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Taxotere

Pronunciation

Generic Name: Docetaxel
Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: [2aR - [2aα,4β,4aβ,6β,9α(αR*,βS*),11α,12α,12aα,12bα]] - 12b - (acetyloxy) - 12 - (benzoyloxy) - 2a,3,4,4a,5,6,9,10,11,12,12a,12b - dodecahydro - 4,6,11 - trihydroxy - 4a,8,13,13 - tetramethyl - 5 - oxo - 7,11 - methano - 1H - cyclodeca[3,4]benz[1,2 - b]oxet - 9 - yl ester β-[[(1,1-dimethylethoxy)carbonyl]amino]-α-hydroxybenzenepropanoic acid
Molecular Formula: C43H53NO14
CAS Number: 114977-28-5

Warning(s)

Special Alerts:

ISSUE: FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk.

BACKGROUND: Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer.

RECOMMENDATION: Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications. For more information visit the FDA website at: and .

Warning(s)

  • Treatment-related Mortality
  • Incidence of treatment-related mortality increased in patients with abnormal hepatic function, patients receiving higher doses, and patients with non-small cell lung carcinoma (NSCLC) previously treated with platinum-based chemotherapy who received docetaxel monotherapy at a dose of 100 mg/m2.1 84 85 86 (See Treatment-related Mortality under Cautions.)

  • Hepatic Impairment
  • Do not administer to patients with serum total bilirubin >ULN or patients with serum AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN.1 84 85 86 These patients are at increased risk for grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death.1 84 85 86

  • Increased risk for grade 4 febrile neutropenia, but not toxic death, in patients with isolated elevations of AST or ALT >1.5 times ULN.1 84 85 86

  • Obtain and review bilirubin, AST or ALT, and alkaline phosphatase values prior to each cycle.1 84 85 86

  • Hematologic Monitoring
  • Do not administer to patients with neutrophil counts <1500/mm3.1 84 85 86 (See Hematologic Effects under Cautions.)

  • Monitor blood cell counts frequently.1 84 85 86

  • Hypersensitivity
  • Severe hypersensitivity reactions (hypotension and/or bronchospasm, generalized rash/erythema, and, rarely, fatal anaphylaxis) reported in some patients despite receiving recommended 3-day dexamethasone premedication.1 84 85 86

  • Severe hypersensitivity reactions require immediate discontinuance of docetaxel and initiation of appropriate treatment.1 84 85 86 (See Hypersensitivity Reactions under Cautions.)

  • Do not administer to patients with a history of severe hypersensitivity reactions to docetaxel or polysorbate 80.1 84 85 86

  • Fluid Retention
  • Severe fluid retention (poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, pronounced abdominal distention, ascites) reported in patients despite receiving the 3-day dexamethasone premedication.1 84 85 86 (See Cardiovascular Toxicity under Cautions.)

Introduction

Semisynthetic taxoid; an antineoplastic agent.1 2 3 4 5 6 7 8

Uses for Taxotere

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Breast Cancer

In combination with doxorubicin and cyclophosphamide as adjuvant treatment for operable node-positive breast cancer.1 65 68 84 86

Other docetaxel-containing regimens under investigation as adjuvant therapy for early-stage breast cancer, including nonanthracycline-containing regimens.80

In combination with doxorubicin for the initial treatment of metastatic breast cancer.65 67 74

In combination with capecitabine for the treatment of metastatic breast cancer in patients with disease that has failed anthracycline-containing chemotherapy.64 65 66

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Monotherapy for the second-line treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy.1 13 14 15 16 17 41 42 54 63 65 84 85 86

Non-small Cell Lung Cancer

In combination with cisplatin as first-line therapy for unresectable, locally advanced or metastatic NSCLC.1 52 54 69 84 86

Monotherapy for second-line treatment of locally advanced or metastatic NSCLC in patients with disease that has recurred or progressed following prior treatment with platinum-based chemotherapy.1 52 54 59 84 85 86

Prostate Cancer

In combination with prednisone for the treatment of androgen-independent (hormone-refractory) metastatic prostate cancer.1 70 84 85 86

Gastric Cancer

In combination with cisplatin and fluorouracil for the initial treatment of advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction.1 71 86

Head and Neck Cancer

In combination with cisplatin and fluorouracil as induction chemotherapy for locally advanced squamous cell carcinoma of the head and neck.1 72 73 86

Ovarian Cancer

In combination with carboplatin as an alternative regimen for the first-line treatment of ovarian epithelial cancer.54 82 83

Treatment of recurrent or persistent ovarian epithelial cancer that is platinum-resistant or platinum-refractory.54 82

Taxotere Dosage and Administration

General

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Consult specialized references for procedures for proper handling and disposal of antineoplastics.1 84 85 86

Premedication

  • Premedicate all patients with oral corticosteroids to prevent severe hypersensitivity reactions and to reduce the incidence and severity of fluid retention.1 84 85 86 Patients with hormone-refractory prostate cancer may receive dexamethasone 8 mg orally at 1, 3, and 12 hours prior to docetaxel administration.1 84 85 86 Patients with other cancers may receive dexamethasone 8 mg orally twice daily for 3 days, starting 1 day prior to docetaxel administration.1 84 85 86

  • Patients with gastric cancer or head and neck cancer: Administer appropriate antiemetic premedication and hydration before and after cisplatin administration in the docetaxel/cisplatin/fluorouracil regimen.1 86

Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.1 84 85 86

Handle cautiously; use protective equipment (e.g., gloves).1 84 85 86

Immediately treat accidental contact with skin by thoroughly washing with soap and water; immediately treat accidental contact with mucous membranes by thoroughly washing with water.1 84 85 86

Contact of docetaxel injection concentrate or reconstituted solution with PVC equipment or devices used to prepare solutions for infusion is not recommended.1 36 84 85 86 (See Storage under Stability.)

Administer through polyethylene-lined administration sets.1 36 84 85 86 Use of inline filters is neither required nor recommended.37

Commercially available as injection concentrate and lyophilized powder.1 84 85 86 Lyophilized powder must be reconstituted and then diluted to prepare final infusion solution.85 Injection concentrate must be diluted prior to IV administration.1 84 86

Precautions for Use of Injection Concentrate

Procedure for preparing a final docetaxel infusion solution from an injection concentrate may vary by manufacturer (i.e., some preparations may require 1 dilution step; others may require 2 dilution steps).1 84 86 Taxotere injection concentrate has been reformulated to require 1 dilution step rather than 2 dilution steps.88

Injection concentrates available from various manufacturers may contain different concentrations of the drug.1 84 86

Consult manufacturer’s instructions for the specific formulation being used to ensure that the correct preparation procedure is followed.1 84 85 86 87

Do not use formulations requiring 2 dilution steps with formulations requiring 1 dilution step.1

Dilution of Injection Concentrate Requiring One Dilution Step

If vial was refrigerated, allow to stand at room temperature for approximately 5 minutes prior to dilution.1

Inject required amount of docetaxel injection concentrate into a 250-mL infusion bag or bottle containing 0.9% sodium chloride injection or 5% dextrose injection (using a 21-gauge needle) to produce a final solution with docetaxel concentration of 0.3–0.74 mg/mL.1 84 If required dose is >200 mg, increase solution volume accordingly so that docetaxel concentration does not exceed 0.74 mg/mL.1 84

Mix docetaxel infusion solution thoroughly by gentle manual rotation.1 84

Dilution of Injection Concentrate Requiring Two Dilution Steps

First dilution step: Add entire contents of the vial of diluent supplied by the manufacturer (13% w/v polyethylene glycol 400 in water for injection; approximately 1.95 mL of diluent for docetaxel 20 mg and approximately 7.2 mL of diluent for docetaxel 80 mg) to the appropriate vial of docetaxel injection concentrate to create an initial diluted solution of docetaxel 10 mg/mL.86

Invert vial repeatedly for ≥45 seconds to fully mix the concentrate and diluent; do not shake the vial.86 Allow solution to stand for a few minutes to let any foam on top dissipate; then preparation may continue even if some foam remains.86 Initial diluted solution should be clear.86

Use initial diluted solution immediately to prepare final diluted solution for infusion or store in refrigerator or at room temperature for up to 8 hours.86

Second dilution step: Inject required amount of the initial diluted solution (docetaxel 10 mg/mL) into a 250-mL infusion bag or bottle containing 0.9% sodium chloride injection or 5% dextrose injection to produce a final solution with docetaxel concentration of 0.3–0.74 mg/mL.86 If required dose is >200 mg, increase solution volume accordingly so that docetaxel concentration does not exceed 0.74 mg/mL.86

Mix docetaxel infusion solution thoroughly by manual rotation.86

Reconstitution and Dilution (Lyophilized Powder for Injection)

Remove appropriate number of vials of diluent (ethanol 35.4% w/w and polysorbate 80) and docetaxel lyophilized powder from the refrigerator; allow to stand at room temperature for approximately 5 minutes prior to reconstitution.85

Reconstitute powder by adding 1 mL of diluent to a vial containing docetaxel 20 mg to provide a solution containing 20 mg in 0.8 mL or by adding 4 mL of diluent to a vial containing docetaxel 80 mg to provide a solution containing 24 mg/mL.85

Shake vial well to ensure complete dissolution.85 Allow solution to stand for a few minutes to let any air bubbles dissipate.85 Solution should be clear.85

Use reconstituted solution immediately to prepare final diluted docetaxel solution for infusion or store in refrigerator or at room temperature for up to 8 hours.85

To prepare final diluted docetaxel solution for infusion, inject required amount of reconstituted docetaxel solution into a 250-mL infusion bag or bottle containing 0.9% sodium chloride injection or 5% dextrose injection to produce a final solution with docetaxel concentration of 0.3–0.74 mg/mL.85 If required dose is >200 mg, increase solution volume accordingly so that docetaxel concentration does not exceed 0.74 mg/mL. 85

Mix docetaxel infusion solution thoroughly by manual rotation.85

Rate of Administration

Administer over 1 hour.1 84 85 86

Dosage

Adults

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

If concomitant use with a potent CYP3A4 inhibitor cannot be avoided, consider reducing docetaxel dosage by 50%.1 84 85 86 (See Interactions.)

If neutropenia or thrombocytopenia occurs, do not administer subsequent cycle until neutrophil count is >1500/mm3 and platelet count is >100,000/mm3.1 84 85 86

If severe neutropenia (neutrophil count <500/mm3) lasting more than 1 week, febrile neutropenia, or grade 4 infection occurs during a cycle of therapy, reduce dose by 25% for subsequent cycles.1 84 85 86

Breast Cancer (Adjuvant Therapy)
IV

75 mg/m2 administered 1 hour following doxorubicin 50 mg/m2 IV and cyclophosphamide 500 mg/m2 IV in repeated 3-week cycles for up to 6 cycles.1 84 86

Prophylactic granulocyte colony-stimulating factor (G-CSF) may be used. 1 76 77 78 84 86

Dosage Modification for Toxicity
IV

If febrile neutropenia occurs, initiate G-CSF for all subsequent cycles.1 84 86 If patient continues to experience febrile neutropenia, continue G-CSF and reduce docetaxel dose to 60 mg/m2.1 84 86

If severe or cumulative cutaneous reactions, moderate neurosensory manifestations, or grade 3 or 4 stomatitis occurs, reduce docetaxel dose to 60 mg/m2.1 84 86 If patient continues to experience severe or cumulative cutaneous reactions or moderate neurosensory manifestations, discontinue treatment.1 84 86

Breast Cancer (Advanced Disease)
IV

60–100 mg/m2 in repeated 3-week cycles.1 84 85 86

Higher doses may be tolerated by patients who are dosed initially at 60 mg/m2 and who do not experience febrile neutropenia, neutrophil count <500/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy.1 84 85 86

Dosage Modification for Toxicity
IV

In patients initially dosed at 100 mg/m2 who experience febrile neutropenia, neutrophil count <500/mm3 for more than 1 week, or severe or cumulative cutaneous reactions, reduce dose to 75 mg/m2 for subsequent courses of therapy.1 37 84 85 86 If the patient continues to experience these reactions, further reduce dose to 55 mg/m2 or discontinue treatment.1

If grade 3 or greater peripheral neuropathy develops, discontinue treatment.1 84 85 86

NSCLC (First-line Therapy for Advanced Disease)
IV

Docetaxel 75 mg/m2 immediately followed by cisplatin 75 mg/m2 IV in repeated 3-week cycles.1 84 86

Dosage Modification for Toxicity
IV

If nadir platelet count is <25,000/mm3 or febrile neutropenia or serious nonhematologic toxicity occurs, reduce docetaxel dose to 65 mg/m2 for subsequent cycles.1 84 86 If further dose reduction is required, 50 mg/m2 is recommended.1 84 86

Cisplatin dosage adjustments may be necessary; consult manufacturer's labeling.1 84 86

NSCLC (Second-line Therapy for Advanced Disease)
IV

75 mg/m2 in repeated 3-week cycles; higher doses are associated with increased hematologic toxicity, infection, and treatment-related mortality and are not recommended.1 59 60 84 85 86

Dosage Modification for Toxicity
IV

If febrile neutropenia, neutrophil count <500/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or other grade 3/4 nonhematologic toxicity occurs, withhold drug until toxicity resolves and then resume at 55 mg/m2.1 84 85 86

If grade 3 or greater peripheral neuropathy develops, discontinue treatment.1 84 85 86

Prostate Cancer
IV

75 mg/m2 in repeated 3-week cycles; given in combination with prednisone 5 mg orally twice daily continuously.1 84 85 86

Dosage Modification for Toxicity
IV

If febrile neutropenia, neutrophil count <500/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or moderate neurosensory manifestations occur, reduce dose to 60 mg/m2.1 84 85 86 If patient continues to experience these reactions, discontinue treatment.1 84 85 86

Gastric Cancer
IV

Docetaxel 75 mg/m2 followed by cisplatin 75 mg/m2 on day 1, then fluorouracil 750 mg/m2 per day as a 24-hour continuous IV infusion for 5 days (days 1–5) initiated upon completion of cisplatin infusion; regimen repeated in 3-week cycles.1 86

Consider primary prophylaxis with G-CSF.71

Dosage Modification for Hematologic Toxicity
IV

If febrile neutropenia, documented infection with neutropenia, or neutropenia lasting more than 1 week occurs, administer G-CSF during the second and/or subsequent cycles; if such toxicity occurs despite use of G-CSF, reduce docetaxel dose to 60 mg/m2.1 86 If subsequent episodes of complicated neutropenia occur, further reduce dose to 45 mg/m2.1 86 If these reactions persist, discontinue treatment.1 86

If grade 4 thrombocytopenia occurs, reduce docetaxel dose to 60 mg/m2.1 86 If reaction persists, discontinue treatment.1 86

Dosage Modification for Hepatotoxicity
IV

See Table 1 for docetaxel dosage modifications for hepatotoxicity.1 86 89

Table 1. Docetaxel Dosage Modification for Hepatotoxicity in Gastric Cancer18689

Hepatic Enzyme Elevation

Dosage Modification

AST and/or ALT >2.5 to ≤5 times ULN and alkaline phosphatase ≤2.5 times ULN

Reduce docetaxel dose by 20%

AST and/or ALT >1.5 to ≤5 times ULN and alkaline phosphatase >2.5 to ≤5 times ULN

Reduce docetaxel dose by 20%

AST and/or ALT >5 times ULN and/or alkaline phosphatase >5 times ULN

Discontinue docetaxel

Dosage Modification for GI Toxicity
IV

See Table 2 for docetaxel and fluorouracil dosage modifications for GI toxicity.1 86

Table 2. Dosage Modification for GI Toxicity for Docetaxel and Fluorouracil Given in Combination with Cisplatin in Gastric or Head and Neck Cancer186

Toxicity

Dosage Modification

Diarrhea grade 3

First episode: Reduce fluorouracil dose by 20%

Second episode: Reduce docetaxel dose by 20%

Diarrhea 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 for all subsequent cycles

Third episode: Reduce docetaxel dose by 20%

Stomatitis/mucositis grade 4

First episode: Discontinue fluorouracil for all subsequent cycles

Second episode: Reduce docetaxel dose by 20%

Other Dosage Modifications
IV

Dosage adjustments for cisplatin and fluorouracil may be necessary; consult manufacturers' labelings in addition to the dosage adjustments described here.1

If grade 2 peripheral neuropathy occurs, reduce cisplatin dose by 20%; discontinue treatment if grade 3 peripheral neuropathy occurs.1

If grade 2 or greater palmar-plantar erythrodysesthesia (hand-foot syndrome) occurs, withhold fluorouracil until resolution and then resume fluorouracil with a 20% dose reduction.1

If grade 3 ototoxicity occurs, discontinue treatment.1

If other grade 3 toxicities occur (except alopecia and anemia), delay chemotherapy for a maximum of 2 weeks until resolution to grade 1 or less, and then resume therapy if medically appropriate.1

See Table 3 for cisplatin dosage modifications for nephrotoxicity.1 86

Table 3. Dosage Modification for Nephrotoxicity for Cisplatin Given in Combination with Docetaxel and Fluorouracil in Gastric or Head and Neck Cancer186

Clcr (mL/min)

Cisplatin Dosage

≥60

Administer full cisplatin dose; measure Clcr prior to each treatment cycle

40–59

Reduce cisplatin dose by 50% for the subsequent cycle

If Clcr >60 mL/min at the end of the cycle using the 50% cisplatin dose, resume cisplatin at full dose for the next cycle

If recovery does not occur at the end of the cycle using the 50% cisplatin dose, omit cisplatin from the next cycle

<40

Omit cisplatin from treatment cycle

If Clcr remains <40 mL/min at the end of the cycle, discontinue cisplatin

If Clcr is 40–59 mL/min at the end of the cycle omitting cisplatin, reduce cisplatin dose by 50% for the subsequent cycle

If Clcr >60 mL/min at the end of the cycle omitting cisplatin, resume cisplatin at full dose for the next cycle

Head and Neck Cancer
IV

Induction treatment followed by radiotherapy: Docetaxel 75 mg/m2 followed by cisplatin 75 mg/m2 on day 1, then fluorouracil 750 mg/m2 per day as a 24-hour continuous IV infusion for 5 days (days 1–5) initiated upon completion of cisplatin infusion; regimen repeated in 3-week cycles for up to 4 cycles.1 86 Following completion of chemotherapy, administer radiotherapy.1 86

Induction treatment followed by chemoradiotherapy: Docetaxel 75 mg/m2 followed by cisplatin 100 mg/m2 on day 1, then fluorouracil 1 g/m2 per day as a 24-hour continuous IV infusion for 4 days (days 1–4); regimen repeated in 3-week cycles for up to 3 cycles.1 86 Following completion of chemotherapy, administer chemoradiotherapy.1 86

Administer prophylaxis for neutropenic infection; in clinical trials, patients received prophylactic antibiotic treatment.1 86

Dosage Modification for Hematologic Toxicity
IV

If febrile neutropenia, documented infection with neutropenia, or neutropenia lasting more than 1 week occurs, administer G-CSF during the second and/or subsequent cycles; if such toxicity occurs despite use of G-CSF, reduce docetaxel dose to 60 mg/m2.1 86 If subsequent episodes of complicated neutropenia occur, further reduce dose to 45 mg/m2.1 86 If these reactions persist, discontinue treatment.1 86

If grade 4 thrombocytopenia occurs, reduce docetaxel dose to 60 mg/m2.1 86 If reaction persists, discontinue treatment.1 86

Dosage Modification for GI Toxicity
IV

See Table 2 for docetaxel and fluorouracil dosage modifications for GI toxicity.1 86

Other Dosage Modifications
IV

Dosage adjustments for cisplatin and fluorouracil may be necessary during treatment; consult manufacturer's labelings in addition to the dosage adjustments described here.1

If grade 2 peripheral neuropathy occurs, reduce cisplatin dose by 20%.1 If grade 3 peripheral neuropathy occurs, discontinue treatment.1

If grade 2 or greater palmar-plantar erythrodysesthesia (hand-foot syndrome) occurs, withhold fluorouracil until resolution, and then resume fluorouracil with a 20% dose reduction.1

If grade 3 ototoxicity occurs, discontinue treatment.1

If other grade 3 toxicities occur (except alopecia and anemia), delay chemotherapy for a maximum of 2 weeks until resolution to grade 1 or less, and then resume therapy if medically appropriate.1

See Table 3 for cisplatin dosage modifications for nephrotoxicity.1 86

Prescribing Limits

Adults

Treatment-related mortality is increased at higher dosages.1 84 85 86 (See Treatment-related Mortality under Cautions.)

NSCLC (Second-line Therapy for Advanced Disease)
IV

Maximum 75 mg/m2 in repeated 3-week cycles; higher doses associated with increased hematologic toxicity, infection, and treatment-related mortality.1 59 60 84 85 86

Special Populations

Hepatic Impairment

Do not use in patients with serum total bilirubin >ULN or in patients with serum AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN.1 84 85 86 (See Hepatic Impairment in Boxed Warning.)

Renal Impairment

Dosage adjustment does not appear to be necessary.37

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1 84 85 86

Cautions for Taxotere

Contraindications

  • History of severe hypersensitivity to docetaxel or polysorbate 80.1 84 85 86

  • Baseline neutrophil count <1500/mm3.1 84 85 86

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adequate Patient Evaluation and Monitoring

Prior to each cycle, assess serum bilirubin, AST and/or ALT, and alkaline phosphatase concentrations.1 84 85 86 Frequent monitoring of blood cell counts also recommended.1 84 85 86

Do not administer docetaxel in patients with serum total bilirubin >ULN or patients with serum AST and/or ALT >1.5 times ULN with concomitant alkaline phosphatase >2.5 times ULN.1 84 85 86

Do not administer subsequent cycles until neutrophil count recovers to >1500/mm3 and platelet count recovers to >100,000/mm3.1 84 85 86

Patients who respond to docetaxel may not experience an improvement and/or may experience worsening in performance status.1 84 85 86 The relationship between changes in performance status, response to therapy, and treatment-related adverse effects not established.1 84 85 86

Treatment-related Mortality

Increased incidence of treatment-related mortality in patients with abnormal hepatic function, patients receiving higher doses, and patients with NSCLC previously treated with platinum-based chemotherapy who received docetaxel 100 mg/m2.1 84 85 86

Death possibly or probably related to treatment reported in 11.5% of patients with hepatic dysfunction receiving docetaxel 100 mg/m2 for various tumors; 3 of 7 patients with hepatic dysfunction receiving docetaxel 60 mg/m2 for metastatic breast cancer; and 0.6 or 2% of patients with normal hepatic function receiving docetaxel 60 or 100 mg/m2, respectively, for metastatic breast cancer.1 84 85 86 Approximately half of deaths occurred during the first cycle; most deaths due to sepsis.1 84 85 86

In patients with advanced NSCLC who received prior platinum-based therapy, treatment-related death occurred in 5 or 14% of those receiving docetaxel 100 mg/m2 and 2.8% of those receiving 75 mg/m2.1 84 85 86

Hematologic Effects

Bone marrow suppression is major dose-limiting toxicity.1 3 7 8 84 85 86

Frequency and severity of hematologic toxicity, febrile reactions and infections, and rates of septic death increase with dose and presence of hepatic dysfunction.1 7 22 84 85 86 (See Hepatic Impairment in Boxed Warning.)

Neutropenia (i.e., neutrophils <2000/mm3) occurs in essentially all patients receiving doses of 60–100 mg/m2 and is dose related; grade 4 neutropenia (<500/mm3) reported in >75% of patients.1 84 85 86 Neutrophil nadir at day 7–8;1 8 13 14 19 20 84 85 86 the median duration of grade 4 neutropenia is about 7 days.1 5 7 13 84 85 86

Febrile neutropenia reported in about 12% of patients receiving docetaxel 100 mg/m2; uncommon in patients receiving 60 mg/m2.1 84 85 86 Febrile neutropenia and/or neutropenic infection occurred in 28% of gastric cancer patients receiving docetaxel/cisplatin/fluorouracil regimen without G-CSF compared with 12% of those receiving G-CSF concomitantly; monitor closely during first and subsequent cycles.1 86

Fatal GI bleeding associated with severe thrombocytopenia reported in several breast cancer patients with severe hepatic dysfunction (bilirubin >1.7 times ULN).1 84 85 86

Monitor blood counts frequently and adjust dosage accordingly.1 84 85 86 (See Dosage under Dosage and Administration.)

Patients must have recovered from acute toxicities (e.g., neutrophils recovered to >1500/mm3, platelets to >100,000/mm3) of previous cytotoxic therapy before each cycle.1 84 85 86

Cardiovascular Toxicity

Severe fluid retention reported, sometimes despite dexamethasone premedication.1 3 84 85 86 (See Fluid Retention in Boxed Warning.)

Peripheral edema usually begins in lower extremities and appears to be completely (although sometimes slowly) reversible;1 3 84 85 86 generally responds to standard measures, including sodium restriction and oral diuretics.1 3 13 25 84 85 86

Premedicate with oral corticosteroids to reduce the incidence and severity of fluid retention.1 84 85 86 (See Premedication under Dosage and Administration.)

Monitor patients with preexisting effusions beginning with the first dose.1 84 85 86

Sensitivity Reactions

Hypersensitivity Reactions

Severe reactions (hypotension and/or bronchospasm, generalized rash/erythema, and, rarely, fatal anaphylaxis) reported in some patients despite receiving recommended 3 days of dexamethasone premedication.1 84 85 86

Premedicate with oral corticosteroids to reduce the severity of hypersensitivity reactions.1 84 85 86 (See Premedication under Dosage and Administration.)

Closely observe for hypersensitivity reactions, especially during the first and second infusions.1 84 85 86

Reactions may occur within a few minutes following initiation of the infusion.1 9 25 84 85 86 Interruption of therapy generally is not needed for mild reactions (e.g., flushing, localized skin reactions);1 13 15 18 19 20 23 84 85 86 consider decreasing the infusion rate until symptoms resolve.37

Discontinue immediately and treat if severe reaction occurs.1 84 85 86

Do not administer to any patient who experienced a severe hypersensitivity reaction during a previous course.1 84 85 86

Other Warnings and Precautions

Myelodysplastic Syndrome and Secondary Leukemia

Treatment-related myelodysplasia or acute myeloid leukemia (AML) reported in patients who received docetaxel in combination with other antineoplastic agents with or without radiation therapy.1 84 85 86

Patients receiving docetaxel with cyclophosphamide and doxorubicin as adjuvant therapy for breast cancer require continued hematologic monitoring.1 84 85 86

Dermatologic Effects

Localized erythema of the extremities with edema followed by desquamation reported.1 84 85 86

Reversible cutaneous reactions characterized by rash (e.g., localized eruptions on the feet, hands, arms, face, or thorax) and pruritus reported; generally occur within 1 week of administration, resolve before the next infusion, and are not disabling.1 84 85 86

Adjust dosage if severe skin toxicity occurs.1 84 85 86 (See Dosage under Dosage and Administration.)

Nervous System Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Severe neurosensory symptoms (paresthesia, dysesthesia, pain) reported; spontaneous reversal reported in a median of 9 weeks from onset.1 84 85 86 Neuromotor toxicity reported less frequently.1 27 28 29 84 85 86 Dosage reduction or drug discontinuance may be required (see Dosage under Dosage and Administration).1 84 85 86

Severe asthenia reported; fatigue and weakness may last a few days to several weeks and may be associated with deterioration of performance status in patients with progressive disease.1 84 85 86

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; embryotoxic and fetotoxic in animals.1 84 85 86 Avoid pregnancy during therapy.1 84 85 86 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1 84 85 86

Prescribing and Dispensing Precautions

Ensure accuracy of prescription; similarity of spelling of Taxotere (docetaxel) and Taxol (paclitaxel) may result in errors.62

Specific Populations

Pregnancy

Category D.1 84 85 86 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether distributed into milk; discontinue nursing or drug.1 84 85 86

Pediatric Use

Has been studied in patients 1–26 years of age with various recurrent or refractory solid tumors;1 however, efficacy in pediatric patients not established.1 84 85 86 Safety and pharmacokinetic (i.e., clearance) data appeared similar to data for adults.1 Primary dose-limiting toxicity was neutropenia.1

Geriatric Use

Certain toxicities associated with docetaxel therapy may occur more frequently and with greater severity in geriatric patients ≥65 years of age; select dose with caution because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.1 84 85 86

Docetaxel with cisplatin as first-line therapy for advanced NSCLC: Similar survival but increased incidence of diarrhea, infections, peripheral edema, and stomatitis in patients ≥65 years of age compared with younger adults.1 81 84 86

Docetaxel with prednisone for treatment of advanced prostate cancer: Increased incidence of anemia, infection, nail changes, anorexia, and weight loss in patients ≥65 years of age compared with younger adults.1 84 85 86

Docetaxel with cisplatin and fluorouracil for treatment of advanced gastric cancer: Increased incidence of lethargy, stomatitis, diarrhea, dizziness, edema, febrile neutropenia, and neutropenic infection in patients ≥65 years of age compared with younger adults; insufficient experience to determine whether geriatric patients respond differently than younger adults.1 86

Docetaxel with cisplatin and fluorouracil as induction therapy for advanced head and neck cancer: Insufficient experience to determine whether geriatric patients respond differently than younger adults.1 86

Docetaxel with doxorubicin and cyclophosphamide as adjuvant therapy for breast cancer: Insufficient experience to determine age-related differences in response or tolerance.1 84 86

Hepatic Impairment

Increased incidence of treatment-related mortality in patients with abnormal liver function.1 84 85 86 (See Hepatic Impairment in Boxed Warning.)

Common Adverse Effects

Alopecia, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, fluid retention, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, asthenia, pain, nausea, diarrhea, vomiting, infections, mucositis, skin reactions, myalgia.1 84 85 86

Interactions for Taxotere

Metabolized by CYP3A4.1 84 85 86

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP3A.1 84 85 86

Potent CYP3A4 inhibitors: Possible pharmacokinetic interaction (increased exposure to docetaxel).1 84 85 86 Avoid concomitant use; if concomitant use cannot be avoided, consider reducing docetaxel dosage and carefully monitor for toxicity.1 84 85 86 Manufacturer recommends considering a 50% reduction in docetaxel dosage based on limited pharmacokinetic data for ketoconazole; however, clinical data not available for use of this adjusted dosage in patients receiving potent CYP3A4 inhibitors.1 84 85 86 (See Specific Drugs under Interactions.)

Specific Drugs

Drug

Interaction

Comments

Antifungals, azoles (itraconazole, ketoconazole, voriconazole)

Ketoconazole: Reduced clearance (by 49%) and increased exposure (by 2.2-fold) of docetaxel1 84 85 86

Itraconazole, voriconazole: Possible increased docetaxel exposure1 84 85 86

Avoid concomitant use; if concomitant use cannot be avoided, consider 50% reduction in docetaxel dosage and monitor for toxicity1 84 85 86

Cisplatin

Pharmacokinetic interaction unlikely1 84 86

Corticosteroids (dexamethasone, prednisone)

No effect on docetaxel clearance1 84 85 86

Fluorouracil

Pharmacokinetic interaction unlikely1 84 86

HIV protease inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)

Possible increased docetaxel exposure1 84 85 86

Avoid concomitant use; if concomitant use cannot be avoided, consider 50% reduction in docetaxel dosage and monitor for toxicity1 84 85 86

Macrolides (clarithromycin, telithromycin)

Possible increased docetaxel exposure1 84 85 86

Avoid concomitant use; if concomitant use cannot be avoided, consider 50% reduction in docetaxel dosage and monitor for toxicity1 84 85 86

Nefazodone

Possible increased docetaxel exposure1 84 85 86

Avoid concomitant use; if concomitant use cannot be avoided, consider 50% reduction in docetaxel dosage and monitor for toxicity1 84 85 86

Taxotere Pharmacokinetics

Distribution

Extent

Not known whether docetaxel is distributed into milk.1 84 85 86

Plasma Protein Binding

94–97%.1 84 85 86

Elimination

Metabolism

Metabolized by CYP3A4.1 84 85 86

Elimination Route

Eliminated in feces (75%) and in urine (6%), mainly as metabolites; <8% recovered in feces as unchanged drug within 48 hours.1 84 85 86

Half-life

Half-lives for the α, β, and γ phases are about 4 minutes, 36 minutes, and 11.1 hours, respectively.1 84 85 86

Special Populations

Clearance reduced and systemic exposure increased in patients with mild to moderate hepatic impairment (serum AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN).1 84 85 86 Wide interindividual variation; insufficient data for dosage recommendation.1 84 85 86

Stability

Storage

Parenteral

Polysorbate 80 (in docetaxel injection) can cause leaching of diethylhexyl phthalate (DEHP) from PVC containers.36 Do not permit contact of docetaxel injection concentrate or reconstituted docetaxel solution with plasticized PVC equipment or devices.1 36 84 85 86 Store final diluted docetaxel solutions for infusion in glass or polypropylene containers or in plastic (polypropylene or polyolefin) bags and administer through polyethylene-lined administration sets.1 36 84 85 86

Injection Concentrate Requiring One Dilution Step

Taxotere: Store unopened vials at 2–25°C in original package to protect from bright light.1

Docetaxel injection concentrate (Hospira): Store unopened vials at 25°C (may be exposed to 15–30°C) in original package to protect from bright light.84 Store multiple-dose vials at 2–8°C between uses, protected from light, for up to 28 days.84

Freezing does not adversely affect injection concentrate.1 84

Docetaxel infusion solution (prepared by mixing injection concentrate with 0.9% sodium chloride injection or 5% dextrose injection): Store for up to 3 hours at 2–25°C before initiating the 1-hour IV infusion.1 84

Injection Concentrate Requiring Two Dilution Steps

Docetaxel injection concentrate (Accord): Store unopened vials at 25°C (may be exposed to 15–30°C); protect from bright light.86

Initial diluted solution (prepared by mixing contents of diluent vial with docetaxel injection concentrate): Store in refrigerator or at room temperature for up to 8 hours.86

Final diluted solution for infusion (prepared by mixing initial diluted solution with 0.9% sodium chloride injection or 5% dextrose injection): Store for up to 3 hours at 2–25°C before initiating the 1-hour IV infusion.86

Powder for Injection

Docefrez: 2–8°C in original package to protect from bright light.85

Reconstituted solution: Store in refrigerator or at room temperature for up to 8 hours.85

Docetaxel infusion solution (prepared by mixing reconstituted solution with 0.9% sodium chloride injection or 5% dextrose injection): Store for up to 3 hours at 2–25°C before initiating the 1-hour IV infusion.85

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility1 HID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility
Y-site CompatibilityHID

Compatible

Acyclovir sodium

Amifostine

Amikacin sulfate

Aminophylline

Ampicillin sodium

Ampicillin sodium–sulbactam sodium

Anidulafungin

Aztreonam

Bumetanide

Buprenorphine HCl

Butorphanol tartrate

Calcium gluconate

Cefazolin sodium

Cefepime HCl

Cefotaxime sodium

Cefotetan disodium

Cefoxitin sodium

Ceftazidime

Ceftriaxone sodium

Cefuroxime sodium

Chlorpromazine HCl

Cimetidine HCl

Ciprofloxacin

Clindamycin phosphate

Co-trimoxazole

Dexamethasone sodium phosphate

Diphenhydramine HCl

Dobutamine HCl

Dopamine HCl

Doripenem

Doxycycline hyclate

Droperidol

Enalaprilat

Famotidine

Fluconazole

Furosemide

Ganciclovir sodium

Gemcitabine HCl

Gentamicin sulfate

Granisetron HCl

Haloperidol lactate

Heparin sodium

Hydrocortisone sodium succinate

Hydromorphone HCl

Hydroxyzine HCl

Imipenem–cilastatin sodium

Leucovorin calcium

Lorazepam

Magnesium sulfate

Mannitol

Meperidine HCl

Meropenem

Mesna

Metoclopramide HCl

Metronidazole

Morphine sulfate

Ondansetron HCl

Oxaliplatin

Palonosetron HCI

Pemetrexed disodium

Piperacillin sodium–tazobactam sodium

Potassium chloride

Prochlorperazine edisylate

Promethazine HCl

Ranitidine HCl

Sodium bicarbonate

Ticarcillin disodium–clavulanate potassium

Tobramycin sulfate

Vancomycin HCl

Zidovudine

Incompatible

Amphotericin B

Doxorubicin HCl liposome injection

Methylprednisolone sodium succinate

Nalbuphine HCl

Actions

  • A semisynthetic taxoid produced from the needles of the European yew (Taxus baccata) tree.1 2 3 4 5 6 Structurally and pharmacologically similar to paclitaxel.2 4 5 7 8

  • Disrupts the microtubular network in cells that is essential for mitotic and interphase cellular function.1

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of recognizing and reporting adverse effects including myalgia, neurologic effects, and cutaneous reactions.1 84 85 86

  • Importance of reading the patient information leaflet.1 84 85 86

  • Importance of recognizing and immediately reporting manifestations of a hypersensitivity reaction (e.g., difficulty breathing or swallowing, facial swelling, rash).1 84 85 86

  • Importance of taking the oral corticosteroid premedication as directed to prevent severe hypersensitivity reactions and minimize incidence and severity of fluid retention; importance of patients informing clinicians of noncompliance.1 84 85 86

  • Importance of recognizing and reporting signs of fluid retention (e.g., peripheral edema in lower extremities, weight gain, dyspnea).1 84 85 86

  • Importance of obtaining routine blood cell counts; inform patients to monitor temperature frequently and immediately inform clinician of fever.1 84 85 86

  • Risk of nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site reactions, and alopecia.1 84 85 86

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy and to use an effective method of contraception during therapy.1 84 85 86 Advise pregnant women of risk to fetus.1 84 85 86

  • Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illness.1 84 85 86

  • Importance of informing patients of other important precautionary information.1 84 85 86 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Docetaxel

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV infusion

20 mg

Docefrez (with ethanol 35.4% w/w in polysorbate 80 diluent)

Caraco

80 mg

Docefrez (with ethanol 35.4% w/w in polysorbate 80 diluent)

Caraco

Injection concentrate, for IV infusion

10 mg (of anhydrous docetaxel) per mL (20, 80, or 160 mg)

Docetaxel Injection

20 mg (of anhydrous docetaxel) per mL (20 or 80 mg)

Taxotere

Sanofi-Aventis

40 mg (of anhydrous docetaxel) per mL (20 or 80 mg)

Docetaxel Injection (with 13% w/v polyethylene glycol 400 in water for injection diluent)

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions February 15, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Sanofi-Aventis. Taxotere (docetaxel) injection concentrate prescribing information. Bridgewater, NJ; 2011 Sep.

2. Bissery MC, Nohynek G, Sanderink G-J et al. Docetaxel (Taxotere): a review of preclinical and clinical experience. Part I: preclinical experience. Anti-Cancer Drugs. 1995; 6:339-68. [PubMed 7670132]

3. Cortes JE, Pazdur R. Docetaxel. J Clin Oncol. 1995; 13:2643-55. [IDIS 356145] [PubMed 7595719]

4. Pazdur R, Kudelka AP, Kavanagh JJ et al. The taxoids: paclitaxel (Taxol) and docetaxel (Taxotere. Cancer Treat Rev. 1993; 19:351-86. [PubMed 8106152]

5. Eisenhauer EA, Trudeau M. An overview of phase II studies of docetaxel in patients with metastatic breast cancer. Eur J Cancer. 1995; 31A(Suppl 4):S11-3. [PubMed 7577098]

6. Gelmon K. The taxoids: paclitaxel and docetaxel. Lancet. 1994; 344:1267-72. [IDIS 338182] [PubMed 7967989]

7. Huizing MT, Sewberath Misser VH, Pieters RC et al. Taxanes: a new class of antitumor agents. Cancer Invest. 1995; 13:381-404. [PubMed 7627725]

8. Pronk LC, Stoter G, Verweij J. Docetaxel (Taxotere): single agent activity, development of combination treatment and reducing side-effects. Cancer Treat Rev. 1995; 21:463-78. [PubMed 8556719]

9. Verweij J, Clavel M, Chevalier B. Paclitaxel (Taxol) and docetaxel (Taxotere: not simply two of a kind. Ann Oncol. 1994; 5:495-505. [PubMed 7918121]

10. Abrams JS, Moore TD, Friedman M. New chemotherapeutic agents for breast cancer. Cancer. 1994; 74:1164-76. [IDIS 334183] [PubMed 7913662]

11. Eisenhauer EA. Docetaxel: current status and future prospects. J Clin Oncol. 1995; 13:2865-8. [IDIS 357156] [PubMed 8523048]

12. Capri G, Tarenzi E, Fulfaro F et al. The role of taxanes in the treatment of breast cancer. Semin Oncol. 1996; 23(Suppl 2):68-75. [PubMed 8614849]

13. Ravdin PM, Burris HA III, Cook G et al. Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer. J Clin Oncol. 1995; 13:2879-85. [IDIS 357157] [PubMed 8523050]

14. Valero V, Holmes FA, Walters RS et al. Phase II trial of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer. J Clin Oncol. 1995; 13:2886-94. [IDIS 357158] [PubMed 8523051]

15. ten Bokkel Huinink WW, Prove AM, Piccart M et al. A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer: a study of the EORTC Early Clinical Trials Group. Ann Oncol. 1994; 5:527-32. [PubMed 7918124]

16. van Oosterom AT. Docetaxel (Taxotere): an effective agent in the management of second-line breast cancer. Semin Oncol. 1995; 22(Suppl 13):22-8. [PubMed 8604449]

17. Guastalla JP, Bonneterre J, Fumoleau P et al. A phase II trial of docetaxel in patients (pts) with anthracycline resistant (AR) metastatic breast cancer (MBC). Eur J Cancer. 1995; 31A(Suppl 5):S75-6.

18. Chevallier B, Fumoleau P, Kerbrat P et al. Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: a phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer. J Clin Oncol. 1995; 13:314-22. [IDIS 342589] [PubMed 7844592]

19. Trudeau ME, Eisenhauer EA, Higgins BP et al. Docetaxel in patients with metastatic breast cancer: a phase II study of the National Cancer Institute of Canada-Clinical Trials Group. J Clin Oncol. 1996; 14:422-8. [IDIS 362034] [PubMed 8636752]

20. Hudis CA, Seidman AD, Crown JPA et al. Phase II and pharmacologic study of docetaxel as initial chemotherapy for metastatic breast cancer. J Clin Oncol. 1996; 14:58- 65. [IDIS 358668] [PubMed 8558221]

21. Trudeau ME. Docetaxel (Taxotere): an overview of first-line monotherapy. Semin Oncol. 1995; 22(Suppl 13):17-21. [PubMed 8604448]

22. Aapro M, Bruno R. Early clinical studies with docetaxel. Eur J Cancer. 1995; 31A(Suppl 4):S7-10. [PubMed 7577102]

23. Adache I, Watanabe T, Takashima S et al. A late phase II study of RP56976 (docetaxel) in patients with advanced or recurrent breast cancer. Br J Cancer. 1996; 73:210-6. [PubMed 8546908]

24. Fumoleau P, Chevallier B, Kerbrat P et al. Current status of Taxotere (docetaxel) as a new treatment in breast cancer. Breast Cancer Res Treat. 1994; 33:39-46.

25. van Oosterom AT, Schriivers D. Docetaxel (Taxotere), a review of preclinical and clinical experience. Part II: clinical experience. Anti-Cancer Drugs. 1995; 6:256-68.

26. Schrijvers D, Wanders J, Dirix L et al. Coping with toxicities of docetaxel (Taxotere). Ann Oncol. 1993; 4:610-11. [IDIS 360811] [PubMed 8103352]

27. Apfel SC. Docetaxel neuropathy. Neurology. 1996; 46:2-3. [IDIS 362120] [PubMed 8559375]

28. Hilkens PHE, Verweij J, Stoter G et al. Peripheral neurotoxicity induced by docetaxel. Neurology. 1996; 46:104-8. [IDIS 362128] [PubMed 8559354]

29. New PZ, Jackson CE, Rinaldi D et al. Peripheral neuropathy secondary to docetaxel (Taxotere). Neurology. 1996; 46:108-11. [IDIS 362129] [PubMed 8559355]

30. Zulian GB, Aapro MS. Docetaxel and radiation-recall severe mucositis. Ann Oncol. 1994; 5:964-6. [PubMed 7696172]

31. Zimmerman GC, Keeling JH, Burris HA et al. Acute cutaneous reactions to docetaxel, a new chemotherapeutic agent. Arch Dermatol. 1995; 131:202-6. [IDIS 342246] [PubMed 7857119]

32. Lemenager M, Genouville C, Bessa EH et al. Docetaxel-induced alopecia can be prevented. Lancet. 1995; 346:371-2. [IDIS 351261] [PubMed 7623542]

33. Battafarano DF, Zimmerman GC, Older SA et al. Docetaxel (Taxotere) associated scleroderma-like changes of the lower extremities: a report of three cases. Cancer. 1995; 76:110-5. [IDIS 349389] [PubMed 8630861]

34. Zimmerman GC, Keeling JH, Lowry M et al. Prevention of docetaxel-induced erythrodysesthesia with local hypothermia. J Natl Cancer Inst. 1994; 86:557-8. [IDIS 327975] [PubMed 7907667]

35. Food and Drug Administration. Prescription drug advertising; content and format for labeling of human prescription drugs. Fed Regist. 1979; 44:37434-67.

36. Pearson SD, Trissel LA. Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components. Am J Hosp Pharm. 1993; 50:1405-9. [PubMed 8362871]

37. Rhone-Poulenc Rorer Pharmaceuticals, Collegeville, PA: Personal communication.

38. Francis P, Bruno R, Seidman A et al. Pharmacodynamics (PD) of docetaxel (Taxotere) in patients (pts) with liver metastases (mets). Proc Ann Meet Am Soc Clin Oncol. 1994; 13:A346.

39. Cardenal F, Montes A, Llort G et al. Typhlitis associated with docetaxel treatment. J Natl Cancer Inst. 1996; 88:1078-9. [PubMed 8683639]

40. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Taxotere (docetaxel) [June 22, 1998]. From FDA web site

41. Nabholtz JM, Senn HJ, Bezwoda WR et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group. J Clin Oncol. 1999; 17:1413-24. [PubMed 10334526]

42. Chan S, Friedrichs K, Noel D et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999; 17:2341-54. [PubMed 10561296]

43. Fossella FV, Lee JS, Murphy WK et al. Phase II study of docetaxel for recurrent or metastatic non-small-cell lung cancer. J Clin Oncol. 1994; 12:1238-44. [IDIS 331847] [PubMed 7911160]

44. Francis PA, Rigas JR, Kris MG et al. Phase II trial of docetaxel in patients with stage III and IV non-small-cell lung cancer. J Clin Oncol. 1994; 12:1232-7. [IDIS 331846] [PubMed 7911159]

45. Miller VA, Rigas JR, Francis PA et al. Phase II trial of a 75-mg/m2 dose of docetaxel with prednisone premedication for patients with advanced non-small cell lung cancer. Cancer. 1995; 75:968-72. [IDIS 342401] [PubMed 7842417]

46. Kunitoh H, Watanabe K, Onoshi T et al. Phase II trial of docetaxel in previously untreated advanced non-small-cell lung cancer: a Japanese cooperative study. J Clin Oncol. 1996; 14:1649-55. [IDIS 366407] [PubMed 8622084]

47. Fossella FV, Lee JS, Shin DM et al. Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer. J Clin Oncol. 1995; 13:645-51. [IDIS 343787] [PubMed 7884425]

48. Fossella FV, Lee JS, Berille J et al. Summary of phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of advanced non-small cell lung cancer. Semin Oncol. 1995; 22(2 Suppl 4):22-9. [PubMed 7740327]

49. Saarinen A, Jekunen A, Halme M et al. A phase II trial of docetaxel in advanced non-small cell lung cancer. Anti-Cancer Drugs. 1996; 7:890-2. [PubMed 8991195]

50. Cerny T, Kaplan S, Pavlidis N et al. Docetaxel (TaxotereTM) is active in non-small-cell lung cancer: a phase II trial of the EORTC Early Clinical Trials Group (ECTG). Br J Cancer. 1994; 70:384-7. [PubMed 7914429]

51. Zalcberg J, Millward M, Bishop J et al. Phase II study of docetaxel and cisplatin in advanced non-small-cell lung cancer. J Clin Oncol. 1998; 16:1948-53. [IDIS 406137] [PubMed 9586914]

52. Non-small cell lung cancer. From PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2007 May 1.

53. Non-small Cell Lung Cancer Collaborative Group. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. BMJ. 1995; 311:899-909. [PubMed 7580546]

54. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52.

55. Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. Adopted on May 16, 1997 by the American Society of Clinical Oncology. J Clin Oncol. 1997; 15:2996-3018. [IDIS 391214] [PubMed 9256144]

56. Weick JK, Crowley J, Natale RB et al. A randomized trial of five cisplatin-containing treatments in patients with metastatic non-small-cell lung cancer: a Southwest Oncology Group study. J Clin Oncol. 1991; 9:1157-62. [PubMed 1646292]

57. Ramanathan RK, Belani CP. Chemotherapy for advanced non-small cell lung cancer: past, present, and future. Semin Oncol. 1997; 24:440-54. [PubMed 9280224]

58. Georgoulias V, Androulakis N, Dimopoulos AM et al. First-line treatment of advanced non-small-cell lung cancer with docetaxel and cisplatin: a multicenter phase II study. Ann Oncol. 1998; 9:331-4. [PubMed 9602269]

59. Shepherd FA, Dancey J, Ramlau R et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000; 18:2095-103. [IDIS 455768] [PubMed 10811675]

60. Fossella FV, DeVore R, Kerr RN et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol. 2000; 18:2354-62. [IDIS 449176] [PubMed 10856094]

61. Anon. FDA approves new indication for Taxotere. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 1999 Dec 23.

62. FDA advise-ERR: medication errors associated with Taxotere and Taxol. Rockville, MD: US Food and Drug Administration; 2001 Feb 7.

63. Harvey V, Mouridsen H, Semiglazov V et al. Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol. 2006; 24:4963-70. [PubMed 17033039]

64. Roche Laboratories Inc. Xeloda (capecitabine) tablets prescribing information. Nutley, NJ; 2006 Jun 12.

65. Breast cancer. From PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2007 Aug 2.

66. O'Shaughnessy J, Miles D, Vukelja S et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002; 20:2812-23.

67. Nabholtz JM, Falkson C, Campos D et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol. 2003; 21:968-75. [PubMed 12637459]

68. Martin M, Pienkowski T, Mackey J et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005; 352:2302-13. [PubMed 15930421]

69. Fossella F, Pereira JR, von Pawel J et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol. 2003; 21:3016-24. [PubMed 12837811]

70. Tannock IF, de Wit R, Berry WR et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004; 351:1502-12. [PubMed 15470213]

71. Van Cutsem E, Moiseyenko VM, Tjulandin S et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006; 24:4991-7. [PubMed 17075117]

72. Vermorken JB, Remenar E, van Herpen C et al. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007; 357:1695-704. [PubMed 17960012]

73. 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; 357:1705-15. [PubMed 17960013]

74. Alba E, Martín M, Ramos M et al. Multicenter randomized trial comparing sequential with concomitant administration of doxorubicin and docetaxel as first-line treatment of metastatic breast cancer: a Spanish Breast Cancer Research Group (GEICAM-9903) phase III study. J Clin Oncol. 2004; 22:2587-93. [PubMed 15226326]

75. Perez EA. TAC—a new standard in adjuvant therapy for breast cancer? N Engl J Med. 2005; 352:2346-8. Editorial.

76. Noronha V. Adju vant docetaxel for node-positive breast cancer. N Engl J Med. 2005; 353:954. Letter. [PubMed 16136712]

77. Martin M, Vogel C. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005; 353:954-5. Reply.

78. Brain EG, Bachelot T, Serin D et al. Life-threatening sepsis associated with adjuvant doxorubicin plus docetaxel for intermediate-risk breast cancer. JAMA. 2005; 293:2367-71. [PubMed 15900007]

79. Martin M, Vogel C, Crown J et al. Life-threatening complications from doxorubicin-docetaxel chemotherapy for breast cancer. JAMA. 2005; 294:2166. Letter. [PubMed 16264153]

80. Jones SE, Savin MA, Holmes FA et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006; 24:5381-7. [PubMed 17135639]

81. Belani CP, Fossella F. Elderly subgroup analysis of a randomized phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for first-line treatment of advanced nonsmall cell lung carcinoma (TAX 326). Cancer. 2005; 104:2766-74. [PubMed 16288485]

82. Ovarian epithelial cancer. From PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2007 Jun 8.

83. Vasey PA, Jayson GC, Gordon A et al. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004; 96:1682-91. [PubMed 15547181]

84. Hospira. Docetaxel injection prescribing information. Lake Forest, IL; 2011 Aug.

85. Caraco Pharmaceutical Laboratories, Ltd. Docefrez (docetaxel) injection prescribing information. Detroit, MI; 2011 May.

86. Accord Healthcare, Inc. Docetaxel injection prescribing information. Durham, NC; 2011 Jun.

87. Ramachandra S. Dear health care professional letter: important preparation information for docetaxel injection. Lake Forest, IL: Hospira; Undated. Available at ION Solutions website. Accessed 2011 Aug 12.

88. Sanofi-aventis. FDA approves new Taxotere (docetaxel) injection concentrate formulation. Bridgewater, NJ: 2010 Aug 5. Press release. Available at Sanofi website.

89. Sanofi-Aventis, Bridgewater, NJ: Personal communication.

HID. Trissel LA. Handbook on injectable drugs. [online]. Bethesda, MD: American Society of Health-System Pharmacists. Available at MedicinesComplete website. Accessed 2012 Apr 4.

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