Docetaxel


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Breast cancer 60-100 mg/m2 once every 3 wk as monotherapy or in combination w/ other antineoplastics. Non-small cell lung cancer; Gastric adenocarcinoma; Head and neck cancer; Prostate cancer 75 mg/m2 once every 3 wk.
Dosage Details
Intravenous
Breast cancer
Adult: 60-100 mg/m2 by infusion over 1 hr once every 3 wk. In combination w/ doxorubicin or capecitabine or as adjuvant therapy w/ doxorubicin and cyclophosphamide: 75 mg/m2 once every 3 wk. In combination w/ trastuzumab: 100 mg/m2 once every 3 wk.

Intravenous
Gastric adenocarcinoma, Head and neck cancer, Non-small cell lung cancer, Prostate cancer
Adult: 75 mg/m2 by infusion over 1 hr once every 3 wk. For gastric adenocarcinoma: Dose is given before cisplatin and fluorouracil. For head and neck cancer: Given before cisplatin and fluorouracil for 3 cycles followed by chemoradiotherapy or 4 wk followed by radiotherapy alone. For prostate cancer: May be given w/ oral prednisolone 5 mg bid continuously during treatment.
Hepatic Impairment
Breast cancer: Mild to moderate: Reduce dose from 100 mg/m2 to 75 mg/m2. Severe: Avoid use.
Non-small cell lung cancer; Gastric adenocarcinoma; Head and neck cancer; Prostate cancer Severe: Avoid use.
Reconstitution
Add 1 mL of diluent to a 20 mg vial to provide a soln containing 20 mg/0.8 mL or 4 mL of diluent to 80 mg vial to provide a soln containing 24 mg/mL of the drug. Shake well to ensure complete dissolution of the drug. The required amount of reconstituted soln should be injected into a 250-mL infusion bag or bottle containing NaCl 0.9% inj or dextrose 5% inj to produce a final soln of 0.3-0.74 mg/mL. For doses >200 mg, the vol of IV soln should be increased accordingly so that the concentration does not exceed 0.74 mg/mL.
Incompatibility
Y-site: Amphotericin B, doxorubicin liposome, methylprednisolone Na succinate, nalbuphine.
Contraindications
Baseline neutrophil count of <1,500 cells/mm3. Severe hepatic impairment.
Special Precautions
Patient w/ severe fluid retention, resp disorders, eye disorders. Renal and mild to moderate hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Fluid retention, localised erythema of extremities, severe neurosensory symptoms, cystoid macular oedema, severe asthenia,, infections, anaemia, thrombocytopenia, neuropathy, dysgeusia, constipation, anorexia, nail disorders, pain, nausea, diarrhoea, vomiting, mucositis, alopecia, skin reactions, myalgia; resp disorders (e.g. dyspnoea, acute pulmonary oedema, acute resp distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, pulmonary fibrosis), acute myeloid leukemia, renal failure.
Potentially Fatal: Toxic deaths, hepatotoxicity, neutropenia, severe hypersensitivity reactions (e.g. anaphylaxis), resp failure, tumour lysis syndrome, heart failure (when given w/ other cytotoxic drugs esp trastuzumab).
IV/Parenteral: D
Patient Counseling Information
May cause symptoms of alcohol intoxication. May impair ability to drive or operate machinery.
MonitoringParameters
Monitor haematologic, hepatic and renal functions; monitor for hypersensitivity reactions, neurosensory symptoms, GI toxicity, cutaneous reactions, visual impairment, fluid retention, epiphora, and canalicular stenosis; baseline cardiac assessment and cardiac function monitoring in patients given docetaxel w/ other cytotoxic drugs esp trastuzumab.
Overdosage
Symptoms: Bone marrow suppression, peripheral neurotoxicity and mucositis. Management: Symptomatic treatment. Admin therapeutic granulocyte-colony stimulating factor (G-CSF) as soon as possible.
Drug Interactions
CYP3A4 inducers, inhibitors, or substrates may alter docetaxel metabolism.
Action
Description: Docetaxel promotes the assembly of microtubules from tubulin dimers, and inhibits the depolymerisation of tubulin which stabilizes microtubules in the cell. This results in inhibition of DNA, RNA, and protein synthesis. Most activity occurs during the M phase of the cell cycle.
Pharmacokinetics:
Distribution: Rapidly distributed to body tissues. Plasma protein binding: >95%.
Metabolism: Extensively hepatic, by CYP3A4 isoenzyme.
Excretion: Mainly via faeces (as metabolites); via urine (approx 6%). Terminal elimination half-life: Approx 11 hr.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Docetaxel, CID=148124, https://pubchem.ncbi.nlm.nih.gov/compound/Docetaxel (accessed on Jan. 21, 2020)

Storage
Store between 2-25°C.
References
Anon. Docetaxel . Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/11/2014.

Buckingham R (ed). Docetaxel. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/11/2014.

Docetaxel Anhydrous Injection, Solution (Hospira, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/11/2014.

Docetaxel: Drug Safety Communication. U.S. FDA. https://www.fda.gov/. Accessed 05/11/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Docetaxel. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 05/11/2014.

Taxotere Injection Concentrate. U.S. FDA. https://www.fda.gov/. Accessed 05/11/2014.

Disclaimer: This information is independently developed by MIMS based on Docetaxel from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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