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Adverse Events: Androgen-Independent (Hormone-Refractory) Metastatic Prostate Cancer (AIPC)

Taxotere® (docetaxel) Injection Concentrate 75 mg/m2

The following table summarizes adverse events from the TAX 327 clinical trial comparing Taxotere® 75 mg/m2 + prednisone 5 mg to mitoxantrone 12 mg/m2 + prednisone 5 mg in the treatment of AIPC.1



Adverse Events With Taxotere® 75 mg/m2: TAX 327 Trial

 

 Taxotere® 75 mg/m2
Every 3 Weeks
+ Prednisone
5 mg Twice Daily
(n=332)
% 		Mitoxantrone 12 mg/m2
Every 3 Weeks
+ Prednisone
5 mg Twice Daily
(n=335)
%
  Adverse Event Any Grade 3/4 Any Grade 3/4
  Anemia 66.5 4.9 57.8 1.8
  Neutropenia 40.9 32.0 48.2 21.7
  Thrombocytopenia 3.4 0.6 7.8 1.2
  Febrile neutropenia 2.7 N/A 1.8 N/A
  Infection 32.2 5.7 20.3 4.2
  Epistaxis 5.7 0.3 1.8 0.0
  Allergic Reactions 8.4 0.6 0.6 0.0
  Fluid Retention*
    Weight gain*
    Peripheral edema*		 24.4
7.5
18.1		 0.6
0.3
0.3		 4.5
3.0
1.5		 0.3
0.0
0.0
  Neuropathy  Sensory 30.4 1.8 7.2 0.3
  Neuropathy Motor 7.2 1.5 3.0 0.9
  Rash/Desquamation 6.0 0.3 3.3 0.6
  Alopecia 65.1 N/A 12.8 N/A
  Nail Changes 29.5 0.0 7.5 0.0
  Nausea 41.0 2.7 35.5 1.5
  Diarrhea 31.6 2.1 9.6 1.2
  Stomatitis/Pharyngitis 19.6 0.9 8.4 0.0
  Taste Disturbance 18.4 0.0 6.6 0.0
  Vomiting 16.9 1.5 14.0 1.5
  Anorexia 16.6 1.2 14.3 0.3
  Cough 12.3 0.0 7.8 0.0
  Dyspnea 15.1 2.7 8.7 0.9
  Cardiac Left
  Ventricular Function 		9.6 0.3 22.1 1.2
  Fatigue 53.3 4.5 34.6 5.1
  Myalgia 14.5 0.3 12.8 0.9
  Tearing 9.9 0.6 1.5 0.0
  Arthralgia 8.1 0.6 5.1 1.2

* Related to treatment

Addressing Adverse Events

The occurrence of side effects or special considerations may require Taxotere® dosing adjustments in certain individuals. Please visit the dosing adjustment guidelines section of this site for more information about dose adjustments.

For more information on Taxotere® adverse events and important safety information, please refer to the Taxotere® full prescribing information.

Reference

  1. Taxotere® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; March 2007.
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US.DOC.06.05.015  Last update:  March 2007
WARNING
  • 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 transaminase (SGOT) and/or serum glutamic-pyruvic transaminase (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.

  • 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

    • 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).