Taxotere

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

• 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 previously treated with platinum-based chemotherapy who received docetaxel monotherapy at a dose of 100 mg/m².^a Approximately half of deaths reported in breast cancer patients occurred during the first cycle; most deaths were due to sepsis.¹

  
  

• Hepatic Impairment


• 
  

  Docetaxel should not be administered 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 These patients are at increased risk for grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death.¹ 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

  
  


• 
  

  Obtain and review bilirubin, AST, ALT, and alkaline phosphatase values prior to each cycle.¹

  
  

• Hematologic Monitoring


• 
  

  Docetaxel should not be administered to patients with neutrophil counts <1500/mm³.¹

  
  


• 
  

  Monitor blood cell counts frequently.¹

  
  

• Hypersensitivity


• 
  

  Severe hypersensitivity reactions (hypotension and/or bronchospasm, generalized rash/erythema) reported in patients who received the recommended 3-day dexamethasone premedication.¹ Hypersensitivity reactions requiring discontinuance reported in patients who did not receive dexamethasone premedication.¹ Hypersensitivity reactions resolved following discontinuance of the infusion and appropriate treatment.¹

  
  


• 
  

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

  
  

• 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

  
  

• Experience of Supervising Clinician


• 
  

  Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹ Adequate diagnostic and treatment facilities should be readily available to manage complications.¹

  
  

Introduction

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

Uses for Taxotere

Breast Cancer

Treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy.^{a 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 40 54 b}

Non-small Cell Lung Carcinoma

Monotherapy of locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.^{a 54 59 60 61 b}

In combination with cisplatin for treatment of unresectable locally advanced or metastatic non-small cell lung cancer in patients who have not previously received chemotherapy for this condition;^a also used in combination with carboplatin.^b

Taxotere Dosage and Administration

General

• 
  

  All patients should be premedicated before docetaxel administration to prevent severe hypersensitivity reactions and to reduce the incidence and severity of fluid retention.¹

  
  


• 
  

  Oral dexamethasone 8 mg twice daily for 3 days, starting 1 day prior to docetaxel administration, can be given.^a

  
  


• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastics.^a

  
  

Administration

IV Administration

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

Administer by IV infusion.¹

Handle cautiously (by trained nonpregnant personnel); use protective equipment (e.g., gloves) and wash hands after removal of the gloves.¹

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

Administer through polyethylene-lined administration sets.^{1 36} Use of inline filters is neither required nor recommended.³⁷

Dilution

Docetaxel for injection concentrate requires 2 dilutions prior to administration.¹

Remove vials from refrigerator and allow to stand at room temperature for approximately 5 minutes. Add the contents of the diluent vial to the vial of docetaxel for injection concentrate, to give a solution containing docetaxel 10 mg/mL.¹

Mix this solution by repeated inversions for at least 45 seconds; do not shake.^a If foaming occurs, allow solution to stand for a few minutes to allow foam to dissipate; all foam does not have to dissipate to continue preparation.^a

Withdraw the appropriate dose with a calibrated syringe and inject into 250 mL of either 0.9% sodium chloride injection or 5% dextrose injection to produce a final docetaxel concentration of 0.3–0.74 mg/mL.^a

If doses larger than 200 mg of docetaxel are required, increase volume of IV solution accordingly so that a docetaxel concentration of 0.74 mg/mL is not exceeded.^a

Rate of Administration

Administer over 1 hour.¹

Dosage

Adults

Breast Cancer

IV

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

Dosage adjustment during treatment may be necessary.¹ In patients initially dosed at 100 mg/m² who experience febrile neutropenia, neutrophil count <500/mm³ for more than 1 week, severe or cumulative cutaneous reactions, or peripheral neuropathy, reduce dose by 25% (e.g., from 100 to 75 mg/m²) for subsequent courses of therapy.^{1 37} If the patient continues to experience these reactions, reduce dosage from 75 to 55 mg/m² or discontinue.¹ Discontinue entirely if >grade 3 peripheral neuropathy develops.^a

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 peripheral neuropathy.¹

Non-small Cell Lung Carcinoma

IV

Treatment after failure of platinum-based chemotherapy: 75 mg/m² in repeated 3-week cycles.^a Higher doses (i.e., 100 mg/m²) associated with increased hematologic toxicity, infection, and treatment-related mortality.^a

Chemotherapy-naive patients: 75 mg/m² immediately followed by cisplatin in repeated 3-week cycles.^a

Dosage adjustment during treatment may be necessary.^a In patients who are dosed initially at 75 mg/m² after failure of platinum-based chemotherapy who experience febrile neutropenia, neutrophil count <500/mm³ for more than 1 week, severe or cumulative cutaneous reactions, or other grade 3/4 nonhematologic toxicities, withhold until toxicity resolves and then resume at 55 mg/m².^a Discontinue entirely if >grade 3 peripheral neuropathy develops.^a

In chemotherapy-naive patients who are dosed initially at 75 mg/m² in conjunction with cisplatin whose nadir platelet count during the previous course is <25,000/mm³, or who experience febrile neutropenia or serious nonhematologic toxicities, reduce dose to 65 mg/m² for subsequent cycles.^a In patients who need further dose reduction, a dose of 50 mg/m² is recommended.^a

Prescribing Limits

Adults

Breast Cancer

IV

100 mg/m².¹

Special Populations

Hepatic Impairment

Not recommended in patients with hepatic impairment.¹ (See Hepatic Impairment under 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.^a

Cautions for Taxotere

Contraindications

• 
  

  Known hypersensitivity to docetaxel, polysorbate 80, or any other ingredient in the formulation.¹

  
  


• 
  

  Baseline neutrophil count <1500/mm³.¹

  
  

Warnings/Precautions

Warnings

Adequate Patient Evaluation and Monitoring

Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹

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

Prior to and during therapy, assess serum bilirubin, AST and/or ALT, and alkaline phosphatase concentrations.¹ Frequent monitoring of blood cell counts also recommended.¹

Hematologic Effects

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}

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 Neutrophil nadir at day 7–8;^{1 8 13 14 19 20} the median duration of grade 4 neutropenia is about 7 days.^{1 5 7 13}

Cardiovascular Toxicity

Severe fluid retention reported despite 3 days of dexamethasone premedication.^{1 3} (See Fluid Retention in Boxed Warning.)

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

Patients should be premedicated with oral corticosteroids to reduce the incidence and severity of fluid retention.¹ (See General under Dosage and Administration.)

Monitor patients with preexisting effusions beginning with the first dose.¹

Fetal/Neonatal Morbidity and Mortality

Embryotoxic and fetotoxic in animals.¹ If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard or potential risk of losing pregnancy.^a (See Pregnancy under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Severe reactions, characterized by hypotension and/or bronchospasm or generalized rash/erythema, reported in some patients despite receiving recommended 3 days of dexamethasone premedication.¹ Hypersensitivity reactions requiring discontinuance reported in patients who did not receive corticosteroid premedication.^a

Patients should be premedicated with oral corticosteroids to reduce the severity of hypersensitivity reactions.¹ (See General under Dosage and Administration.)

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

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

Discontinue immediately and treat if severe reaction occurs.¹

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

Dermatologic Effects

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

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

Major Toxicities

Nervous System Effects

Severe neurosensory symptoms (paresthesia, dysesthesia, pain) reported.¹ Reduce dosage if occurs (see Dosage under Dosage and Administration); if symptoms persist, discontinue docetaxel.¹ Discontinue docetaxel in patients who develop >grade 3 peripheral neuropathy.^a

Asthenia reported; symptoms of 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

General Precautions

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

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 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Discontinue nursing because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy in pediatric patients <16 years of age not established.^{1 37}

Geriatric Use

Geriatric patients ≥65 years of age receiving docetaxel with cisplatin experienced a higher incidence of diarrhea, infections, peripheral edema, and stomatitis than younger adults.^a

Hepatic Impairment

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

Common Adverse Effects

Alopecia, myelosuppression (neutropenia, leukopenia, anemia), fluid retention, neurosensory effects, nausea, diarrhea, stomatitis.¹

Interactions for Taxotere

Appears to be metabolized by CYP3A4.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

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

Specific Drugs

Drug	Interaction
Cisplatin	Pharmacokinetic interaction unlikelya
Cyclosporine	Possible interactiona
Dexamethasone	No effect on docetaxel protein binding1
Erythromycin	Possible increased plasma docetaxel concentrationsa
Ketoconazole	Possible increased plasma docetaxel concentrationsa
Nifedipine	Possible increased plasma docetaxel concentrationsa

Taxotere Pharmacokinetics

Distribution

Extent

Not known whether docetaxel is distributed into milk.¹

Plasma Protein Binding

94–97%.¹

Elimination

Metabolism

Metabolized by CYP3A4 isoenzyme.¹

Elimination Route

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

Half-life

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

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 Wide interindividual variation; insufficient data for dosage recommendation.¹

Stability

Storage

Parenteral

For Injection Concentrate

2–25°C in the original package to protect from bright light.¹ Freezing does not adversely affect the product.¹

Polysorbate 80 (in docetaxel injection) can cause leaching of diethylhexyl phthalate (DEHP) from PVC containers or administration sets.³⁶ Do not permit contact of undiluted docetaxel for injection concentrate with plasticized PVC equipment or devices.^{1 36} Stored diluted docetaxel solutions in glass or polypropylene containers or in plastic (polypropylene or polyolefin) bags and administer through polyethylene-lined administration sets.^{1 36}

Docetaxel solutions that have been diluted to 10 mg/mL (initial dilution) may be stored at room temperature or in the refrigerator for up to 8 hours.¹

Docetaxel solutions that have been diluted to 0.3–0.74 mg/mL (final dilution for infusion) should be used within 4 hours (including the 1 hour for administration).¹

Compatibility

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

Parenteral

Solution Compatibility^{a 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
Aztreonam
Bumetanide
Buprenorphine HCl
Butorphanol tartrate
Calcium gluconate
Cefazolin sodium
Cefepime HCl
Cefotaxime sodium
Cefoxitin sodium
Ceftazidime
Ceftizoxime sodium
Ceftriaxone sodium
Cefuroxime sodium
Chlorpromazine HCl
Cimetidine HCl
Ciprofloxacin
Clindamycin phosphate
Co-trimoxazole
Dexamethasone sodium phosphate
Diphenhydramine HCl
Dobutamine HCl
Dopamine HCl
Doxycycline hyclate
Droperidol
Enalaprilat
Famotidine
Fluconazole
Furosemide
Ganciclovir sodium
Gemcitabine HCl
Gentamicin sulfate
Granisetron HCl
Haloperidol lactate
Heparin sodium
Hydrocortisone sodium phosphate
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
Ofloxacin
Ondansetron HCl
Oxaliplatin
Palonosetron HCI
Pemetrexed disodium
Piperacillin sodium–tazobactam sodium
Potassium chloride
Prochlorperazine edisylate
Promethazine HCl
Ranitidine HCl
Ringer’s injection, lactated
Sodium bicarbonate
Ticarcillin disodium–clavulanate potassium
Tobramycin sulfate
Vancomycin HCl
Zidovudine
Incompatible
Amphotericin B
Doxorubicin HCl liposome injection
Methylprednisolone sodium succinate
Nalbuphine HCl

ActionsActions

• 
  

  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

• 
  

  Importance of recognizing and reporting adverse effects including myelosuppressive effects, infectious complications, and cutaneous reactions.¹

  
  


• 
  

  Importance of reading the patient information leaflet.¹

  
  


• 
  

  Probable alopecia.¹

  
  


• 
  

  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 during therapy and advise pregnant women of risk to fetus.¹

  
  


• 
  

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

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (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 concentrate, for IV infusion	40 mg (of anhydrous docetaxel) per mL (20 or 80 mg)	Taxotere (with bacteriostatic water for injection containing alcohol 13% w/w diluent)	Aventis

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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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]

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

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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]

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