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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Medication Safety Issues
Sound-alike/look-alike issues:
Taxotere® may be confused with Taxol®
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
Pronunciation
(doe se TAKS el)
U.S. Brand Names
Index Terms
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of breast cancer; locally-advanced or metastatic nonsmall cell lung cancer (NSCLC); hormone refractory, metastatic prostate cancer; advanced gastric adenocarcinoma; locally-advanced squamous cell head and neck cancer
Use: Unlabeled/Investigational
Treatment of bladder cancer, ovarian cancer, small cell lung cancer, and soft tissue sarcoma
Pregnancy Risk Factor
D
Pregnancy Considerations
Animal studies have demonstrated embryotoxicity, fetal toxicity, and maternal toxicity. There are no adequate and well-controlled studies in pregnant women; however, fetal harm may occur. Women of childbearing potential should avoid becoming pregnant. A pregnancy registry is available for all cancers diagnosed during pregnancy at Cooper Health (856-757-7876).
Lactation
Excretion in breast milk unknown/not recommended
Breast-Feeding Considerations
Due to the potential for serious adverse reactions in nursing the infant, breast-feeding is not recommended.
Contraindications
Hypersensitivity to docetaxel or any component of the formulation; prior hypersensitivity to medications containing polysorbate 80; pre-existing bone marrow suppression (neutrophils <1500 cells/mm3)
Warnings/Precautions
Boxed warnings:
• Fluid retention syndrome: See “Concerns related to adverse effects” below.
• Hepatic impairment: See “Disease-related concerns” below.
• Hypersensitivity reactions: See “Concerns related to adverse effects” below.
• Neutropenia: See “Concerns related to adverse effects” below.
• Treatment-related mortality: See “Concerns related to adverse effects” below.
Special handling:
• Hazardous agent: Use appropriate precautions for handling and disposal.
Concerns related to adverse effects:
• Cutaneous reactions: With use, cutaneous reactions including erythema and desquamation have been reported; may require dose reduction.
• Fluid retention: [U.S. Boxed Warning]: Fluid retention syndrome characterized by pleural effusions, ascites, edema, and weight gain (2-15 kg) has also been reported. The incidence and severity of the syndrome increase sharply at cumulative doses ?400 mg/m2. Patients should be premedicated with a corticosteroid to prevent fluid retention; severity is reduced with dexamethasone premedication starting one day prior to docetaxel administration.
• Hypersensitivity reactions: [U.S. Boxed Warning]: Severe hypersensitivity reactions characterized by rash/erythema, hypotension, bronchospasms, or anaphylaxis may occur; minor reactions including flushing or localized skin reactions may also occur. Patients should be premedicated with a corticosteroid to prevent hypersensitivity reactions; severity is reduced with dexamethasone premedication starting one day prior to docetaxel administration.
• Neurosensory symptoms: Dosage adjustment is recommended with severe neurosensory symptoms (paresthesia, dysesthesia, pain); persistent symptoms may require discontinuation.
• Neutropenia: [U.S. Boxed Warning]: Patients with an absolute neutrophil count <1500 cells/mm3 should not receive docetaxel. The dose-limiting toxicity is neutropenia; however, this rarely results in treatment delays and prophylactic colony stimulating factors have not been routinely used. Patients with increased liver function tests experienced more episodes of neutropenia with a greater number of severe infections. When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before platinum derivatives (carboplatin, cisplatin) to limit myelosuppression and to enhance efficacy.
• Treatment-related mortality: [U.S. Boxed Warning]: Patients with abnormal liver function, those receiving higher doses, and patients with nonsmall cell lung cancer and a history of prior treatment with platinum derivatives who receive docetaxel doses higher than 100 mg/m2 are at higher risk for treatment-related mortality.
Disease-related concerns:
• Hepatic impairment: [U.S. Boxed Warning]: Avoid use in patients with bilirubin exceeding upper limit of normal (ULN) or AST and/or ALT >1.5 times ULN in conjunction with alkaline phosphatase >2.5 times ULN. Use caution in hepatic disease; patients with abnormal liver function are at increased risk of treatment-related adverse events.
Special populations:
• Pediatrics: Safety and efficacy have not been established in children.
Adverse Reactions
Percentages reported for docetaxel monotherapy; frequency may vary depending on diagnosis, dose, liver function, prior treatment, and premedication. The incidence of adverse events was usually higher in patients with elevated liver function tests.
>10%:
Cardiovascular: Fluid retention (13% to 60%; dose dependent)
Central nervous system: Neurosensory events (20% to 58%; including neuropathy), fever (31% to 35%), neuromotor events (16%)
Dermatologic: Alopecia (56% to 76%), cutaneous events (20% to 48%), nail disorder (11% to 41%)
Gastrointestinal: Stomatitis (19% to 53%; severe 1% to 8%), diarrhea (23% to 43%; severe: 5% to 6%), nausea (34% to 42%), vomiting (22% to 23%)
Hematologic: Neutropenia (84% to 99%; grade 4: 75% to 86%; onset: 4-7 days, nadir: 5-9 days, recovery: 21 days; dose dependent), leukopenia (84% to 99%; grade 4: 32% to 44%), anemia (65% to 94%; dose dependent; grades 3/4: 8% to 9%), thrombocytopenia (8% to 14%; grade 4: 1%; dose dependent), febrile neutropenia (6% to 12%; dose dependent)
Hepatic: Transaminases increased (4% to 19%)
Neuromuscular & skeletal: Weakness (53% to 66%; severe 13% to 18%), myalgia (3% to 23%)
Respiratory: Pulmonary events (41%)
Miscellaneous: Infection (1% to 34%; dose dependent), hypersensitivity (1% to 21%; with premedication 15%)
1% to 10%:
Cardiovascular: Left ventricular ejection fraction decreased (prostate cancer: 10%; metastatic breast cancer: 8%), hypotension (3%)
Dermatologic: Rash/erythema (2%)
Gastrointestinal: Taste perversion (6%)
Hepatic: Bilirubin increased (9%), alkaline phosphatase increased (4% to 7%)
Local: Infusion-site reactions (4%, including hyperpigmentation, inflammation, redness, dryness, phlebitis, extravasation, swelling of the vein)
Neuromuscular and skeletal: Arthralgia (3% to 9%)
Ocular: Epiphora associated with canalicular stenosis (?77% with weekly administration; ?1% with every 3-week administration)
<1%, postmarketing and/or case reports (limited to important or life-threatening): Acute myeloid leukemia (AML), acute respiratory distress syndrome (ARDS), anaphylactic shock, angina, ascites, atrial fibrillation, atrial flutter, bleeding episodes, bronchospasm, cardiac tamponade, chest pain, chest tightness, colitis, conjunctivitis, constipation, cutaneous lupus erythematosus, deep vein thrombosis, dehydration, disseminated intravascular coagulation (DIC), drug fever, duodenal ulcer, dyspnea, dysrhythmia, ECG abnormalities, erythema multiforme, esophagitis, gastrointestinal hemorrhage, gastrointestinal obstruction, gastrointestinal perforation, hand and foot syndrome, hearing loss, heart failure, hepatitis, hypertension, ileus, interstitial pneumonia, ischemic colitis, lacrimal duct obstruction, loss of consciousness (transient), MI, multiorgan failure, myelodysplastic syndrome, neutropenic enterocolitis, ototoxicity, pleural effusion, pruritus, pulmonary edema, pulmonary embolism, pulmonary fibrosis, radiation pneumonitis, radiation recall, renal insufficiency, seizure, sepsis, sinus tachycardia, Stevens-Johnson syndrome, syncope, toxic epidermal necrolysis, tachycardia, thrombophlebitis, unstable angina, visual disturbances (transient)
Metabolism/Transport Effects
Substrate of CYP3A4 (major); Inhibits CYP3A4 (weak)
Drug Interactions
Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Docetaxel. Risk D: Consider therapy modification
Antineoplastic Agents (Anthracycline): Taxane Derivatives may enhance the adverse/toxic effect of Antineoplastic Agents (Anthracycline). Taxane Derivatives may increase the serum concentration of Antineoplastic Agents (Anthracycline). Taxane Derivatives may also increase the formation of toxic anthracycline metabolites in heart tissue. Risk D: Consider therapy modification
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification
Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination
P-Glycoprotein Inducers: May decrease the serum concentration of P-Glycoprotein Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy
P-Glycoprotein Inhibitors: May increase the serum concentration of P-Glycoprotein Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy
Platinum Derivatives: May enhance the myelosuppressive effect of Taxane Derivatives. Administer Taxane derivative before Platinum derivative when given as sequential infusions to limit toxicity. Risk D: Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (due to GI irritation).
Herb/Nutraceutical: Avoid St John's wort (may decrease docetaxel levels).
Storage
Intact vials should be stored at 2°C to 25°C (36°F to 77°F) and protected from light. Freezing does not adversely affect the product. If refrigerated, vials should be stored at room temperature for approximately 5 minutes before using. Diluted solutions in the vial are stable for 8 hours at room temperature or under refrigeration. Solutions diluted for infusion in D5W or NS are stable for up to 4 weeks at room temperature of 15°C to 25°C (59°F to 77°F) in polyolefin containers; however, the manufacturer recommends use within 4 hours.
Reconstitution
Vials should be diluted with 13% (w/w) ethanol/water (provided with the drug) to a final concentration of 10 mg/mL. Do not shake. The solution should be further diluted in 250-1000 mL of NS or D5W to a final concentration of 0.3-0.9 mg/mL (although the manufacturer recommends a final concentration of 0.3-0.74) and dispensed in a non-DEHP container (eg, glass, polypropylene, polyolefin).
Compatibility
Stable in D5W, NS.
Y-site administration: Compatible: Acyclovir, amifostine, amikacin, aminophylline, ampicillin, ampicillin/sulbactam, anidulafungin, aztreonam, bumetanide, buprenorphine, butorphanol, calcium gluconate, cefazolin, cefepime, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftizoxime, ceftriaxone, cefuroxime, chlorpromazine, cimetidine, ciprofloxacin, clindamycin, co-trimoxazole, dexamethasone sodium phosphate, diphenhydramine, dobutamine, dopamine, doxycycline, droperidol, enalaprilat, famotidine, fluconazole, furosemide, ganciclovir, gemcitabine, gentamicin, granisetron, haloperidol, heparin, hydrocortisone sodium succinate, hydromorphone, hydroxyzine, imipenem/cilastatin, leucovorin calcium, lorazepam, magnesium sulfate, mannitol, meperidine, meropenem, mesna, metoclopramide, metronidazole, morphine, ofloxacin, ondansetron, oxaliplatin, palonosetron, pemetrexed, piperacillin, piperacillin/tazobactam, potassium chloride, prochlorperazine edisylate, promethazine, ranitidine, Ringer's injection (lactated), sodium bicarbonate, ticarcillin/clavulanate, tobramycin, vancomycin, zidovudine. Incompatible: Amphotericin B, doxorubicin liposome, methylprednisolone sodium succinate, nalbuphine.
Mechanism of Action
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.
Pharmacodynamics/Kinetics
Exhibits linear pharmacokinetics at the recommended dosage range
Distribution: Extensive extravascular distribution and/or tissue binding; Vd: 80-90 L/m2, Vdss: 113 L (mean steady state)
Protein binding: ~94% to 97%, primarily to alpha1-acid glycoprotein, albumin, and lipoproteins
Metabolism: Hepatic; oxidation via CYP3A4 to metabolites
Half-life elimination: Terminal: 11 hours
Excretion: Feces (75%, <8% as unchanged drug); urine (6%); ~80% within 48 hours
Clearance: Total body: Mean: 21 L/hour/m2
Dosage
Adults: I.V. infusion: Refer to individual protocols: Note: Premedicate with corticosteroids, beginning the day before docetaxel administration, (administer for 1-5 days) to reduce the severity of hypersensitivity reactions and pulmonary/peripheral edema
Breast cancer:
Locally-advanced or metastatic: 60-100 mg/m2 every 3 weeks; patients initially started at 60 mg/m2 who do not develop toxicity may tolerate higher doses
Operable, node-positive (adjuvant treatment): 75 mg/m2 every 3 weeks for 6 courses (in combination with doxorubicin and cyclophosphamide)
Nonsmall cell lung cancer: 75 mg/m2 every 3 weeks (as monotherapy or in combination with cisplatin)
Prostate cancer: 75 mg/m2 every 3 weeks (in combination with prednisone)
Gastric adenocarcinoma: 75 mg/m2 every 3 weeks (in combination with cisplatin and fluorouracil)
Head and neck cancer: 75 mg/m2 every 3 weeks (in combination with cisplatin and fluorouracil) for 3 or 4 cycles, followed by radiation therapy
Dosing adjustment for toxicity:
Note: Toxicity includes febrile neutropenia, neutrophils ?500/mm3 for >1 week, severe or cumulative cutaneous reactions; in nonsmall cell lung cancer, this may also include platelets <25,000/mm3 and other grade 3/4 nonhematologic toxicities.
Breast cancer: Patients dosed initially at 100 mg/m2; reduce dose to 75 mg/m2; Note: If the patient continues to experience these adverse reactions, the dosage should be reduced to 55 mg/m2 or therapy should be discontinued; discontinue for peripheral neuropathy ? grade 3
Breast cancer, adjuvant treatment: TAC regimen should be administered when neutrophils are ?1500 cells/mm3. Patients experiencing febrile neutropenia should receive G-CSF in all subsequent cycles. Patients with persistent febrile neutropenia (while on G-CSF) or patients experiencing severe/cumulative cutaneous reactions or moderate neurosensory effects (signs/symptoms) should receive a reduced dose (60 mg/m2) of docetaxel. Patients who experience grade 3 or 4 stomatitis should also receive a reduced dose (60 mg/m2) of docetaxel. Discontinue therapy with persistent toxicities after dosage reduction.
Nonsmall cell lung cancer:
Monotherapy: Patients dosed initially at 75 mg/m2 should have dose held until toxicity is resolved, then resume at 55 mg/m2; discontinue for peripheral neuropathy ? grade 3.
Combination therapy (with cisplatin): Patients dosed initially at 75 mg/m2 should have the docetaxel dosage reduced to 65 mg/m2 in subsequent cycles; if further adjustment is required, dosage may be reduced to 50 mg/m2
Prostate cancer: Reduce dose to 60 mg/m2; 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. Neutropenic complications in subsequent cycles should be further dose reduced to 45 mg/m2. Patients who experience grade 4 thrombocytopenia should receive a dose reduction from 75 mg/m2 to 60 mg/m2. 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%
Dosing adjustment in renal impairment: Docetaxel has minimal renal excretion; dosage adjustments for renal dysfunction may not be needed.
Dosing adjustment in hepatic impairment:
The FDA-approved labeling recommends the following adjustments:
Total bilirubin greater than the ULN, or AST and/or ALT >1.5 times ULN concomitant with alkaline phosphatase >2.5 times ULN: Docetaxel generally should not be administered.
Hepatic impairment dosing adjustment specific for gastric adenocarcinoma:
AST/ALT >2.5 to ?5 times ULN and alkaline phosphatase ?2.5 times ULN: Administer 80% of dose
AST/ALT >1.5 to ?5 times ULN and alkaline phosphatase >2.5 to ?5 times ULN: Administer 80% of dose
AST/ALT >5 times ULN and /or alkaline phosphatase >5 times ULN: Discontinue docetaxel
The following guidelines have been used by some clinicians (Floyd, 2006):
Transaminases 1.6-6 times ULN: Administer 75% of dose
Transaminases >6 times ULN: Use clinical judgment
Dosage: Combination Regimens
Bladder cancer:
Cisplatin-Docetaxel
Gemcitabine-Docetaxel (Bladder Cancer)
Breast cancer:
AT
Capecitabine + Docetaxel (Breast Cancer)
Docetaxel-Bevacizumab
Docetaxel-Cyclophosphamide (TC)
Docetaxel-FEC
Docetaxel-Trastuzumab
Docetaxel-Trastuzumab-Carboplatin
Docetaxel-Trastuzumab-Cisplatin
Docetaxel-Trastuzumab-FEC
Docetaxel (Weekly)-Trastuzumab
Doxorubicin (Liposomal)-Docetaxel (Breast Cancer)
TAC
TEX (Capecitabine + Docetaxel + Epirubicin)
Esophageal cancer: Docetaxel-Cisplatin-Fluorouracil (Gastric/Esophageal Cancer)
Gastric cancer:
Capecitabine + Docetaxel (Gastric Cancer)
Docetaxel-Cisplatin-Fluorouracil (Gastric/Esophageal Cancer)
Head and neck cancer: Docetaxel-Cisplatin-Fluorouracil (Head and Neck Cancer)
Lung cancer (nonsmall cell):
Capecitabine + Docetaxel (NSCLC)
Docetaxel-Cisplatin
Osteosarcoma: Gemcitabine-Docetaxel (Sarcoma)
Ovarian cancer:
Docetaxel-Carboplatin (Ovarian Cancer)
Docetaxel-Oxaliplatin (Ovarian Cancer)
Prostate cancer:
Docetaxel-Prednisone
Docetaxel-Thalidomide
Docetaxel (Weekly Regimen)
Estramustine + Docetaxel
Estramustine + Docetaxel + Calcitriol
Estramustine + Docetaxel + Carboplatin
Estramustine + Docetaxel + Hydrocortisone
Estramustine + Docetaxel + Prednisone
Soft tissue sarcoma: Gemcitabine-Docetaxel (Sarcoma)
Administration: I.V.
Administer I.V. 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). Note: Premedication with corticosteroids for 1-5 days, beginning the day before docetaxel administration, is recommended to prevent hypersensitivity reactions and pulmonary/peripheral edema (see Additional Information or Pharmacotherapy Pearls).
Monitoring Parameters
CBC with differential, liver function tests, bilirubin, alkaline phosphatase, renal function; monitor for hypersensitivity reactions, fluid retention, epiphora, and canalicular stenosis
Patient Education
Do not take any new medication during therapy unless approved by prescriber. This medication can only be administered by infusion; report immediately any pain, burning, swelling, or redness at infusion site, difficulty breathing or swallowing, chest pain, or sudden chills. It is important to maintain adequate hydration unless instructed to restrict fluid intake and adequate nutrition (small frequent meals may help). You will be more susceptible to infection (avoid crowds and exposure to infection and do not have any vaccinations without consulting prescriber). May cause nausea or vomiting (small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); loss of hair (reversible); or diarrhea (if unresolved, contact prescriber for medication relief). Report immediately swelling of extremities, respiratory difficulty, unusual weight gain, abdominal distention, chest pain, palpitations, fever, chills, unusual bruising or bleeding, signs of infection, excessive fatigue, or rash. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant while taking this drug. Consult prescriber for appropriate contraceptives. Do not breast-feed.
Additional Information
Premedication with oral corticosteroids is recommended to decrease the incidence and severity of fluid retention and severity of hypersensitivity reactions. Dexamethasone 8-10 mg orally twice daily for 3-5 days, starting the day before docetaxel administration, is usually recommended. When prednisone is part of the antineoplastic regimen (eg, prostate cancer), the prednisone is sometimes withheld on the days dexamethasone is administered.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Mucositis, stomatitis, and taste perversion.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause confusion
Mental Health: Effects on Psychiatric Treatment
May cause leukopenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Assess potential for interactions with other pharmacological agents or herbal products patient may be taking (eg, drugs that may increase or decrease levels/effects of docetaxel). Caution: Severe hypersensitivity reactions have been reported; premedication with dexamethasone may be advisable. Patient should be monitored continuously during infusion; dosing adjustment may be necessary. Assess results of laboratory tests, therapeutic response, and adverse effects (eg, neutropenia, severe fluid retention, pleural effusion, opportunistic infections, anemia) prior to each infusion and on a regular basis throughout therapy. Teach patient possible side effects/appropriate interventions and adverse symptoms to report.
Oncology: Emetic Potential
Low (10% to 30%)
Oncology: Vesicant
No; may be an irritant
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [concentrate]:
Taxotere®: 20 mg/0.5 mL (0.5 mL, 2 mL) [contains Polysorbate 80®; diluent contains ethanol 13%]
References
Ajani JA, Fodor MD, Tjulandin SA, et al, “Phase II Multi-Institutional Randomized Trial of Docetaxel Plus Cisplatin With or Without Fluorouracil in Patients With Untreated, Advanced Gastric, or Gastroesophageal Adenocarcinoma,” J Clin Oncol, 2005, 23(24):5660-7.
Bruno R and Sanderink GJ, “Pharmacokinetics and Metabolism of Taxotere® (Docetaxel),” Cancer Surv, 1993, 17:305-13.
Cortes JE and Pazdur R, “Docetaxel,” J Clin Oncol, 1995, 13(10):2643-55.
De Santis M, Lucchese A, De Carolis S, et al, “Metastatic Breast Cancer in Pregnancy: First Case of Chemotherapy With Docetaxel,” Eur J Cancer Care (Engl), 2000, 9(4):235-7.
Floyd J, Mirza I, Sachs B, et al, "Hepatotoxicity of Chemotherapy," Semin Oncol, 2006, 33(1):50-67.
Fulton B and Spencer CM, “Docetaxel. A Review of Its Pharmacodynamic and Pharmacokinetic Properties and Therapeutic Efficacy in the Management of Metastatic Breast Cancer,” Drugs, 1996, 51(6):1075-92.
Posner MR, Glisson B, Frenette G, et al, “Multicenter Phase I-II Trial of Docetaxel, Cisplatin, and Fluorouracil Induction Chemotherapy for Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck,” J Clin Oncol, 2001, 19(4):1096-104.
Posner MR, Hershock DM, Blajman CR, et al, “Cisplatin and Fluorouracil Alone or With Docetaxel in Head and Neck Cancer,” N Engl J Med, 2007, 357(17):1705-15.
Ravdin PM, “The International Experience With Docetaxel in the Treatment of Breast Cancer,” Oncology, 1997, 11(3 Suppl 2):38-42.
Schrijvers D, Van Herpen C, Kerger J, et al, “Docetaxel, Cisplatin and 5-Fluorouracil in Patients With Locally Advanced Unresectable Head and Neck Cancer: A Phase I-II Feasibility Study,” Ann Oncol, 2004, 15(4):638-45.
Thiesen J and Kramer I, “Physico-Chemical Stability of Docetaxel Premix Solution and Docetaxel Infusion Solutions in PVC Bags and Polyolefine Containers,” Pharm World Sci, 1999, 21(3):137-41.
Trudeau ME, “Docetaxel: A Review of Its Pharmacology and Clinical Activity,” Can J Oncol, 1996, 6(1):443-57.
Vermorken JB, Remenar E, van Herpen C, et al, “Cisplatin, Fluorouracil, and Docetaxel in Unresectable Head and Neck Cancer,” N Engl J Med, 2007, 357(17):1695-704.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2009
Content last modified August 2009
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