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Taxotere® Preparation

Formulation

Taxotere® (docetaxel) is formulated as a concentrate for dilution. It is a clear-yellow to brownish-yellow viscous solution. Each milliliter contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80. The diluent for Taxotere® is 13% ethanol in water for injection.1

Steps for preparation of Taxotere
Please note the following important information about Taxotere® preparation:

  • Taxotere® requires two dilutions prior to administration.
  • Each vial is a single-dose vial and should not be used for multiple doses.
  • The initial diluted solution may be used immediately or stored either in the refrigerator or at room temperature for a maximum of 8 hours.
  • Taxotere® initial diluted solution should be visually inspected prior to use. Solutions containing any precipitate or particulate matter must not be used.
  • Infusion solution should be used within 4 hours.1

First dilution: Preparation of Taxotere® initial diluted solution1

1. Preparation of Taxotere® initial diluted solution It is not necessary to store Taxotere® under refrigeration; however, if Taxotere® is stored in the refrigerator, the Taxotere® and diluent vials should stand at room temperature for at least 5 minutes before preparation.
2. Preparation of Taxotere® initial diluted solution Aseptically withdraw the entire contents of the diluent vial by partially inverting the vial and inserting the needle through the diaphragm at an angle. Place the needle — bevel side down — against the glass, with the tip touching the neck of the vial. Pull back the plunger and extract all the solution. This is necessary to ensure the initial diluted solution of 10 mg/mL.

NOTE: Both the Taxotere® Injection Concentrate and the diluent vials contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with entire contents (approximately 1.8 mL for Taxotere® 20 mg and approximately 7.1 mL for Taxotere® 80 mg) of the accompanying diluent, there is an initial diluted solution containing 10 mg/mL docetaxel.

3. Preparation of Taxotere® initial diluted solution Insert the needle at an angle into the Taxotere® vial. Inject all of the diluent along the side of the vial to reduce foaming. Be careful not to scratch the glass wall with the needle.
4. Preparation of Taxotere® initial diluted solution Mix the initial diluted solution by repeated inversions for at least 45 seconds to assure full mixture of the concentrate and diluent. To minimize foaming, DO NOT SHAKE.
5. Preparation of Taxotere® initial diluted solution Allow the premix vial to stand for 5 minutes at room temperature and then check that the solution is homogeneous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation). Solutions containing any precipitate or particulate matter must not be used. The initial diluted Taxotere® solution contains 10 mg docetaxel/mL and may be used immediately or stored either in the refrigerator or at room temperature for a maximum of 8 hours.

Second dilution: Final dilution for infusion solution1

1. Final dilution for infusion solution Aseptically withdraw the required amount of Taxotere® initial diluted solution (10 mg/mL) with a calibrated syringe.
2. Final dilution for infusion solution Inject the required amount of Taxotere® into the appropriate (non-PVC) infusion bag or bottle of either 0.9% sodium chloride or 5% dextrose solution. The final concentration should be between 0.3 and 0.74 mg/mL.
3. Final dilution for infusion solution Thoroughly mix the infusion solution by manual rotation.
4. Final dilution for infusion solution Inspect Taxotere® visually for particulate matter or discoloration. Solutions containing any precipitate or particulate matter must not be used, and should be discarded. Any unused Taxotere® should also be discarded.

Reference

  1. Taxotere® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; Rev.December 2006.
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US.DOC.06.04.156  Last update:  March 2007
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).