Docetaxel


Generic Medicine Info
Indications and Dosage
Intravenous
Operable node-negative breast cancer, Operable node-positive breast cancer
Adult: As adjuvant treatment in combination with doxorubicin and cyclophosphamide: 75 mg/m2 once every 3 weeks for 6 cycles, given via IV infusion over 1 hour. Premedicate with oral corticosteroid for 3 days starting 1 day prior to infusion. Primary granulocyte-colony stimulating factor (G-CSF) may be used as prophylaxis to reduce the risk of haematological toxicities. For patients with node-negative cases, treatment must be restricted to patients eligible to receive chemotherapy based on internationally established criteria for primary treatment of early breast cancer. Dose reduction, dosing interruption, or discontinuation may be required if severe or febrile neutropenia, severe cutaneous reactions, severe peripheral neuropathy, or other severe adverse reactions occur (refer to detailed product guidelines).

Intravenous
Locally advanced breast cancer, Metastatic breast cancer
Adult: As 1st-line treatment in combination with doxorubicin, or in combination with capecitabine after failure of cytotoxic chemotherapy: 75 mg/m2 once every 3 weeks via IV infusion over 1 hour. As monotherapy after failure of previous chemotherapy: 60-100 mg/m2 once every 3 weeks via IV infusion over 1 hour. Premedicate with oral corticosteroid for 3 days starting 1 day prior to infusion. Dose reduction, dosing interruption, or discontinuation may be required if severe or febrile neutropenia, severe cutaneous reactions, severe peripheral neuropathy, or other severe adverse reactions occur (refer to detailed product guidelines).

Intravenous
Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult: In combination with cisplatin in chemotherapy-naive patients with unresectable cases, or as monotherapy after failure of prior platinum-based chemotherapy: 75 mg/m2 once every 3 weeks via IV infusion over 1 hour. Premedicate with oral corticosteroid for 3 days starting 1 day prior to infusion. Dose reduction, dosing interruption, or discontinuation may be required if severe or febrile neutropenia, severe cutaneous reactions, severe peripheral neuropathy, or other severe adverse reactions occur (refer to detailed product guidelines).

Intravenous
Gastro-oesophageal junction adenocarcinoma, Metastatic gastric adenocarcinoma
Adult: In combination with cisplatin and fluorouracil for patients who have not received prior chemotherapy: 75 mg/m2 every 3 weeks via IV infusion over 1 hour. Premedicate with oral corticosteroid for 3 days starting 1 day prior to infusion. Granulocyte-colony stimulating factor (G-CSF) may be used as prophylaxis to reduce the risk of haematological toxicities. Dose reduction, dosing interruption, or discontinuation may be required if severe or febrile neutropenia, severe cutaneous reactions, severe peripheral neuropathy, or other severe adverse reactions occur (refer to detailed product guidelines).

Intravenous
Metastatic castration-resistant prostate cancer
Adult: In combination with prednisone or prednisolone: 75 mg/m2 once every 3 weeks via IV infusion over 1 hour. Premedicate with oral dexamethasone at 12 hours, 3 hours, and 1 hour prior to infusion. Dose reduction, dosing interruption, or discontinuation may be required if severe or febrile neutropenia, severe cutaneous reactions, severe peripheral neuropathy, or other severe adverse reactions occur (refer to detailed product guidelines).

Intravenous
HER2-overexpressing metastatic breast cancer
Adult: In combination with trastuzumab for patients who have not previously received chemotherapy: 100 mg/m2 once every 3 weeks via IV infusion over 1 hour. Premedicate with oral corticosteroid for 3 days starting 1 day prior to infusion. Dose reduction, dosing interruption, or discontinuation may be required if severe or febrile neutropenia, severe cutaneous reactions, severe peripheral neuropathy, or other severe adverse reactions occur (refer to detailed product guidelines).

Intravenous
Locally advanced squamous cell carcinoma of the head and neck
Adult: As induction treatment in combination with cisplatin and fluorouracil: 75 mg/m2 once every 3 weeks for 3 cycles (followed by chemoradiotherapy) or for 4 cycles (followed by radiotherapy alone). Doses are given via IV infusion over 1 hour. Premedicate with oral corticosteroid for 3 days starting 1 day prior to infusion. Granulocyte-colony stimulating factor (G-CSF) may be used as prophylaxis to reduce the risk of haematological toxicities. Dose reduction, dosing interruption, or discontinuation may be required if severe or febrile neutropenia, severe cutaneous reactions, severe peripheral neuropathy, or other severe adverse reactions occur (refer to detailed product guidelines).
Special Patient Group
Patients taking strong CYP3A4 inhibitors: Dose reduction of docetaxel and close monitoring may be necessary.
Hepatic Impairment
Severe: Contraindicated.
Reconstitution
Dilute with appropriate amount of NaCl 0.9% or dextrose 5% in water solution to make a final concentration of 0.3-0.74 mg/mL. Preparation instructions may vary among individual products and between countries (refer to specific product guidelines).
Contraindications
History of severe hypersensitivity reaction to docetaxel. Baseline neutrophil count of <1,500 cells/mm3. Severe hepatic impairment. Lactation.
Special Precautions
Patient with previous hypersensitivity reaction to paclitaxel, severe fluid retention (e.g. pleural effusion, pericardial effusion, ascites); at risk of tumour lysis syndrome (e.g. hyperuricaemia, bulky tumour, rapid progression). Patient taking strong CYP3A4 inhibitors. Avoid extravasation. Avoid use in mild to moderate hepatic impairment (bilirubin above ULN, or AST and/or ALT >1.5 times the ULN with concurrent alkaline phosphatase >2.5 times the ULN). Renal impairment. Elderly. Pregnancy.
Adverse Reactions
Significant: Neutropenia or febrile neutropenia, hypersensitivity reactions, localised erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation; severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis); severe fluid retention characterised by pleural effusion (requiring urgent drainage), poorly tolerated peripheral oedema, ascites with pronounced abdominal distention, dyspnoea at rest, cardiac tamponade, and/or generalised oedema; cystoid macular oedema, second primary malignancies (e.g. acute myeloid leukaemia, myelodysplastic syndrome, non-Hodgkin lymphoma, renal cancer), tumour lysis syndrome, severe neurosensory symptoms (e.g. paraesthesia, dysaesthesia, pain), severe peripheral motor neuropathy (manifesting as distal extremity weakness); fatigue and weakness (may be severe).
Blood and lymphatic system disorders: Anaemia, leucopenia, thrombocytopenia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, stomatitis, dysgeusia, constipation, abdominal pain.
General disorders and administration site conditions: Infusion site reactions (e.g. hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, swelling of the vein), fever.
Infections and infestations: Infections.
Investigations: Increased ALT, AST, alkaline phosphatase or bilirubin.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Skin and subcutaneous tissue disorders: Alopecia, nail disorders.
Vascular disorders: Hypotension, hypertension, haemorrhage.
Potentially Fatal: Increased treatment-related mortality (in patients with abnormal liver function, receiving higher doses, and in patients with non-small cell lung cancer and prior platinum-based therapy receiving 100 mg/m2 docetaxel), enterocolitis, neutropenic colitis (typhlitis), acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, ILD, pulmonary fibrosis, respiratory failure, anaphylactic shock; ventricular arrhythmia including ventricular tachycardia (particularly in patients receiving docetaxel in combination regimens), heart failure (particularly in patients receiving docetaxel and trastuzumab combination). Very rarely, hepatitis (mainly in patients with pre-existing hepatic disorders).
IV/Parenteral: D
Monitoring Parameters
Confirm pregnancy status in females of childbearing potential prior to initiation of treatment. Obtain CBC with differential and LFTs such as bilirubin, ALT, AST, and alkaline phosphatase (before each cycle and as clinically indicated). Perform eye examination before therapy and in patients with impaired vision. Monitor renal function; cardiac function (at baseline and during combination treatment with trastuzumab). Assess for signs and symptoms of hypersensitivity reaction (particularly during 1st and 2nd infusions), CHF, neurosensory symptoms, gastrointestinal toxicity, skin reactions, fluid retention, visual impairment, second primary malignancies; tumour lysis syndrome (before starting and periodically during treatment).
Overdosage
Symptoms: Bone marrow suppression, peripheral neurotoxicity, and mucositis. Management: Symptomatic treatment. Administer G-CSF immediately after the discovery of overdose.
Drug Interactions
May increase the risk of adverse effects with CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole).
Action
Description:
Mechanism of Action: Docetaxel, a semisynthetic taxane, promotes the assembly of tubulin into stable microtubules and inhibits the depolymerisation of tubulin which stabilises microtubules in the cell, resulting in the inhibition of DNA, RNA, and protein synthesis.
Pharmacokinetics:
Distribution: Rapidly distributed to body tissues. Plasma protein binding: Approx 94-97%, mainly to α1-acid glycoprotein, albumin, and lipoproteins.
Metabolism: Extensively metabolised in the liver via oxidation by CYP3A4 isoenzyme into metabolites.
Excretion: Mainly via faeces (approx 75%, <8% as unchanged drug); urine (approx 6%). Terminal elimination half-life: 116 hours (range: 92-135 hours).
Chemical Structure

Chemical Structure Image
Docetaxel

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 148124, Docetaxel. https://pubchem.ncbi.nlm.nih.gov/compound/Docetaxel. Accessed Oct. 24, 2023.

Storage
Store intact vials below 25°C. Protect from light. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal. Storage and stability recommendations may vary among individual products and between countries (refer to specific product guidelines).
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD02 - docetaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.
References
Anon. Docetaxel. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/09/2023.

Anon. Docetaxel. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/04/2023.

Buckingham R (ed). Docetaxel. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2023.

Daxotel Injection Concentrate 20 mg/mL (Fresenius Kabi Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 03/04/2023.

Docetaxel 20 mg/mL Concentrate for Solution for Infusion (Seacross Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/04/2023.

Docetaxel Injection, Solution, Concentrate (Accord Healthcare Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/04/2023.

Joint Formulary Committee. Docetaxel. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2023.

Pfizer New Zealand Limited. DBL Docetaxel Concentrated Injection 10 mg/mL Solution for Infusion data sheet 13 December 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 03/04/2023.

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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
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