Do not administer paclitaxel (protein bound) to patients who have 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 (Shroff 2019).
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 (Sahai 2018).
Bladder cancer, metastatic, platinum-resistant (off-label use): IV: 260 mg/m2 once every 3 weeks; continue until disease progression or unacceptable toxicity (Ko 2013).
Breast cancer, metastatic: IV: 260 mg/m2 every 3 weeks (Gradishar 2005).
Weekly dosing (off-label dose): IV: 100 to 150 mg/m2 on days 1, 8, and 15 of a 28-day cycle (Gradishar 2009).
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 (Yardley 2018).
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 (Alberts 2012).
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 (Hersh 2010).
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 (Hersh 2010).
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) (Socinski 2012).
Off-label combinations: 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 (Paz-Ares 2018) or 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 (West 2019).
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 (Teneriello 2009) or 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity (Coleman 2011).
Pancreatic adenocarcinoma, metastatic: IV: 125 mg/m2 on days 1, 8, and 15 of a 28-day cycle (in combination with gemcitabine) (Von Hoff 2013).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (insufficient data).
End-stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (insufficient data).
Dosage adjustment for hepatic impairment at treatment initiation:
No dose adjustment is necessary for patients with mild hepatic function impairment (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/m2d |
80 mg/m2e |
Not recommended |
Severe |
≤10 × ULN |
and |
>3 to ≤5 × ULN |
200 mg/m2d |
80 mg/m2e |
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
Refer to adult dosing.
American Society of Clinical Oncology guidelines for appropriate chemotherapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; 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 with subsequent cycles if cause of toxicity (eg, hepatic or renal impairment) is clearly established and fully resolved, and performance status has markedly improved (ASCO [Griggs 2021]).
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Intravenous:
Abraxane: 100 mg (1 ea)
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Intravenous:
Abraxane: 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 (Gradishar 2009; Hersh 2010; Rizvi 2008). 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 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).
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
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.
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:
• Elderly: 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.
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
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
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
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
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: In the US, after receipt of the single dose COVID-19 adenovirus vector vaccine (Janssen), administer an additional 2nd dose using an mRNA COVID-19 vaccine, at least 28 days after the primary vaccine dose, in patients taking immunosuppressive therapies. 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: Consider administration of a 3rd dose of COVID-19 vaccine, at least 28 days after completion of the primary 2-dose series, in patients 5 years of age and older taking immunosuppressive therapies. 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
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
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
Echinacea: May diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider avoiding echinacea in patients receiving therapeutic immunosuppressants, such cytotoxic chemotherapy. If combined, monitor for reduced efficacy of cytotoxic chemotherapy. Risk D: Consider therapy modification
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
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
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
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
Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
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
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
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 post-exposure rabies vaccination is required during immunosuppressant therapy, administer a 5th dose of vaccine and check for rabies antibodies. Risk D: Consider therapy modification
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
Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of 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 Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
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
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated). 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 neurotoxic effect of Vinorelbine. 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
Paclitaxel (protein bound) serum concentrations may be increased when taken with grapefruit or grapefruit juice. Management: Monitor for increased effects/toxicity with concomitant use.
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.
Suspension (reconstituted) (Abraxane Intravenous)
100 mg (per each): $1,896.07
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