Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2019
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Taxotere (Injection, Solution, Concentrate)
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dailymed-instance:boxedWarn... |
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/m[see Warnings and
Precautions (5.1)]. 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��ULN concomitant with
alkaline phosphatase>2.5��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��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/mm. 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. Hypersensitivity
reactions require immediate discontinuation of the TAXOTERE infusion
and administration of appropriate therapy [see Warnings and
Precautions (5.2)]. 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
(4)]. 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 (5.10)].
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dailymed-instance:activeMoi... | |
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dailymed-instance:possibleD... | |
dailymed-instance:genericMe... |
docetaxel
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dailymed-instance:fullName |
Taxotere (Injection, Solution, Concentrate)
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Taxotere
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