DOCEtaxel

General

High Alert Medication: This medication bears a heightened risk of causing significant patient harm when it is used in error.

Pronunciation
doe-se-TAX-el [Pronunciation]

Trade Name(s)

• Docefrez

• Taxotere

Indications

• Breast cancer (locally advanced/metastatic breast cancer or with doxorubicin and cyclophosphamide as adjuvant treatment of node-positive disease).

• Non–small-cell lung cancer (locally advanced/metastatic) after failure on platinum regimen or with platinum as initial therapy).

• Advanced metastatic hormone-refractory prostate cancer (with prednisone).

• Squamous cell carcinoma of the head and neck (locally advanced) with cisplatin and fluorouracil.

• Gastric adenocarcinoma (locally advanced) with cisplatin and fluorouracil.

Action

Interferes with normal cellular microtubule function required for interphase and mitosis.

Therapeutic Effect(s):
Death of rapidly replicating cells, particularly malignant ones.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Extensively metabolized by the liver; metabolites undergo fecal elimination.

Half-life: 11.1 hr.

TIME/ACTION PROFILE (effect on blood counts)

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity;

• Hypersensitivity to polysorbate 80;

• Known alcohol intolerance;

• Neutrophil count <1500/mm³;

• Liver impairment (serum bilirubin > upper limit of normal, ALT and/or AST >1.5 times upper limit of normal, with alkaline phosphatase >2.5 times upper limit of normal);

• OB: Lactation: Pregnancy or lactation.

• OB: Patients with childbearing potential;

• Pedi: Efficacy not established.

Adverse Reactions/Side Effects

CNS: fatigue, weakness.

Resp: bronchospasm.

CV: ASCITES, CARDIAC TAMPONADE, PERICARDIAL EFFUSION, PULMONARY EDEMA, peripheral edema.

GI: diarrhea, nausea, stomatitis, vomiting.

Derm: alopecia, edema, rash, dermatitis, desquamation, erythema, nail disorders.

Hemat: anemia, leukopenia, thrombocytopenia, leukemia.

Local: injection site reactions.

MS: myalgia, arthralgia.

Neuro: neurosensory deficits, peripheral neuropathy.

Misc: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS .

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• ↑ bone marrow depression may occur with other antineoplastics or radiation therapy .

• Strong inhibitors of CYP3A4, including atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole ↑ levels and the risk of toxicity; avoid concomitant use (if need to use, ↓ docetaxel dose by 50%).

Route/Dosage

• IV (Adults): Breast cancer—60–100 mg/m² every 3 wk; Breast cancer adjuvant therapy—75 mg/m² every 3 wk for 6 cycles (with doxorubicin and cyclophosphamide); Non–small-cell lung cancer—75 mg/m² every 3 wk (alone or with platinum); Prostate cancer—75 mg/m² every 3 wk (with oral prednisone); Squamous cell head and neck cancer—75 mg/m² every 3 wk for 3–4 cycles (with cisplatin and fluorouracil); Gastric adenocarcinoma-75 mg/m² every 3 wk (with cisplatin and fluorouracil)..

Availability

• Injection concentrate: 10 mg/mL, 20 mg/mL, 40 mg/mL

• Lyophilized powder for injection: 20 mg/vial, 80 mg/vial

Assessment

• Monitor vital signs before and after administration.

• Assess infusion site for patency. Docetaxel is not a vesicant. If extravasation occurs, discontinue docetaxel immediately and aspirate the IV needle. Apply cold compresses to the site for 24 hr.

• Monitor for hypersensitivity reactions continuously during infusion. These are most common after the first and second doses of docetaxel. Reactions may consist of bronchospasm, hypotension, and/or erythema. Mild to moderate reactions may be treated symptomatically and infusion slowed or stopped until reaction subsides. Severe reactions require discontinuation of therapy and symptomatic treatment. Do not readminister docetaxel to patients with previous severe reactions. Severe edema may also occur. Weigh patients before each treatment. Fluid accumulation may result in edema, ascites, and pleural or pericardial effusions. Pretreatment with corticosteroids (such as dexamethasone 8 mg PO twice daily for 3 days, starting 1 day before docetaxel) is recommended to minimize edema and hypersensitivity reactions. PO furosemide may be used to treat edema. For hormone-refractory metastatic prostate cancer (given with prednisone), recommended premedication regimen is dexamethasone 8 mg PO, at 12 hours, 3 hours and 1 hour before docetaxel infusion.

• Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae; guaiac stools, urine, and emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.

• Assess for rash. May occur on feet or hands but may also occur on arms, face, or thorax, usually with pruritus. Rash usually occurs within 1 wk after infusion and resolves before next infusion.

• Assess for development of neurosensory deficit (paresthesia, dysesthesia, pain, burning). May also cause weakness. Pyridoxine may be used to minimize symptoms. Severe symptoms may require dose reduction or discontinuation.

• Assess for arthralgia and myalgia, which are usually relieved by nonopioid analgesics but may be severe enough to require treatment with opioid analgesics.

• Assess for diarrhea and stomatitis. If Grade 3 or 4, reduce dose.

• Monitor CBC and differential before each treatment. Frequently causes neutropenia (<2000 neutrophils/mm³); may require dose adjustment. If the neutrophil count is less than 1500/mm³, hold dose. Neutropenia is reversible and not cumulative. The nadir is 8 days, with a duration of 7 days. May also cause thrombocytopenia and anemia.

» Monitor liver function studies (AST, ALT, alkaline phosphatase, bilirubin) before each cycle. If AST/ALT >2.5 to ≤5 x upper limit of normal and AP ≤2.5 x upper limit of normal, or AST/ALT >1.5 to ≤5 x upper limit of normal and AP >2.5 to ≤5 x ULN, reduce dose by 20%. If AST/ALT >5 x upper limit of normal and/or AP >5 x upper limit of normal discontinue therapy.

Potential Nursing Diagnoses

• Risk for infection (Adverse Reaction)

• Risk for injury (Adverse Reaction)

Implementation

• High Alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double-check original order, calculations, and infusion pump settings. Do not confuse Taxotere (docetaxel) with Taxol (paclitaxel).

• Premedicate with dexamethasone 8 mg twice daily for 3 days starting 1 day before docetaxel infusion to reduce incidence and severity of fluid retention and hypersensitivity reactions Premedicate patients with hormone-refractory metastatic prostate cancer with PO dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before docetaxel infusion.

• Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling medication. Discard IV equipment in specially designated containers.

• pH:
No Data.

• Intermittent Infusion:
For injection concentrate: Before dilution, allow vials to stand at room temperature for 5 min. Solution is pale yellow to brownish yellow. For powder for injection: Allow number of vials required for dose to stand at room temperature for 5 min. Reconstitute with diluent provided, 1 mL for 20 mg vial or 4 mL for 80 mg vial. Shake vial to dissolve. Solution should be clear; do not administer solutions that are discolored or contain a precipitate. Allow solution to stand for a few minutes for air bubbles to dissipate. May be refrigerated for up to 8 hrs.
Concentration: 20 mg/0.8 mL for 20 mg vial; 24 mg/mL for 80 mg vial.
Diluent: Withdraw required amount and inject into 250 mL bag of 0.9% NaCl or D5W. If a dose greater than 200 mg is required, use a larger volume diluent so that concentration of 0.74 mg/mL is not exceeded. Rotate gently to mix. Do not administer solutions that are cloudy or contain a precipitate. Diluted solution must be infused within 4 hrs.
Concentration: 0.3 mg/mL to 0.74 mg/mL.

• Rate:
Administer over 1 hr.

• Y-Site Compatibility:

» acyclovir

» alfentanil

» allopurinol

» amifostine

» amikacin

» aminocaproic acid

» aminophylline

» amiodarone

» amphotericin B lipid complex

» ampicillin

» ampicillin/sulbactam

» anidulafungin

» argatroban

» atracurium

» azithromycin

» aztreonam

» bivalirudin

» bleomycin

» bumetanide

» buprenorphine

» busulfan

» butorphanol

» calcium chloride

» calcium gluconate

» carboplatin

» carmustine

» caspofungin

» cefazolin

» cefepime

» cefotaxime

» cefotetan

» cefoxitin

» ceftazidime

» ceftriaxone

» cefuroxime

» chlorpromazine

» ciprofloxacin

» cisatracurium

» cisplatin

» clindamycin

» cyclophosphamide

» cyclosporine

» cytarabine

» dacarbazine

» dactinomycin

» daptomycin

» dexamethasone sodium phosphate

» dexmedetomidine

» dextrazoxane

» diazepam

» digoxin

» diltiazem

» diphenhyrdamine

» dobutamine

» dopamine

» doripenem

» doxacurium

» doxycycline

» droperidol

» enalaprilat

» ephedrine

» epinephrine

» epirubicin

» ertapenem

» erythromycin

» esmolol

» etoposide

» etoposide phosphate

» famotidine

» fenoldopam

» fentanyl

» fluconazole

» fludarabine

» fluorouracil

» foscarnet

» fosphenytoin

» furosemide

» ganciclovir

» gemcitabine

» gentamicin

» glycopyrrolate

» granisetron

» haloperidol

» heparin

» hydralazine

» hydrocortisone

» hydromorphone

» ifosfamide

» imipenem/cilastatin

» insulin

» irinotecan

» isoproterenol

» ketorolac

» leucovorin

» levofloxacin

» levorphanol

» lidocaine

» linezolid

» lorazepam

» LR

» magnesium sulfate

» mannitol

» meperidine

» meropenem

» mesna

» methotrexate

» methyldopate

» metoclopramide

» metoprolol

» metronidazole

» midazolam

» mitoxantrone

» mivacurium

» morphine

» nafcillin

» naloxone

» nesiritide

» nitroglycerin

» nitroprusside

» norepinephrine

» octreotide

» ondansetron

» oxaliplatin

» palonosetron

» pamidronate

» pancuronium

» pantoprazole

» pemetrexed

» pentamidine

» pentazocine

» pentobarbital

» phenobarbital

» phentolamine

» phenylephrine

» piperacillin/tazobactam

» potassium acetate

» potassium chloride

» potassium phosphates

» procainamide

» prochlorperazine

» promethazine

» propranolol

» quinupristin/dalfopristin

» ranitidine

» remifentanil

» rituximab

» rocuronium

» sodium acetate

» sodium bicarbonate

» sodium phosphates

» succinylcholine

» sufentanil

» tacrolimus

» teniposide

» theophylline

» thiotepa

» ticarcillin/clavulanate

» tigecycline

» tirofiban

» tobramycin

» tolazoline

» trastuzumab

» trimethoprim/sulfamethoxazole

» vancomycin

» vecuronium

» vincristine

» vinorelbine

» voriconazole

» zidovudine

» zolendronic acid

• Y-Site Incompatibility:

» amphotericin B colloidal

» amphotericin B liposome

» dantrolane

» doxorubicin liposome

» idarubicin

» methylprednisolone

» nalbuphine

» phenytoin

Patient/Family Teaching

• Instruct patient to report symptoms of hypersensitivity reactions (trouble breathing; sudden swelling of face, lips, tongue, throat; trouble swallowing; hives; rash; redness all over body) to health care professional immediately.

• Advise patient to notify health care professional if fever >101°F; chills; sore throat; signs of infection; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occur. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor.

• Patient should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.

• Fatigue is a frequent side effect of docetaxel. Advise patient that frequent rest periods and pacing of activities may minimize fatigue.

• Instruct patient to notify health care professional if signs of fluid retention (peripheral edema in the lower extremities, weight gain, dyspnea), abdominal pain, yellow skin, weakness, paresthesia, gait disturbances, swelling of the feet, or joint or muscle aches occur.

• Instruct patient to inspect oral mucosa for redness and ulceration. If mouth sores occur, advise patient to use sponge brush and rinse mouth with water after eating and drinking.

• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.

• Discuss with patient the possibility of hair loss. Complete hair loss usually begins after 1 or 2 treatments and is reversible after discontinuation of therapy. Explore coping strategies.

• Instruct patient not to receive any vaccinations without advice of health care professional.

• Advise female patients to use effective contraception during therapy and to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

• Emphasize the need for periodic lab tests to monitor for side effects.

Evaluation/Desired Outcomes

• Decrease in size or spread of malignancy in women with advanced breast cancer.

• Decrease in size or spread of malignancy in locally advanced or metastatic non–small-cell lung cancer, squamous cell carcinoma of the head and neck and gastric adenocarcinoma.

• Decreased size or spread of advanced metastatic hormone-refractory prostate cancer.