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Nanoparticle albumin bound paclitaxel (nabpaclitaxel): Drug information

Nanoparticle albumin bound paclitaxel (nabpaclitaxel): Drug information
(For additional information see "Nanoparticle albumin bound paclitaxel (nabpaclitaxel): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Neutropenia:

Do not administer paclitaxel (protein bound) to patients with baseline neutrophil counts of <1,500 cells/mm3. Monitor for neutropenia, which may be severe and result in infection or sepsis. Perform frequent CBC on all patients receiving paclitaxel (protein bound).

Brand Names: US
  • Abraxane
Brand Names: Canada
  • Abraxane
Pharmacologic Category
  • Antineoplastic Agent, Antimicrotubular;
  • Antineoplastic Agent, Taxane Derivative
Dosing: Adult

Note: Paclitaxel (protein bound) is not interchangeable with other paclitaxel formulations; do not substitute. When administered as part of a combination chemotherapy regimen, sequence of administration may vary by regimen; refer to specific protocol for sequence of administration. Consider premedication in patients with prior mild to moderate hypersensitivity reactions to paclitaxel (protein bound). Do not administer paclitaxel (protein bound) if baseline neutrophil count is <1,500/mm3.

Biliary tract cancer, advanced or metastatic

Biliary tract cancer, advanced or metastatic (off-label use):

Cholangiocarcinoma (intrahepatic and extrahepatic) and gall bladder cancer: IV: 100 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with cisplatin and gemcitabine); continue until disease progression or unacceptable toxicity (Ref).

Cholangiocarcinoma (first-line treatment): IV: 125 mg/m2 on days 1, 8, and 15 of a 28-day cycle (in combination with gemcitabine); continue until disease progression or unacceptable toxicity (Ref).

Bladder cancer, metastatic, platinum-resistant

Bladder cancer, metastatic, platinum-resistant (off-label use): IV: 260 mg/m2 once every 3 weeks; continue until disease progression or unacceptable toxicity (Ref).

Breast cancer, metastatic

Breast cancer, metastatic: IV: 260 mg/m2 every 3 weeks (Ref).

Weekly dosing (off-label dose): IV: 100 to 150 mg/m2 on days 1, 8, and 15 of a 28-day cycle (Ref).

Breast cancer (triple-negative), locally advanced or metastatic (off-label combination): IV: 125 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with carboplatin) until disease progression or unacceptable toxicity (Ref).

Cervical cancer, advanced, recurrent or persistent

Cervical cancer, advanced, recurrent or persistent (off-label use): IV: 125 mg/m2 on days 1, 8, and 15 of a 28-day cycle; continue until disease progression or unacceptable toxicity (Ref).

Melanoma, metastatic

Melanoma, metastatic (off-label use):

Previously treated patients: IV: 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle; if tolerated, may increase dose by 25 mg/m2 in cycle 2 and beyond; continue until disease progression or unacceptable toxicity (Ref).

Previously untreated patients: IV: 150 mg/m2 on days 1, 8, and 15 of a 28-day cycle; continue until disease progression or unacceptable toxicity (Ref).

Non–small cell lung cancer, locally advanced or metastatic

Non–small cell lung cancer, locally advanced or metastatic: IV: 100 mg/m2 on days 1, 8, and 15 of each 21-day cycle (in combination with carboplatin) (Ref).

Off-label combinations:

In combination with durvalumab, tremelimumab, and carboplatin : IV: 100 mg/m2 on days 1, 8, and 15 of each 21-day cycle (in combination with carboplatin, durvalumab, and tremelimumab) for 4 cycles, followed by tremelimumab (for 1 additional dose) and durvalumab; continue durvalumab until disease progression or unacceptable toxicity; refer to protocol for further information (Ref).

In combination with carboplatin and pembrolizumab: IV: 100 mg/m2 on days 1, 8, and 15 of each 21-day cycle (in combination with carboplatin and pembrolizumab) for 4 cycles, followed by pembrolizumab maintenance therapy (Ref).

In combination with atezolizumab and carboplatin: IV: 100 mg/m2 on days 1, 8, and 15 of each 21-day cycle (in combination with atezolizumab and carboplatin) for 4 to 6 cycles, followed by atezolizumab maintenance therapy (Ref).

Ovarian, fallopian tube, or primary peritoneal cancer, recurrent

Ovarian, fallopian tube, or primary peritoneal cancer, recurrent (off-label use): IV: 260 mg/m2 on day 1 of a 21-day cycle for 6 to 8 cycles (Ref) or 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity (Ref).

Pancreatic adenocarcinoma, metastatic

Pancreatic adenocarcinoma, metastatic: IV: 125 mg/m2 on days 1, 8, and 15 of a 28-day cycle (in combination with gemcitabine) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

CrCl ≥30 mL/minute: No dosage adjustment necessary (Ref).

CrCl <30 mL/minute: No pharmacokinetic studies in severe kidney impairment exist; however, no dosage adjustment likely to be necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed (highly protein bound): No supplemental dose or dosage adjustment likely to be necessary (Ref).

Peritoneal dialysis: Unlikely to be dialyzed (highly protein bound): No dosage adjustment likely to be necessary (Ref).

CRRT: No dosage adjustment likely to be necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment likely to be necessary (Ref).

Dosing: Hepatic Impairment: Adult

Dosage adjustment for hepatic impairment at treatment initiation:

Mild hepatic impairment: No dose adjustment is necessary (regardless of indication).

Paclitaxel Protein-Bound Starting Dosage Adjustment in Hepatic Impairment

AST levels

Bilirubin levels

Recommended dosea

Metastatic breast cancer

Non–small cell lung cancerb

Pancreatic adenocarcinomac

a Dosage recommendations are for the first course of therapy; further dose adjustments in subsequent courses should be based on individual tolerance. Monitor closely for severe hematologic toxicity.

b Patients with bilirubin levels above the ULN were excluded from clinical trials for lung cancer.

c Patients with bilirubin levels above the ULN were excluded from clinical trials for pancreatic cancer. However, data from a small retrospective analysis evaluating the safety and efficacy of paclitaxel (protein bound) in combination with gemcitabine in patients with advanced pancreatic cancer and cholestatic hyperbilirubinemia found that no unexpected hematologic or hepatic toxicities occurred, even in patients with an initial bilirubin level >5 mg/dL; median overall survival did not differ based on total bilirubin levels, and the majority of patients received an initial paclitaxel (protein bound) dose of 125 mg/m2 (Pelzer 2018). If administering paclitaxel (protein bound) in patients with hyperbilirubinemia (particularly if due to cholestasis), monitor closely and adjust dose as clinically necessary, based on toxicities and clinical status.

d Consider a dose increase to 260 mg/m2 in subsequent courses if the reduced dose is tolerated for 2 cycles.

e Consider a dose increase to 100 mg/m2 in subsequent courses if the reduced dose is tolerated for 2 cycles.

Mild

≤10 × ULN

and

>ULN to ≤1.5 × ULN

260 mg/m2

100 mg/m2

125 mg/m2

Moderate

≤10 × ULN

and

>1.5 to ≤3 × ULN

200 mg/m2 d

80 mg/m2 e

Not recommended

Severe

≤10 × ULN

and

>3 to ≤5 × ULN

200 mg/m2 d

80 mg/m2 e

Not recommended

>10 × ULN

or

>5 × ULN

Not recommended

Not recommended

Not recommended

Dosage adjustment for hepatic impairment during treatment: AST >10 times ULN or bilirubin >5 times ULN: Withhold treatment

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

Hypersensitivity reaction (severe): Discontinue paclitaxel (protein bound); do not rechallenge.

Breast cancer (metastatic; every-3-week regimen):

Severe neutropenia (<500/mm3) ≥1 week: Reduce dose to 220 mg/m2 (every 3 weeks) for subsequent courses.

Recurrent severe neutropenia: Reduce dose to 180 mg/m2 (every 3 weeks) for subsequent courses.

Sensory neuropathy

Grade 1 or 2: Dosage adjustment generally not required.

Grade 3: Hold treatment until resolved to grade 1 or 2, then resume with reduced dose for all subsequent cycles.

Severe sensory neuropathy: Reduce dose to 220 mg/m2 (every 3 weeks) for subsequent courses.

Recurrent severe sensory neuropathy: Reduce dose to 180 mg/m2 for (every 3 weeks) subsequent courses.

Non–small cell lung cancer:

Neutropenia: ANC <1,500/mm3: Withhold therapy until ANC is ≥1,500/mm3 on day 1 or ≥500/mm3 on days 8 or 15. Reduce dose upon therapy reinitiation if:

Neutropenic fever (ANC <500/mm3 with fever >38°C) or delay of next cycle by >7 days due to ANC <1,500/mm3 or ANC <500/mm3 for >7 days:

First occurrence: Permanently reduce dose to 75 mg/m2.

Second occurrence: Permanently reduce dose to 50 mg/m2 .

Third occurrence: Discontinue therapy.

Thrombocytopenia: Platelet count <100,000/mm3: Withhold therapy until platelet count is ≥100,000/mm3 on day 1 or ≥50,000/mm3 on days 8 or 15. Reduce dose upon therapy reinitiation if:

Platelet count <50,000/mm3:

First occurrence: Permanently reduce dose to 75 mg/m2.

Second occurrence: Discontinue therapy.

Sensory neuropathy: Withhold therapy for grade 3 or 4 peripheral neuropathy. Resume therapy at reduced doses when neuropathy resolves completely or improves to grade 1:

First occurrence: Permanently reduce dose to 75 mg/m2.

Second occurrence: Permanently reduce dose to 50 mg/m2.

Third occurrence: Discontinue therapy.

Pancreatic adenocarcinoma:

Note: Dose level reductions for toxicity (may also require WBC growth factor support):

Full dose: 125 mg/m2.

First dose reduction: 100 mg/m2.

Second dose reduction: 75 mg/m2.

If additional dose reduction is necessary: Discontinue.

Hematologic toxicity (neutropenia and/or thrombocytopenia):

Day 1: If ANC is <1,500/mm3 or platelet count is <100,000/mm3: Withhold therapy until ANC is ≥1,500/mm3 and platelet count is ≥100,000/mm3.

Day 8:

If ANC is 500 to <1,000/mm3 or platelet count is 50,000 to <75,000/mm3: Reduce 1 dose level.

If ANC is <500/mm3 or platelet count is <50,000/mm3: Withhold day 8 dose.

Day 15:

If day 8 doses were reduced or given without modification:

If ANC is 500 to <1,000/mm3 or platelet count is 50,000 to <75,000/mm3: Reduce 1 dose level from day 8.

If ANC is <500/mm3 or platelet count is <50,000/mm3: Withhold day 15 dose.

If day 8 doses were withheld:

If ANC is ≥1,000/mm3 or platelet count is ≥75,000/mm3: Reduce 1 dose level from day 1.

If ANC is 500 to <1,000/mm3 or platelet count is 50,000 to <75,000/mm3: Reduce 2 dose levels from day 1.

If ANC is <500/mm3 or platelet count is <50,000/mm3: Withhold day 15 dose.

Neutropenic fever: Withhold therapy for grade 3 or 4 fever. Resume therapy at next lower dose level when fever resolves and ANC is ≥1,500/mm3.

Sepsis: Biliary obstruction and/or the presence of a biliary stent may be risk factors for severe and/or fatal sepsis. If fever occurs, manage promptly with broad spectrum antibiotics (regardless of ANC).

Peripheral neuropathy: Withhold therapy for grade 3 or 4 peripheral neuropathy. Resume therapy at next lower dose level when neuropathy improves to ≤ grade 1.

Dermatologic toxicity: For grade 2 or 3 toxicity, reduce dose to next lower dose level; if toxicity persists, discontinue.

GI toxicity: Withhold therapy for grade 3 mucositis or diarrhea. Resume therapy at next lower dose level when improves to ≤ grade 1.

Pulmonary toxicity : If signs/symptoms of pneumonitis develop, interrupt paclitaxel (protein bound) during diagnostic process. Permanently discontinue if pneumonitis is confirmed.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency may vary based on indication and/or concomitant therapy.

>10%:

Cardiovascular: ECG abnormality (60%; 35% in patients with a normal baseline), peripheral edema (10% to 46%)

Dermatologic: Alopecia (50% to 90%), skin rash (10% to 30%)

Endocrine & metabolic: Dehydration (21%), hypokalemia (12%), increased gamma-glutamyl transferase (grades 3/4: 14%)

Gastrointestinal: Constipation (16%), decreased appetite (17% to 36%), diarrhea (15% to 44%), dysgeusia (16%), nausea (27% to 54%), vomiting (12% to 36%)

Genitourinary: Urinary tract infection (11%)

Hematologic & oncologic: Anemia (33% to 98%; grades 3/4: 1% to 28%), bone marrow depression, neutropenia (73% to 85%; grades 3/4: 9% to 47%), thrombocytopenia (2% to 74%; grades 3/4: ≤18%)

Hepatic: Increased serum alkaline phosphatase (36%), increased serum aspartate aminotransferase (39%)

Infection: Infection (24%; including respiratory tract infection)

Nervous system: Depression (12%), fatigue (25% to 59%), headache (14%), peripheral neuropathy (48% to 54%; grade 3: 3% to 17%), peripheral sensory neuropathy (71%; grades ≥3: 10%; dose dependent; cumulative)

Neuromuscular & skeletal: Arthralgia (≤44%), asthenia (16% to 47%), limb pain (11%), myalgia (≤44%)

Ophthalmic: Visual disturbance (13%; including blurred vision, keratitis)

Renal: Increased serum creatinine (11%)

Respiratory: Cough (7% to 17%), dyspnea (1% to 12%), epistaxis (7% to 15%)

Miscellaneous: Fever (41%)

1% to 10%:

Cardiovascular: Cardiac failure (<10%), edema (≤10%), fluid retention (≤10%), hypertension (<10%), hypotension (≤5%), significant cardiovascular event (grades ≥3: 3%), tachycardia (<10%)

Gastrointestinal: Oral candidiasis (<10%), stomatitis (7% to 10%; grade ≥3: ≤1%)

Hematologic & oncologic: Febrile neutropenia (2%), hemorrhage (2%)

Hepatic: Increased serum bilirubin (7%)

Hypersensitivity: Hypersensitivity reaction (4%; including severe hypersensitivity reaction)

Infection: Sepsis (5%)

Ophthalmic: Cystoid macular edema (<10%)

Respiratory: Pneumonia (<10%), pneumonitis (4%)

Frequency not defined:

Cardiovascular: Acute myocardial infarction, ischemic heart disease, pulmonary embolism, pulmonary thromboembolism, supraventricular tachycardia, thrombosis

Hematologic & oncologic: Pancytopenia

<1%:

Cardiovascular: Bradycardia, flushing

Infection: Neutropenic sepsis

Nervous system: Peripheral motor neuropathy

Respiratory: Pneumothorax

Postmarketing:

Cardiovascular: Atrioventricular block, cardiac arrhythmia, cerebrovascular accident, chest pain, left ventricular dysfunction, transient ischemic attacks

Dermatologic: Cellulitis, changes in nails (pigmentation), erythema of skin, maculopapular rash, nail discoloration, palmar-plantar erythrodysesthesia (in patients previously exposed to capecitabine), pruritus, skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis

Gastrointestinal: Intestinal obstruction, intestinal perforation, ischemic colitis, neutropenic enterocolitis, pancreatitis, paralytic ileus

Hematologic & oncologic: Tumor lysis syndrome

Hepatic: Hepatic encephalopathy, hepatic necrosis

Hypersensitivity: Anaphylaxis

Local: Cellulitis at injection site, fibrosis at injection site, induration at injection site, injection site extravasation, injection site phlebitis, tissue necrosis at injection site

Nervous system: Autonomic neuropathy, cranial nerve palsy, vocal cord paralysis

Neuromuscular & skeletal: Systemic sclerosis

Ophthalmic: Conjunctivitis, decreased visual acuity, increased lacrimation, optic nerve damage

Respiratory: Interstitial pulmonary disease (interstitial pneumonia), pulmonary fibrosis, radiation pneumonitis (with concurrent radiation therapy)

Miscellaneous: Radiation recall phenomenon

Contraindications

Baseline neutrophil count of <1,500/mm3; history of severe hypersensitivity reaction to paclitaxel (protein bound) or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Neutropenia may be severe and result in infection or sepsis. Severe myelosuppression (primarily neutropenia) is dose dependent and dose limiting. Grade 3 or 4 neutropenia has occurred.

• Cardiovascular effects: In a scientific statement from the American Heart Association, conventional paclitaxel has been determined to be an agent that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate) (AHA [Page 2016]).

• Extravasation: Closely monitor infusion site during administration; limiting the infusion duration to 30 minutes may reduce the risk of local infusion-related reactions.

• Hypersensitivity: Severe (and sometimes fatal) hypersensitivity reactions (including anaphylactic reactions) have been reported. Cross-sensitivity between paclitaxel (protein bound) and other taxanes has been reported, and severe reactions, including anaphylaxis, may occur; closely monitor patients initiating therapy with a previous hypersensitivity to other taxanes.

• Neuropathy: Dose- and schedule-related sensory neuropathy is common; severe sensory neuropathy may occur.

• Ocular effects: Vision disturbances, including decreased visual acuity associated with cystoid macular edema, have been observed; resolution may improve following therapy discontinuation.

• Pneumonitis: Pneumonitis (including fatal cases) was observed in clinical trials when used in combination with gemcitabine.

• Sepsis: Sepsis was observed in both neutropenic and non-neutropenic patients treated with paclitaxel (protein bound) in combination with gemcitabine; biliary obstruction and/or the presence of a biliary stent may be risk factors for severe and/or fatal sepsis.

Special populations:

• Older adult: Certain adverse events (myelosuppression, peripheral neuropathy, arthralgia, diarrhea, decreased appetite, dehydration, fatigue, and epistaxis) occurred more frequently in patients ≥65 years of age compared to patients <65 years of age.

Dosage form specific issues:

• Albumin: Product contains albumin, which confers a remote risk of viral disease transmission and a theoretical risk of transmission of Creutzfeldt-Jakob disease.

Other warnings/precautions:

• Do not substitute: Paclitaxel (protein bound) is not interchangeable with other paclitaxel formulations, including Cremophor-based (polyoxyl 35/polyoxyethylated castor oil based) or unbound paclitaxel.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Intravenous:

Abraxane: 100 mg (1 ea)

Suspension Reconstituted, Intravenous [preservative free]:

Generic: 100 mg (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Suspension (reconstituted) (Abraxane Intravenous)

100 mg (per each): $1,896.07

Suspension (reconstituted) (PACLitaxel Protein-Bound Part Intravenous)

100 mg (per each): $1,801.27 - $1,928.20

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Intravenous:

Abraxane: 100 mg (1 ea)

Generic: 100 mg (1 ea)

Administration: Adult

IV: Administer over 30 minutes (breast cancer and non-small cell lung cancer [NSCLC]) or over 30 to 40 minutes (pancreatic cancer). When administered on a weekly (off label) schedule, infusions were administered over ~30 minutes (Ref). Closely monitor infusion site during infusion; avoid extravasation. Limiting the infusion duration to 30 minutes may reduce the risk of local infusion-related reactions.

When administered as part of a combination chemotherapy regimen, sequence of administration may vary by regimen; refer to specific protocol for sequence of administration. According to the manufacturer, paclitaxel (protein bound) should be given first, followed immediately by carboplatin (NSCLC) or gemcitabine (pancreatic cancer).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Use: Labeled Indications

Breast cancer, metastatic: 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.

Non-small cell lung cancer, locally advanced or metastatic: First-line treatment of locally advanced or metastatic non-small cell lung cancer (in combination with carboplatin) in patients who are not candidates for curative surgery or radiation therapy.

Pancreatic adenocarcinoma, metastatic: First-line treatment of metastatic adenocarcinoma of the pancreas (in combination with gemcitabine).

Guideline recommendations:

The American Society of Clinical Oncology (ASCO) guidelines for metastatic pancreatic cancer recommend paclitaxel (protein bound) (in combination with gemcitabine) as first-line therapy in patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, a relatively favorable comorbidity profile, a preference for relatively aggressive therapy, and a suitable support system. Paclitaxel (protein bound) (in combination with gemcitabine) may be utilized as second-line therapy in patients who received first-line FOLFIRINOX therapy, have an ECOG performance status of 0 or 1, have a relatively favorable comorbidity profile, a preference for aggressive therapy, and a suitable support system. In patients with an ECOG performance status of 2 or a comorbidity profile that prohibits more aggressive therapy, paclitaxel (protein bound) may be added to gemcitabine (with proactive dose/schedule adjustments to minimize toxicities) for first-line therapy when there is a preference for cancer-directed treatment. Second-line therapy with gemcitabine (alone or with paclitaxel [protein bound]) may also be considered as an option (with proactive dose/schedule adjustments) in patients with ECOG performance status of 2 or a comorbidity profile prohibiting more aggressive regimens when there is a preference to pursue cancer-directed therapy (ASCO [Sohal 2020]).

According to the ASCO guidelines for locally advanced, unresectable pancreatic cancer, induction with at least 6 months of initial systemic therapy (with a combination regimen) is generally recommended in patients with ECOG performance status of 0 or 1, a favorable comorbidity profile, a preference for aggressive therapy, and a suitable support system; there is no clear evidence to encourage one regimen over another. The paclitaxel (protein bound)-gemcitabine combination regimen (recommended in the metastatic setting) has not been evaluated in randomized, controlled studies for locally advanced, unresectable pancreatic cancer, but may be an option in patients with good performance status. If disease progression occurs, treatment according to guidelines for metastatic pancreatic cancer should be offered (ASCO [Balaban 2016]).

Use: Off-Label: Adult

Biliary tract cancer, advanced; Bladder cancer, metastatic, platinum-resistant; Cervical cancer, advanced, recurrent or persistent; Melanoma, metastatic; Ovarian, fallopian tube, or primary peritoneal cancers, recurrent

Medication Safety Issues
Sound-alike/look-alike issues:

PACLitaxel (protein bound) may be confused with cabazitaxel, DOCEtaxel, PACLitaxel (conventional)

Abraxane may be confused with Paxil, Taxol, Taxotere

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

Substrate of CYP2C8 (major), CYP3A4 (major), OATP1B1/1B3 (SLCO1B1/1B3), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Anthracyclines: Taxane Derivatives may enhance the adverse/toxic effect of Anthracyclines. Taxane Derivatives may increase the serum concentration of Anthracyclines. Taxane Derivatives may also increase the formation of toxic anthracycline metabolites in heart tissue. Management: Consider separating doxorubicin and paclitaxel administration by as much time as possible, using liposomal doxorubicin or epirubicin instead of doxorubicin, or using docetaxel instead of paclitaxel. Monitor closely for cardiovascular and other toxicities. Risk D: Consider therapy modification

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Atazanavir: May increase the serum concentration of PACLitaxel (Protein Bound). Management: Use of paclitaxel or other narrow therapeutic index CYP2C8 substrates with atazanavir without concurrent ritonavir is not recommended. If paclitaxel is used with ritonavir-boosted atazanavir, monitor for increased paclitaxel exposure. Risk X: Avoid combination

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Bexarotene (Systemic): May decrease the serum concentration of PACLitaxel (Protein Bound). PACLitaxel (Protein Bound) may increase the serum concentration of Bexarotene (Systemic). Risk C: Monitor therapy

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

CYP2C8 Inhibitors (Moderate): May increase the serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor therapy

CYP2C8 Inhibitors (Strong): May increase the serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

DOXOrubicin (Conventional): PACLitaxel (Protein Bound) may increase the serum concentration of DOXOrubicin (Conventional). Management: Administer doxorubicin prior to paclitaxel if these agents are used in combination. Monitor cardiac function if combined. Risk D: Consider therapy modification

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Gemcitabine: PACLitaxel (Protein Bound) may enhance the adverse/toxic effect of Gemcitabine. Specifically, the risk for thrombotic microangiopathy may be increased with this combination. Risk C: Monitor therapy

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Lumacaftor and Ivacaftor: May decrease the serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase the serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor therapy

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider therapy modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Platinum Derivatives: May enhance the myelosuppressive effect of Taxane Derivatives. Administer Taxane derivative before Platinum derivative when given as sequential infusions to limit toxicity. Management: Administer paclitaxel before cisplatin, when given as sequential infusions, to limit toxicity. Problems associated with other taxane/platinum combinations are possible, although unsubstantiated. Administering the taxane before platinum is likely warranted Risk D: Consider therapy modification

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

SORAfenib: May enhance the adverse/toxic effect of PACLitaxel (Protein Bound). Management: Concurrent sorafenib with carboplatin and paclitaxel in patients with squamous cell lung cancer is contraindicated. Use in other settings is not specifically contraindicated but should be approached with added caution. Risk X: Avoid combination

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Vinorelbine: PACLitaxel (Protein Bound) may enhance the adverse/toxic effect of Vinorelbine. Specifically hematologic toxicity may be increased. PACLitaxel (Protein Bound) may enhance the neurotoxic effect of Vinorelbine. Risk C: Monitor therapy

Warfarin: PACLitaxel (Protein Bound) may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Food Interactions

Paclitaxel (protein bound) serum concentrations may be increased when taken with grapefruit or grapefruit juice. Management: Monitor for increased effects/toxicity with concomitant use.

Reproductive Considerations

Patients who could become pregnant should have pregnancy status verified prior to treatment initiation and use effective contraception during therapy and for at least 6 months after the last paclitaxel (protein bound) dose. Patients with partners who could become pregnant should use effective contraception during therapy and for at least 3 months after the last paclitaxel (protein bound) dose.

Pregnancy Considerations

Based on the mechanism of action and on findings in animal reproduction studies, paclitaxel (protein bound) may cause fetal harm if administered during pregnancy.

An ex vivo human placenta perfusion model illustrated that paclitaxel (non-protein bound preparation) crossed the placenta at term. Placental transfer was low and affected by the presence of albumin; higher albumin concentrations resulted in lower paclitaxel placental transfer (Berveiller 2012).

A pregnancy registry is available for all cancers diagnosed during pregnancy at Cooper Health (877-635-4499).

Breastfeeding Considerations

Paclitaxel (non-protein bound) is present in breast milk (case report). The mother (3 months postpartum) was treated with paclitaxel 30 mg/m2 (56.1 mg) and carboplatin once weekly for papillary thyroid cancer. Milk samples were obtained 4 to 316 hours after the infusion given at the sixth and final week of therapy. The average paclitaxel milk concentration over the testing interval was 0.78 mg/L. Although maternal serum concentrations were not noted in the report, the relative infant dose to a breastfeeding infant was calculated to be ~17% of the maternal dose. Paclitaxel continued to be detected in breast milk when sampled at 172 hours after the dose and was below the limit of detection when sampled at 316 hours after the infusion (Griffin 2012).

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends patients not breastfeed during therapy and for 2 weeks following the last paclitaxel (protein bound) dose.

Monitoring Parameters

CBC with differential (frequently, including prior to day 1 of cycle for metastatic breast cancer and prior to days 1, 8, and 15 for non–small cell lung cancer and pancreatic cancer); monitor hepatic function. Verify pregnancy status (prior to treatment initiation in patients who could become pregnant). Monitor infusion site. Monitor for signs/symptoms of neuropathy, hypersensitivity, pneumonitis, and infection/sepsis. Monitor for ocular toxicity; consider prompt/complete ophthalmologic evaluation in patients with vision changes/decreased acuity.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Paclitaxel (protein bound) is an albumin-bound paclitaxel nanoparticle formulation; paclitaxel promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication. May also distort mitotic spindles, resulting in the breakage of chromosomes. Paclitaxel may also suppress cell proliferation and modulate immune response.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 1741 L (extensive extravascular distribution and/or tissue binding).

Protein binding: 94%.

Metabolism: Hepatic primarily via CYP2C8 to 6-alpha-hydroxypaclitaxel; also to minor metabolites via CYP3A4.

Half-life elimination: Terminal: 13 to 27 hours.

Excretion: Feces (~20%); urine (4% as unchanged drug, <1% as metabolites).

Clearance: 13 to 30 L/hour/m2.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Plasma paclitaxel exposure is increased in patients with hepatic impairment. Patients with moderate (bilirubin >1.5 to ≤3 × ULN and AST ≤10 × ULN) or severe (bilirubin >3 to ≤5 × ULN) hepatic impairment had ~20% increase in AUC compared with patients with normal hepatic function.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Abraxane;
  • (AR) Argentina: Pazenir;
  • (AT) Austria: Abraxane | Pazenir;
  • (AU) Australia: Abraxane;
  • (BE) Belgium: Abraxane;
  • (BG) Bulgaria: Pazenir;
  • (BR) Brazil: Abraxane;
  • (CH) Switzerland: Abraxane;
  • (CL) Chile: Abraxane;
  • (CN) China: Ai yue | Ke ai li | Paclitaxel for injection (albumin bound);
  • (CO) Colombia: Abraxane;
  • (CZ) Czech Republic: Abraxane | Pazenir;
  • (DE) Germany: Abraxane | Pazenir;
  • (DO) Dominican Republic: Abraxane;
  • (EC) Ecuador: Abraxane;
  • (EE) Estonia: Abraxane | Pazenir;
  • (EG) Egypt: Abraxane;
  • (ES) Spain: Abraxane | Pazenir;
  • (FI) Finland: Abraxane;
  • (FR) France: Abraxane | Pazenir;
  • (GB) United Kingdom: Abraxane | Pazenir;
  • (GR) Greece: Abraxane;
  • (HK) Hong Kong: Abraxane;
  • (HU) Hungary: Abraxane | Pazenir;
  • (IE) Ireland: Abraxane | Pazenir;
  • (IN) India: Ab pacli | Abraxane | Nab celtax | Nab mitotax | Nab paclitero | Nabcure | Nanopacli | Pacliall | Paclitax Nab;
  • (IT) Italy: Abraxane | Pazenir;
  • (JP) Japan: Abraxane;
  • (KR) Korea, Republic of: Abraxane;
  • (LB) Lebanon: Abraxane;
  • (LT) Lithuania: Abraxane;
  • (LV) Latvia: Abraxane;
  • (MX) Mexico: Abraxane | Abraxus;
  • (MY) Malaysia: Abraxane;
  • (NL) Netherlands: Abraxane | Pazenir;
  • (NO) Norway: Abraxane | Pazenir;
  • (NZ) New Zealand: Abraxane;
  • (PE) Peru: Abraxane;
  • (PR) Puerto Rico: Abraxane;
  • (PT) Portugal: Abraxane | Pazenir;
  • (RO) Romania: Abraxane | Pazenir;
  • (RU) Russian Federation: Abraxane;
  • (SA) Saudi Arabia: Abraxane;
  • (SE) Sweden: Abraxane | Pazenir;
  • (SG) Singapore: Abraxane;
  • (SI) Slovenia: Abraxane | Pazenir;
  • (SK) Slovakia: Abraxane | Pazenir;
  • (TH) Thailand: Abraxane;
  • (TR) Turkey: Pacliall;
  • (TW) Taiwan: Abraxane;
  • (UY) Uruguay: Abraxane;
  • (ZA) South Africa: Abraxane
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