Uses
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) ... Read more
Dosage
Taxodoc IV Infusion 20 mg/vial dosage
Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.
BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent
BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles
NSCLC: after platinum therapy failure: 75 mg/m2 single agent
NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2
HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously
GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion
SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatinin fusion; for 4 cycles
SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles
For all patients:
Premedicate with oral corticosteroids
Adjust dose as needed
Side Effects
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.
Precaution
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
Interaction
Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.
Pregnancy & Breastfeeding use
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.
Contraindication
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
Acute Overdose
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.
Storage Condition
Store between 2°C and 25°C and protected from light. Freezing does not adversely affect the product.
Innovators Monograph
