Newtaxel-A Adverse Reactions

Hematologic: Reversible marrow suppression was the major dose-limiting toxicity of Docetaxel. The median time to nadir was 7 days, while the median duration of severe neutropenia (<500 cells/mm³) was 7 days. Frequent monitoring of blood counts is essential, and patients should not be given Docetaxel until neutrophil counts recover to a level >1,500/mm³. Febrile neutropenia (<500 cells/mm³), thrombocytopenia (<100,000 cells/mm³), anemia, leucopenia, oligochromemia has been reported. Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported. Very rare cases of acute myeloid leukemia and myelodysplastic syndrome have been reported in association with Docetaxel when used in combination with other chemotherapy agents and/or radiotherapy. Treatment-related acute myeloid leukemia has occurred in 3 of 744 patients (0.4%) who received Docetaxel, doxorubicin and cyclophosphamide and in 1 of 736 patients (0.1%) who received fluorouracil, doxorubicin and cyclophosphamide.
Hypersensitivity Reactions: Hypersensitivity reactions may occur within a few minutes following initiation of a Docetaxel infusion. Minor events, including flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever, or chills, have been reported. Hypersensitivity reactions require immediate discontinuation of the Docetaxel infusion and administration of appropriate therapy. Docetaxel must not be given to patients who have a history of severe hypersensitivity reactions. Rare cases of anaphylactic shock have been reported. Very rarely these cases resulted in a fatal outcome in patients who received premedication.
Cutaneous: Eruptions generally occurred within 1 week after Docetaxel infusion. Reversible cutaneous reactions characterized by a rash including localized eruptions, mainly on the feet and/or hands, but also on the arms, face, or thorax, usually associated with pruritus, have been observed. Very rare cases of cutaneous lupus erythematosus and rare cases of bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis occurs. In some cases multiple factors may have contributed to the development of these effects.
Nerve System: Severe neurosensory symptoms (paresthesia, dysesthesia, pain) were observed in 4.1% of metastatic breast cancer patients, and resulted in treatment discontinuation in 2%. When these symptoms occur, dosage must be adjusted. If symptoms persist, treatment should be discontinued. Confusion and rare cases of seizures or transient loss of consciousness have been observed, sometimes appearing during the infusion of the drug.
Cardiovascular: Hypotension, sinus tachycardia, atrial flutter, dysrhythmia, unstable angina, pulmonary edema, and hypertension occurred rarely. In combination therapy with Docetaxel, doxorubicin and cyclophosphamide, cardiovascular events were reported; congestive heart failure (2.3% at 70 months median follow-up), one patient died due to heart failure.
Others: Alopecia, arthralgia, myalgia, asthenia, fatigue have been reported. Excessive tearing, which can be related to conjunctivitis or blockage of the tear ducts, may occur. Infusion site reactions were generally mild and consisted of hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, or swelling of the vein. Diffuse pain, chest pain, radiation recall phenomenon have been reported rarely. When these symptoms occur, dosage must be adjusted or treatment should be discontinued.