Version July 2025
Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, patients receiving higher doses, and patients with non-small cell lung cancer and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m2.
Avoid the use of docetaxel in patients with bilirubin > ULN, or in patients with AST and/or ALT >1.5 times the ULN concomitant with alkaline phosphatase >2.5 times the ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 times the ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel therapy.
Do not administer docetaxel to patients with neutrophil counts <1,500 cells/mm3. Monitor blood counts frequently as neutropenia may be severe and result in infection.
Do not administer docetaxel to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80 (excluding products that do not contain polysorbate 80). Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel infusion and administration of appropriate therapy.
Severe fluid retention occurred in 6.5% (6/92) of patients despite the use of dexamethasone premedication. It was characterized by 1 or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).
Dosage guidance:
Safety: Neutrophils should recover to >1,500/mm3 and platelets should recover to >100,000/mm3 prior to treatment with subsequent cycles. To reduce the potential risk and severity of tumor lysis syndrome, correct high uric acid serum levels and dehydration prior to docetaxel initiation.
Premedication: To reduce the incidence and severity of fluid retention and hypersensitivity reactions, the manufacturer recommends premedication for 3 days beginning 1 day prior to docetaxel administration with oral corticosteroids (eg, dexamethasone 8 mg orally twice daily for 3 days beginning 1 day prior to docetaxel). When prednisone is a backbone component of the antineoplastic regimen in the treatment of prostate cancer, administer dexamethasone 8 mg orally at 12 hours, 3 hours, and 1 hour prior to docetaxel. Data from 2 retrospective reviews describe the use a single dose of dexamethasone 10 or 20 mg IV prior to docetaxel (on the day of docetaxel infusion) to prevent hypersensitivity reactions (Ref).
Clinical considerations: Refer to the protocol or institutional guidance for additional details of off-label dosing.
Anal carcinoma, squamous cell, advanced (off-label use): Modified DCF regimen: IV: 40 mg/m2 every 2 weeks (in combination with cisplatin, fluorouracil, and filgrastim) until disease progression or unacceptable toxicity up to a maximum of 8 cycles (Ref).
Bladder cancer, advanced or metastatic (off-label use): IV: 100 mg/m2 every 3 weeks (as a single agent) until disease progression or unacceptable toxicity (Ref) or 35 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with gemcitabine and cisplatin) for at least 6 cycles or until disease progression or unacceptable toxicity (Ref).
Bladder cancer, non–muscle invasive, refractory (off-label use):
Single-agent docetaxel: Intravesicular instillation: 75 mg per 100 mL NS; retain for 2 hours once weekly for 6 weeks during induction, followed 3 months later by (if complete response to induction) 75 mg per 100 mL NS once a month for up to 9 maintenance treatments (Ref).
Docetaxel/gemcitabine: Intravesicular instillation: 37.5 mg per 50 mL NS; retain for 1 to 2 hours once weekly (gemcitabine is administered and dwelled for 1 to 1.5 hours, followed by docetaxel) for 6 weeks during induction, followed by (if recurrence free) once-monthly maintenance treatments for up to 24 months (Ref).
Breast cancer:
Locally advanced or metastatic: IV: 60 to 100 mg/m2 every 3 weeks (as a single agent) until disease progression or unacceptable toxicity for at least 6 cycles (Ref) or 100 mg/m2 every 3 weeks (as a single agent) for a maximum of 7 or 10 cycles (Ref).
Operable, node-positive (adjuvant treatment): IV: TAC regimen: 75 mg/m2 every 3 weeks for 6 courses (in combination with doxorubicin and cyclophosphamide) (Ref).
Adjuvant treatment (off-label dosing): IV: 75 mg/m2 every 21 days (in combination with cyclophosphamide) for 4 cycles (Ref) or 75 mg/m2 every 21 days (in combination with carboplatin and trastuzumab) for 6 cycles (Ref) or 75 mg/m2 every 21 days (in combination with cyclophosphamide and trastuzumab) for 4 cycles (Ref).
Neoadjuvant treatment (off-label dosing): IV: 75 mg/m2 (cycle 1; if tolerated, may increase to 100 mg/m2 in subsequent cycles) every 21 days for a total of 4 cycles (in combination with trastuzumab and pertuzumab) (Ref) or 75 mg/m2 every 21 days for 6 cycles (in combination with carboplatin and WBC growth factor support) (Ref) or 75 mg/m2 every 21 days for 6 cycles (in combination with carboplatin, trastuzumab, and pertuzumab) (Ref) or 75 mg/m2 initially (if tolerated, may increase to 100 mg/m2 in subsequent cycles) every 21 days for 3 cycles (following 3 cycles of fluorouracil, epirubicin, and cyclophosphamide and in combination with trastuzumab and pertuzumab) (Ref).
Metastatic treatment (off-label dosing):
Every-3-week administration: IV: 75 mg/m2 (cycle 1; may increase to 100 mg/m2 in subsequent cycles) every 21 days for at least 6 cycles (in combination with trastuzumab and pertuzumab) (Ref) or 100 mg/m2 every 21 days (in combination with trastuzumab) for at least 6 cycles (Ref) or 75 mg/m2 every 21 days (in combination with capecitabine) until disease progression or unacceptable toxicity (Ref) or 60 mg/m2, 75 mg/m2, or 100 mg/m2 every 21 days for at least 6 cycles until disease progression, unacceptable toxicity, or discontinuation (Ref).
Weekly administration: IV: 40 mg/m2 once a week (as a single agent) for 6 weeks followed by a 2-week rest, repeat until disease progression or unacceptable toxicity (Ref) or 35 mg/m2 once weekly for 3 weeks, followed by a 1-week rest, may increase to 40 mg/m2 once weekly for 3 weeks followed by a 1-week rest with cycle 2 (Ref) or 35 mg/m2 once weekly (in combination with trastuzumab) for 3 weeks followed by a 1-week rest; repeat until disease progression or unacceptable toxicity (Ref).
Esophageal cancer (off-label use):
Sequential chemotherapy and chemoradiation: IV: Induction: 75 mg/m2 on days 1 and 22 (in combination with cisplatin) for 2 cycles, followed by chemoradiation: 20 mg/m2 weekly for 5 weeks (in combination with cisplatin and radiation) (Ref).
Definitive chemoradiation: IV: 60 mg/m2 on days 1 and 22 (in combination with cisplatin and radiation) for 1 cycle (Ref).
Locally advanced, resectable gastroesophageal junction adenocarcinoma: IV: 50 mg/m2 on day 1 every 2 weeks (in combination with fluorouracil, leucovorin, and oxaliplatin; FLOT regimen) for 4 preoperative and 4 postoperative cycles (Ref).
Locally advanced or metastatic disease: IV: 75 mg/m2 on day 1 every 3 weeks (in combination with cisplatin and fluorouracil) (Ref) or 40 mg/m2 on day 1 every 2 weeks (in combination with fluorouracil, leucovorin, and cisplatin) until disease progression or unacceptable toxicity (Ref) or 50 mg/m2 on day 1 every 2 weeks (in combination with fluorouracil, leucovorin, and oxaliplatin) until disease progression or unacceptable toxicity up to a maximum of 8 cycles (Ref) or 35 mg/m2 on days 1, 8, 15, 29, 36, 43, 50, and 57 (in combination with cisplatin, fluorouracil, and radiotherapy; neoadjuvant setting) (Ref).
Ewing sarcoma, recurrent or refractory (off-label use; based on limited data): IV: 75 to 100 mg/m2 on day 8 of a 21-day cycle (in combination with gemcitabine) (Ref).
Gastric adenocarcinoma : IV: 75 mg/m2 every 3 weeks (in combination with cisplatin and fluorouracil) until disease progression or unacceptable toxicity (Ref).
Sequential chemotherapy and chemoradiation (off-label dosing): Induction: IV: 75 mg/m2 on days 1 and 22 (in combination with cisplatin) for 2 cycles, followed by chemoradiation: 20 mg/m2 weekly for 5 weeks (in combination with cisplatin and radiation) (Ref).
Locally advanced resectable disease (off-label dosing): IV: 50 mg/m2 on day 1 every 2 weeks (in combination with fluorouracil, leucovorin, and oxaliplatin; FLOT regimen) for 4 preoperative and 4 postoperative cycles (Ref).
Locally advanced or metastatic disease (off-label dosing): IV: 40 mg/m2 on day 1 every 2 weeks (in combination with fluorouracil, leucovorin, and cisplatin) until disease progression or unacceptable toxicity (Ref) or 50 mg/m2 on day 1 every 2 weeks (in combination with fluorouracil, leucovorin, and oxaliplatin) until disease progression or unacceptable toxicity up to a maximum of 8 cycles (Ref).
Head and neck cancer: IV: 75 mg/m2 every 3 weeks (in combination with cisplatin and fluorouracil) for 3 or 4 cycles, followed by radiation therapy (Ref).
Nasopharyngeal carcinoma, locally advanced:
Induction chemotherapy: IV: 60 mg/m2 every 3 weeks (in combination with cisplatin and fluorouracil) for 3 cycles, followed by concurrent chemoradiotherapy (Ref) or 75 mg/m2 every 3 weeks (in combination with cisplatin) for 2 cycles, followed by chemoradiotherapy (Ref). A minimum of 2 induction cycles are recommended (Ref).
Non–small cell lung cancer: IV: 75 mg/m2 every 3 weeks (as a single agent) for at least 6 cycles or until disease progression or unacceptable toxicity (Ref) or (in combination with cisplatin) for at least 6 cycles or until disease progression or unacceptable toxicity (Ref).
Neoadjuvant therapy (off label): IV: 75 mg/m2 on day 1 every 3 weeks (in combination with nivolumab and cisplatin [squamous histology]) 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).
Advanced or metastatic disease (off-label dosing/combinations): IV: 75 mg/m2 every 3 weeks (in combination with carboplatin) for at least 6 cycles or until disease progression or unacceptable toxicity (Ref) or 85 mg/m2 on day 8 of a 3-week treatment cycle (in combination with gemcitabine) for 8 cycles or until disease progression or unacceptable toxicity (Ref) or 75 mg/m2 every 3 weeks (in combination with ramucirumab) until disease progression or unacceptable toxicity (Ref).
Osteosarcoma, recurrent or refractory (off-label use): IV: 75 to 100 mg/m2 on day 8 of a 21-day cycle (in combination with gemcitabine) until disease progression or unacceptable toxicity (Ref).
Ovarian cancer (off-label use): IV: 60 mg/m2 every 3 weeks (in combination with carboplatin) for up to 6 cycles (Ref) or 75 mg/m2 every 3 weeks (in combination with carboplatin) for 6 cycles (Ref) or 35 mg/m2 (maximum dose: 70 mg) weekly for 3 weeks followed by a 1-week rest (in combination with carboplatin) (Ref).
Prostate cancer, metastatic, castration resistant: IV: 75 mg/m2 every 3 weeks (in combination with prednisone) (Ref).
Docetaxel/carboplatin (off-label combination): IV: 75 mg/m2 every 3 weeks (in combination with carboplatin) for at least 4 cycles or until disease progression or unacceptable toxicity (Ref).
Prostate cancer , metastatic , hormone sensitive (off-label use): IV: 75 mg/m2 on day 1 every 3 weeks (in combination with androgen-deprivation therapy and prednisolone) for 6 cycles (Ref) or 75 mg/m2 on day 1 every 3 weeks (in combination with androgen-deprivation therapy; daily prednisone not required) for 6 cycles (Ref) or 75 mg/m2 on day 1 every 3 weeks (in combination with darolutamide and androgen-deprivation therapy) for 6 cycles; darolutamide was continued after the 6 docetaxel cycles (Ref) or 75 mg/m2 (maximum dose: 150 mg) on day 1 every 3 weeks (in combination with abiraterone, prednisone, and androgen-deprivation therapy) for 6 cycles; abiraterone and prednisone were continued after the 6 docetaxel cycles (Ref).
Small cell lung cancer, relapsed (off-label use): IV: 100 mg/m2 every 3 weeks (Ref).
Soft tissue sarcoma, recurrent or progressive (off-label use): IV: 100 mg/m2 on day 8 of a 3-week treatment cycle (in combination with gemcitabine and filgrastim or pegfilgrastim) (Ref).
Thyroid carcinoma, anaplastic (off-label use):
Radiosensitizing therapy: IV: 20 mg/m2 once weekly during radiation therapy (either as a single agent or in combination with doxorubicin) (Ref).
Advanced or metastatic disease: IV: 60 mg/m2 on day 1 every 3 weeks (as a single agent) until disease progression or unacceptable toxicity (Ref).
Unknown primary, adenocarcinoma (off-label use): IV: 65 mg/m2 every 3 weeks (in combination with carboplatin) (Ref) or 75 mg/m2 on day 8 of a 3-week treatment cycle (in combination with gemcitabine) for up to 6 cycles (Ref) or 60 mg/m2 on day 1 of a 3-week treatment cycle (in combination with cisplatin) (Ref).
Uterine leiomyosarcoma, advanced or high grade (off-label use):
Unresectable leiomyosarcoma: IV: 100 mg/m2 (75 mg/m2 if received prior radiation therapy) on day 8 of a 3-week treatment cycle (in combination with gemcitabine and filgrastim) for 6 cycles (Ref).
High-grade leiomyosarcoma, previously untreated: IV: 75 mg/m2 on day 8 of a 3-week treatment cycle (in combination with gemcitabine and filgrastim or pegfilgrastim) for 4 cycles (Ref) or 75 mg/m2 on day 8 of a 3-week treatment cycle (in combination with gemcitabine) for up to 6 cycles in the absence of disease progression or unacceptable toxicity (Ref).
Metastatic leiomyosarcoma: IV: 75 mg/m2 (60 mg/m2 if received prior radiation therapy) on day 8 of a 3-week treatment cycle (in combination with gemcitabine and filgrastim or pegfilgrastim) until disease progression or unacceptable toxicity (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (~6% eliminated in urine) (Ref).
Hemodialysis, intermittent (thrice weekly): Not significantly dialyzed (Ref): No supplemental dose or dosage adjustment necessary (Ref).
Peritoneal dialysis: Unlikely to be significantly dialyzed (highly protein bound): No dosage adjustment necessary (Ref).
CRRT: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).
Note: The alcohol content of the docetaxel formulation should be taken into account when administering to patients with hepatic impairment.
Total bilirubin > ULN: Avoid docetaxel use.
AST and/or ALT >1.5 × ULN combined with alkaline phosphatase >2.5 × ULN: Avoid docetaxel use.
Isolated transaminase elevations >1.5 × ULN: Consider docetaxel dose modification.
Hepatic impairment dosing adjustment specific for gastric or head and neck cancer:
AST/ALT >2.5 to ≤5 × ULN and alkaline phosphatase ≤2.5 × ULN: Administer 80% of dose.
AST/ALT >1.5 to ≤5 × ULN and alkaline phosphatase >2.5 to ≤5 × ULN: Administer 80% of dose.
AST/ALT >5 × ULN and /or alkaline phosphatase >5 × ULN: Discontinue docetaxel.
The following adjustments have also been used:
Transaminases 1.6 to 6 × ULN: Administer 75% of dose (Ref).
Transaminases >6 × ULN: Use clinical judgment (Ref).
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: Other concomitant anticancer therapies may also require treatment interruption, dosage reduction, and/or discontinuation. Refer to specific reference/protocol for dosage adjustments for off-label uses, doses, or combinations.
General recommendations (apply to all indications):
Dermatologic toxicity: Consider permanent docetaxel discontinuation in patients who develop severe cutaneous adverse reactions.
Hypersensitivity: Interruption of therapy is not required for minor hypersensitivity reaction (eg, flushing or localized skin reaction). Immediately discontinue docetaxel for severe hypersensitivity reaction (and administer appropriate medical management). Do not rechallenge if severe hypersensitivity occurred.
Neurosensory symptoms (eg, paresthesia, dysesthesia, pain): Adjust docetaxel dose for severe neurosensory symptoms; discontinue docetaxel for persistent symptoms.
Ocular disorders: Discontinue docetaxel if cystoid macular edema is diagnosed (consider alternate non-taxane therapies). A prompt comprehensive ophthalmic exam is recommended if vision impairment occurs.
Peripheral edema: Manage with standard measures (eg, salt restriction, oral diuresis).
Breast cancer (single agent):
|
Adverse reaction |
Severity |
Docetaxel dosage modification |
|---|---|---|
|
a Patients initiated docetaxel at 60 mg/m2 who do not develop toxicity may tolerate higher doses. | ||
|
Hematologic toxicity | ||
|
Neutropeniaa |
ANC <500/mm3 for >7 days or febrile neutropenia |
Starting dose (100 mg/m2): First occurrence: Reduce docetaxel dose to 75 mg/m2. Subsequent or persistent occurrences: Reduce docetaxel dose to 55 mg/m2 or discontinue. |
|
Nonhematologic toxicity | ||
|
Cutaneous reactionsa |
Severe or cumulative |
Starting dose (100 mg/m2): First occurrence: Reduce docetaxel dose to 75 mg/m2. Subsequent occurrences: Reduce docetaxel dose to 55 mg/m2 or discontinue. |
|
Peripheral neuropathya |
Grade ≥3 |
Discontinue docetaxel. |
Breast cancer, adjuvant treatment (combination therapy with doxorubicin and cyclophosphamide):
|
Adverse reaction |
Severity |
Docetaxel dosage modification |
|---|---|---|
|
Hematologic toxicity | ||
|
Docetaxel (in combination with doxorubicin and cyclophosphamide; TAC regimen) should be administered when neutrophils are ≥1,500/mm3. | ||
|
Neutropenia |
Febrile neutropenia |
Starting dose (75 mg/m2): Administer G-CSF in all subsequent cycles. Persistent febrile neutropenia (while on G-CSF): Reduce docetaxel dose to 60 mg/m2; continue G-CSF. If adverse effect continues at reduced dose, discontinue docetaxel. |
|
Nonhematologic toxicity | ||
|
Cutaneous reactions |
Severe or cumulative |
Starting dose (75 mg/m2): Reduce docetaxel dose to 60 mg/m2. If adverse effect continues at reduced dose, discontinue docetaxel. |
|
Neurosensory effects |
Moderate signs/symptoms |
Starting dose (75 mg/m2): Reduce docetaxel dose to 60 mg/m2. If adverse effect continues at reduced dose, discontinue docetaxel. |
|
Stomatitis |
Grade 3 or 4 |
Starting dose (75 mg/m2): Reduce docetaxel dose to 60 mg/m2. If adverse effect continues at reduced dose, discontinue docetaxel. |
Non–small cell lung cancer (single agent):
|
Adverse reaction |
Severity |
Docetaxel dosage modification |
|---|---|---|
|
Hematologic toxicity | ||
|
Neutropenia |
ANC <500/mm3 for >7 days or febrile neutropenia |
Starting dose (75 mg/m2): Withhold docetaxel until resolution of toxicity; resume docetaxel at reduced dose of 55 mg/m2. |
|
Nonhematologic toxicity | ||
|
Cutaneous reactions |
Severe or cumulative |
Starting dose (75 mg/m2): Withhold docetaxel until resolution of toxicity; resume docetaxel at reduced dose of 55 mg/m2. |
|
Peripheral neuropathy |
Grade ≥3 |
Discontinue docetaxel. |
|
Other nonhematologic adverse reactions |
Grade 3 or 4 |
Starting dose (75 mg/m2): Withhold docetaxel until resolution of toxicity; resume docetaxel at reduced dose of 55 mg/m2. |
Non–small cell lung cancer (combination therapy with cisplatin):
|
Adverse reaction |
Severity |
Docetaxel dosage modification |
|---|---|---|
|
Hematologic toxicity | ||
|
Neutropenia |
Febrile neutropenia |
Starting dose (75 mg/m2): First occurrence: Reduce docetaxel dose to 65 mg/m2. Subsequent occurrences: Reduce docetaxel dose to 50 mg/m2. |
|
Thrombocytopenia |
Nadir platelet count <25,000/mm3 |
Starting dose (75 mg/m2): First occurrence: Reduce docetaxel dose to 65 mg/m2. Subsequent occurrences: Reduce docetaxel dose to 50 mg/m2. |
|
Nonhematologic toxicity | ||
|
Other nonhematologic adverse reactions |
Serious |
Starting dose (75 mg/m2): First occurrence: Reduce docetaxel dose to 65 mg/m2. Subsequent occurrences: Reduce docetaxel dose to 50 mg/m2. |
Prostate cancer (combination therapy with prednisone):
|
Adverse reaction |
Severity |
Docetaxel dosage modification |
|---|---|---|
|
Hematologic toxicity | ||
|
Docetaxel (in combination with prednisone) should be administered when neutrophils are ≥1,500/mm3. | ||
|
Neutropenia |
ANC <500/mm3 for >7 days or febrile neutropenia |
Starting dose (75 mg/m2): Reduce docetaxel dose to 60 mg/m2; continue G-CSF. If adverse effect continues at reduced dose, discontinue docetaxel. |
|
Nonhematologic toxicity | ||
|
Cutaneous reactions |
Severe or cumulative |
Starting dose (75 mg/m2): Reduce docetaxel dose to 60 mg/m2. If adverse effect continues at reduced dose, discontinue docetaxel. |
|
Neurosensory effects |
Moderate signs/symptoms |
Starting dose (75 mg/m2): Reduce docetaxel dose to 60 mg/m2. If adverse effect continues at reduced dose, discontinue docetaxel. |
Gastric cancer, head and neck cancer (combination therapy with cisplatin and fluorouracil):
|
Adverse reaction |
Severity |
Docetaxel dosage modification |
|---|---|---|
|
Hematologic toxicity | ||
|
Subsequent cycles of docetaxel (in combination with cisplatin and fluorouracil) should be administered when neutrophils are >1,500/mm3 and platelets >100,000/mm3. | ||
|
Neutropenia |
ANC <500/mm3 for >7 days, febrile neutropenia, documented infection with neutropenia |
Starting dose (75 mg/m2): First occurrence: Administer G-CSF in all subsequent cycles. Second occurrence (while on G-CSF): Reduce docetaxel dose to 60 mg/m2. Subsequent occurrences (while on G-CSF): Reduce docetaxel dose to 45 mg/m2. Discontinue docetaxel if toxicity persists. |
|
Thrombocytopenia |
Grade 4 |
Starting dose (75 mg/m2): Reduce docetaxel dose to 60 mg/m2. Discontinue docetaxel if toxicity persists. |
|
Nonhematologic toxicity | ||
|
Diarrhea |
Grade 3 |
First episode: Reduce fluorouracil dose by 20%. Second episode: Reduce docetaxel dose by 20%. |
|
Grade 4 |
First episode: Reduce docetaxel and fluorouracil doses by 20%. Second episode: Discontinue treatment. | |
|
Stomatitis/Mucositis |
Grade 3 |
First episode: Reduce fluorouracil dose by 20%. Second episode: Discontinue fluorouracil only for all subsequent cycles. Third episode: Reduce docetaxel dose by 20%. |
|
Grade 4 |
First episode: Discontinue fluorouracil only for all subsequent cycles. Second episode: Reduce docetaxel dose by 20%. | |
Refer to adult dosing.
(For additional information see "Docetaxel: Pediatric drug information")
Note: Dose, frequency, number of doses, and start date may vary by protocol and treatment phase. Refer to individual protocols: Premedicate with corticosteroids, beginning the day before docetaxel administration (administer corticosteroids for 1 to 3 days), to reduce the severity of hypersensitivity reactions and pulmonary/peripheral edema. For adults, the manufacturer recommends dexamethasone 16 mg (8 mg twice daily) orally for 3 days. In one pediatric clinical trial, dexamethasone 3 mg/m2 orally or IV every 6 hours for 2 doses, starting 12 hours before docetaxel administration has been described (Ref).
Sarcomas, Ewing Sarcoma; osteosarcoma (recurrent or progressive): Limited data available:
Mora 2009: G + D regimen: Children and Adolescents: IV: 100 mg/m2 over 2 to 4 hours on Day 8 of a 21-day cycle in combination with gemcitabine.
Rapkin 2012: GEMDOX regimen:
Infants: IV: 2.5 mg/kg over 1 hour on Day 8 of a 21-day cycle in combination with gemcitabine.
Children and Adolescents: IV: 75 mg/m2 over 1 hour on Day 8 of a 21-day cycle in combination with gemcitabine.
Hepatoblastoma (refractory or relapsed): Limited data available, case-series reports (Ref): Infants and Children:
Patient weight <10 kg: IV: 3.3 mg/kg as a 1-hour infusion every 21 days.
Patient weight >10 kg: IV: 100 mg/m2 given as a 1-hour infusion every 21 days.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity: The presented dosing adjustments are based on experience in adult patients; specific recommendations for pediatric patients are limited. Refer to specific protocol for management in pediatric patients if available.
Adult: Note: Toxicity includes febrile neutropenia, neutrophils <500/mm3 for >1 week, severe or cumulative cutaneous reactions; in non-small cell lung cancer, this may also include platelets <25,000/mm3 and other grade 3/4 nonhematologic toxicities.
Breast cancer (single agent): Patients dosed initially at 100 mg/m2 (adult); reduce dose to 75 mg/m2 (adult); Note: If the patient continues to experience these adverse reactions, the dosage should be reduced to 55 mg/m2 (adult) or therapy should be discontinued; discontinue for peripheral neuropathy ≥ grade 3. Patients initiated at 60 mg/m2 (adult) who do not develop toxicity may tolerate higher doses.
Breast cancer, adjuvant treatment (combination chemotherapy): TAC regimen should be administered when neutrophils are ≥1,500/mm3. Patients experiencing febrile neutropenia should receive G-CSF in all subsequent cycles. Patients with persistent febrile neutropenia (while on G-CSF), patients experiencing severe/cumulative cutaneous reactions, moderate neurosensory effects (signs/symptoms) or grade 3 or 4 stomatitis should receive a reduced dose (60 mg/m2 in adults) of docetaxel. Discontinue therapy with persistent toxicities after dosage reduction.
Non-small cell lung cancer:
Monotherapy: Patients dosed initially at 75 mg/m2 (adult) should have dose held until toxicity is resolved, then resume at 55 mg/m2 (adult); discontinue for peripheral neuropathy ≥ grade 3.
Combination therapy (with cisplatin): Patients dosed initially at 75 mg/m2 (adult) should have the docetaxel dosage reduced to 65 mg/m2 (adult) in subsequent cycles; if further adjustment is required, dosage may be reduced to 50 mg/m2 (adult).
Prostate cancer: Reduce dose to 60 mg/m2 (adult); discontinue therapy if toxicities persist at lower dose.
Gastric cancer, head and neck cancer: Note: Cisplatin may require dose reductions/therapy delays for peripheral neuropathy, ototoxicity, and/or nephrotoxicity. Patients experiencing febrile neutropenia, documented infection with neutropenia or neutropenia >7 days should receive G-CSF in all subsequent cycles. For neutropenic complications despite G-CSF use, further reduce dose to 60 mg/m2 (adult). Dosing with neutropenic complications in subsequent cycles should be further reduced to 45 mg/m2 (adult). Patients who experience grade 4 thrombocytopenia should receive a dose reduction from 75 mg/m2 to 60 mg/m2 (adult dosing). Discontinue therapy for persistent toxicities.
Gastrointestinal toxicity for docetaxel in combination with cisplatin and fluorouracil for treatment of gastric cancer or head and neck cancer:
Diarrhea, grade 3:
First episode: Reduce fluorouracil dose by 20%.
Second episode: Reduce docetaxel dose by 20%.
Diarrhea, grade 4:
First episode: Reduce fluorouracil and docetaxel doses by 20%.
Second episode: Discontinue treatment.
Stomatitis, grade 3:
First episode: Reduce fluorouracil dose by 20%.
Second episode: Discontinue fluorouracil for all subsequent cycles.
Third episode: Reduce docetaxel dose by 20%.
Stomatitis, grade 4:
First episode: Discontinue fluorouracil for all subsequent cycles.
Second episode: Reduce docetaxel dose by 20%.
There are no pediatric specific recommendations available; refer to protocols; based on experience in adult patients, renal excretion is minimal; therefore, the need for dosage adjustments for renal dysfunction is unlikely (Ref). Not removed by hemodialysis; may be administered before or after hemodialysis (Ref).
There are no pediatric specific recommendations available; refer to protocols; based on experience in adult patients, dosage adjustment suggested based on elevations of liver enzymes and/or total bilirubin levels.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Percentages reported for docetaxel monotherapy; frequency may vary depending on diagnosis, dose, liver function, prior treatment, and premedication.
>10%:
Dermatologic: Alopecia (56% to 76%, can be permanent), dermatological reaction (20% to 48%; severe dermatological reaction: 5%), nail disease (11% to 41%)
Endocrine & metabolic: Fluid retention (26% to 60%)
Gastrointestinal: Diarrhea (23% to 43%; severe diarrhea: ≤6%), nausea (34% to 42%; severe nausea: ≤5%), stomatitis (19% to 53%; grades 3/4: 2%), vomiting (22% to 23%; severe vomiting: ≤5%)
Hematologic & oncologic: Anemia (65% to 97%; grades 3/4: 8% to 9%), febrile neutropenia (5% to 14%), leukopenia (84% to 99%; grades 3/4: 49%; grade 4: 32% to 44%), neutropenia (84% to 99%; grades 3/4: 65%; grade 4: 75% to 86%; nadir [median]: 7 days, duration [severe neutropenia]: 7 days), thrombocytopenia (7% to 14%; grades 3/4: 3%; grade 4: 1%)
Hepatic: Increased serum alanine aminotransferase (≤19%), increased aspartate aminotransferase (≤19%)
Hypersensitivity: Hypersensitivity reaction (6% to 21%, including back pain, chest tightness, chills, drug fever, dyspnea, flushing, skin rash; severe hypersensitivity reaction: 3% to 4%)
Infection: Infection (1% to 34%; severe infection: 2% to 6%)
Nervous system: Central nervous system toxicity (20% to 58%; including dysesthesia: ≤6%, paresthesia: ≤6%)
Neuromuscular & skeletal: Asthenia (53% to 66%; severe weakness: 13% to 18%), myalgia (3% to 23%; severe myalgia: 2%), neuromuscular reaction (16%)
Respiratory: Pulmonary disease (41%)
Miscellaneous: Fever (31% to 35%)
1% to 10%:
Cardiovascular: Hypotension (3%)
Gastrointestinal: Dysgeusia (6%)
Hepatic: Increased serum alkaline phosphatase (7%), increased serum bilirubin (9%)
Local: Infusion site reaction (4%; including erythema at injection site, exfoliation of skin, inflammation at injection site, injection site extravasation, local dryness of skin, skin discoloration at injection site, swelling at injection site [vein])
Nervous system: Peripheral motor neuropathy (4%; severe; mainly distal extremity weakness)
Neuromuscular and skeletal: Arthralgia (3% to 9%)
<1%: Dermatologic: Onycholysis
Frequency not defined:
Cardiovascular: Decreased left ventricular ejection fraction, localized phlebitis
Dermatologic: Localized erythema of the extremities, nail depigmentation, nail hyperpigmentation
Nervous system: Fatigue
Postmarketing:
Cardiovascular: Acute myocardial infarction, atrial fibrillation, atrial flutter, cardiac arrhythmia, cardiac failure, chest pain, deep vein thrombosis, ECG abnormality, hypertension, pulmonary embolism, sinus tachycardia, syncope, tachycardia, thrombophlebitis, unstable angina pectoris
Dermatologic: Acute generalized exanthematous pustulosis, cutaneous lupus erythematosus, dermatological reaction (injection site recall at previous site of extravasation), erythema multiforme, palmar-plantar erythrodysesthesia, skin changes (scleroderma-like), Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Electrolyte disorder, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia
Gastrointestinal: Abdominal pain, anorexia, colitis, constipation, duodenal ulcer, enterocolitis, esophagitis, gastrointestinal hemorrhage, gastrointestinal perforation, intestinal obstruction, ischemic colitis, neutropenic enterocolitis
Hematologic & oncologic: Acute myelocytic leukemia, bleeding tendency disorder, disseminated intravascular coagulation, lymphedema (peripheral), myelodysplastic syndrome, non-Hodgkin's lymphoma, tumor lysis syndrome
Hepatic: Acute hepatic failure (Ref), hepatitis
Hypersensitivity: Anaphylactic shock, anaphylaxis
Infection: Sepsis
Nervous system: Confusion, loss of consciousness (transient), pain, seizure
Neuromuscular & skeletal: Myositis
Ophthalmic: Conjunctivitis, cystoid macular edema, disease of the lacrimal apparatus (duct obstruction), epiphora (more common with weekly administration [Kintzel 2006]), lacrimation, visual disturbance (transient)
Otic: Auditory disturbance, hearing loss, ototoxicity
Renal: Renal failure syndrome, renal insufficiency, renal neoplasm
Respiratory: Acute respiratory distress, interstitial pulmonary disease, pneumonia (interstitial), pneumonitis, pulmonary edema, pulmonary fibrosis, respiratory failure
Miscellaneous: Multi-organ failure, radiation recall phenomenon
History of severe hypersensitivity to docetaxel or any component of the formulation; severe hypersensitivity to other medications containing polysorbate 80 (excluding products that do not contain polysorbate 80); neutrophil count <1,500/mm3.
Canadian labeling: Additional contraindications (not in the US labeling): Severe hepatic impairment; pregnancy; breastfeeding.
Concerns related to adverse effects:
• Bone marrow suppression: Neutropenia may be severe and may result in infection; the dose-limiting toxicity is neutropenia. Patients with increased LFTs experienced more episodes of neutropenia with a greater number of severe infections.
• Cutaneous reactions: Cutaneous reactions, including erythema (with edema) and desquamation, have been reported. Severe cutaneous adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis have been reported and may be associated with docetaxel.
• Extravasation: Docetaxel is an irritant with vesicant-like properties; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
• Fluid retention: Severe fluid retention, characterized by pleural effusion (requiring immediate drainage), ascites with pronounced abdominal distention, peripheral edema (poorly tolerated), dyspnea at rest, cardiac tamponade, and/or generalized edema, has been reported (despite the use of premedication with dexamethasone). Fluid retention may begin as lower extremity peripheral edema and become generalized with a median weight gain of 2 kg. In 92 patients with breast cancer who received corticosteroid premedication, moderate and severe fluid retention occurred in ~27% and ~7%, respectively; the median cumulative dose to onset of moderate or severe fluid retention was 819 mg/m2; fluid retention resolves in a median of 16 weeks (range: up to 42 weeks) after discontinuation. Patients should be premedicated with a corticosteroid (starting 1 day prior to administration) to reduce the incidence and severity of fluid retention. Closely monitor patients with existing effusions.
• GI toxicity: Enterocolitis and neutropenic colitis (typhlitis) have occurred with docetaxel (either as a single agent or in combination with other chemotherapy) and despite administration of filgrastim; may occur at any time and could be fatal on the first day of symptom onset. Use with caution in patients with neutropenia, particularly those at increased risk for developing GI complications. Patients should report new-onset or worsening symptoms of GI toxicity.
• Hypersensitivity: Severe hypersensitivity reactions have been reported despite dexamethasone premedication. Severe hypersensitivity reactions have been characterized by generalized rash/erythema, hypotension, bronchospasm, and/or fatal anaphylaxis. Patients with a history of hypersensitivity reaction to paclitaxel may develop hypersensitivity to docetaxel; may be severe or fatal (including anaphylaxis); monitor patients with paclitaxel hypersensitivity closely during initiation of docetaxel therapy. Minor reactions including flushing or localized skin reactions may also occur.
• Neurosensory symptoms: Severe neurosensory symptoms (paresthesia, dysesthesia, pain) have been observed; reversal of symptoms may be delayed after discontinuation. Severe peripheral motor neuropathy manifesting as distal extremity weakness has been reported.
• Ocular adverse effects: Cystoid macular edema (CME) has been reported; if vision impairment occurs, a prompt comprehensive ophthalmic exam is recommended. In a study of patients receiving docetaxel for the adjuvant treatment of breast cancer, a majority of patients experienced tearing, which occurred in patients with and without lacrimal duct obstruction at baseline. Onset was generally after cycle 1, but subsided in most patients within 4 months after therapy completion (Chan 2013).
• Secondary malignancies: Second primary malignancies, including acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), non-Hodgkin lymphoma, and renal cancer have occurred in patients several months or years after receiving docetaxel-containing regimens. Treatment-related AML or MDS has occurred in patients receiving docetaxel in combination with anthracyclines and/or cyclophosphamide (with or without fluorouracil), including patients who received docetaxel-containing regimens as adjuvant therapy.
• Treatment-related mortality: Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, those receiving higher doses, and patients with non-small cell lung cancer and a history of prior treatment with platinum derivatives who receive single-agent docetaxel at a dose of 100 mg/m2.
• Tumor lysis syndrome: Tumor lysis syndrome (TLS) has occurred; closely monitor patients at high risk of TLS (eg, renal impairment, hyperuricemia, bulky tumor) prior to therapy and periodically during therapy.
• Weakness: Fatigue and weakness (may be severe) have been reported; symptoms may last a few days up to several weeks. In patients with progressive disease, weakness may be associated with a decrease in performance status.
Disease-related concerns:
• Heart failure: In a scientific statement from the American Heart Association, docetaxel has been determined to be an agent that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate) (AHA [Page 2016]).
• Hepatic impairment: Patients with bilirubin elevations or abnormal transaminases (with concurrent abnormal alkaline phosphatase) are at increased risk for severe neutropenia, neutropenic fever, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated transaminase elevations >1.5 times ULN also had a higher rate of neutropenic fever.
Dosage form specific issues:
• Alcohol content: Some docetaxel formulations contain alcohol (content varies by formulation), which may affect the central nervous system and cause symptoms of alcohol intoxication. Consider alcohol content and use with caution in patients for whom alcohol intake should be avoided or minimized. Patients should avoid driving or operating machinery immediately after the infusion.
• Cyclodextrin: Some dosage forms may contain cyclodextrin, which may accumulate in patients with renal insufficiency, although the clinical significance of this finding is uncertain (Luke 2010).
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Beizray: FDA approved October 2024; anticipated availability is currently unknown. Information pertaining to this product within the monograph is pending revision. Beizray is a polysorbate 80 free formulation of docetaxel that is provided as a kit consisting of docetaxel 80 mg/4 mL vials and a vial of 25% Human Albumin solution (used as an IV solution stabilizer). Consult the prescribing information for additional information.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Concentrate, Intravenous:
Generic: 20 mg/mL (1 mL); 80 mg/4 mL (4 mL); 160 mg/8 mL (8 mL)
Concentrate, Intravenous [preservative free]:
Generic: 20 mg/mL (1 mL)
Solution, Intravenous:
Docivyx: 20 mg/2 mL (2 mL); 80 mg/8 mL (8 mL); 160 mg/16 mL (16 mL) [contains alcohol, usp, polyethylene glycol 300 (peg-6)]
Generic: 20 mg/2 mL (2 mL); 80 mg/8 mL (8 mL); 160 mg/16 mL (16 mL)
Yes
Concentrate (DOCEtaxel Intravenous)
20 mg/mL (per mL): $26.40 - $365.15
80 mg/4 mL (per mL): $23.40 - $365.15
160 mg/8 mL (per mL): $25.50 - $365.15
Solution (DOCEtaxel Intravenous)
20 mg/2 mL (per mL): $26.40 - $194.31
80 mg/8 mL (per mL): $24.00 - $189.77
160 mg/16 mL (per mL): $20.48 - $189.77
Solution (Docivyx Intravenous)
20 mg/2 mL (per mL): $617.76
80 mg/8 mL (per mL): $617.76
160 mg/16 mL (per mL): $617.76
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: 20 mg/mL (1 mL, 4 mL, 8 mL)
Solution, Intravenous:
Generic: 10 mg/mL (2 mL, 8 mL, 16 mL)
IV: Infuse over 1 hour through nonsorbing polyethylene lined (non-DEHP) tubing. Note: Premedication with corticosteroids for 3 days, beginning the day before docetaxel administration, is recommended to reduce the incidence and severity of hypersensitivity reactions and fluid retention (see "Dosing: Adult" for premedication information). Monitor for hypersensitivity reactions, especially during the first and second infusion. Formulations contain alcohol (content varies by formulation and/or region); use with caution in patients for whom alcohol intake should be avoided or minimized.
The use of an in-line filter is not necessary during administration of the Taxotere brand; according to the manufacturer, studies have not been performed to determine the compatibility of IV filters for administration and filters are not recommended for use with docetaxel (data on file [Sanofi Aventis 2016]).
Irritant with vesicant-like properties; avoid extravasation. Assure 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; elevate extremity. Information conflicts regarding the use of warm or cold compresses (Ref).
Intravesicular administration for non–muscle invasive bladder cancer (off-label use): Empty bladder prior to docetaxel instillation; instruct patient to retain for 1 to 2 hours (based on protocol) and then empty bladder (Ref).
Administer as an IV infusion over 1 hour through nonsorbing polyethylene-lined (non-DEHP) tubing; in-line filter is not necessary (the use of a filter during administration is not recommended by the manufacturer). Infusion should be completed within 4 hours of preparation. Note: Premedication with corticosteroids for 3 days, beginning the day before docetaxel administration, is recommended to prevent hypersensitivity reactions and pulmonary/peripheral edema. Some docetaxel formulations contain alcohol (content varies by formulation); use with caution in patients for whom alcohol intake should be avoided or minimized.
Irritant with vesicant-like properties; avoid extravasation. Assure proper needle or catheter position prior to administration. 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; elevate extremity. Information conflicts regarding the use of warm or cold compresses (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: Treatment of breast cancer (locally advanced/metastatic) after prior chemotherapy failure; adjuvant treatment (in combination with doxorubicin and cyclophosphamide) of operable node-positive breast cancer.
Gastric adenocarcinoma: Treatment of advanced gastric adenocarcinoma, including gastroesophageal junction adenocarcinoma (in combination with cisplatin and fluorouracil) in patients who have not received prior chemotherapy for advanced disease.
Head and neck cancer: Treatment (induction) of locally advanced squamous cell head and neck cancer (in combination with cisplatin and fluorouracil).
Non–small cell lung cancer: Treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy; treatment of previously untreated unresectable locally advanced or metastatic NSCLC (in combination with cisplatin).
Prostate cancer: Treatment of metastatic castration-resistant prostate cancer (in combination with prednisone).
Anal carcinoma (squamous cell), advanced; Bladder cancer, advanced or metastatic; Bladder cancer, non–muscle invasive, refractory (intravesical); Cervical cancer, advanced or recurrent; Esophageal cancer, chemoradiation; Esophageal cancer, locally advanced or metastatic disease; Ewing sarcoma (recurrent or refractory); Osteosarcoma (recurrent or refractory); Ovarian cancer; Prostate cancer, metastatic, hormone-sensitive; Small cell lung cancer, relapsed; Soft tissue sarcoma (recurrent or progressive); Thyroid carcinoma, anaplastic; Unknown primary, adenocarcinoma; Uterine leiomyosarcoma (advanced or high-grade)
DOCEtaxel may be confused with cabazitaxel, PACLitaxel (conventional), PACLitaxel (protein bound).
Taxotere may be confused with Abraxane, Taxol.
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).
Multiple concentrations: Docetaxel is available at concentrations of 10 mg/mL (generic formulation) and 20 mg/mL (concentrate/solution). Admixture errors have occurred due to the availability of various docetaxel concentrations.
Substrate of CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers), OATP1B1/1B3, P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Anthracyclines: Taxane Derivatives may increase adverse/toxic effects of Anthracyclines. Specifically, the risk of cardiotoxicity may be increased with this combination. Taxane Derivatives may increase serum concentration of Anthracyclines. Management: Administer doxorubicin before paclitaxel, administer idarubicin after paclitaxel has been stopped for 5 half lives, consider use of liposomal doxorubicin, epirubicin, or docetaxel instead of doxorubicin/paclitaxel. Monitor for cardiovascular toxicities. Risk D: Consider Therapy Modification
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
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
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of DOCEtaxel. Risk C: Monitor
CYP3A4 Inhibitors (Moderate): May increase serum concentration of DOCEtaxel. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of DOCEtaxel. Management: Avoid the concomitant use of docetaxel and strong CYP3A4 inhibitors when possible. If combined use is unavoidable, consider a 50% docetaxel dose reduction and monitor for increased docetaxel toxicities. Risk D: Consider Therapy Modification
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
Dronedarone: May increase serum concentration of DOCEtaxel. Management: Avoid this combination whenever possible. If this combination must be used, consider using a reduced docetaxel dose, and/or increase monitoring for evidence of serious docetaxel toxicity (e.g., neutropenia, mucositis, hepatotoxicity etc.). Risk D: Consider Therapy Modification
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
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
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
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification
Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor
Platinum Derivatives: May increase myelosuppressive effects of Taxane Derivatives. Administer Taxane derivative before Platinum derivative when given as sequential infusions to limit toxicity. Management: Administer paclitaxel before cisplatin, when given as sequential infusions, to limit toxicity. Problems associated with other taxane/platinum combinations are possible, although unsubstantiated. Administering the taxane before platinum is likely warranted Risk D: Consider Therapy Modification
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
SORAfenib: May increase serum concentration of DOCEtaxel. Risk C: Monitor
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
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
Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraceptive measures before beginning treatment, during therapy, and for 2 months after the last docetaxel dose. Patients with partners who could become pregnant should use effective contraceptives during therapy and for 4 months after the last docetaxel dose.
An ex vivo human placenta perfusion model illustrated that docetaxel crossed the placenta at term. Placental transfer was low and affected by the presence of albumin; higher albumin concentrations resulted in lower docetaxel placental transfer (Berveiller 2012).
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to docetaxel may cause fetal harm. Formulations may contain alcohol, which is also associated with adverse fetal effects.
Some pharmacokinetic properties of docetaxel may be altered in pregnant women (van Hasselt 2014). Data related to the use of docetaxel for the treatment of breast cancer in pregnancy is limited. Use should be restricted for clinically urgent situations; use of other agents is preferred. 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 (ESMO [Peccatori 2013]).
A pregnancy registry is available for all cancers diagnosed during pregnancy at Cooper Health (877-635-4499).
It is not known if docetaxel is present in breast milk.
Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended by the manufacturer during treatment and for 1 week after the last docetaxel dose.
CBC with differential (prior to each cycle; monitor frequently in patients with hematologic toxicity), LFTs (bilirubin, ALT, AST, alkaline phosphatase; prior to each cycle; more frequently if clinically indicated), renal function. Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor for hypersensitivity reactions (particularly with the first and second infusion; patients with a history of paclitaxel hypersensitivity require close monitoring during initiation). Monitor for signs/symptoms of neurosensory symptoms, GI toxicity (eg, diarrhea, stomatitis, enterocolitis, neutropenic colitis), cutaneous reactions or severe skin toxicity, visual impairment, fluid retention (patients with existing effusions should be monitored closely during the first infusion for potential exacerbation), epiphora, canalicular stenosis, tumor lysis syndrome (prior to initiation and periodically during therapy), and second primary malignancies. A prompt comprehensive ophthalmic exam is recommended if vision impairment occurs.
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.
Docetaxel promotes the assembly of microtubules from tubulin dimers, and inhibits the depolymerization of tubulin which stabilizes microtubules in the cell. This results in inhibition of DNA, RNA, and protein synthesis. Most activity occurs during the M phase of the cell cycle.
Distribution: Vdss (mean): 113 L.
Protein binding: ~94% to 97%, primarily to alpha1-acid glycoprotein, albumin, and lipoproteins.
Metabolism: Hepatic; oxidation via CYP3A4 to metabolites.
Half-life elimination: Terminal (mean): 116 hours (range: 92 to 135 hours).
Excretion: Feces (~75%, <8% as unchanged drug); urine (~6%).
Clearance (mean): 18 L/hour/m2.
Hepatic function impairment: Total body clearance is reduced by average of 27% and AUC increased 38% in patients with mild to moderate hepatic function impairment (ALT and/or AST more than 1.5 × ULN concomitant with alkaline phosphatase more than 2.5 × ULN).
