TAXOTERE (docetaxel) for Injection Concentrate should be administered
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 platinumbased
chemotherapy who receive TAXOTERE at a dose of 100 mg/ m2
TAXOTERE should generally not be given to patients with bilirubin
> upper limit of normal (ULN), or to patients with SGOT and/
or 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 hypotension
and/ or bronchospasm, or generalized rash/ erythema occurred
in 2.2% (2/ 92) of patients who received the recommended 3- day
dexamethasone premedication. Hypersensitivity reactions requiring
discontinuation of the TAXOTERE infusion were reported in five patients
who did not receive premedication. These reactions resolved after
discontinuation of the infusion and the administration of appropriate
therapy. 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 WARNINGS).
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).