Version July 2025
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).
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 (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 (off-label use): IV: 260 mg/m2 once every 3 weeks; continue until disease progression or unacceptable toxicity (Ref).
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 (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 (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: 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).
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.
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).
Dosage adjustment for hepatic impairment at treatment initiation:
Mild hepatic impairment: No dose adjustment is necessary (regardless of indication).
|
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
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).
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.
Refer to adult dosing.
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
Baseline neutrophil count of <1,500/mm3; history of severe hypersensitivity reaction to paclitaxel (protein bound) or any component of the formulation.
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.
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)
Yes
Suspension (reconstituted) (Abraxane Intravenous)
100 mg (per each): $1,896.07
Suspension (reconstituted) (PACLitaxel Protein-Bound Part Intravenous)
100 mg (per each): $1,777.57 - $1,966.76
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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)
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 agent (NIOSH 2024 [table 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 2023; NIOSH 2024; USP-NF 2020).
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]).
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
PACLitaxel (protein bound) may be confused with cabazitaxel, DOCEtaxel, PACLitaxel (conventional)
Abraxane may be confused with Paxil, Taxol, Taxotere
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Substrate of CYP2C8 (Major with inhibitors), CYP2C8 (Minor with inducers), CYP3A4 (Major), OATP1B1/1B3, P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Anthracyclines: Taxane Derivatives may increase adverse/toxic effects of Anthracyclines. Specifically, the risk of cardiotoxicity may be increased with this combination. Taxane Derivatives may increase serum concentration of Anthracyclines. Management: Administer doxorubicin before paclitaxel, administer idarubicin after paclitaxel has been stopped for 5 half lives, consider use of liposomal doxorubicin, epirubicin, or docetaxel instead of doxorubicin/paclitaxel. Monitor for cardiovascular toxicities. Risk D: Consider Therapy Modification
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Atazanavir: May increase 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
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Bexarotene (Systemic): May decrease serum concentration of PACLitaxel (Protein Bound). PACLitaxel (Protein Bound) may increase serum concentration of Bexarotene (Systemic). Risk C: Monitor
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. 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 (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects 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 decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP2C8 Inhibitors (Moderate): May increase serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor
CYP2C8 Inhibitors (Strong): May increase serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor
CYP3A4 Inhibitors (Moderate): May increase serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects 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 decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects 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 increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Gemcitabine: PACLitaxel (Protein Bound) may increase adverse/toxic effects of Gemcitabine. Specifically, the risk for thrombotic microangiopathy may be increased with this combination. Risk C: Monitor
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects 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 increase immunosuppressive effects 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 decrease therapeutic effects 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
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Linzagolix: May increase serum concentration of PACLitaxel (Protein Bound). Risk X: Avoid
Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects 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 serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Palifermin: May increase adverse/toxic effects 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 decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor
Platinum Derivatives: May increase myelosuppressive effects 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 decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of 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 increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects 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 increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects 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 increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects 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 increase adverse/toxic effects 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
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects 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
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Vinorelbine: PACLitaxel (Protein Bound) may increase neurotoxic effects of Vinorelbine. PACLitaxel (Protein Bound) may increase adverse/toxic effects of Vinorelbine. Specifically hematologic toxicity may be increased. Risk C: Monitor
Warfarin: PACLitaxel (Protein Bound) may increase anticoagulant effects of Warfarin. Risk C: Monitor
Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
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.
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).
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.
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.
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.
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.
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.
