Sign Out
CAUTION: CYTOTOXIC AGENT.
Treatment-related mortality has been reported; increased risk in patients with abnormal liver function, receiving higher doses, and with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m2.
Concomitant use with CYP3A4 inhibitors should be avoided; if coadministration with a potent CYP3A4 inhibitor is necessary, closely monitor patients for toxicity and consider a docetaxel dosage adjustment.
Severe thrombocytopenia has occurred; monitor blood cell counts frequently; do not retreat with subsequent cycles until the platelet count is greater than 100,000 cells/mm3.
Severe (grade 4) neutropenia has been reported, with some cases associated with infection; monitor blood cell counts frequently and for signs of febrile neutropenia or neutropenic infections; dose reduction or therapy discontinuation may be warranted; do not retreat with subsequent cycles until the neutrophil count is greater than 1500 cells/mm3.
In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic GCSF. Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection). Patients receiving TCF should be closely monitored.
Observe patients closely for hypersensitivity reactions especially during the first and second infusions. Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel. Flushing or localised cutaneous reactions do not require interruption of therapy. However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy. Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel.
Cutaneous toxicity (eg, localized erythema of the extremities with edema followed by desquamation) has occurred; dose reduction or therapy discontinuation may be warranted if severe skin toxicity develops.
Severe fluid retention (eg, peripheral edema, generalized edema, pleural effusion, and ascites) has occurred; pretreatment with oral corticosteroids recommended prior to each dose.
Hepatic impairment; increased risk of severe or life-threatening toxicities; do not use in patients with a bilirubin level greater than the ULN or SGOT and/or SGPT levels greater than 1.5 x ULN concomitant with an alkaline phosphatase (AP) level greater than 2.5 x ULN; monitor LFTs prior to each treatment cycle; dosage adjustment recommended for LFT elevations during treatment; discontinue treatment in patients who develop AST/ALT levels greater than 5 x ULN and/or AP level greater than 5 x ULN.
Severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) have been reported; dose reduction or therapy discontinuation may be warranted.
Contraceptive measures must be taken during and for at least three months after cessation of therapy.
Acute myeloid leukemia has been reported rarely in patients with breast cancer who received adjuvant therapy with docetaxel, doxorubicin, and cyclophosphamide; hematological follow-up recommended in this patient population.
Additional cautions for use in adjuvant treatment of breast cancer.
Complicated neutropenia: For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered.
Gastrointestinal reactions: Symptoms such as early abdominal pain and tenderness, fever, diarrhea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Congestive heart failure: Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Leukemia: In the Docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires haematological follow-up.
Patients with 4+ nodes: The benefit/risk ratio for TAC in patients with 4+ nodes was not defined fully at the interim analysis.
Use in Elderly: Elderly patients (aged 65 yr or older); higher incidence of serious adverse events compared with younger patients.
