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Dosing Adjustment Guidelines

The occurrence of side effects or special considerations may require Taxotere® (docetaxel) dosing adjustments in certain individuals.1

Dosing for metastatic breast cancer

For patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy

  • Taxotere® 60 mg/m2 to 100 mg/m2 IV infusion over 1 hour, administered every 3 weeks
Initial Dose Adverse Event Management
100 mg/m2
  • Febrile neutropenia, or
  • ANC < 500 cells/mm3 > 7 days, or
  • Severe/cumulative cutaneous reactions

Reduce Taxotere® dose to 75 mg/m2

  • Reduce to 55 mg/m2 if reactions persist, or discontinue Taxotere®
60 mg/m2
  • No febrile neutropenia, and
  • No ANC < 500 cells/mm3 > 7 days, and
  • No severe/cumulative cutaneous reactions
 Consider increasing Taxotere® dose
60–100 mg/m2 >Grade 3 peripheral neuropathy Discontinue Taxotere®

Dosing for early-stage breast cancer

In combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable, node-positive breast cancer

  • Doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 followed by Taxotere® 75 mg/m2 IV infusion over 1 hour every 3 weeks for 6 cycles (or 18 weeks)
  • Taxotere® in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is ≥ 1500 cells/mm3
  • Prophylaxis with G-CSF may be used to mitigate the potential risk of hematologic toxicities
Adverse Event Initial Management Management for continued Symptoms
Febrile neutropenia Use G-CSF for subsequent cycles Reduce Taxotere® dose to 60 mg/m2

Severe/cumulative cutaneous reactions

Moderate neurosensory effects

 Reduce Taxotere® dose to 60 mg/m2 Discontinue Taxotere®
Grade 3–4 stomatitis Reduce Taxotere® dose to 60 mg/m2  

Dosing for prostate cancer

In combination with prednisone for the treatment of patient with androgen-independent (hormone-refractory) metastatic prostate cancer

  • Taxotere® 75 mg/m2 IV infusion over 1 hour, administered every 3 weeks
  • Prednisone 5 mg orally twice daily is administered continuously
  • Taxotere® in combination with prednisone should be administered when the neutrophil count is ≥1500 cells/mm3
Adverse Event Management

Febrile neutropenia, or

ANC < 500 cells/mm3 > 7 days, or


Severe/cumulative cutaneous reactions, or


Moderate neurosensory effects

Reduce Taxotere® dose to 60 mg/m2.

If reaction continues, discontinue Taxotere®

Dosing for non-small cell lung cancer (NSCLC)-First line

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

  • Taxotere® 75 mg/m2 IV infusion over 1 hour, immediately followed by cisplatin 75 mg/m2 over 30 to 60 minutes, administered every 3 weeks
Adverse Event Management

Platelet count nadir < 25,000 cells/mm3 in previous course, or


Febrile neutropenia, or


Any severe nonhematologic toxicity

Reduce Taxotere® dose to 65 mg/m2

  • Reduce to 50 mg/m2 if symptoms continue

Dosing for non-small cell lung cancer (NSCLC)-Second line

For patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy

  • Taxotere® 75 mg/m2 IV infusion over 1 hour, administered every 3 weeks

Adverse Event Management

Febrile neutropenia, or

ANC < 500 cells/mm3 > 7 days, or


Severe/cumulative cutaneous reactions, or


Other grade 3–4 nonhematologic toxicities

Withhold Taxotere® until toxicity resolves


Resume Taxotere® at 55 mg/m2
≥ Grade 3 peripheral neuropathy Discontinue Taxotere®

Dosing for gastric cancer

In combination with cisplatin and fluorouracil for the first-line treatment of advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction

  • Taxotere® 75 mg/m2 IV infusion over 1 hour, followed by cisplatin 75mg/m2 as a 1- to 3-hour IV infusion (both on day 1 only), followed by fluorouracil 750 mg/m2/day given as a 24-hour continuous IV infusion for 5 days, starting at the end of the cisplatin infusion
  • Treatment is repeated every 3 weeks
  • Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration
Adverse Event Initial Management   Management
for Continued Symptoms

Febrile neutropenia, or


Documented infection with neutropenia, or


Neutropenia > 7 days

 Use G-CSF for subsequent cycles

Withhold Taxotere® until neutrophils >1500 cells/mm3 and platelets
>100,000 cells/mm3

Reduce Taxotere® dose to 60 mg/m2

  • Reduce to 45 mg/m2 for subsequent episodes
  • Discontinue treatment if toxicity persists
Grade 4 thrombocytopenia Reduce Taxotere® dose to 60 mg/m2 Discontinue Taxotere®

Adverse Event Initial Management Management for Continued Symptoms

Grade 3 diarrhea

 Reduce 5-FU dose by 20%

Reduce Taxotere® dose by 20%
Grade 4 diarrhea Reduce Taxotere® and 5-FU doses by 20% Discontinue all therapy
Grade 3 stomatitis/mucositis Reduce 5-FU dose by 20%

Discontinue 5-FU

  • Third episode: Reduce Taxotere® dose by 20%
Grade 4 stomatitis/mucositis Discontinue 5-FU Reduce Taxotere® dose by 20%

Dosing for head and neck cancer

In combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck

  • Taxotere® 75mg/m2 IV infusion over 1 hour, followed by cisplatin 75 mg/m2 IV infusion over 1 hour (both on day 1 only), followed by fluorouracil 750 mg/m2/day given as a 24-hour continuous IV infusion for 5 days
  • Treatment is repeated every 3 weeks
  • Patients must receive premedication with atiemetics and appropriate hydration for cisplatin administration
Adverse Event Initial Management   Management for Continued Symptoms

Febrile neutropenia, or


Documented infection with neutropenia, or


Neutropenia > 7 days

 Use G-CSF for subsequent cycles Withhold Taxotere® until neutrophils >1500 cells/mm3 and platelets
>100,000 cells/mm3

Reduce Taxotere® dose to 60 mg/m2

  • Reduce to 45 mg/m2 for subsequent episodes
  • Discontinue treatment if toxicity persists
Grade 4 thrombocytopenia Reduce Taxotere® dose to 60 mg/m2 Discontinue Taxotere®

Adverse Event Initial Management Management for Continued Symptoms
Grade 3 diarrhea Reduce 5-FU dose by 20% Reduce Taxotere® dose by 20%
Grade 4 diarrhea Reduce Taxotere® and 5-FU doses by 20% Discontinue all therapy
Grade 3 stomatitis/mucositis Reduce 5-FU dose by 20%

Discontinue 5-FU

  • Third episode: Reduce Taxotere® dose by 20%
Grade 4 stomatitis/mucositis Discontinue 5-FU Reduce Taxotere® dose by 20%

Special Populations1

In the hepatically impaired

Patients with bilirubin greater than the upper limit of normal (ULN) should generally not receive Taxotere®. Also, patients with serum glutamic-oxaloacetic transaminase (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN should generally not receive Taxotere®.

In pediatric patients

The safety and effectiveness of docetaxel in pediatric patients have not been established.

In geriatric patients

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy in elderly patients.

Reference

  1. Taxotere® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; October 2007.
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US.DOC.07.07.080  Last update:  March 2008
WARNING
  • Taxotere® should be administered only under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available
  • The incidence of treatment-related mortality associated with Taxotere® therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive Taxotere® as a single agent at a dose of 100 mg/m2 (see WARNINGS section of the prescribing information)
  • Taxotere® should generally not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with serum glutamic-oxaloacetic transferase (SGOT) and/or serum glutamic-pyruvic transferase (SGPT) > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN
    • Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death
    • Patients with isolated elevations of transaminase > 1.5 X ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death
    • Bilirubin, SGOT or SGPT, and alkaline phosphatase values should be obtained prior to each cycle of Taxotere® therapy and reviewed by the treating physician
  • Taxotere® therapy should not be given to patients with neutrophil counts of < 1500 cells/mm3
    • In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood-cell counts should be performed on all patients receiving Taxotere®
  • Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received the recommended 3-day dexamethasone premedication
    • Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions
  • Taxotere® must not be given to patients who have a history of severe hypersensitivity reactions to Taxotere® or to other drugs formulated with polysorbate 80
    • All patients should be premedicated with oral corticosteroids such as dexamethasone (see DOSAGE AND ADMINISTRATION section of the prescribing information)
  • Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) (see PRECAUTIONS section of the prescribing information)

Additional Warnings
  • Treatment-related acute myeloid leukemia (AML) or myelodysplasia has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere® in adjuvant therapy of breast cancer

  • Taxotere® can cause fetal harm when administered to pregnant women. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Taxotere®


    • Precautions
  • Localized erythema of the extremities with edema followed by desquamation has been observed

    • — In case of severe skin toxicity, an adjustment in dosage is recommended (see DOSAGE AND ADMINISTRATION section of the prescribing information)
  • Severe neurosensory symptoms (paresthesia, dysesthesia, pain) were observed in 5.5% (53/965) of metastatic breast cancer patients, and resulted in treatment discontinuation in 6.1%

    • — When these symptoms occur, dosage must be adjusted; if symptoms persist, treatment should be discontinued (see DOSAGE AND ADMINISTRATION section of the prescribing information)
  • Severe asthenia was reported in 14.9% (144/965) of metastatic breast cancer patients, but led to treatment discontinuation in only 1.8%

    • — 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
  • In patients treated with TCF for gastric cancer, the incidence of serious adverse events was higher in patients >65 years than in younger patients. Adverse events (all grades) occurring at rates >10% higher in elderly patients included lethargy, stomatitis, diarrhea, dizziness, edema, and febrile neutropenia/neutropenic infection.

    • Please see important safety information and full prescribing information, including boxed WARNING.

    Taxotere Indications

    Breast Cancer
    TAXOTERE® is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy
    TAXOTERE® in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer

    Non-Small Cell Lung Cancer
    TAXOTERE®, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy
    TAXOTERE® in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.

    Prostate Cancer
    TAXOTERE® in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

    Gastric Cancer
    TAXOTERE® in combination with cisplatin and flouroucil is indicated for the treatment of patients with advanced gastric adenocercinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

    Head and neck Cancer
    TAXOTERE® in combination with cisplatin and flourouracil is indicated for the induction treatment of patients with locally advanced squamous cell cercinoma of the head and neck (SCCHN).