docetaxel (Rx)

Brand and Other Names:Taxotere
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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

Avoid in patients with bilirubin >ULN and patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × 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

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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, myositis

            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, tumor lysis syndrome, sometimes fatal

            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

            Avoid use in patients with bilirubin > upper limit of normal (ULN), or patients with AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN; patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death; patients with isolated elevations of transaminase > 1.5 × ULN also had a higher rate of febrile neutropenia; measure bilirubin, AST or ALT, and alkaline phosphatase prior to each therapeutic cycle

            Perform blood cell counts on all patients receiving docetaxel; if neutrophil count <1500 cells/mm3, do not administer; monitor blood counts frequently as neutropenia may be severe and result in infection

            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/mm3

            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 monotherapy at 100 mg/m²

            Sepsis reported in breast cancer patients receiving therapy; half of them reported during first cycle of therapy

            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 >100,000 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

            A 25% reduction in dose of recommended during subsequent cycles following severe neutropenia (<500 cells/mm3) lasting 7 days or more, febrile neutropenia, or a grade 4 infection in a treatment cycle

            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

            Monitor patients closely from onset of any symptoms of gastrointestinal toxicity. Inform patients to contact their healthcare provider with new, or worsening symptoms of gastrointestinal toxicity

            In gastric cancer patients treated with docetaxel in combination with cisplatin and fluorouracil (TCF), febrile neutropenia and/or neutropenic infection reported; monitor patients receiving TCF during first and subsequent cycles for febrile neutropenia and neutropenic infection

            Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) reported in association with docetaxel treatment; patients should be informed about signs and symptoms of serious skin manifestations and monitored closely; permanent treatment discontinuation should be considered in patients who experience SCARs

            If minor reactions such as flushing or localized skin reactions occur, interruption of therapy not required; all patients should be premedicated with an oral corticosteroid prior to initiation of infusion of drug

            Tumor lysis syndrome reported; patients at risk of tumor lysis syndrome (e.g., with renal impairment, hyperuricemia, bulky tumor) should be closely monitored prior to initiating therapy and periodically during treatment; correction of dehydration and treatment of high uric acid levels are recommended prior to initiation of treatment

            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 2 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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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            docetaxel intravenous
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            20 mg/mL (1 mL) vial
            docetaxel intravenous
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            20 mg/mL (1 mL) vial
            docetaxel intravenous
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            160 mg/8 mL (20 mg/mL) vial
            docetaxel intravenous
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            80 mg/4 mL (20 mg/mL) vial
            docetaxel intravenous
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            20 mg/mL (1 mL) vial
            docetaxel intravenous
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            160 mg/16 mL (10 mg/mL) vial
            docetaxel intravenous
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            80 mg/8 mL (10 mg/mL) vial
            docetaxel intravenous
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            20 mg/2 mL (10 mg/mL) vial
            docetaxel intravenous
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            160 mg/8 mL (20 mg/mL) vial
            docetaxel intravenous
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            80 mg/4 mL (20 mg/mL) vial
            docetaxel intravenous
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            20 mg/mL (1 mL) vial
            docetaxel intravenous
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            80 mg/4 mL (20 mg/mL) vial
            docetaxel intravenous
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            160 mg/16 mL (10 mg/mL) vial
            docetaxel intravenous
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            80 mg/8 mL (10 mg/mL) vial
            docetaxel intravenous
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            20 mg/2 mL (10 mg/mL) vial
            docetaxel intravenous
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            80 mg/4 mL (20 mg/mL) vial
            docetaxel intravenous
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            20 mg/mL (1 mL) vial
            docetaxel intravenous
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            80 mg/4 mL (20 mg/mL) vial

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            docetaxel intravenous

            DOCETAXEL - INJECTION

            (doh-seh-TAX-ell)

            COMMON BRAND NAME(S): Taxotere

            WARNING: Docetaxel has caused severe (rarely fatal) allergic reactions and swelling (fluid retention/edema) even with the use of preventive medications. This drug must not be used in patients who have previously had an allergic reaction to it or to other medications containing polysorbate 80.There is an increased risk of serious (possibly fatal) reactions in patients using docetaxel who have liver problems, patients receiving higher doses, and patients with non-small cell lung cancer who have received certain other chemotherapy drugs known as "platinums."If you have a low white blood cell count or liver problems, notify your doctor before using docetaxel.Get medical help right away if you experience swelling, dizziness or fainting, difficulty breathing, irregular heartbeat, severe swelling of the abdomen, skin rash, easy bleeding or bruising, sores in the mouth or throat, or symptoms of infection (such as fever and sore throat).Your doctor will closely monitor you and your blood counts and liver tests while you are receiving docetaxel.

            USES: This medication is used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). Docetaxel is a member of a family of drugs called taxanes. This drug works by slowing cell growth.

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start receiving docetaxel and each time you get a treatment. If you have any questions, ask your doctor, nurse, or pharmacist.This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually over 1 hour every 3 weeks. The dosage and frequency is based on your medical condition, body size, and response to treatment.Your doctor may prescribe pre-medications (such as corticosteroids such as dexamethasone) to prevent side effects like swelling (fluid retention/edema) and allergic reactions. These are generally started 1 day before treatment and continued for a total of 3 days. Carefully follow your doctor's orders to prepare for your treatment. If you forget to take your pre-medication, or do not take it on schedule, tell your doctor or nurse before you receive your docetaxel treatment.

            SIDE EFFECTS: See also Warning section.Pain or swelling at the injection site, nausea, vomiting, diarrhea, excessive tearing, fatigue, dizziness, drowsiness, feeling drunk, constipation, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Temporary hair loss and nail changes may occur. Normal hair growth and nail appearance should return after treatment has ended. However, hair loss may be permanent for some people.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: unusual tiredness/weakness, swelling of the hands/feet/legs, unexplained weight gain, numbness/tingling of arms/legs, muscle/joint pain, eye pain, irregular heartbeat, stomach/abdominal pain, severe diarrhea, diarrhea with blood or mucus, severe headache.This medication can decrease your body's ability to fight an infection. Tell your doctor right away if you develop any signs of an infection (such as a sore throat that doesn't go away, fever, or chills).Although docetaxel is used to treat cancer, it may rarely increase your risk of getting other cancers (such as acute myeloid leukemia-AML, Non-Hodgkin's Lymphoma, kidney cancer). This may occur months to years after treatment. Your doctor should monitor you closely while you receive this medication and after treatment with this medication.Docetaxel sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.Get medical help right away if you have any very serious side effects, including: chest pain, vision changes (such as blurred vision, decreased vision, seeing flashes of light).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: See also Warning section.Before using docetaxel, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (taxane-type drugs such as paclitaxel, cabazitaxel); or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate 80), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before receiving docetaxel, tell your doctor or pharmacist your medical history, especially of: liver problems, lung problems (such as pulmonary effusions), heart problems (such as heart failure), weak immune system (such as neutropenia), blood problems (such as anemia, thrombocytopenia), blood pressure problems.This medication may make you dizzy or drowsy. It also contains alcohol, which can increase these symptoms and also make you feel drunk. Caution is advised if you have liver disease or any other condition that requires you to limit/avoid alcohol. Marijuana (cannabis) can also make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness for 1 to 2 hours after you receive this medication and until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Docetaxel can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using docetaxel before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be more sensitive to the side effects of this drug, especially anemia, dizziness, diarrhea, infection, swelling, mouth sores, and weight loss.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using docetaxel. Docetaxel may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should use reliable forms of birth control during treatment and for 6 months after stopping treatment. Men using this medication should use reliable forms of birth control during treatment and for 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 1 week after stopping treatment. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: medications that may have a bad reaction with alcohol (such as disulfiram, metronidazole, tinidazole).Other medications can affect the removal of docetaxel from your body, which may affect how docetaxel works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), ritonavir, HIV drugs (such as atazanavir), St. John's wort, among others.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as other alcohol-containing medications or alcoholic beverages, marijuana (cannabis), opioid pain or cough relievers (such as codeine, hydrocodone), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Lab and/or medical tests (such as blood cell counts, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

            STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • 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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.