Docetaxel

Class
Antimetabolites
Subclass
Mitotic inhibitors
Substance name
DOCEtaxel
Common formulations
Solution for injection
Dosage and administration
Adults patients
Breast cancer in females • Locally advanced or metastatic, after failure of prior chemotherapy
•
60-100 mg/m² IV q3 weeks, administered over 1 hour
Head and neck SCC • Metastatic
•
75 mg/m² IV q3 weeks
Non-small cell lung cancer
•
75 mg/m² IV q3 weeks
Other off-label uses
•
Treatment of ovarian cancer with BRCA germline mutation
•
Treatment of solid tumors in patients with NTRK gene fusion (unresectable or metastatic)
Indications for use
Labeled indications
Adults
•
Treatment of breast cancer in females
•
Treatment of breast cancer in females (advanced or metastatic)
•
Treatment of breast cancer in females (locally advanced or metastatic, after failure of prior chemotherapy)
•
Treatment of breast cancer in females (operable, node-positive, adjuvant setting)
•
Treatment of gastric adenocarcinoma
•
Treatment of head and neck SCC (metastatic)
•
Treatment of non-small cell lung cancer
Off-label indications
Adults
•
Treatment of ovarian cancer with BRCA germline mutation
•
Treatment of solid tumors in patients with NTRK gene fusion (unresectable or metastatic)
Safety risks
Boxed warnings
Tumor lysis syndrome
•
Use extreme caution with renal impairment, hyperuricemia, and bulky tumor. Administer aggressive hydration and appropriate prophylactic medications to prevent tumor lysis syndrome. Discontinue Docetaxel, initiate supportive measures including hydration, electrolyte management, and medical interventions as necessary.
Contraindications
A history of severe docetaxel hypersensitivity or polysorbate 80 hypersensitivity
•
Prior to administering Docetaxel, screen patients for potential hypersensitivity reactions and consider premedication with corticosteroids and antihistamines.
Pre-existing neutropenia and thrombocytopenia
•
Monitor blood counts regularly during Docetaxel treatment, and adjust doses.
Warnings and precautions
Anaphylaxis
•
Use caution with taxane hypersensitivity. Administer premedication with corticosteroids and antihistamines before Docetaxel infusion to mitigate the risk of anaphylaxis in high-risk patients. Immediately stop the infusion, provide appropriate medical interventions such as epinephrine and supportive care, and closely monitor the patient.
Colitis
•
Use caution who are neutropenic. Monitor patients receiving Docetaxel for signs of neutropenia and colitis, and consider dose adjustments. Promptly discontinue Docetaxel, initiate appropriate medical management for colitis, and administer growth factors or antibiotics as needed.
Cystoid macular edema
•
Use caution with pre-existing ocular disease. Regularly monitor patients for visual changes and symptoms of cystoid macular edema during Docetaxel treatment. Consider discontinuing Docetaxel and referring the patient to an ophthalmologist for further evaluation and management.
Neutropenia
•
Use caution with biliary tract disease or hepatic disease. Assess patients with biliary tract or hepatic disease carefully before initiating Docetaxel. Manage it by adjusting the treatment regimen, providing growth factors, or considering discontinuation of Docetaxel, depending on the severity, under medical supervision.
Peripheral edema
•
Use caution with a history of fluid retention. Monitor patients for signs of salt and fluid retention during Docetaxel treatment, and manage their hydration status. Consider adjusting the treatment regimen, administering diuretics, or providing supportive care as needed under medical guidance.
Skin rash
•
Use caution with a history of skin toxicity. Prior to administering Docetaxel, screen patients for potential hypersensitivity reactions. Cease the Docetaxel infusion, provide appropriate medical treatments.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
Do not use. - Consider a docetaxel dose reduction in patients with isolated transaminase elevations.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. Pregnancy should be avoided by females of reproductive potential during docetaxel treatment and for at least 2 months after the last dose.
•
Although there are no adequately controlled studies in pregnant women, docetaxel can cause fetal harm or death when administered during pregnancy based on its mechanism of action and animal studies.
•
Women who are pregnant or who become pregnant while receiving docetaxel should be apprised of the potential hazard to the fetus.
Breastfeeding
Do not use during breastfeeding.
•
Women who are undergoing antineoplastic therapy are expected to have difficulty in breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Alopecia, anemia, ↓ WBC count, ↓ blood neutrophil count, ↓ platelet count, edema, esophagitis, hyperlacrimation, ↑ liver enzymes, amenorrhea, asthenia, change in smell, cough, diarrhea, dysphagia, loss of appetite, nausea, odynophagia, stomatitis
Common 1-10%
•
Acute respiratory distress syndrome, anaphylaxis, exfoliative dermatitis, fluid retention, gastrointestinal bleeding, heart failure, hypotension, ↑ serum TBIL, lethargy, myocardial infarction, peripheral vasodilation, phlebitis, pneumonitis, pulmonary fibrosis, abdominal pain, arthralgia, constipation, dizziness, dysgeusia, dyspepsia, dyspnea, fatigue, fever, injection site reactions, myalgia, nosebleed, skin rash, syncope, vomiting, weight loss, skin dryness
Uncommon < 1%
•
Leukemia, onycholysis
Unknown frequency
•
AF, acute generalized exanthematous pustulosis, anaphylactic shock, ascites, atrial flutter, bleeding, bronchospasm, cardiac tamponade, colitis, disseminated intravascular coagulation, ↓ serum calcium, ↓ serum magnesium, ↓ serum potassium, ↓ serum sodium, dehydration, enterocolitis, erythema multiforme, gastrointestinal perforation, hyperpigmentation, hypertension, ileus, ischemic colitis, lymphoma, nail discoloration, ototoxicity, pulmonary embolism, palmar-plantar erythrodysesthesia, peptic ulcer disease, peripheral edema, peripheral neuropathy, pleural effusion, radiation recall reaction, renal failure, angina pectoris, back pain, chills, confusion, dysesthesia, hearing loss, itching, paresthesia, seizure, skin flushing, weight gain, sinus tachycardia, skin erythema, Stevens-Johnson syndrome, thrombosis, toxic epidermal necrolysis, tumor lysis syndrome, VT
Interactions
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