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(docetaxel) Injection Concentrate, Intravenous Infusion (IV).
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
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 AND PRECAUTIONS].
TAXOTERE should not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT > 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, AST or ALT, and alkaline phosphatase values should be obtained prior to each cycle of TAXOTERE therapy [see WARNINGS AND PRECAUTIONS]. 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 [see WARNINGS AND PRECAUTIONS].
Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received a 3-day dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the TAXOTERE infusion and administration of appropriate therapy [see WARNINGS AND PRECAUTIONS]. 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 [see CONTRAINDICATIONS].
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 WARNINGS AND PRECAUTIONS].
Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-l,2α,4,7β,10β,13α-hexahydroxytax-ll-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:
Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14•3H2O and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water.
One-vial TAXOTERE (Injection Concentrate)
TAXOTERE (docetaxel) Injection Concentrate is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration.
Each mL contains 20 mg docetaxel (anhydrous) in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution.
TAXOTERE is available in single use vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous).
TAXOTERE Injection Concentrate requires NO prior dilution with a diluent and is ready to add to the infusion solution.
Last reviewed on RxList: 1/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Taxotere Information
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