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docetaxel (Rx)Brand and Other Names:Taxotere, Docefrez

 
 
 

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
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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 hour 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, 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

Dose 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 >5 times ULN or lakaline phosphatase >5 times ULN

Reduce dose by 20% if AST/ALT >2.5 - 5 times ULN and alkaline is 2.5 times ULN or lower; alternatively lower the dose by 20% if AST/ALT > 1.5-5 times ULN and alkaline phosphatase >2.5-5 times ULN

Alcohol content of docetaxel injection concentrate should be taken into account when given to patients with hepatic impairment

Administration

Premedicate to prevent hypersensitivity reactions (eg, dexamethasone)

Monitor: CBC, LFTs

Other Indications & Uses

Off-label: Melanoma, NHL, urothelial cancer, ovarian cancer, soft-tissue sarcoma

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

docetaxel and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

            Diffuse pain, chest pain, radiation recall phenomenon

            Atrial fibrillation, DVT, ECG abnormalities, thrombophlebitis, pulmonary embolism, syncope, tachycardia, myocardial infarction

            Bullous eruptions (eg, erythema multiforme, Stevens-Johnson syndrome, TEN, scleroderma-like changes usually preceded by peripheral lymphedema), cutaneous lupus erythematosus, severe hand and foot syndrome may occur

            Bleeding episodes, DIC often in association with sepsis or multiorgan failure, acute myeloid leukemia and myelodysplastic syndrome

            Anaphylactic shock, very rarely these cases resulted in a fatal outcome in patients who received premedication

            Hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders

            Confusion, rare cases of seizures or transient loss of consciousness

            Conjunctivitis, lacrimation or lacrimation with or without conjunctivitis; excessive tearing (possible lacrimal duct obstruction); transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during drug infusion and in association with hypersensitivity reactions; cystoid macular edema reported when treated with docetaxel injection concentrate

            Rare cases of ototoxicity, hearing disorders and/or hearing loss, including cases associated with other ototoxic drugs

            Dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, pulmonary fibrosis, radiation pneumonitis (with concomitant radiotherapy)

            Hyponatremia

            Permanent or irreversible alopecia

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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

            Irritant; use caution

            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

            Monitor for delayed myelodysplasia or myeloid leukemia in patients who received docetaxel injection concentrate, doxorubicin and cyclophosphamide

            Coadministration with CYP3A4 inhibitors may increase exposure to docetaxel and should be avoided; consider docetaxel dose reduction if unable to avoid

            Consider adjusting dose if cutaneous reactions like erythema of the extremities with edema followed by desquamation occur

            Risk of severe fluid retention even with dexamethasone

            Women of childbearing potential should not become pregnant when receiving docetaxel injection concentrate; it causes fetal harm

            Reactions including paresthesia, dysesthesia, and pain may occur; severe neurosensory symptoms require dose adjustment or discontinuation if persistent

            Consider therapy discontinuation if severe asthenia occurs

            Cystoid macular edema reported and requires treatment discontinuation

            The diluent for docetaxel contains 13% ethanol; alcohol intoxication has been reported following IV infusion

            Renal failure have been reported, the majority of these cases were associated with concomitant nephrotoxic drugs

            Avoid pregnancy

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Not known if excreted in breast milk, do not nurse

            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

            Store intact vials at 2-25 degrees C (36-77 degrees F)

            Protect from light

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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