Daxotel Adverse Reactions

The most common adverse reactions across all Docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication.
The following side effects have been reported from several clinical trials on Docetaxel.
Bone Marrow Suppression: Usually mild but in some cases severe neutropenia (neutrophils <500 cell/mm³) has been reported. This is non-cumulative and reversible. Neutropenic fevers and anaemia have also been reported. Severe thrombocytopenia has been reported in few patients.
Hypersensitivity Reactions: Mild hypersensitivity reactions such as flushing, tightness in the chest, rashes, pruritis, mild dyspnoea, or chills may occur.
Severe hypersensitivity reactions: In the form of hypotension (fall in B.P. by more than 20mm Hg) and bronchospasm may occur. This may require discontinuation of therapy and aggressive symptomatic treatment.
Fluid retention: Gain of body weight by more than 3 kg has been reported after 4 or more cycles or after a cumulative dose of > 400 mg/m² as a result of fluid retention. Fluid retention in the form of oedema, pleural effusion, ascites, and increased capillary permeability has been reported. Discontinuation of Docetaxel treatment causes slow reversal of this fluid retention.
Premedication with oral corticosteroids has been observed to reduce the fluid retention.
Skin Reaction: Skin reactions have been observed in the form of rash, localized eruptions mainly on feet, hands, arms, face and chest and are often associated with itching. Usually these reactions occur within a week of docetaxel infusion and recover before the next infusion. Rarely severe symptoms such as desquamation may occur. Nails have also been reported to exhibit symptoms of toxicity as hyperpigmentation, pain and onycholysis.
Gastrointestinal effects such as nausea, vomiting, or diarrhoea may occur.
Neurotoxicity has been reported during the clinical trials conducted abroad.
Cardiovascular events of clinical meaning occurred rarely.
Other undesirable effects have included alopecia, asthenia, mucositis, arthralgias, toxic deaths.