Description

Docetaxel is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN

Docetaxel is contraindicated in patients with: Neutrophil counts of <1500 cells/mm3 A history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred

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. Adverse reactions are described according to indication. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Based on findings in animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted.

Docetaxel should be administered under the supervision of a physician experienced in the use of antineoplastic agents There is a higher risk of developing severe adverse reactions including toxic death and fatal gastrointestinal hemorrhage in patients with hepatic impairment Docetaxel therapy should not be given to patients with neutrophil counts of less than 1,500 cells/mm3 Fatal cases of enterocolitis, including ischemic colitis, colitis and neutropenic enterocolitis have been reported  Severe hypersensitivity reactions, with a potential fatal outcome, requiringb immediate discontinuation of Docetaxel may occur. Patients should be closely monitored  Treatment related acute myeloid leukemia may occur. No studies have been conducted to assess the carcinogenic potential of Docetaxel

There were a few reports of overdosage. There is no known antidote for docetaxel overdose. In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In case of overdosage, exacerbation of adverse events may be expected. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.

Cytotoxic Chemotherapy