Version July 2025
Paclitaxel should be administered under the supervision of a health care provider experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2% to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and histamine H2 antagonists. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.
Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1,500 cells/mm3 or to patients with AIDS-related Kaposi sarcoma if the baseline neutrophil count is less than 1,000 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving paclitaxel.
Dosage guidance:
Safety: Do not substitute for or with other paclitaxel formulations (eg, paclitaxel protein-bound).
Premedication: The manufacturers recommend premedication with dexamethasone (20 mg orally at 12 and 6 hours prior to paclitaxel [reduce dexamethasone dose to 10 mg orally with advanced HIV disease]), diphenhydramine (50 mg IV 30 to 60 minutes prior to paclitaxel), and cimetidine or famotidine (IV 30 to 60 minutes prior to paclitaxel). Alternative premedication regimens have also been described. Refer to citations for further information.
Data from several reports support the use of a single 10 or 20 mg IV dexamethasone dose (in combination with diphenhydramine and an H2 antagonist) to prevent hypersensitivity reactions (HSR) in patients receiving paclitaxel (Ref).
Data from a prospective single-arm study and a retrospective analysis suggest dexamethasone may be omitted from future cycles of paclitaxel chemotherapy if no HSR occurred during the initial cycles; in the studies, patients received standard dexamethasone, diphenhydramine, and an H2 antagonist premedication prior to the first 2 paclitaxel doses, and if no HSR occurred during the first 2 infusions, dexamethasone was omitted from the premedication regimen for the remaining cycles (Ref). In another retrospective study, patients received the standard premedication regimen prior to the first 2 paclitaxel infusions; if no HSR occurred, all premedications were discontinued for future paclitaxel doses (Ref).
Clinical considerations: Refer to the protocol or institutional guidance for additional details of off-label dosing.
B ladder cancer, advanced or metastatic (off-label use):
Paclitaxel/gemcitabine regimens: IV: 150 mg/m2 every 2 weeks (in combination with gemcitabine) for up to 10 to 12 cycles (Ref) or 200 mg/m2 over 1 hour every 3 weeks (in combination with gemcitabine) for 6 cycles (Ref) or 175 mg/m2 over 3 hours once every 3 weeks (in combination with gemcitabine) for a maximum of 6 cycles (Ref).
Paclitaxel/cisplatin/gemcitabine (PCG) regimen: IV: 80 mg/m2 on days 1 and 8 every 3 weeks (in combination with cisplatin and gemcitabine; refer to protocol for administration sequence details) for up to 6 cycles or until disease progression or unacceptable toxicity (Ref).
Single-agent paclitaxel: IV: 80 mg/m2 over 1 hour once weekly until disease progression or unacceptable toxicity (Ref).
Chemoradiation (muscle invasive bladder cancer):
Induction: IV: 50 mg/m2 on days 1, 8, and 15 (in combination with cisplatin and radiation), followed by consolidation chemoradiation (in patients who achieved a complete response) of 50 mg/m2 on days 1 and 8 (in combination with cisplatin and radiation).
Adjuvant chemotherapy (following chemoradiation and surgery): IV: 50 mg/m2 on days 1 and 8 (in combination with gemcitabine and cisplatin) every 3 weeks for 4 cycles (Ref).
Breast cancer, adjuvant treatment: IV: 175 mg/m2 over 3 hours every 3 weeks for 4 cycles (administer sequentially following an anthracycline-containing regimen).
Off-label dosing/combinations (adjuvant and/or neoadjuvant therapy):
Paclitaxel weekly: IV: 80 mg/m2 over 1 hour once weekly for 12 doses (administer sequentially following an anthracycline-containing regimen) (Ref).
AC-T (dose dense): IV: 175 mg/m2 every 2 weeks for 4 cycles (with growth factor support; following 4 cycles of dose-dense doxorubicin and cyclophosphamide [AC]) (Ref).
AC -TH (HER-2 positive): IV: 80 mg/m2 once weekly for 12 weeks or 175 mg/m2 every 3 weeks for 4 cycles (in combination with trastuzumab, following 4 cycles of AC) (Ref) or 175 mg/m2 every 2 weeks for 4 cycles (with growth factor support; in combination with trastuzumab, following 4 cycles of dose-dense AC) (Ref).
AC-THP (neoadjuvant therapy; HER-2 positive): IV: 80 mg/m2 once weekly for 12 weeks (in combination with pertuzumab and trastuzumab; following 4 cycles of dose-dense AC) (Ref).
TH ( HER-2 positive): IV: 80 mg/m2 once weekly for 12 weeks (in combination with trastuzumab) (Ref).
Keynote-522 regimen (early triple-negative breast cancer; neoadjuvant therapy): IV: 80 mg/m2 once weekly (in combination with carboplatin and pembrolizumab [first neoadjuvant therapy]) for 12 weeks, followed by second neoadjuvant therapy of pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab (Ref).
Breast cancer, metastatic or relapsed: IV: 175 mg/m2 over 3 hours every 3 weeks.
Off-label dosing/combinations: IV: 80 mg/m2 once weekly (in combination with trastuzumab and pertuzumab); if progression-free after 6 months, paclitaxel may be discontinued and trastuzumab and pertuzumab continued until disease progression or unacceptable toxicity (Ref) or 90 mg/m2 on days 1, 8, and 15 of a 28-day cycle (in combination with bevacizumab) until disease progression or unacceptable toxicity (Ref) or 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with gemcitabine) until disease progression or unacceptable toxicity (Ref).
Cervical cancer, advanced (off-label use): IV: 135 or 175 mg/m2 every 3 weeks (in combination with bevacizumab and cisplatin) until disease progression or unacceptable toxicity (Ref) or 175 mg/m2 every 3 weeks (in combination with bevacizumab and topotecan) until disease progression or unacceptable toxicity (Ref) or 135 mg/m2 over 24 hours every 3 weeks (in combination with cisplatin) for 6 cycles (Ref) or 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin) until disease progression or unacceptable toxicity or for a maximum of 6 cycles (Ref) or 175 mg/m2 on day 1 every 3 weeks (in combination with pembrolizumab and either cisplatin or carboplatin, ± bevacizumab) for 6 cycles; patients could continue chemotherapy beyond 6 cycles if experiencing clinical benefit without unacceptable toxicity (Ref) or 175 mg/m2 on day 1 every 3 weeks (in combination with atezolizumab, cisplatin or carboplatin, and bevacizumab); continue until disease progression or unacceptable toxicity. Patients with a complete response following ≥6 cycles could discontinue chemotherapy and continue maintenance therapy with atezolizumab and bevacizumab (Ref).
Endometrial cancer, advanced or recurrent (off-label use): IV: 175 mg/m2 over 3 hours (135 mg/m2 in patients with a history of pelvic/spine irradiation) on day 1 every 3 weeks (in combination with carboplatin) for up to 7 cycles (Ref) or 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin and dostarlimab) for 6 cycles, followed by dostarlimab (as a single agent) until disease progression, unacceptable toxicity, or for up to 3 years (Ref) or 175 mg/m2 on day 1 every 3 weeks (in combination with durvalumab and carboplatin) for 6 cycles, followed by durvalumab (as a single agent) every 4 weeks until disease progression or unacceptable toxicity (Ref) or 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with pembrolizumab and carboplatin) for 6 cycles, followed by pembrolizumab (as a single agent) until disease progression, unacceptable toxicity, or (in patients without disease progression) for up to a total of 24 months (Ref) or 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin) for 6 to 9 cycles or until disease progression or unacceptable toxicity (Ref) or 80 mg/m2 over 1 hour on days 1, 8, and 15 every 28 days (in combination with carboplatin) until disease progression or unacceptable toxicity (Ref) or (for HER2-positive uterine serous cancer) 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin and trastuzumab) for ~6 cycles, followed by trastuzumab maintenance therapy (Ref) or 80 mg/m2 over 1 hour on days 1, 8, 15, and 22 every 28 days for at least 2 cycles and until disease progression or unacceptable toxicity (Ref) or 175 mg/m2 over 3 hours on day 1 every 3 weeks for 10 cycles (Ref).
Esophageal cancer, metastatic or unresectable locally advanced (off-label use):
Paclitaxel/platinum/tislelizumab: IV: 175 mg/m2 on day 1 of a 21-day treatment cycle (in combination with cisplatin or oxaliplatin and tislelizumab; may limit platinum to 6 cycles per local guidelines or provider discretion); continue treatment until disease progression or unacceptable toxicity (in patients without disease progression, tislelizumab could be discontinued after 2 years of treatment per provider discretion) (Ref).
Paclitaxel/carboplatin: IV: 200 mg/m2 (cycle 1; escalated to 225 mg/m2 in cycle 2 if acceptable ANC and platelets) over 3 hours on day 1 of a 21-day treatment cycle (in combination with carboplatin); continue until best response (Ref).
Paclitaxel/cisplatin: IV: 90 mg/m2 over 3 hours on day 1 of a 14-day treatment cycle (in combination with cisplatin); continue until disease progression or unacceptable toxicity (Ref).
Single-agent paclitaxel : IV: 80 mg/m2 over 1 hour on days 1, 8, 15, and 22 of a 28-day treatment cycle (as a single agent); continue until disease progression or unacceptable toxicity (Ref).
Esophageal/Esophagogastric cancer, preoperative chemoradiation (off-label use): Paclitaxel/carboplatin/radiation therapy: IV: 50 mg/m2 over 1 hour on days 1, 8, 15, 22, and 29 (in combination with carboplatin and radiation therapy) followed by surgery within 4 to 6 weeks (Ref).
Gastric cancer, metastatic or unresectable locally advanced (off-label use): IV: 80 mg/m2 on days 1, 8, and 15 every 28 days (in combination with ramucirumab) until disease progression or unacceptable toxicity (Ref) or 200 mg/m2 (cycle 1; escalated to 225 mg/m2 in cycle 2 if acceptable ANC and platelets) over 3 hours on day 1 every 3 weeks (in combination with carboplatin); evaluate for response every 2 cycles (Ref) or 80 mg/m2 on days 1, 8, and 15 every 28 days (as a single agent) until disease progression or unacceptable toxicity (Ref).
Gestational trophoblastic neoplasia, high risk, refractory (off-label use): TP/TE regimen: IV: 135 mg/m2 over 3 hours on days 1 and 15 of a 28-day cycle (in combination with cisplatin and etoposide; TP [paclitaxel and cisplatin] alternates every 2 weeks with TE [paclitaxel and etoposide]); continue until hCG level is normal for at least 8 weeks, or until treatment resistance (plateaued or rising hCG) or unacceptable toxicity (Ref).
Head and neck cancers, advanced (off-label use): IV: 175 mg/m2 over 3 hours every 3 weeks (in combination with cisplatin) for at least 6 cycles (Ref) or 80 mg/m2 over 1 hour once weekly for 6 consecutive weeks, or until disease progression or unacceptable toxicity (if disease response or stabilization occurred) (Ref).
Kaposi sarcoma, AIDS related: IV: 135 mg/m2 over 3 hours every 3 weeks or 100 mg/m2 over 3 hours once every 2 weeks (due to dose-related toxicity, the 100 mg/m2 dose should be used for patients with a lower performance status). Note: Reduce the dexamethasone premedication dose to 10 mg.
Melanoma, advanced or metastatic (alternative therapy) (off-label use): IV: 225 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin) for 4 cycles followed by (if dose not previously reduced) 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin) for up to 6 additional cycles (Ref) or 100 mg/m2 on days 1, 8, and 15 every 4 weeks (in combination with carboplatin) until disease progression or unacceptable toxicity (Ref).
Non–small cell lung cancer: IV: 135 mg/m2 over 24 hours every 3 weeks (in combination with cisplatin) or
Off-label dosing/combinations: IV: 200 mg/m2 on day 1 every 3 weeks (in combination with carboplatin or cisplatin and cemiplimab) for 4 cycles followed by cemiplimab (as a single agent) until disease progression or unacceptable toxicity, or for up to 108 weeks (Ref) or 200 mg/m2 on day 1 every 3 weeks (in combination with carboplatin, nivolumab, and ipilimumab) for 2 cycles followed by nivolumab/ipilimumab until disease progression, unacceptable toxicity, or for up to 2 years in patients without disease progression (Ref) or 200 mg/m2 on day 1 every 3 weeks for 4 cycles (in combination with pembrolizumab and carboplatin) followed by pembrolizumab (as a single agent) until disease progression, unacceptable toxicity, or (in patients without disease progression) up to 35 cycles (Ref) or 200 mg/m2 (175 mg/m2 for Asian patients) on day 1 every 3 weeks for 4 to 6 cycles (in combination with atezolizumab, bevacizumab [non-squamous non-small cell lung cancer], and carboplatin) followed by atezolizumab/bevacizumab maintenance therapy until disease progression or unacceptable toxicity (Ref) or 200 mg/m2 on day 1 every 3 weeks for 6 cycles (in combination with carboplatin and bevacizumab) followed by bevacizumab (as a single agent) until disease progression or unacceptable toxicity (Ref) or 200 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin) for at least 3 cycles and until disease progression or unacceptable toxicity (Ref).
Neoadjuvant therapy: IV: 175 or 200 mg/m2 on day 1 every 3 weeks (in combination with carboplatin and nivolumab) for up to 3 cycles (Ref) or 200 mg/m2 on day 1 every 3 weeks (in combination with carboplatin and durvalumab) for 4 cycles, followed by surgery, and then durvalumab (as a single agent) for a maximum of 12 cycles after surgery, or until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity (Ref) or 175 or 200 mg/m2 on day 1 every 3 weeks (in combination with carboplatin and nivolumab) until disease progression, unacceptable toxicity, or for 4 cycles (whichever comes first), followed by surgery, and then nivolumab (as a single agent) for up to 1 year, or until disease progression or unacceptable toxicity (Ref).
Ovarian cancer, advanced:
Previously treated: IV: 135 or 175 mg/m2 over 3 hours every 3 weeks.
Previously untreated: IV: 175 mg/m2 over 3 hours every 3 weeks (in combination with cisplatin) or 135 mg/m2 over 24 hours administered every 3 weeks (in combination with cisplatin).
Previously untreated (off-label route): Intraperitoneal: 60 mg/m2 on day 8 of a 21-day treatment cycle for 6 cycles, in combination with IV paclitaxel (135 mg/m2 over 24 hours on day 1) and intraperitoneal cisplatin (Ref). Note: Administration of intraperitoneal paclitaxel should include the standard paclitaxel premedication regimen.
Previously untreated (off-label combinations): IV: 175 mg/m2 over 3 hours every 3 weeks (in combination with carboplatin) for 6 cycles, or 60 mg/m2 over 1 hour weekly (in combination with carboplatin) for 18 weeks (Ref) or 175 mg/m2 on day 1 every 3 weeks (in combination with bevacizumab [delayed until cycle 2] and carboplatin) for up to 6 cycles, followed by bevacizumab monotherapy for a total of up to 22 cycles or until disease progression (whichever occurs earlier) (Ref) or 80 mg/m2 over 1 hour on days 1, 8, and 15 every 3 weeks (in combination with carboplatin) for 6 cycles (Ref).
Neoadjuvant therapy (off-label combination/schedule): Note: According to guidelines from the Society of Gynecologic Oncology and American Society of Clinical Oncology for neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer, neoadjuvant therapy should be utilized only in properly selected patients. Selection criteria include patients with newly diagnosed suspected stage IIIC or IV ovarian cancer who have a high perioperative risk profile and/or a low likelihood of achieving cytoreduction to <1 cm of residual disease (Ref).
IV: 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin) for 3 neoadjuvant cycles, followed by debulking surgery, followed by 3 additional chemotherapy cycles (Ref) or 175 mg/m2 on day 1 every 3 weeks (in combination with carboplatin) for 3 to 4 neoadjuvant cycles, followed by debulking surgery, followed by 2 to 3 additional chemotherapy cycles, for a total of 6 cycles (Ref) or 175 mg/m2 over 3 hours on day 1 every 3 weeks (in combination with carboplatin) for a total of 6 cycles, with debulking surgery occurring after cycles 3 to 6 (Ref) or 80 mg/m2 over 1 hour on days 1, 8, and 15 every 3 weeks (in combination with carboplatin) for a total of 6 cycles, with debulking surgery occurring after cycles 3 to 6 (Ref).
Penile cancer, metastatic (off-label use): IV: 175 mg/m2 over 3 hours every 3 to 4 weeks (in combination with ifosfamide and cisplatin) for 4 cycles (Ref).
Soft tissue sarcoma, angiosarcoma, advanced or unresectable (off-label use): IV: 80 mg/m2 over 1 hour on days 1, 8, and 15 of a 4-week treatment cycle (as a single agent) for up to 6 cycles (Ref) or 135 to 175 mg/m2 over 3 hours every 3 weeks (as a single agent) (Ref) or 75 to 100 mg/m2 once weekly (as a single agent) (Ref).
Testicular germ cell tumors, relapsed/refractory (off-label use):
GOP regimen : IV: 80 mg/m2 over 1 hour on days 1 and 8 of a 3-week treatment cycle (in combination with gemcitabine and oxaliplatin) for 2 cycles beyond best response and up to a maximum of 8 cycles (Ref).
TIP regimen: IV: 250 mg/m2 over 24 hours on day 1 of a 3-week treatment cycle (in combination with ifosfamide, mesna, and cisplatin) for 4 cycles (Ref).
Alternate TIP regimen: IV: 175 mg/m2 over 3 hours on day 1 of a 3-week treatment cycle (in combination with ifosfamide, mesna, and cisplatin) for 4 cycles (Ref).
Paclitaxel-gemcitabine regimen: IV: 100 mg/m2 over 1 hour on days 1, 8, and 15 of a 4-week treatment cycle (in combination with gemcitabine) for up to 6 cycles (Ref).
Thymoma or thymic carcinoma, localized, potentially resectable (off-label use):
Neoadjuvant chemotherapy:
Note: The number of primary/induction chemotherapy cycles usually administered prior to reassessment to determine resectability varies (eg, 2 to 4 cycles) (Ref).
Carboplatin and paclitaxel regimen: IV: 225 mg/m2 on day 1 every 3 weeks (in combination with carboplatin) (Ref) or 200 mg/m2 on day 1 every 3 weeks (in combination with carboplatin) (Ref).
Thymoma or thymic carcinoma, locally advanced, unresectable (off-label use):
Definitive chemoradiotherapy:
Note: There are no randomized clinical trials to provide specific guidance; dosing is derived from locally advanced non–small cell lung cancer clinical trials.
Carboplatin and paclitaxel regimen: IV: 45 mg/m2 once weekly (in combination with carboplatin and concurrent radiotherapy) for 6 weeks (Ref).
Thymoma or thymic carcinoma, advanced or metastatic (initial therapy) (off-label use):
Carboplatin and paclitaxel regimen: IV: 225 mg/m2 on day 1 every 3 weeks (in combination with carboplatin) for up to 6 cycles (Ref) or 200 mg/m2 on day 1 every 3 weeks (in combination with carboplatin) for up to 6 cycles (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: Kenar D. Jhaveri, MD; Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: IV: No dosage adjustment likely to be necessary for any degree of kidney impairment (Ref).
Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Young patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).
IV: No dosage adjustment necessary (Ref).
Hemodialysis, intermittent (thrice weekly): Not significantly dialyzable (Ref): IV: No dosage adjustment or supplemental dose necessary (Ref).
Peritoneal dialysis: IV: No dosage adjustment necessary (Ref).
CRRT: IV: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): IV: No dosage adjustment necessary (Ref).
Note: Use with extreme caution in patients with hepatic dysfunction (hematologic toxicity may be worsened in patients with total bilirubin >2 times ULN). The manufacturer's labeled dosage adjustment recommendations are based upon the patient's first course of therapy where the usual dose (in patients with normal hepatic function) would be 135 mg/m2 dose over 24 hours or the 175 mg/m2 dose over 3 hours. Dosage in subsequent courses should be based upon individual tolerance. Adjustments for other regimens are not available.
24-hour infusion:
Transaminases <2 times upper limit of normal (ULN) and bilirubin level ≤1.5 mg/dL: 135 mg/m2
Transaminases 2 to <10 times ULN and bilirubin level ≤1.5 mg/dL: 100 mg/m2
Transaminases <10 times ULN and bilirubin level 1.6 to 7.5 mg/dL: 50 mg/m2
Transaminases ≥10 times ULN or bilirubin level >7.5 mg/dL: Avoid use
3-hour infusion:
Transaminases <10 times ULN and bilirubin level ≤1.25 times ULN: 175 mg/m2
Transaminases <10 times ULN and bilirubin level 1.26 to 2 times ULN: 135 mg/m2
Transaminases <10 times ULN and bilirubin level 2.01 to 5 times ULN: 90 mg/m2
Transaminases ≥10 times ULN or bilirubin level >5 times ULN: Avoid use
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).
Note: Refer to protocol and/or study reference for specific dosage adjustment details. Other concomitant anticancer therapies may also require treatment interruption, dosage reduction, and/or discontinuation.
Dosage modification for toxicity (solid tumors, including ovary, breast, and lung carcinoma): Adjustment recommendations are based on the labeled doses (135 mg/m2 dose over 3 hours or 24 hours every 3 weeks or 175 mg/m2 dose over 3 hours every 3 weeks): Courses of paclitaxel should not be repeated until the neutrophil count is ≥1,500/mm3 and the platelet count is ≥100,000/mm3; reduce dosage by 20% for patients experiencing severe peripheral neuropathy or severe neutropenia (neutrophil <500/mm3 for a week or longer).
Dosage modification for immunosuppression in AIDS-related Kaposi sarcoma: Adjustment recommendations are based on the labeled doses (135 mg/m2 over 3 hours every 3 weeks or 100 mg/m2 over 3 hours every 2 weeks): Paclitaxel should not be given to patients with HIV if the baseline or subsequent neutrophil count is <1,000/mm3. Additional modifications include: Reduce dosage of dexamethasone in premedication to 10 mg orally; reduce dosage by 20% in patients experiencing severe peripheral neuropathy or severe neutropenia (neutrophil <500/mm3 for a week or longer); initiate concurrent hematopoietic growth factor (G-CSF) as clinically indicated.
Refer to adult dosing.
Neutropenia is the main dose-limiting hematologic toxicity of paclitaxel. Severe, grade 4 neutropenia and febrile neutropenia have been reported. Less frequently, paclitaxel may cause thrombocytopenia, and anemia but severe cases are rare. Neutrophil nadir is generally rapidly reversible (Ref).
Onset: Intermediate; neutrophil nadir typically occurs at a median of 11 days.
Risk factors:
• Higher doses
• Longer duration of infusion (Ref)
• Extent of prior cytotoxic chemotherapy (Ref)
Immediate, severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred with paclitaxel. All grade hypersensitivity reactions occur in ~10% of premedicated patients. Fatal hypersensitivity reactions have been reported (Ref). Delayed hypersensitivity reactions are less common and include maculopapular rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and acute generalized exanthematous pustulosis (AGEP) (Ref).
Mechanism:
• Immediate hypersensitivity reactions: Non–dose-related, not schedule dependent. While patients may have direct immunologic response to paclitaxel itself, the hypersensitivity reactions are more often associated with the solubilizing agent, polyoxyl 35 castor oil (Cremophor EL, Kolliphor EL) (Ref). These reactions are likely due to complement activation or direct release of mast cell mediators such as histamine and tryptase, although may be IgE or IgG-mediated responses directed against the taxane moiety or Kolliphor EL (Ref).
• Delayed hypersensitivity reactions are T-cell mediated (Ref).
Onset:
• Immediate hypersensitivity reactions: Rapid; often occur within the first 30 minutes of infusion and rarely after the third course of paclitaxel (Ref).
• Delayed hypersensitivity reactions: Varied; may occur 48 hours to 1 week after paclitaxel (Ref). Delayed reactions may predispose patients to severe or fatal immediate hypersensitivity reactions with subsequent doses (Ref).
Risk factors:
• History of hypersensitivity to other drugs formulated in polyoxyl 35 castor oil (Cremophor EL, Kolliphor EL)
• History of hypersensitivity to other formulations of paclitaxel (such as nab-paclitaxel (Ref)
• Younger age (Ref)
• Obesity (BMI >25) (Ref)
Peripheral neuropathy, primarily a distal sensory neuropathy, may occur with paclitaxel. Neuropathy presents as a mixture of paresthesias and dysesthesias, including burning, numbness, tingling, and shooting pains, typically in a stocking-glove distribution (Ref). While severe symptoms are unusual, peripheral neuropathy often leads to subsequent dose reductions in many patients. Most mild to moderate cases resolve several months after discontinuation but may be longer in patients with diabetes. Severe neuropathy may be irreversible in some patients (Ref).
Mechanism: Dose and cumulative dose-related; Taxanes may either be directly toxic to nerve cells and/or aggregation of microtubules in neuronal cells may lead to neuropathies (Ref). The tips of the longest nerves are affected first, contributing to its distribution (Ref).
Onset: Delayed; onset is dose and cumulative dose-dependent (Ref).
Risk factors:
• Dose and cumulative dose
• Older patients (Ref)
• Patients with diabetes (with or without preexisting neuropathy) (Ref)
• Concurrent or sequential treatment with other neuropathy inducing chemotherapies (eg, platinums, vinca, proteosome inhibitors) (Ref)
• Obesity and low physical activity (Ref)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: ECG abnormality (14% to 23%), edema (21%; severe: 1%), hypotension (12%)
Dermatologic: Alopecia (87%)
Gastrointestinal: Diarrhea (38%), nausea and vomiting (52%), stomatitis (17% to 31%; grades 3/4: ≤3%)
Hematologic & oncologic: Anemia (47% to 90%; grades 3/4: 2% to 16%), hemorrhage (14%), leukopenia (90%; grade 4: 17%), neutropenia (78% to 98%; grade 4: 14% to 75%), thrombocytopenia (4% to 20%; grades 3/4: 1% to 7%)
Hepatic: Increased serum alkaline phosphatase (22%), increased serum aspartate aminotransferase (19%)
Hypersensitivity: Hypersensitivity reaction (31% to 45%; severe hypersensitivity reaction: ≤4%)
Infection: Infection (15% to 30%)
Local: Injection-site reaction (13%)
Nervous system: Asthenia (17%), peripheral neuropathy (42% to 70%; grades 3/4: ≤7%)
Neuromuscular & skeletal: Arthralgia (≤60%), myalgia (≤60%)
Miscellaneous: Fever (12%)
1% to 10%:
Cardiovascular: Bradycardia (3%), cardiac arrhythmia (≤1%; including bigeminy, complete atrioventricular block, ventricular tachycardia [asymptomatic]), hypertension (≤1%), syncope (≤1%), venous thrombosis (≤1%)
Dermatologic: Changes in nails (2%)
Hematologic & oncologic: Febrile neutropenia (2%)
Hepatic: Increased serum bilirubin (7%)
Hypersensitivity: Anaphylaxis (≤4%), angioedema (≤4%)
<1%: Nervous system: Ataxia, encephalopathy, tonic-clonic seizure
Frequency not defined:
Gastrointestinal: Peritonitis
Infection: Sepsis
Local: Erythema at injection site, skin discoloration at injection site, swelling at injection site, tenderness at injection site
Respiratory: Pneumonia
Postmarketing:
Cardiovascular: Acute myocardial infarction (Ref), atrial fibrillation (Ref), pulmonary embolism, supraventricular tachycardia (Ref)
Dermatologic: Acute generalized exanthematous pustulosis (Ref), dermatomyositis-like skin changes (Ref), maculopapular rash (Ref), pruritus, skin edema (diffuse), skin sclerosis, Stevens-Johnson syndrome (Ref), thickening of skin, toxic epidermal necrolysis (Ref)
Endocrine & metabolic: Dehydration
Gastrointestinal: Anorexia, constipation, esophagitis, intestinal obstruction, intestinal perforation, ischemic colitis, neutropenic enterocolitis, pancreatitis
Hepatic: Ascites, hepatic encephalopathy, hepatic necrosis
Local: Cellulitis at injection site, fibrosis at injection site, induration at injection site, injection-site phlebitis, local skin exfoliation (injection site), tissue necrosis at injection site
Nervous system: Autonomic neuropathy, confusion, dizziness, headache, malaise, seizure, vertigo
Neuromuscular & skeletal: Exacerbation of scleroderma, subacute cutaneous lupus erythematosus (Ref)
Ophthalmic: Conjunctivitis, increased lacrimation, optic nerve damage, photopsia, visual disturbance (including scintillating scotomata, visual floaters)
Otic: Hearing loss, tinnitus
Renal: Increased serum creatinine
Respiratory: Interstitial pneumonitis, pleural effusion, pulmonary fibrosis, respiratory failure
Miscellaneous: Radiation recall phenomenon
Hypersensitivity to paclitaxel, polyoxyl 35/polyoxyethylated castor oil (Cremophor EL), or any component of the formulation; treatment of solid tumors in patients with baseline neutrophil counts <1,500/mm3; treatment of Kaposi sarcoma in patients with baseline neutrophil counts <1,000/mm3.
Concerns related to adverse effects:
• Cardiovascular effects: Infusion-related hypotension, bradycardia, and/or hypertension may occur. Rare but severe conduction abnormalities have been reported. 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: Paclitaxel is an irritant with vesicant-like properties; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. Injection-site reactions are generally mild (skin discoloration, tenderness, erythema, or swelling) and occur more commonly with an extended infusion duration (eg, 24 hours); injection-site reactions may be delayed (7 to 10 days). More severe reactions (phlebitis, cellulitis, skin exfoliation, necrosis, fibrosis, and induration) have also been reported. Recall skin reactions may occur despite administering through a different IV site.
Special populations:
• Older adult: Across multiple studies, severe neutropenia and severe neuropathy were more common in patients ≥65 years of age (compared to patients <65 years of age). Patients ≥65 years of age also experienced a higher incidence of cardiovascular events (compared to patients <65 years of age) in 2 non-small cell lung cancer studies.
Other warnings/precautions:
• Excipients: Conventional paclitaxel formulations contain polyoxyl 35/polyoxyethylated castor oil (Cremophor EL), which is associated with hypersensitivity reactions. Formulations also contain dehydrated alcohol which may cause adverse CNS effects.
• Intraperitoneal administration: Intraperitoneal administration of paclitaxel is associated with a higher incidence of chemotherapy- related toxicity (Armstrong 2006).
CNS toxicity has been reported in pediatric patients receiving high doses of paclitaxel (350 to 420 mg/m2 as a 3-hour infusion) possibly due to the ethanol contained in the formulation.
Paclitaxel injection contains polyoxyl 35/polyoxyethylated castor oil (Cremophor EL)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Concentrate, Intravenous:
Generic: 100 mg/16.7 mL (16.7 mL); 30 mg/5 mL (5 mL); 150 mg/25 mL (25 mL); 300 mg/50 mL (50 mL)
Concentrate, Intravenous [preservative free]:
Generic: 100 mg/16.7 mL (16.7 mL [DSC]); 30 mg/5 mL (5 mL [DSC]); 300 mg/50 mL (50 mL [DSC])
Yes
Concentrate (PACLitaxel Intravenous)
30 mg/5 mL (per mL): $2.23 - $5.64
100 mg/16.7 mL (per mL): $2.03 - $4.46
150 mg/25 mL (per mL): $3.17
300 mg/50 mL (per mL): $1.44 - $3.56
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Concentrate, Intravenous:
Generic: 6 mg/mL (5 mL, 16.7 mL, 25 mL, 50 mL, 100 mL); 30 mg/5 mL (5 mL)
IV: Infuse over 3 or 24 hours (depending on indication/protocol); some off-label protocols use a 1-hour infusion. Infuse through a 0.22-micron in-line filter and polyethylene-lined (non-PVC) administration set. When administered as a part of a combination chemotherapy regimen, sequence of administration may vary by regimen; refer to specific protocol for sequence recommendation.
Premedication is recommended to prevent hypersensitivity reactions.
Irritant with vesicant-like properties; avoid extravasation. Ensure proper needle or catheter position prior to administration.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; initiate antidote (hyaluronidase) if appropriate; remove needle/cannula; elevate extremity. Information conflicts regarding the use of warm or cold compresses (Ref). Clinical experience suggests hyaluronidase may be used in the management of paclitaxel extravasations (Ref); data is limited.
If using hyaluronidase: If needle/cannula still in place: Administer 1 to 6 mL (150 units/mL) into existing IV line; usual dose is 1 mL for each 1 mL of extravasated drug; if needle/cannula has been removed, inject subcutaneously in a clockwise manner around area of extravasation; may repeat several times over the next 3 to 4 hours (Ref).
Intraperitoneal (off-label route): Solution was prepared in warmed saline and infused as rapidly as possible through an implantable intraperitoneal catheter (Ref).
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: Adjuvant treatment of node-positive breast cancer (as sequential therapy following anthracycline-containing combination chemotherapy); treatment of metastatic 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 contraindicated).
Kaposi sarcoma, AIDS-related: Second-line treatment of AIDS-related Kaposi sarcoma.
Non-small cell lung cancer: First-line treatment of non-small cell lung cancer (in combination with cisplatin) in patients who are not candidates for potentially curative surgery and/or radiation therapy.
Ovarian cancer, advanced: Subsequent therapy for treatment of advanced ovarian cancer; first-line therapy of ovarian cancer (in combination with cisplatin).
Anal cancer, advanced; Bladder cancer, advanced or metastatic; Cervical cancer, advanced; Endometrial cancer, advanced or recurrent; Esophageal cancer, metastatic or unresectable locally advanced; Esophageal/esophagogastric cancer, preoperative chemoradiation; Gastric cancer, metastatic or unresectable locally advanced; Gestational trophoblastic neoplasia, high-risk, refractory; Head and neck cancers, advanced; Melanoma, advanced or metastatic; Penile cancer, metastatic; Small cell lung cancer, relapsed/refractory; Soft tissue sarcoma, angiosarcoma, advanced or unresectable; Testicular germ cell tumors, relapsed/refractory; Thymoma or thymic carcinoma; Thyroid cancer, anaplastic; Unknown primary adenocarcinoma
PACLitaxel may be confused with cabazitaxel, DOCEtaxel, PARoxetine, Paxil
PACLitaxel (conventional) may be confused with PACLitaxel (protein-bound)
Taxol may be confused with Abraxane, Paxil, 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
Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification
Amisulpride (Oral): May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
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
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor
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
Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Atazanavir: May increase serum concentration of PACLitaxel (Conventional). 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
Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
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
Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Bexarotene (Systemic): PACLitaxel (Conventional) may increase serum concentration of Bexarotene (Systemic). Bexarotene (Systemic) may decrease serum concentration of PACLitaxel (Conventional). Risk C: Monitor
Blood Pressure Lowering Agents: May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. 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
Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. 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 (Conventional). Risk C: Monitor
CYP2C8 Inhibitors (Strong): May increase serum concentration of PACLitaxel (Conventional). Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of PACLitaxel (Conventional). Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of PACLitaxel (Conventional). Risk C: Monitor
CYP3A4 Inhibitors (Moderate): May increase serum concentration of PACLitaxel (Conventional). Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of PACLitaxel (Conventional). 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
Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor
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
Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. 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
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Linzagolix: May increase serum concentration of PACLitaxel (Conventional). 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
Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
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
Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor
Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. 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
Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor
Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification
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
Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor
Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
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
Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Quinagolide: May increase hypotensive effects of Blood Pressure Lowering 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
Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
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 (Conventional). 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 (Conventional) may increase neurotoxic effects of Vinorelbine. PACLitaxel (Conventional) may increase adverse/toxic effects of Vinorelbine. Specifically hematologic toxicity may be increased. Risk C: Monitor
Warfarin: PACLitaxel (Conventional) 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 should be advised to avoid becoming pregnant.
Paclitaxel crosses the placenta (Berveiller 2012; Berveiller 2019). In one case, paclitaxel was detected in cord blood 7 days after the last maternal dose. Paclitaxel was not detected in cord blood when delivery occurred 21 days after the last maternal dose in a second case (Berveiller 2019).
Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of paclitaxel may be altered during pregnancy (Van Calsteren 2010; van Hasselt 2014).
Use of paclitaxel may be appropriate for the treatment of breast cancer and some gynecologic cancers during pregnancy (Amant 2019; Korenaga 2020; Loibl 2015; Shachar 2017). The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy; the guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team). In general, if chemotherapy is indicated, it should be avoided in the first trimester and there should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation. Close monitoring is recommended (ESMO [Peccatori 2013]).
A long-term observational research study is collecting information about the diagnosis and treatment of cancer during pregnancy. For additional information about the pregnancy and cancer registry or to become a participant, contact Cooper Health (1-877-635-4499).
Paclitaxel is present in breast milk.
Information is available from a mother (3 months' postpartum) 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 (RID) 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 (0.08 mg/L) when sampled at 316 hours after the infusion (Griffin 2012). In a second case report, breast milk was sampled over 15 days following the ninth weekly dose of paclitaxel 80 mg/m2 for the treatment of breast cancer, first diagnosed during pregnancy. Peak breast milk concentrations (0.1114 mg/L) occurred 2.75 hours after the maternal dose and were below the limit of quantification (<0.0025 mg/L) at 71.25 hours. Authors of this study calculated the RID of paclitaxel 72 hours after the maternal dose to be <1%, based on actual maternal weight (Jackson 2019).
Due to the potential for serious adverse reactions in a breastfeeding infant, breastfeeding is not recommended by the manufacturer. Avoidance of breastfeeding for 6 to 10 days after the last paclitaxel dose, based on the serum half-life, has been suggested (ABM [Johnson 2020]).
CBC with differential and platelet count (frequently), liver and kidney function. Monitor for hypersensitivity reactions, vital signs (frequently during the first hour of infusion), continuous cardiac monitoring (patients with conduction abnormalities). Monitor for signs/symptoms of peripheral neuropathy. Monitor infusion site during infusion.
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 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. In addition, the drug can distort mitotic spindles, resulting in the breakage of chromosomes. Paclitaxel may also suppress cell proliferation and modulate immune response.
Vdss: 24-hour infusion: 227 to 688 L/m2; biphasic with initial rapid distribution to the peripheral compartment; later phase is a slow efflux of paclitaxel from the peripheral compartment; widely distributed into body fluids and tissues; affected by dose and duration of infusion
Protein binding: 89% to 98%
Metabolism: Hepatic via CYP2C8 and 3A4; forms metabolites (primarily 6α-hydroxypaclitaxel)
Half-life elimination:
Children: 4.6 to 17 hours (varies with dose and infusion duration)
Adults:
3-hour infusion: Mean (terminal): ~13 to 20 hours
24-hour infusion: Mean (terminal): ~16 to 53 hours
Excretion: Feces (~71%; ~5% as unchanged drug); urine (~14%)
Hepatic function impairment: Plasma paclitaxel exposure is increased.
