docetaxel (Rx)

Brand and Other Names:Taxotere, Docefrez
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 10mg/mL (2mL, 8mL, 16mL vials)
  • 20mg/mL (1mL, 4mL vials)

alcohol-free solution for injection

  • 20mg/mL
  • 80mg/4mL
  • 160mg/8mL

Breast Cancer

Locally advanced or metastatic

  • For locally advanced or metastatic breast cancer after failure of prior chemotherapy
  • Monotherapy: 60-100 mg/m² IV over 1 hr q3Weeks  

Operable node-positive

  • Adjuvant combination therapy: 75 mg/m² IV 1 hr after doxorubicin and cyclophosphamide q3Weeks x 6 cycles

Dosage modifications (advanced or metastatic)

  • Inital 100 mg/m²
  • Febrile neutropenia, ANC <500/mm³ for ≥1 week, or severe/cumulative cutaneous reactions
  • Reduce first to 75 mg/m²
  • If AEs persist: Reduce further to 55 mg/m² or discontinue

Dosage modifications (adjuvant treatment)

  • Initial: 75 mg/m²
  • Reduce to 60 mg/m² in patients with febrile neutropenia treated with G-CSF, or severe or cumulative cutaneous or neurosensory reactions

Other dosage modifications

  • Grade 3 peripheral neuropathy: Discontinue
  • Combo therapy (with doxorubicin and cyclophosphamide): Febrile neutropenia (give G-CSF in all, if continues, reduce to 60 mg/m², continue G-CSF)
  • Grade 3/4 Stomatitis: Decrease to 60 mg/m²
  • Severe/cumulative cutaneous reactions, moderate neurosensory S/S: Reduce to 60 mg/m²
  • Discontinue if adverse effects persists

Non-small Cell Lung Cancer

Indicated for treatment (as monotherapy) in patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy

Also indicated in combination with cisplatin for the treatment of unresectable, locally advanced or metastatic NSCLC in patients who have not previously received chemotherapy

75 mg/m2 IV over 1 hr q3Weeks  

Dose Modifications (Monotherapy)

  • Febrile neutropenia, ANC <500/mm3 for ≥1 week, other grade 3/4 nonhematological toxicities, severe/cumulative cutaneous reactions (withhold treatment until resolution; THEN, resume at 55 mg/m2)
  • Grade 3 peripheral neuropathy: Discontinue

Dose Modifications (Combination Therapy)

  • Febrile neutropenia,platelet nadir <25,000 cells/mm3 serious non-hematologic toxicities: Reduce first to 65 mg/m2; may reduce further to 50 mg/m²

Gastric Cancer

Indicated in combination with cisplatin and fluorouracil advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, in patients who have not received prior chemotherapy for advanced disease

Day 1: 75 mg/m2 IV infusion over 1 hour, followed by cisplatin 75 mg/m2 as a 1-3 hr infusion  

Post cisplatin: Fluorouracil 750 mg/m2 qDay given as a 24-hr continuous infusion for 5 days

Repeat cycle q3Weeks

Dose modifications (neutropenia)

  • Febrile neutropenia, prolonged neutropenia or neutropenic infection
  • First time: Use G-CSF
  • If continues despite G-CSF: Reduce to 60 mg/m2
  • If recurs thereafter: Reduce to 45 mg/m2

Grade 4 thrombocytopenia

  • Do not resume until ANC >1500/mm3 and platelets >100,000/mm3
  • Reduce to 60 mg/m2
  • If toxicities persist: Discontinue

Diarrhea

  • Grade 3 (first episode): Reduce fluorouracil dose by 20%
  • Grade 3 (second episode): Then reduce docetaxel dose by 20%
  • Grade 4 (first episode): Reduce docetaxel & fluorouracil doses by 20%
  • Grade 4 (second episode): Discontinue treatment

Hepatotoxicity

  • AST/ALT 2.5-5 times ULN & alkaline phosphatase 2.5 times ULN, OR AST/ALT 1.5-5 times ULN & alkaline phosphatase 2.5-5 times ULN: Reduce by 20%
  • If AST/ALT >5 times upper limit of normal &/or alkaline phosphatase >5 times ULN: Discontinue

Head & Neck Cancer

Indicated in combination with cisplatin and fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Induction chemotherapy followed by radiotherapy

  • For the induction treatment of locally advanced inoperable SCCHN
  • Day 1: 75 mg/m2 IV infusion over 1 hour, followed by cisplatin 75 mg/m2 as a 1 hr infusion  
  • Post cisplatin: Fluorouracil 750 mg/m2 qDay given as a 24-hr continuous IV infusion times 5 days
  • Repeat cycle q3Weeks 4 times

Induction chemotherapy followed by chemoradiotherapy

  • For the induction treatment of patients with locally advanced (unresectable, low surgical cure, or organ preservation) SCCHN
  • Day 1: 75 mg/m2 IV infusion over 1 hr, followed by cisplatin 100 mg/m2 as a 0.5-3 hr IV infusion
  • Post cisplatin: Fluorouracil 1000 mg/m2 qDay given as a 24-hr continuous IV infusion from day 1 to day 4
  • Repeat cycle q3Weeks times 3 cycles

Dosage Modifications

  • As with gastric cancer

Prostate Cancer

Indicated for hormone-refractory metastatic prostate cancer in combination with prednisone

75 mg/m2 IV over 1 hr q3Weeks with daily prednisone 5 mg PO q12hr  

Dose Modifications

  • Febrile neutropenia, ANC <500/mm3 for >1 week, or severe/cumulative cutaneous reactions, moderate neurosensory S/S
  • Reduce to 60 mg/m2
  • If AEs persist: Discontinue

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Do not administer if AST/ALT >5x ULN or alkaline phosphatase (AP) >5x ULN

Reduce dose by 20% if AST/ALT >2.5-5x ULN and AP ≤2.5x ULN

Reduce dose by 20% if AST/ALT >1.5-5x ULN and AP >2.5-5x ULN

Consider alcohol content of docetaxel when given to patients with hepatic impairment

Safety and efficacy not established

Investigational use for a variety of solid tumors in children is ongoing

Docetaxel has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluorouracil (see Prescribing Information)

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Interactions

Interaction Checker

and docetaxel

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            Adverse Effects

            Varies according to indication and treatment regimen

            >50%

            Alopecia

            Anemia

            Leukopenia

            Neutropenia

            Asthenia

            10-50%

            Fever

            Infections

            Fluid retention

            Hypersensitivity

            Skin reactions

            Diarrhea

            Nausea

            Vomiting

            Sensory neuropathy

            Myalgia

            Nail changes

            1-10%

            Arthralgia

            Thrombocytopenia

            Postmarketing Reports

            Body as a whole: Diffuse pain, chest pain, radiation recall phenomenon, injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) at the site of previous extravasation

            Cardiovascular: Atrial fibrillation, DVT, ECG abnormalities, thrombophlebitis, pulmonary embolism, syncope, tachycardia, myocardial infarction; ventricular arrhythmia including ventricular tachycardia reported when treated with docetaxel in combination regimens including doxorubicin, 5-FU and/or cyclophosphamide, and may be associated with fatal outcome

            Cutaneous: Cutaneous lupus erythematosus (very rare) and rare cases of bullous eruptions (eg, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and scleroderma-like changes usually preceded by peripheral lymphedema); in some cases multiple factors may have contributed to the development of these effects; severe hand and foot syndrome; permanent alopecia

            Gastrointestinal: Enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, reported with a potential fatal outcome; abdominal pain, anorexia, constipation, duodenal ulcer, esophagitis, gastrointestinal hemorrhage, GI perforation, intestinal obstruction, ileus, and dehydration as a consequence to GI events

            Hearing: Ototoxicity (rare); hearing disorders and/or hearing loss, including cases associated with other ototoxic drugs;

            Hematologic: Bleeding episodes; DIC, often in association with sepsis or multiorgan failure

            Hepatic: Hepatitis (rare), including fatalities primarily in patients with preexisting liver disorders

            Hypersensitivity: Anaphylactic shock (rare), including fatal outcomes despite premedication (very rare); hypersensitivity reactions with potential fatal outcome reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel

            Metabolism and nutrition disorders: Electrolyte imbalance, including hyponatremia, hypokalemia, hypomagnesemia, and hypocalcemia

            Neurologic: Confusion; seizures or transient loss of consciousness (rare) observed, sometimes appearing during administration

            Ophthalmologic: Conjunctivitis, lacrimation or lacrimation with or without conjunctivitis; excessive tearing which may be attributable to lacrimal duct obstruction; rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during drug infusion and in association with hypersensitivity reactions reported; these were reversible upon discontinuation; cystoid macular edema (CME)

            Respiratory: Dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis have rarely been reported and may be associated with fatal outcome; radiation pneumonitis (rare) reported in patients receiving concomitant radiotherapy

            Renal: Renal insufficiency and renal failure, majority associated with concomitant nephrotoxic drugs

            Second primary malignancies: Second primary malignancies reported, including AML, MDS, NHL, and renal cancer

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            Increased mortality reported in patients with liver impairment receiving higher doses, patients with non-small lung cancer, and a history of platinum-based chemotherapy receiving docetaxel as a single agent at a dose of 100 mg/m²

            Patients with elevations in bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk of developing grade 4 neutropenia, febrile neutropenia, infections, severe neutropenia, severe stomatitis, and toxic death

            Generally not given if bilirubin >ULN, or if SGOT and/or SGPT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN

            Perform blood cell counts on all patients receiving docetaxel; if neutrophil count <1500 cells/mm3, do not administer

            Severe hypersensitivity reactions, characterized by generalized rash/erythema, hypotension, and/or bronchospasm, or very rarely fatal anaphylaxis, reported in patients receiving the recommended 3-day dexamethasone premedication; discontinue infusion and administer appropriate therapy if hypersensitivity reaction occurs

            Do not give docetaxel to patients with documented hypersensitivity to the drug or drugs formulated with polysorbate 80

            Severe fluid retention may occur despite use of a 3-day dexamethasone premedication regimen; it may be characterized by poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites)

            Contraindications

            Hypersensitivity to docetaxel or polysorbate 80

            Solid tumor with baseline ANC<1500/cu.mm

            Cautions

            Treatment-related mortality higher in patients with hepatic impairment, those receiving higher doses, and in patients with NSCLC and history of prior platinum-based chemotherapy who receive docetaxel as a monotherapy at 100 mg/m²

            Patients with combined abnormalities of transaminases and alkaline phosphatase should not be treated docetaxel

            Perform frequent blood cell counts on all patients; do not retreat until neutrophils recover to >1500 cells/mm3 and platelets to >1000,000 cell/mm3 (see Dosage Modifications

            Enterocolitis and neutropenic colitis (typhlitis) reported; caution for patients with neutropenia, who are particularly at risk for developing GI complications; enterocolitis and neutropenic enterocolitis may develop at any time, and could lead to death as early as the first day of symptom onset

            Observed closely for hypersensitivity reactions, especially during the first and second infusions; severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients premedicated with 3 days of corticosteroids; severe hypersensitivity reactions require immediate discontinuation of the infusion and aggressive therapy; patients with history of severe hypersensitivity reactions should not be rechallenged; patients with history of paclitaxel hypersensitivity may develop a reaction to docetaxel

            Severe fluid retention reported; premedicate with oral corticosteroids prior to each administration to reduce incidence and severity

            Second primary malignancies reported, notably acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL), and renal cancer; may occur several months or years after docetaxel therapy

            Localized erythema of the extremities with edema followed by desquamation has been observed; adjust dose for severe skin toxicity

            Severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) were observed; adjust dose or discontinue if symptoms persist

            Cystoid macular edema (CME) reported; if impaired vision occurs, promptly schedule a comprehensive ophthalmologic examination; if CME diagnosed, discontinue docetaxel

            Severe asthenia reported; symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease

            Based on findings from animal reproduction studies and its mechanism of action, can cause fetal harm when administered to pregnant women

            Cases of alcohol intoxication reported with some formulations of docetaxel owing to the alcohol content (100 mg/m2 dose delivers 2 g/m2 of ethanol)

            Drug interaction overview

            • Docetaxel is a CYP3A4 substrate
            • Metabolism of docetaxel may be modified if coadministered with CYP3A4 inducers or inhibitors
            • Avoid use with strong CYP3A4 inhibitors; if unable to avoid, consider reducing docetaxel dose by 50%
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            Pregnancy & Lactation

            Pregnancy

            Based on findings in animal reproduction studies and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited available human data are not sufficient to inform drug-associated risk during pregnancy

            Verify the pregnancy status of females of reproductive potential prior to initiating therapy

            Animal studies

            • Administration to pregnant rats and rabbits during period of organogenesis caused an increased incidence of embryo-fetal toxicities, including intra-uterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively
            • Advise pregnant women and females of reproductive potential of potential risk to fetus

            Contraception

            • Females of reproductive potential: Use effective contraception during treatment and for 6 months following last dose
            • Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months following last dose

            Infertility

            • Based on findings in animal studies, therapy may impair fertility in males of reproductive potential

            Lactation

            There is no information regarding presence of docetaxel in human milk, or effects on milk production or the breast-fed child; no lactation studies in animals have been conducted; because of potential for serious adverse reactions in a breast-fed child from docetaxel exposure, including toxic death, hepatotoxicity, neutropenia, and acute myeloid leukemia, advise women not to breastfeed during treatment and for 2 weeks after last dose

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Semisynthetic taxane, prevents depolymerization of cellular microtubules, which results in DNA, RNA, and protein synthesis inhibition

            Pharmacokinetics

            Half-life elimination: 11 hr (terminal)

            Protein bound: 94-97%

            Vd: 80-90 L/m²

            Metabolism: Liver (CYP3A4)

            Clearance: 21 L/hr/m²

            rExcretion: Feces 75%; urine 6%

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            Administration

            IV Incompatibilities

            Y-site: amphotericin B, doxorubicin liposomal, methylprednisolone sodium succinate, nalbuphine

            IV Compatibilities

            Solution: D5W, NS

            Y-site (partial list): acyclovir, ampicillin, ampicillin/sulbactam, most cephalosporins, clindamycin, diphenhydramine, dopamine, fluconazole, gemcitabine, heparin, hydromorphone, hydroxyzine, imipenem-cilastatin, lorazepam, meperidine, morphine SO4, ondansetron, KCl, prochlorperazine, NaHCO3, TMP-SMX, vancomycin, zidovudine

            IV Preparation

            Dual vial formulation

            • Requires 2-step dilution
            • Reconstitute vial contents (20 mg/0.5 mL or 80 mg/2 mL) with supplied diluent (13% (w/w) ethanol/water) to obtain a 10 mg/mL solution
            • Further dilute with NS or D5W to a final concentration of 0.3-0.74 mg/mL and prepare in a glass bottle, polypropylene, or polyolefin plastic bag to prevent leaching of plasticizers
            • Use within 4 hr (including the 1 hr infusion)
            • Non-PVC tubing must be used

            Single vial formulation

            • Requires 1-step dilution
            • Available as 20 mg/mL solution; further dilute with NS or D5W to a final concentration of 0.3-0.74 mg/mL and prepare in a glass bottle, polypropylene, or polyolefin plastic bag to prevent leaching of plasticizers
            • Use within 4 hr (including the 1 hr infusion)
            • Non-PVC tubing must be used

            IV Administration

            Anaphylactoid-like reactions have been reported: premedicate with dexamethasone (Breast CA, NSCLC: 8 mg PO q12hr for 3 days starting 1 day prior to administration of docetaxel; Prostate CA: 8 mg PO at 12 hr-, 3 hr- and 1 hr preinfusion)

            Infuse over 1 hr

            When administered as sequential infusions, taxane derivatives should be administered before platinum derivatives (cisplatin, carboplatin) to limit myelosuppression and to enhance efficacy

            Storage

            Unused vials: Store at 2-25°C (36-77°F)

            Opened multi-use vials: Store at 2-8°C (36-46°F) and stable for up to 28 days

            Diluted solutions: Store at 2-25°C (36-77°F); use within 4 hr including 1 hr of IV infusion

            Protect from light

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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