapy is not possible.³⁵⁴ ³⁵⁸ ³⁶⁰

Conventional paclitaxel: Adjuvant therapy^{† [off-label]} in selected patients with completely resected NSCLC; used in conjunction with a platinum agent (e.g., carboplatin).²¹⁷ ³¹¹

Small Cell Lung Cancer

Conventional paclitaxel: Active in the treatment of small cell lung carcinoma^{† [off-label]}.⁹⁷ ⁹⁸ ¹⁰⁶ ¹⁰⁷ ¹⁰⁸ ¹²² ²²⁷ ²²⁸

AIDS-related Kaposi’s Sarcoma

Conventional paclitaxel: Second-line therapy for the palliative treatment of advanced or refractory AIDS-related Kaposi’s sarcoma¹ ¹¹⁶ ¹¹⁷ ¹¹⁸ ¹¹⁹ ¹²⁰ ¹²¹ ¹²² ²¹⁶ (designated an orphan drug by FDA for this use).¹³⁹

Pancreatic Cancer

Albumin-bound paclitaxel: First-line therapy of metastatic adenocarcinoma of the pancreas in combination with gemcitabine.³⁵⁴ ³⁶¹

Esophageal Cancer

Conventional paclitaxel: Has been used for the treatment of esophageal cancer^{† [off-label]} .¹¹⁰ ¹¹¹ ¹¹³ ¹²² ²³¹ ³²¹

Bladder Cancer

Conventional paclitaxel: Active in the treatment of transitional cell bladder cancer^{† [off-label]}.¹⁶⁸ ²³²

Head and Neck Cancer

Conventional paclitaxel: Active in the treatment of advanced (metastatic or locally recurrent) squamous cell carcinoma of the head and neck^†.⁸⁰ ⁸¹ ⁹⁶ ¹²² ²¹³ ²⁶⁰ ³³⁰

Cervical Cancer

Conventional paclitaxel: Active in the treatment of cervical cancer.¹²² ²⁷¹ ²⁷³ ²⁷⁴ ²⁷⁵ ²⁷⁹ ²⁸⁰ ³³⁵

Endometrial Cancer

Conventional paclitaxel: Has been used for the treatment of endometrial cancer^†.¹²² ³³⁶ ³³⁷ ³³⁸ ³³⁹ ³⁴⁰ ³⁴¹ ³⁴²

Paclitaxel Dosage and Administration

General

Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.
Conventional paclitaxel: Premedicate all patients before paclitaxel administration, including intraperitoneal^† administration,³⁴⁴ ¹⁰⁰⁰⁵ to prevent severe hypersensitivity reactions.¹ ²¹ ²² Oral dexamethasone 20 mg (10 mg for HIV-infected patients) administered approximately 12 and 6 hours before paclitaxel as well as IV diphenhydramine hydrochloride (or similar antihistamine) 50 mg and either IV cimetidine hydrochloride (300 mg of cimetidine) or ranitidine hydrochloride (50 mg of ranitidine) administered 30–60 minutes before paclitaxel can be given.¹ ²²
Albumin-bound paclitaxel: Premedication generally not required, but may be necessary in patients who experienced a hypersensitivity reaction during a previous course.³⁵⁴

Administration

Administer conventional and albumin-bound paclitaxel by IV infusion.¹ ³ ¹³ ²⁰ ²¹ ³⁵⁴ Conventional paclitaxel also administered intraperitoneally^†.¹⁰⁰⁰¹ ¹⁰⁰⁰⁸

Handle cautiously (by trained nonpregnant personnel); use protective equipment (e.g., gloves) and wash hands after removal of the gloves.¹ ³⁵⁴

Immediately treat accidental contact with skin by thoroughly washing with soap and water; immediately treat accidental contact with mucous membranes by thoroughly washing with water.¹ ³⁵⁴ Dyspnea, chest pain, ocular burning, sore throat, and nausea reported upon inhalation.¹

IV Administration

Conventional Paclitaxel

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.¹

Contact of undiluted paclitaxel for injection concentrate with plasticized polyvinyl chloride (PVC) equipment or devices used to prepare solutions for infusion is not recommended.¹ Diethylhexyl phthalate (DEHP) can be leached from PVC containers.¹

Diluted paclitaxel solutions preferably should be stored in glass or polypropylene containers or in plastic (polypropylene or polyolefin) bags and administered through polyethylene-lined administration sets.¹

A hydrophilic, microporous inline filter with a pore size ≤0.22 µm is necessary during administration.¹ ⁷ ²⁰ ⁴⁵ Use of filter devices such as IVEX-2 filters, which incorporate short inlet and outlet PVC-coated tubing, has not resulted in significant leaching of DEHP.¹ ⁴⁵ ¹⁹⁵

Do not use a Chemo Dispensing Pen or similar device; these devices may cause the stopper to collapse and contaminate the solution (resulting in loss of sterility).¹

Dilution of Conventional Paclitaxel

The concentrate for injection must be diluted prior to administration.¹ ²⁰

Dilute in 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in Ringer’s injection to a final paclitaxel concentration of 0.3–1.2 mg/mL.¹

Rate of Administration of Conventional Paclitaxel

Infuse appropriate dose IV over 3 or 24 hours, depending on the treatment regimen.¹

Albumin-bound Paclitaxel

Administer by IV infusion; do not use inline filters.³⁵⁴

Reconstitution of Albumin-bound Paclitaxel

Add 20 mL of 0.9% sodium chloride injection to a vial containing 100 mg of paclitaxel lyophilized powder; slowly inject the diluent onto the inside wall of the vial.³⁵⁴ Allow the vial to sit for ≥5 minutes (to ensure wetting of cake/powder); then, gently swirl and/or invert vial for ≥2 minutes.³⁵⁴ Handle in such a manner to avoid foaming.³⁵⁴ Resulting preparation contains 5 mg/mL.³⁵⁴

Withdraw appropriate dose from vial and transfer to an empty sterile PVC IV bag.³⁵⁴ DEHP-free containers and administration sets not needed.³⁵⁴

Rate of Administration of Albumin-bound Paclitaxel

Infuse appropriate dose IV over 30 minutes.³⁵⁴ Limiting infusion duration to 30 minutes reduces risk of infusion-related reactions.³⁵⁴

Intraperitoneal Instillation

In patients with advanced epithelial ovarian cancer (GOG-172 study), dose was diluted in 1 L of 0.9% sodium chloride solution that was warmed to 37°C and infused through a surgically implanted peritoneal catheter, followed by intraperitoneal infusion of 1 L of warmed saline solution.³⁴⁴ ¹⁰⁰⁰⁵ Following peritoneal infusion, patient was asked to roll into a different position every 15 minutes for the next 2 hours to disperse the drug throughout the peritoneal cavity.¹⁰⁰⁰⁵

Consult specialized sources for guidance on how to administer intraperitoneal therapy.³⁴⁵ ¹⁰⁰⁰⁵ Further study needed to optimize techniques for intraperitoneal therapy to minimize risk of complications (e.g., infection, catheter obstruction, catheter retraction, bowel perforation, pain, leakage, port access problems).³⁴⁴ ³⁴⁵ ¹⁰⁰⁰⁵ ¹⁰⁰¹⁷

Dosage

Consult manufacturer's labeling and published protocols for formulation-specific regimens and specific dosages, methods of administration, and administration sequence of other antineoplastic agents used in combination regimens.³⁵⁴ ³⁶²

Adults

Ovarian Cancer

IV (Conventional Paclitaxel)

Previously untreated patients: 175 mg/m² given over 3 hours followed by cisplatin 75 mg/m² in repeated 3-week cycles.¹ Alternatively, 135 mg/m² given over 24 hours followed by cisplatin 75 mg/m² in repeated 3-week cycles.¹

Previously treated patients: 135 mg/m² or 175 mg/m² given over 3 hours in repeated 3-week cycles.¹

Reduce dose by 20% for subsequent cycles in patients who experience severe neutropenia (ANC <500/mm³ for >7 days) or severe peripheral neuropathy.¹

IV and Intraperitoneal (Conventional Paclitaxel)†

Previously untreated patients with optimally debulked disease: IV paclitaxel 135 mg/m² by 24-hour infusion on day 1, followed by intraperitoneal cisplatin 100 mg/m² on day 2 and intraperitoneal paclitaxel 60 mg/m² on day 8, has been administered every 21 days for up to 6 cycles.¹⁰⁰⁰¹

Modified regimens (e.g., with shorter IV infusion times that may permit outpatient administration) are being investigated.¹⁰⁰⁰⁸ ¹⁰⁰¹² ¹⁰⁰¹³ ¹⁰⁰¹⁴

Breast Cancer

IV (Conventional Paclitaxel)

Adjuvant therapy: 175 mg/m² given over 3 hours in repeated 3-week cycles for 4 cycles administered sequentially to doxorubicin-containing chemotherapy.¹

Treatment after failure of initial therapy for metastatic disease or relapse within 6 months of adjuvant therapy: 175 mg/m² given over 3 hours in repeated 3-week cycles.¹

Reduce dose by 20% for subsequent cycles in patients who experience severe neutropenia (ANC <500/mm³ for >7 days) or severe peripheral neuropathy.¹

IV (Albumin-bound Paclitaxel)

Treatment after failure of initial therapy for metastatic disease or relapse within 6 months of adjuvant therapy: 260 mg/m² every 3 weeks.³⁵⁴

Reduce dose to 220 mg/m² for subsequent cycles in patients who experience severe neutropenia (ANC <500/mm³ for >7 days) or severe sensory neuropathy.³⁵⁴ Reduce dose to 180 mg/m² if severe neutropenia or severe sensory neuropathy recurs.³⁵⁴ For grade 3 sensory neuropathy, withhold therapy until resolution to grade 1 or 2; when therapy is resumed, reduce dose.³⁵⁴

Non-small Cell Lung Cancer (NSCLC)

IV (Conventional Paclitaxel)

135 mg/m² given over 24 hours followed by cisplatin 75 mg/m² in repeated 3-week cycles.¹ ²⁵⁴ Alternatively, 175 mg/m² given over 3 hours followed by cisplatin 80 mg/m² in repeated 3-week cycles has been used.²³⁴

Reduce dose by 20% for subsequent cycles in patients who experience severe neutropenia (ANC <500/mm³ for >7 days) or severe peripheral neuropathy.¹

IV (Albumin-bound Paclitaxel)

100 mg/m² given over 30 minutes on days 1, 8, and 15, followed by carboplatin (target AUC 6 mg/mL per minute) on day 1 of each 21-day cycle.³⁵⁴

Table 1. Dosage Modification for Toxicity in Patients Receiving Albumin-bound Paclitaxel and Carboplatin for NSCLC354
Toxicity	Episode	Albumin-bound Paclitaxel and Carboplatin Dosage Modification
Febrile neutropenia (ANC <500/mm³ with fever >38°C) or delay of next cycle by >7 days for ANC <1500/mm³ or ANC <500/mm³ for >7 days	First	Withhold both drugs until ANC ≥1500/mm³ and platelets ≥100,000/mm³ on day 1 or ANC ≥500/mm³ and platelets ≥50,000/mm³ on day 8 or 15 of the cycle; upon resumption, permanently reduce albumin-bound paclitaxel dose to 75 mg/m² and carboplatin target AUC to 4.5 mg/mL per minute
	Second	Withhold both drugs until ANC ≥1500/mm³ and platelets ≥100,000/mm³ on day 1 or ANC ≥500/mm³ and platelets ≥50,000/mm³ on day 8 or 15 of the cycle; upon resumption, permanently reduce albumin-bound paclitaxel dose to 50 mg/m² and carboplatin target AUC to 3 mg/mL per minute
	Third	Discontinue both drugs
Thrombocytopenia (platelet count <50,000/mm³)	First	Withhold both drugs until ANC ≥1500/mm³ and platelets ≥100,000/mm³ on day 1 or ANC ≥500/mm³ and platelets ≥50,000/mm³ on day 8 or 15 of the cycle; upon resumption, permanently reduce albumin-bound paclitaxel dose to 75 mg/m² and carboplatin target AUC to 4.5 mg/mL per minute
	Second	Discontinue both drugs
Severe (grade 3 or 4) peripheral neuropathy	First	Withhold both drugs until neuropathy is grade 1 or less; upon resumption, permanently reduce albumin-bound paclitaxel dose to 75 mg/m² and carboplatin target AUC to 4.5 mg/mL per minute
	Second	Withhold both drugs until neuropathy is grade 1 or less; upon resumption, permanently reduce albumin-bound paclitaxel dose to 50 mg/m² and carboplatin target AUC to 3 mg/mL per minute
	Third	Discontinue both drugs

AIDS-related Kaposi’s Sarcoma

IV (Conventional Paclitaxel)

135 mg/m² given over 3 hours in repeated 3-week cycles.¹ Alternatively, 100 mg/m² over 3 hours in repeated 2-weeks cycles.¹ The regimen given every 3 weeks is more toxic than the regimen given every 2 weeks; patients with poor performance status have been treated with paclitaxel 100 mg/m².¹

Reduce dose by 20% for subsequent cycles in patients who experience severe neutropenia (ANC <500/mm³ for >7 days); initiate granulocyte colony stimulating factor (G-CSF) as indicated.¹

Pancreatic Cancer

IV (Albumin-bound Paclitaxel)

125 mg/m² given over 30–40 minutes followed by gemcitabine 1 g/m² IV over 30–40 minutes on days 1, 8, and 15 of each 28-day cycle.³⁵⁴

When dosage modification is necessary, reduce dose of albumin-bound paclitaxel in decrements of 25 mg/m² (i.e., 1 dose level) and gemcitabine in decrements of 200 mg/m² (i.e., 1 dose level); however, if a dose of albumin-bound paclitaxel 75 mg/m² or a dose of gemcitabine 600 mg/m² requires further reduction, discontinue both drugs.³⁵⁴

Table 2. Dosage Modification for Hematologic Toxicity in Patients Receiving Albumin-bound Paclitaxel and Gemcitabine for Pancreatic Cancer354
Cycle Day and Cell Counts (cells/mm³)	Albumin-bound Paclitaxel and Gemcitabine Dosage Modification
Day 1:
ANC <1500 or platelet count <100,000	Delay start of cycle until recovery
Day 8:
ANC 500 to <1000 or platelet count 50,000 to <75,000	Reduce dose of both drugs by 1 dose level
ANC <500 or platelet count <50,000	Withhold day 8 dose of both drugs
Day 15 (when day 8 doses were reduced or given without modification):
ANC 500 to <1000 or platelet count 50,000 to <75,000	Reduce dose of both drugs by 1 dose level from day 8
ANC <500 or platelet count <50,000	Withhold day 15 dose of both drugs
Day 15 (when day 8 doses were withheld):
ANC ≥1000 or platelet count ≥75,000	Reduce dose of both drugs by 1 dose level from day 1
ANC 500 to <1000 or platelet count 50,000 to <75,000	Reduce dose of both drugs by 2 dose levels from day 1
ANC <500 or platelet count <50,000	Withhold day 15 dose of both drugs

Table 3. Dosage Modification for Other Toxicities in Patients Receiving Albumin-bound Paclitaxel and Gemcitabine for Pancreatic Cancer354
Toxicity	Albumin-bound Paclitaxel and Gemcitabine Dosage Modification
Febrile neutropenia (grade 3 or 4)	Withhold both drugs until fever resolves and ANC is ≥1500/mm³; upon resumption, reduce dose of both drugs by 1 dose level
Severe (grade 3 or 4) peripheral neuropathy	Withhold albumin-bound paclitaxel until neuropathy is grade 1 or less; upon resumption, reduce albumin-bound paclitaxel dose by 1 dose level. No gemcitabine dose reduction required
Dermatologic toxicity (grade 2 or 3)	Reduce dose of both drugs by 1 dose level. Discontinue both drugs if toxicity persists
GI toxicity (grade 3 mucositis or diarrhea)	Withhold both drugs until GI toxicity is grade 1 or less; upon resumption, reduce dose of both drugs by 1 dose level

Special Populations

Hepatic Impairment

Increased risk of toxicity, particularly grade 3 or 4 myelosuppression.¹ ³⁵⁴ Adjust dosage as follows and closely monitor patients.¹ ³⁵⁴

Ovarian Cancer

IV (Conventional Paclitaxel)

See Table 4 for recommended initial doses; base further dose reductions in subsequent courses on individual tolerance.¹ ³⁶² Differences in criteria for bilirubin concentrations between the 3- and 24- hour infusions are due to differences in clinical trial design.¹ ³⁶²

Table 4. Recommended Initial Doses of Conventional Paclitaxel for Ovarian Cancer in Patients with Hepatic Impairment1362
Transaminase Concentration		Bilirubin Concentration	Recommended Initial Dose (for 3- or 24-Hour Infusion)
<2 times ULN	and	≤1.5 mg/dL	135 mg/m² over 24 hours
2 to <10 times ULN	and	≤1.5 mg/dL	100 mg/m² over 24 hours
<10 times ULN	and	1.6–7.5 mg/dL	50 mg/m² over 24 hours
≥10 times ULN	or	>7.5 mg/dL	Not recommended
<10 times ULN	and	≤1.25 times ULN	175 mg/m² over 3 hours
<10 times ULN	and	1.26–2 times ULN	135 mg/m² over 3 hours
<10 times ULN	and	2.01–5 times ULN	90 mg/m² over 3 hours
≥10 times ULN	or	>5 times ULN	Not recommended

Breast Cancer

IV (Conventional Paclitaxel)

See Table 5 for recommended initial doses; base further dose reductions in subsequent courses on individual tolerance.¹

Table 5. Recommended Initial Doses of Conventional Paclitaxel for Breast Cancer in Patients with Hepatic Impairment1362
Transaminase Concentration		Bilirubin Concentration	Recommended Initial Dose (for 3-Hour Infusion)
<10 times ULN	and	≤1.25 times ULN	175 mg/m²
<10 times ULN	and	1.26–2 times ULN	135 mg/m²
<10 times ULN	and	2.01–5 times ULN	90 mg/m²
≥10 times ULN	or	>5 times ULN	Not recommended

IV (Albumin-bound Paclitaxel)

See Table 6 for recommended initial doses; base further dose reductions in subsequent courses on individual tolerance.³⁵⁴

Table 6. Recommended Initial Doses of Albumin-bound Paclitaxel for Breast Cancer in Patients with Hepatic Impairment354
AST Concentration		Bilirubin Concentration	Recommended Initial Dose (for 30-Minute Infusion)
<10 times ULN	and	≤1.25 times ULN	260 mg/m²
<10 times ULN	and	1.26–2 times ULN	200 mg/m²
<10 times ULN	and	2.01–5 times ULN	130 mg/m²; may increase to 200 mg/m² in subsequent courses based on tolerance
>10 times ULN	or	>5 times ULN	Not recommended

Non-small Cell Lung Cancer (NSCLC)

IV (Conventional Paclitaxel)

See Table 7 for recommended initial doses; base further dose reductions in subsequent courses on individual tolerance.¹

Table 7. Recommended Initial Doses of Conventional Paclitaxel for NSCLC in Patients with Hepatic Impairment1362
Transaminase Concentration		Bilirubin Concentration	Recommended Initial Dose (for 24-Hour Infusion)
<2 times ULN	and	≤1.5 times ULN	135 mg/m²
2 to <10 times ULN	and	≤1.5 times ULN	100 mg/m²
<10 times ULN	and	1.6–7.5 times ULN	50 mg/m²
≥10 times ULN	or	>7.5 times ULN	Not recommended

IV (Albumin-bound Paclitaxel)

Patients with serum bilirubin concentrations exceeding the ULN were excluded from clinical studies of albumin-bound paclitaxel for NSCLC.³⁵⁴

See Table 8 for recommended initial doses; base further dose reductions in subsequent courses on individual tolerance.³⁵⁴

Table 8. Recommended Initial Doses of Albumin-bound Paclitaxel for NSCLC in Patients with Hepatic Impairment354
AST Concentration		Bilirubin Concentration	Recommended Initial Dose (for 30-Minute Infusion)
<10 times ULN	and	≤1.25 times ULN	100 mg/m²
<10 times ULN	and	1.26–2 times ULN	75 mg/m²
<10 times ULN	and	2.01–5 times ULN	50 mg/m²
>10 times ULN	or	>5 times ULN	Not recommended

AIDS-related Kaposi’s Sarcoma

IV (Conventional Paclitaxel)

Data not available to make dosage recommendations.¹

Pancreatic Cancer

IV (Albumin-bound Paclitaxel)

Patients with serum bilirubin concentrations exceeding the ULN were excluded from clinical studies in pancreatic cancer.³⁵⁴

If AST <10 times ULN and bilirubin ≤1.25 times ULN, give usual initial dose of 125 mg/m² over 30–40 minutes.³⁵⁴ Base further dose reductions in subsequent courses on individual tolerance.³⁵⁴

Not recommended if AST >10 times ULN, bilirubin >5 times ULN, or AST <10 times ULN and bilirubin 1.26–5 times ULN.³⁵⁴

Renal Impairment

Conventional paclitaxel: Reduction of dosage does not appear to be necessary.²⁰ ²³ ¹²⁴

Cautions for Paclitaxel

Contraindications

Known hypersensitivity to paclitaxel, polyoxyl 35 castor oil (Cremophor EL, polyethoxylated castor oil), or any other ingredient in the formulation.¹
Baseline ANC <1500/mm³ in patients with solid tumors.¹
Baseline ANC <1000/mm³ in patients with AIDS-related Kaposi’s sarcoma.¹

Baseline ANC <1500/mm³.³⁵⁴
Severe hypersensitivity reaction during a previous course.³⁵⁴

Warnings/Precautions

Warnings

Adequate Patient Evaluation and Monitoring

Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹ ³⁵⁴

Patients must have recovered from acute toxicities (e.g., ANC >1500/mm³ [>1000/mm³ for patients with Kaposi’s sarcoma], platelets >100,000/mm³) of previous cytotoxic therapy before each cycle.¹ ³⁵⁴

Prior to and during therapy with conventional paclitaxel, assess blood cell counts, serum bilirubin, and AST and/or ALT.¹

During therapy with albumin-bound paclitaxel, assess blood cell counts frequently, including before each dose.³⁵⁴

Hematologic Effects

Dose-dependent and dose-limiting bone marrow suppression (mainly neutropenia).¹ ²² ²⁵ ²⁶ ²⁸ ²⁹ ³⁵ ¹⁸⁴ ³⁵⁴ Thrombocytopenia occurs less commonly than neutropenia.¹ ²⁵ ²⁸ ²⁹ ³⁵ ³⁵⁴

Conventional paclitaxel: Neutrophil nadir at day 10–12, return to baseline by day 15–21.¹ ³ ²⁵ Platelet nadir at day 8–9.¹

Cardiovascular Effects

Severe conduction abnormalities documented with conventional paclitaxel; ¹ ²⁵ ²⁶ ²⁸ ³¹ pacemaker placement needed in some patients.¹ Institute appropriate therapy if clinically important conduction abnormalities occur; perform continuous cardiac monitoring during subsequent cycles.¹

Hypotension, ¹ ²⁶ bradycardia, ¹ ²⁵ ²⁶ ²⁸ ³¹ and hypertension¹ reported during infusion of conventional paclitaxel; interruption of therapy not needed for mild symptoms.¹ Interruption or discontinuance may be needed because of initial or recurrent hypertension.¹

Monitor vital signs frequently during conventional paclitaxel administration, especially during the first hour of the infusion.¹ Continuous cardiac monitoring not required except in patients with serious conduction abnormalities.¹

Hypotension or bradycardia reported during infusion of albumin-bound paclitaxel: specific therapy or interruption of paclitaxel not needed.³⁵⁴ ECG abnormalities reported.³⁵⁴

Fetal/Neonatal Morbidity and Mortality

Embryotoxic and fetotoxic.¹ ³⁵⁴ (See Pregnancy under Cautions.)

Therapy with albumin-bound paclitaxel not advised in men wishing to father a child.³⁵⁴

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis and severe reactions, characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria, reported during infusion of conventional paclitaxel.¹ Fatal reactions reported in patients who received premedication.¹

Anaphylaxis and severe reactions, including fatal cases, also reported during infusion of albumin-bound paclitaxel.³⁵⁴

Premedicate patients with corticosteroids, diphenhydramine, and histamine H₂-receptor antagonists to reduce the severity of hypersensitivity reactions during infusion of conventional paclitaxel.¹ (See General under Dosage and Administration.)

Interruption of therapy with conventional paclitaxel generally is not needed for mild reactions (e.g., flushing, localized skin reactions, hypotension, tachycardia).¹ Discontinue immediately and treat if severe reaction occurs (hypotension requiring treatment, dyspnea requiring bronchodilators, angioedema, generalized urticaria).¹

Do not administer conventional or albumin-bound paclitaxel to any patient who experienced a severe hypersensitivity reaction during a previous course.¹ ³⁵⁴ Not known whether patients who exhibit hypersensitivity to conventional paclitaxel can subsequently tolerate albumin-bound paclitaxel.³⁵⁴

Sulfite Sensitivity

Some formulations of conventional paclitaxel contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.²⁸² ²⁸³ ²⁸⁴ ²⁸⁵ ²⁸⁶ ²⁸⁷ ²⁸⁸ ²⁸⁹

Major Toxicities

Nervous System Effects

Neuropathy (sensory, peripheral) occurs frequently with conventional or albumin-bound paclitaxel; severe symptoms are unusual.¹ ³⁵⁴ Neuropathy is dose and schedule dependent.³⁵⁴ Reduce dose for severe symptoms.¹ ³⁵⁴

Infectious Complications

Infectious episodes (e.g., sepsis, pneumonia, peritonitis, urinary and respiratory tract infections) reported with conventional paclitaxel; fatal infections reported rarely.¹

Opportunistic infection reported frequently in patients with AIDS-related Kaposi's sarcoma receiving conventional paclitaxel.¹ Febrile neutropenia reported more frequently with conventional paclitaxel 135 mg/m² compared with 100 mg/m².¹

Infectious episodes (e.g., oral candidiasis, respiratory and urinary tract infections, pneumonia) reported with albumin-bound paclitaxel.³⁵⁴

Sepsis (irrespective of ANC) reported in patients with pancreatic cancer receiving albumin-bound paclitaxel and gemcitabine; risk factors for severe or fatal sepsis include biliary obstruction or presence of biliary stent.³⁵⁴ Initiate broad-spectrum anti-infectives if fever develops (regardless of ANC).³⁵⁴

Injection Site Reaction

Injection site reactions to conventional paclitaxel, including reactions secondary to extravasation, are mild and characterized by erythema, tenderness, skin discoloration, or swelling at the injection site.¹ Reactions more frequent with the 24-hour infusion than the 3-hour infusion.¹ Recurrence of skin reactions at a previous site of extravasation (i.e., “recall” reactions) following administration at a different injection site reported rarely.¹ ¹⁵⁹ ¹⁶⁰

Severe events (phlebitis, cellulitis, induration, skin exfoliation, necrosis, fibrosis) reported rarely with conventional paclitaxel.¹

Injection site reaction to conventional paclitaxel usually occurs during prolonged infusion; delayed onset of reaction, 3–13 days after infusion, also reported.¹ ¹⁵⁷ ¹⁵⁸

Specific treatment for extravasation reactions to conventional paclitaxel unknown.¹ Monitor the infusion site for possible infiltration during administration.¹

Mild injection site reactions to albumin-bound paclitaxel reported infrequently.³⁵⁴ Monitor the infusion site for possible infiltration during administration.³⁵⁴

Respiratory Effects

Pneumonitis, sometimes fatal, reported infrequently with albumin-bound paclitaxel and gemcitabine.³⁵⁴ Monitor for pneumonitis.³⁵⁴ If signs and symptoms develop, interrupt therapy during evaluation; permanently discontinue therapy in patients diagnosed with pneumonitis.³⁵⁴

Interstitial pneumonia, lung fibrosis, radiation pneumonitis, pneumothorax, and pulmonary embolism also reported with conventional or albumin-bound paclitaxel.¹ ³⁵⁴

General Precautions

Prescribing and Dispensing Precautions

Ensure accuracy of prescription; similarity of spelling of Taxol (paclitaxel) and Taxotere (docetaxel)²⁹⁰ may result in errors.²⁹⁰

Risk of Transmissible Agents in Plasma-derived Preparations

Albumin-bound paclitaxel: Potential vehicle for transmission of viruses or other infectious agents.³⁵⁴ Despite screening for certain viruses, remote risk for transmission of viral infections.³⁵⁴ Theoretical risk for transmission of Creutzfeldt-Jacob disease.³⁵⁴

Specific Populations

Pregnancy

Category D.¹ ³⁵⁴

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ ³⁵⁴ Discontinue nursing or the drug because of the potential risk to nursing infant.¹ ³⁵⁴

Pediatric Use

Safety and efficacy not established.¹ ³⁵⁴

CNS toxicity, rarely fatal, reported in pediatric patients receiving high doses of conventional paclitaxel (350–420 mg/m²) by 3-hour IV infusion.¹ Paclitaxel injection contains dehydrated alcohol; toxicity may have resulted from administration of large amounts of alcohol over a short period of time.¹ The use of concomitant antihistamine may intensify the toxic effect of the alcohol.¹ The possibility of a direct toxic effect of paclitaxel itself cannot be ruled out.¹

Geriatric Use

Conventional paclitaxel: No substantial differences in efficacy relative to younger adults.¹ Severe myelosuppression and severe neuropathy reported more frequently in geriatric individuals than in younger adults.¹ Increased incidence of cardiovascular events noted in geriatric patients receiving conventional paclitaxel for NSCLC.¹

Albumin-bound paclitaxel for metastatic breast cancer: No difference in toxicity relative to younger adults observed in clinical studies.³⁵⁴

Albumin-bound paclitaxel and carboplatin for NSCLC: No overall differences in efficacy relative to younger adults, but toxicity (myelosuppression, peripheral neuropathy, arthralgia) more common in patients ≥65 years of age.³⁵⁴

Albumin-bound paclitaxel and gemcitabine for pancreatic cancer: No overall differences in efficacy relative to younger adults, but toxicity (diarrhea, decreased appetite, dehydration, epistaxis) more common in patients ≥65 years of age.³⁵⁴

Hepatic Impairment

Conventional paclitaxel: Myelotoxicity may be exacerbated in patients with total bilirubin >2 times ULN.¹ Use with extreme caution in these patients; dosage adjustment recommended.¹ (See Hepatic Impairment under Dosage and Administration.)

Albumin-bound paclitaxel: Toxicity may be exacerbated.³⁵⁴ Use with caution; adjust dosage in patients with moderate or severe impairment.³⁵⁴ Patients with baseline serum bilirubin exceeding the ULN were excluded from clinical trials for NSCLC and pancreatic cancer.³⁵⁴ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Albumin-bound paclitaxel: Not systematically evaluated in patients with renal impairment.³⁵⁴

Common Adverse Effects

Conventional paclitaxel: Alopecia, myelosuppression (neutropenia, leukopenia, anemia, thrombocytopenia), neuropathy (peripheral, sensory), myalgia/arthralgia, nausea and vomiting, diarrhea, mucositis, infection, hypersensitivity reaction, abnormal ECG, elevated alkaline phosphatase concentrations, elevated S_cr.¹ ³⁶²

Albumin-bound paclitaxel: Alopecia, myelosuppression (neutropenia, thrombocytopenia, anemia), neuropathy (peripheral, sensory), myalgia/arthralgia, nausea, diarrhea, mucositis, fatigue/asthenia, infection, peripheral edema, abnormal ECG, elevated AST and alkaline phosphatase concentrations, elevated S_cr, pyrexia, decreased appetite, rash, dehydration.³⁵⁴

Drug Interactions

Metabolized by CYP2C8 and CYP3A4.¹ ³⁵⁴

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions possible with drugs that are inhibitors, inducers, or substrates of CYP2C8 or CYP3A4 with possible alteration in metabolism of paclitaxel and/or other drug.¹ ³⁵⁴ Use concomitantly with caution.³⁵⁴ ³⁶²

Specific Drugs

Drug	Interaction	Comments
Anticonvulsants (phenobarbital, phenytoin)	Decreased paclitaxel concentrations¹⁸⁶ ¹⁸⁸
Carboplatin	Administration of conventional paclitaxel followed by carboplatin associated with less severe thrombocytopenia compared with carboplatin alone;¹⁸⁶ ¹⁸⁸ ²⁰⁴ no pharmacokinetic interaction¹⁸⁸ ²⁰⁴ Administration of albumin-bound paclitaxel followed by carboplatin associated with no clinically important changes in paclitaxel exposure; carboplatin AUC 23% higher than targeted value, but half-life and clearance consistent with carboplatin alone³⁵⁴
Cisplatin	Sequence-dependent interaction; increased severity of myelosuppression when conventional paclitaxel administered following cisplatin compared with the alternative sequence¹ ¹⁸⁶ ¹⁸⁸ Paclitaxel clearance reduced by 25–33% when conventional paclitaxel administered following cisplatin¹ ¹⁸⁶ ¹⁸⁸
CNS depressants	Potentiation of CNS depression due to alcohol in the conventional paclitaxel formulation¹ ¹⁴¹	Use concomitantly with caution¹ ¹⁴¹
Cyclophosphamide	Sequence-dependent interaction; increased severity of neutropenia and thrombocytopenia when conventional paclitaxel (24-hour infusion) administered before cyclophosphamide¹⁸⁶ ¹⁸⁸
Cyclosporine	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴
Dexamethasone	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴ Did not displace paclitaxel from plasma proteins in vitro³⁵⁴ ³⁶²
Diazepam	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴
Diphenhydramine	Did not displace paclitaxel from plasma proteins in vitro³⁵⁴ ³⁶²
Doxorubicin	Conventional paclitaxel: Increased plasma concentrations of doxorubicin and its active metabolite¹ ¹⁶⁷ ¹⁸⁴ ¹⁸⁶ ¹⁸⁸ ²⁰³ In vitro synergistic cytotoxic effects¹⁸⁸ ²⁰³
17α-Ethinyl estradiol	Paclitaxel metabolism inhibited in vitro¹ ³⁵⁴
Etoposide	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴
Histamine H₂-receptor antagonists	Cimetidine, famotidine: Pharmacokinetic interaction unlikely⁴⁵ ¹⁸⁶ ¹⁸⁸ ²⁴³ Cimetidine, ranitidine: Did not displace paclitaxel from plasma proteins in vitro³⁵⁴ ³⁶²
HIV protease inhibitors	Possible interaction¹ ³⁵⁴
Ketoconazole	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴
Quinidine	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴
Teniposide	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴
Testosterone	Paclitaxel metabolism inhibited in vitro¹ ³⁵⁴
Verapamil	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴
Vincristine	Paclitaxel metabolism inhibited in vitro at concentrations greater than usual therapeutic concentrations¹ ³⁵⁴

Paclitaxel Pharmacokinetics

Absorption

Conventional paclitaxel: Exhibits nonlinear pharmacokinetic behavior when administered over short periods (i.e., 3 hours).³⁵ ¹⁸³ ¹⁸⁶ ¹⁹⁶

Albumin-bound paclitaxel: Increase in AUC proportional to increase in dose for doses of 80–375 mg/m².³⁵⁴ Duration of infusion does not affect pharmacokinetics.³⁵⁴

Special Populations

Conventional paclitaxel: Plasma paclitaxel exposure increased with abnormal serum bilirubin concentrations ≤2 times ULN.¹

Albumin-bound paclitaxel: Plasma paclitaxel exposure following 260- or 200-mg/m² dose in patients with mild or moderate hepatic impairment, respectively, was similar to exposure observed in patients with normal hepatic function.³⁵⁴ ³⁶⁴

Distribution

Extent

Widely distributed.¹ ⁴⁵ ¹⁸³ ¹⁸⁴

Conventional paclitaxel is detected in ascitic fluid;²⁰ ⁴⁵ does not penetrate the CNS.²⁰ ⁴⁵ ¹⁸³ ¹⁸⁴ ¹⁸⁶ ¹⁹⁹

Not known whether paclitaxel is distributed into human milk.¹ ³⁵⁴

Following administration of albumin-bound paclitaxel, concentration of drug in tumor cells is increased compared with concentration achieved following an equivalent dose of conventional paclitaxel.³⁵⁷

Plasma Protein Binding

88–98%.¹ ²⁰ ³⁵⁴

Elimination

Metabolism

Metabolized by CYP2C8 and, to a lesser extent, by CYP3A4.¹ ²⁰² ³⁵⁴

Elimination Route

Excreted principally in feces as metabolites and unchanged drug.¹⁸⁴ ¹⁹⁶ ¹⁹⁷ ²⁰⁵ ²⁴⁶

Minimal urinary excretion.¹⁸³ ¹⁸⁴ ¹⁹⁶ ¹⁹⁷ ¹⁹⁸ ²⁰⁵

Half-life

Conventional paclitaxel: Average elimination half-life: 5.8 hours for 6- to 24-hour infusions,¹⁸⁶ 2.33 hours for 3-hour infusions.²⁴⁶

Albumin-bound paclitaxel: 27 hours.³⁵⁴

Stability

Storage

Parenteral

For Injection Concentrate (Conventional Paclitaxel)

20–25°C in the original package to protect from light.¹

No adverse effect on drug from freezing or refrigeration.¹ Drug or vehicle that precipitates during refrigeration or freezing will redissolve at room temperature without potency loss.¹ ²³

Solutions for infusion are stable at ambient temperature (approximately 25°C) and lighting conditions for up to 27 hours.¹

Suspension for Injection (Albumin-bound Paclitaxel)

20–25°C in the original package to protect from bright light.³⁵⁴

Use reconstituted suspension immediately; alternatively, store vial in the original package for up to 8 hours at 2–8°C.³⁵⁴ No adverse effect on drug from freezing or refrigeration.³⁵⁴

Discard reconstituted suspension if precipitation occurs.³⁵⁴

Reconstituted suspension for infusion is stable in the IV infusion bag at ambient temperature (approximately 25°C) and lighting conditions for up to 4 hours.³⁵⁴

Compatibility

Parenteral

Solution Compatibility (Conventional Paclitaxel)HID

Compatible
Sodium chloride 0.9%
Variable
Dextrose 5% in water; white precipitate noted occasionally distal to pump chamber

Drug Compatibility (Conventional Paclitaxel)

Admixture CompatibilityHID
Compatible
Carboplatin
Doxorubicin HCl
Variable
Cisplatin

Y-site CompatibilityHID
Compatible
Acyclovir sodium
Amikacin sulfate
Aminophylline
Ampicillin sodium–sulbactam sodium
Anidulafungin
Bleomycin sulfate
Butorphanol tartrate
Calcium chloride
Carboplatin
Cefotetan disodium
Ceftazidime
Ceftriaxone sodium
Cisplatin
Cladribine
Cyclophosphamide
Cytarabine
Dacarbazine
Dexamethasone sodium phosphate
Diphenhydramine HCl
Doripenem
Doxorubicin HCl
Droperidol
Etoposide
Etoposide phosphate
Famotidine
Floxuridine
Fluconazole
Fluorouracil
Furosemide
Ganciclovir sodium
Gemcitabine HCl
Gentamicin sulfate
Granisetron HCl
Haloperidol lactate
Heparin sodium
Hydrocortisone sodium succinate
Hydromorphone HCl
Ifosfamide
Linezolid
Lorazepam
Magnesium sulfate
Mannitol
Meperidine HCl
Mesna
Methotrexate sodium
Metoclopramide HCl
Morphine sulfate
Nalbuphine HCl
Ondansetron HCl
Ondansetron HCl with ranitidine HCl
Oxaliplatin
Palonosetron HCl
Pemetrexed disodium
Pentostatin
Potassium chloride
Prochlorperazine edisylate
Propofol
Ranitidine HCl
Sodium bicarbonate
Thiotepa
Topotecan HCl
Vancomycin HCl
Vinblastine sulfate
Vincristine sulfate
Zidovudine
Incompatible
Amphotericin B
Amphotericin B cholesteryl sulfate complex
Chlorpromazine HCl
Doxorubicin HCl liposome injection
Hydroxyzine HCl
Methylprednisolone sodium succinate
Mitoxantrone HCl

Actions

A natural or semisynthetic diterpene extracted from the bark of the Western (Pacific) yew (Taxus brevifolia) or produced from the needles and twigs of a more prevalent yew (Taxus baccata).² ³ ⁴ ⁶ ⁷ ²⁰ ²² ³⁵ ⁷¹ ¹⁸³ Structurally and pharmacologically similar to docetaxel.²⁰⁶ ²⁴⁶
Disrupts the microtubular network in cells that is essential for mitotic and interphase cellular function.¹ ³⁵⁴

Advice to Patients

Importance of recognizing and reporting adverse effects including myelosuppressive effects and infectious complications.¹ ³⁵⁴
Importance of reporting adverse effects including persistent vomiting, diarrhea, or signs of dehydration.³⁵⁴
Advise patient about sensory neuropathy.³⁵⁴ Importance of reporting numbness, tingling, pain, or weakness involving the extremities.³⁵⁴
Importance of reading the patient information leaflet.¹
Advise patient about probable alopecia, fatigue/asthenia, and myalgia/arthralgia.¹ ³⁵⁴
Advise patient about risk of severe or fatal hypersensitivity reaction.³⁵⁴
Advise patient about risk of pneumonitis.³⁵⁴ Importance of reporting sudden onset of dry persistent cough or shortness of breath.³⁵⁴
Potential for alcohol in conventional paclitaxel to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual known.¹ ¹⁴¹
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy.¹ ³⁵⁴ Importance of advising men to avoid fathering a child during therapy.³⁵⁴ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹ ³⁵⁴
Importance of informing patients of other important precautionary information.¹ ³⁵⁴ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

PACLitaxel
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, concentrate, for IV infusion	6 mg/mL*	Onxol	Teva
			Paclitaxel Injection

PACLitaxel (albumin-bound)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injectable suspension, for IV infusion	100 mg (of paclitaxel)	Abraxane	Celgene

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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299. Markman M, Liu PY, Wilczynski S et al. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003; 21:2460-5. http://www.ncbi.nlm.nih.gov/pubmed/12829663?dopt=AbstractPlus

300. Ozols RF. Maintenance therapy in advanced ovarian cancer: progression-free survival and clinical benefit. J Clin Oncol. 2003; 21:2451-3. http://www.ncbi.nlm.nih.gov/pubmed/12829660?dopt=AbstractPlus

301. Thigpen T. Maybe more is better. J Clin Oncol. 2003; 21:2454-6. http://www.ncbi.nlm.nih.gov/pubmed/12829661?dopt=AbstractPlus

302. Parmar MK, Ledermann JA, Colombo N et al. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003; 361:2099-106. http://www.ncbi.nlm.nih.gov/pubmed/12826431?dopt=AbstractPlus

303. Goldberg JM, Piver MS, Hempling RE et al. Paclitaxel and cisplatin combination chemotherapy in recurrent epithelial ovarian cancer. Gynecol Oncol. 1996; 63:312-7. http://www.ncbi.nlm.nih.gov/pubmed/8946864?dopt=AbstractPlus

304. Henderson IC, Berry DA, Demetri GD et al. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003; 21:976-83. http://www.ncbi.nlm.nih.gov/pubmed/12637460?dopt=AbstractPlus

305. Mamounas EP, Bryant J, Lembersky B et al. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005; 23:3686-96. http://www.ncbi.nlm.nih.gov/pubmed/15897552?dopt=AbstractPlus

306. Citron ML, Berry DA, Cirrincione C et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003; 21:1431-9. http://www.ncbi.nlm.nih.gov/pubmed/12668651?dopt=AbstractPlus

307. Romond EH, Perez EA, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005; 353:1673-84. http://www.ncbi.nlm.nih.gov/pubmed/16236738?dopt=AbstractPlus

308. Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005; 353:1659-72. http://www.ncbi.nlm.nih.gov/pubmed/16236737?dopt=AbstractPlus

309. Jassem J, Pienkowski T, Pluzanska A et al. Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trial. J Clin Oncol. 2001; 19:1707-15. http://www.ncbi.nlm.nih.gov/pubmed/11251000?dopt=AbstractPlus

310. Biganzoli L, Cufer T, Bruning P et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: the European Organization for Research and Treatment of Cancer 10961 multicenter phase III trial. J Clin Oncol. 2002; 20:3114-21. http://www.ncbi.nlm.nih.gov/pubmed/12118025?dopt=AbstractPlus

311. Strauss GM, Herndon J, Maddaus MA et al. Randomized clinical trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in stage IB non-small cell lung cancer (NSCLC): report of Cancer and Leukemia Group B (CALGB) protocol 9633. Proc ASCO. 2004; Abstract No. 7019.

312. Hotta K, Matsuo K, Ueoka H et al. Role of adjuvant chemotherapy in patients with resected non-small-cell lung cancer: reappraisal with a meta-analysis of randomized controlled trials. J Clin Oncol. 2004; 22:3860-7. http://www.ncbi.nlm.nih.gov/pubmed/15326194?dopt=AbstractPlus

313. Belani CP, Larocca RV, Rinaldi DA et al. A multicenter, phase III randomized trial for stage IIIB/IV NSCLC of weekly paclitaxel and carboplatin vs. standard paclitaxel and carboplatin given every three weeks, followed by weekly paclitaxel. Proc ASCO. 2004; Abstract No. 7017.

314. Kosmidis P, Mylonakis N, Nicolaides C et al. Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol. 2002; 20:3578-85. http://www.ncbi.nlm.nih.gov/pubmed/12202657?dopt=AbstractPlus

315. Rosell R, Gatzemeier U, Betticher DC et al. Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial. Ann Oncol. 2002; 13:1539-49. http://www.ncbi.nlm.nih.gov/pubmed/12377641?dopt=AbstractPlus

316. Soria JC, Le Chevalier T. Is cisplatin still the best platinum compound in non-small-cell lung cancer? Ann Oncol. 2002; 13:1515-7.

317. Glisson BS, Kurie JM, Perez-Soler R et al. Cisplatin, etoposide, and paclitaxel in the treatment of patients with extensive small-cell lung carcinoma. J Clin Oncol. 1999; 17:2309-15. http://www.ncbi.nlm.nih.gov/pubmed/10561292?dopt=AbstractPlus

318. Niell HB, Herndon JE 2nd, Miller AA et al. Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer: Cancer and Leukemia Group B trial 9732. J Clin Oncol. 2005; 23:3752-9. http://www.ncbi.nlm.nih.gov/pubmed/15923572?dopt=AbstractPlus

319. Mavroudis D, Papadakis E, Veslemes M et al. A multicenter randomized clinical trial comparing paclitaxel-cisplatin-etoposide versus cisplatin-etoposide as first-line treatment in patients with small-cell lung cancer. Ann Oncol. 2001; 12:463-70. http://www.ncbi.nlm.nih.gov/pubmed/11398877?dopt=AbstractPlus

320. Ettinger DS, Berkey BA, Abrams RA et al. Study of paclitaxel, etoposide, and cisplatin chemotherapy combined with twice-daily thoracic radiotherapy for patients with limited-stage small-cell lung cancer: a Radiation Therapy Oncology Group 9609 phase II study. J Clin Oncol. 2005; 23:4991-8. http://www.ncbi.nlm.nih.gov/pubmed/15939930?dopt=AbstractPlus

321. Urba SG, Orringer MB, Ianettonni M et al. Concurrent cisplatin, paclitaxel, and radiotherapy as preoperative treatment for patients with locoregional esophageal carcinoma. Cancer. 2003; 98:2177-83. http://www.ncbi.nlm.nih.gov/pubmed/14601087?dopt=AbstractPlus

322. Vaughn DJ, Broome CM, Hussain M et al. Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol. 2002; 20:937-40. http://www.ncbi.nlm.nih.gov/pubmed/11844814?dopt=AbstractPlus

323. Small EJ, Lew D, Redman BG et al. Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point. J Clin Oncol. 2000; 18:2537-44. http://www.ncbi.nlm.nih.gov/pubmed/10893284?dopt=AbstractPlus

324. Vaishampayan UN, Faulkner JR, Small EJ et al. Phase II trial of carboplatin and paclitaxel in cisplatin-pretreated advanced transitional cell carcinoma: a Southwest Oncology Group study. Cancer. 2005; 104:1627-32. http://www.ncbi.nlm.nih.gov/pubmed/16138364?dopt=AbstractPlus

325. Vaughn DJ, Manola J, Dreicer R et al. Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896): a trial of the Eastern Cooperative Oncology Group. Cancer. 2002; 95:1022-7. http://www.ncbi.nlm.nih.gov/pubmed/12209686?dopt=AbstractPlus

326. Johannsen M, Sachs M, Roigas J et al. Phase II trial of weekly paclitaxel and carboplatin chemotherapy in patients with advanced transitional cell cancer. Eur Urol. 2005; 48:246-51. http://www.ncbi.nlm.nih.gov/pubmed/15963636?dopt=AbstractPlus

327. Dreicer R, Manola J, Roth BJ et al. Phase II study of cisplatin and paclitaxel in advanced carcinoma of the urothelium: an Eastern Cooperative Oncology Group Study. J Clin Oncol. 2000; 18:1058-61. http://www.ncbi.nlm.nih.gov/pubmed/10694557?dopt=AbstractPlus

328. Meluch AA, Greco FA, Burris HA 3rd et al. Paclitaxel and gemcitabine chemotherapy for advanced transitional-cell carcinoma of the urothelial tract: a phase II trial of the Minnie Pearl Cancer Research Network. J Clin Oncol. 2001; 19:3018-24. http://www.ncbi.nlm.nih.gov/pubmed/11408496?dopt=AbstractPlus

329. Sternberg CN, Calabro F, Pizzocaro G et al. Chemotherapy with an every-2-week regimen of gemcitabine and paclitaxel in patients with transitional cell carcinoma who have received prior cisplatin-based therapy. Cancer. 2001; 92:2993-8. http://www.ncbi.nlm.nih.gov/pubmed/11753976?dopt=AbstractPlus

330. Gibson MK, Li Y, Murphy B et al. Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an intergroup trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2005; 23:3562-7. http://www.ncbi.nlm.nih.gov/pubmed/15908667?dopt=AbstractPlus

331. Langer CJ, Li Y, Jennings T et al. Phase II evaluation of 96-hour paclitaxel infusion in advanced (recurrent or metastatic) squamous cell carcinoma of the head and neck (E3395): a trial of the Eastern Cooperative Oncology Group. Cancer Invest. 2004; 22:823-31. http://www.ncbi.nlm.nih.gov/pubmed/15641479?dopt=AbstractPlus

332. Garden AS, Harris J, Vokes EE et al. Preliminary results of Radiation Therapy Oncology Group 97-03: a randomized phase II trial of concurrent radiation and chemotherapy for advanced squamous cell carcinomas of the head and neck. J Clin Oncol. 2004; 22:2856-64. http://www.ncbi.nlm.nih.gov/pubmed/15254053?dopt=AbstractPlus

333. Hitt R, Lopez-Pousa A, Martinez-Trufero J et al. Phase III study comparing cisplatin plus fluorouracil to paclitaxel, cisplatin, and fluorouracil induction chemotherapy followed by chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol. 2005; 23:8636-45. http://www.ncbi.nlm.nih.gov/pubmed/16275937?dopt=AbstractPlus

334. Curtin JP, Blessing JA, Webster KD et al. Paclitaxel, an active agent in nonsquamous carcinomas of the uterine cervix: a Gynecologic Oncology Group study. J Clin Oncol. 2001; 19:1275-8. http://www.ncbi.nlm.nih.gov/pubmed/11230468?dopt=AbstractPlus

335. Moore DH, Blessing JA, McQuellon RP et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. J Clin Oncol. 2004; 22:3113-9. http://www.ncbi.nlm.nih.gov/pubmed/15284262?dopt=AbstractPlus

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337. Ball HG, Blessing JA, Lentz SS et al. A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1996; 62:278-81. http://www.ncbi.nlm.nih.gov/pubmed/8751561?dopt=AbstractPlus

338. Lincoln S, Blessing JA, Lee RB et al. Activity of paclitaxel as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2003; 88:277-81. http://www.ncbi.nlm.nih.gov/pubmed/12648575?dopt=AbstractPlus

339. Hoskins PJ, Swenerton KD, Pike JA et al. Paclitaxel and carboplatin, alone or with irradiation, in advanced or recurrent endometrial cancer: a phase II study. J Clin Oncol. 2001; 19:4048-53. http://www.ncbi.nlm.nih.gov/pubmed/11600606?dopt=AbstractPlus

340. Fleming GF, Filiaci VL, Bentley RC et al. Phase III randomized trial of doxorubicin + cisplatin versus doxorubicin + 24-h paclitaxel + filgrastim in endometrial carcinoma: a Gynecologic Oncology Group study. Ann Oncol. 2004; 15:1173-8. http://www.ncbi.nlm.nih.gov/pubmed/15277255?dopt=AbstractPlus

341. Fleming GF, Brunetto VL, Cella D et al. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004; 22:2159-66. http://www.ncbi.nlm.nih.gov/pubmed/15169803?dopt=AbstractPlus

342. Miller D, protocol chair. Phase III randomized study of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) versus carboplatin and paclitaxel in patients with stage III or IV or recurrent endometrial cancer. Protocol ID: GOG-0209. Last modified: 5/19/2006. National Cancer Institute: Clinical Trials (database).

343. Greven K, Winter K, Underhill K et al. Preliminary analysis of RTOG 9708: Adjuvant postoperative radiotherapy combined with cisplatin/paclitaxel chemotherapy after surgery for patients with high-risk endometrial cancer. Int J Radiat Oncol Biol Phys. 2004; 59:168-73. http://www.ncbi.nlm.nih.gov/pubmed/15093913?dopt=AbstractPlus

344. Walker JL, Armstrong DK, Huang HQ et al. Intraperitoneal catheter outcomes in a phase III trial of intravenous versus intraperitoneal chemotherapy in optimal stage III ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 2006; 100:27-32. http://www.ncbi.nlm.nih.gov/pubmed/16368440?dopt=AbstractPlus

345. Trimble EL, Christian MC. Intraperitoneal chemotherapy for women with advanced epithelial ovarian carcinoma. Gynecol Oncol. 2006; 100:3-4. http://www.ncbi.nlm.nih.gov/pubmed/16368439?dopt=AbstractPlus

346. National Cancer Institute (NCI). NCI issues clinical announcement for preferred method of treatment for advanced ovarian cancer: questions and answers (January 4, 2006). From NCI web site. http://www.cancer.gov/newscenter/pressreleases/IntraperitonealQandA

347. National Cancer Institute (NCI). NCI clinical announcement on intraperitoneal chemotherapy in ovarian cancer (January 5, 2006). From NCI web site. http://ctep.cancer.gov/highlights/ovarian.html

348. Piccart-Gebhart MJ. Mathematics and oncology: a match for life? J Clin Oncol. 2003; 21:1425-8.

349. Perez EA, Vogel CL, Irwin DH et al. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2001; 19:4216-23. http://www.ncbi.nlm.nih.gov/pubmed/11709565?dopt=AbstractPlus

350. Spazzapan S, Crivellari D, Lombardi D et al. Nail toxicity related to weekly taxanes: an important issue requiring a change in common toxicity criteria grading? J Clin Oncol. 2002; 20:4404-5.

351. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001; 344:783-92. http://www.ncbi.nlm.nih.gov/pubmed/11248153?dopt=AbstractPlus

352. Eli Lilly and Company. Gemzar (gemcitabine) prescribing information. Indianapolis, IN: 2006 Apr 5.

353. Albain KS, Nag S, Calderillo-Ruiz G et al. Global phase III study of gemcitabine plus paclitaxel (GT) vs. paclitaxel (T) as frontline therapy for metastatic breast cancer (MBC): first report of overall survival. Proc ASCO. 2004; Abstract No. 510.

354. Celgene. Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) prescribing information. Summit, NJ: 2013 Oct.

355. Gradishar WJ, Tjulandin S, Davidson N et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005; 23:7794-803. http://www.ncbi.nlm.nih.gov/pubmed/16172456?dopt=AbstractPlus

356. Ibrahim NK, Samuels B, Page R et al. Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. J Clin Oncol. 2005; 23:6019-26. http://www.ncbi.nlm.nih.gov/pubmed/16135470?dopt=AbstractPlus

357. Desai N, Trieu V, Yao Z et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res. 2006; 12:1317-24. http://www.ncbi.nlm.nih.gov/pubmed/16489089?dopt=AbstractPlus

358. Socinski MA, Bondarenko I, Karaseva NA et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012; 30:2055-62. http://www.ncbi.nlm.nih.gov/pubmed/22547591?dopt=AbstractPlus

359. Azzoli CG, Temin S, Aliff T et al. 2011 Focused Update of 2009 American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer. J Clin Oncol. 2011; 29:3825-31. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=3675703&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/21900105?dopt=AbstractPlus

360. Satouchi M, Okamoto I, Sakai H et al. Efficacy and safety of weekly nab-paclitaxel plus carboplatin in patients with advanced non-small cell lung cancer. Lung Cancer. 2013; 81:97-101. http://www.ncbi.nlm.nih.gov/pubmed/23545279?dopt=AbstractPlus

361. Von Hoff DD, Ervin T, Arena FP et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013; 369:1691-703. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4631139&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/24131140?dopt=AbstractPlus

362. Pfizer Labs. Paclitaxel injection prescribing information. New York, NY: 2011 Jun.

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Paclitaxel Dosage and Administration

General

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IV Administration

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