Docetaxel

Docetaxel is a prescription medication used to treat Breast Cancer, Non-small Cell Lung Cancer, Gastric Cancer, Head and Neck Cancer, and Prostate Cancer. 

• Docetaxel is available under the following different brand name: Taxotere.

Adult dosage

Injectable solution

• 10 mg/mL (2 mL, 8 mL, 16 mL vials)
• 20 mg/mL (1 mL, 4 mL vials)

Alcohol-free solution for injection

• 20 mg/mL
• 80 mg/4mL
• 160 mg/8mL

Breast Cancer 

Adult dosage

Local advanced or metastatic

• Monotherapy: 60-100 mg/m2 IV over 1 hour every 3 weeks
• Operable node-positive
• Adjuvant combination therapy: 75 mg/m2 IV 1 hour after doxorubicin and cyclophosphamide every 3 weeks for 6 cycles

Non-small Cell Lung Cancer

Adult dosage

• 75 mg/m2 IV over 1 hour every 3 weeks

Gastric Cancer

Adult dosage

• Day 1: 75 mg/m2 IV infusion over 1 hour, followed by cisplatin 75 mg/m2 as a 1–3-hours infusion
• Post cisplatin: Fluorouracil 750 mg/m2 once daily given as a 24-hour continuous infusion for 5 days
• Repeat cycle every 3 weeks

Head & Neck Cancer

Adult dosage

Induction chemotherapy followed by radiotherapy

• Day 1: 75 mg/m2 IV infusion over 1 hour, followed by cisplatin 75 mg/m2 as a 1 hour infusion
• Post cisplatin: Fluorouracil 750 mg/m2 once daily given as a 24-hour continuous IV infusion for 5 days
• Repeat cycle every 3 weeks 4 times

Induction chemotherapy followed by chemoradiotherapy

• Day 1: 75 mg/m2 IV infusion over 1 hour, followed by cisplatin 100 mg/m2 as a 0.5-3 hour infusion
• Post cisplatin: Fluorouracil 1000 mg/m2 once daily given as a 24-hour continuous IV infusion from day 1 to day 4
• Repeat cycle every 3 weeks for 3 cycles

Prostate Cancer

Adult dosage

• 75 mg/m2 IV over 1 hour every 3 weeks with daily prednisone 5 mg orally every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Docetaxel include:

• allergic reactions, 
• tissue damage, 
• injection site reactions (swelling, warmth, tenderness, redness, dryness, darkened skin), 
• low blood cell counts, 
• infections, 
• mouth or lip sores, 
• altered sense of taste, 
• nausea, 
• vomiting, 
• loss of appetite, 
• constipation, 
• diarrhea, 
• shortness of breath, 
• eye redness, 
• watery eyes, 
• weakness, 
• tiredness, 
• swelling in the hands, feet, or face, 
• muscle or joint pain, 
• hair loss (may be permanent), and 
• fingernail or toenail change

Serious side effects of Docetaxel include:

• hives, 
• difficult breathing, 
• swelling of the face, lips, tongue, or throat, 
• burning eyes, 
• skin pain, 
• red or purple skin rash with blistering and peeling, 
• fever, 
• sore throat, 
• wheezing, 
• chest tightness, 
• lightheadedness, 
• stomach pain or tenderness, 
• diarrhea, 
• pain, burning, irritation, or skin changes where the injection was given, 
• sudden vision changes, 
• blurred vision, 
• loss of vision, 
• redness or swelling in the arms or legs, 
• skin rash or redness,
• bleeding skin, 
• small red or white bumps on the skin containing pus, 
• numbness, burning, or tingling in the hands or feet, 
• muscle weakness in the arms, legs, feet, or hands, 
• swelling, 
• rapid weight gain, 
• shortness of breath, 
• weakness, 
• muscle cramps, 
• nausea, 
• vomiting, 
• diarrhea, 
• fast or slow heart rate, 
• tingling around the mouth, 
• confusion, 
• stumbling, 
• extreme drowsiness, 
• upper stomach pain, 
• loss of appetite, 
• dark urine, 
• clay-colored stools, 
• yellowing of the skin or eyes (jaundice), 
• fever, 
• chills, 
• tiredness, 
• mouth sores, 
• skin sores, 
• unusual bleeding, 
• pale skin, and
• cold hands and feet

Rare side effects of Docetaxel include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Docetaxel has severe interactions with no other drugs.
• Docetaxel has serious interactions with at least 22 other drugs.
• Docetaxel has moderate interactions with at least 101 other drugs.
• Docetaxel has minor interactions with at least 56 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist about all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity to docetaxel or polysorbate 80
• Solid tumor with baseline ANC less than 1500/mm3

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Docetaxel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Docetaxel?”

Cautions

• Treatment-related mortality is higher in patients with hepatic impairment, those receiving higher doses, and in patients with NSCLC and a history of prior platinum-based chemotherapy who receive docetaxel as monotherapy at 100 mg/m²
• Sepsis was reported in breast cancer patients receiving therapy; half of them reported it during the first cycle of therapy
• Patients with combined abnormalities of transaminases and alkaline phosphatase should not be treated with docetaxel
• Perform frequent blood cell counts on all patients; do not retreat until neutrophils recover to over 1500 cells/mm3 and platelets to over 100,000 cell/mm3 (see Dosage Modifications)
• Enterocolitis and neutropenic colitis (typhlitis) were reported; caution for patients with neutropenia, who are particularly at risk for developing GI complications; enterocolitis and neutropenic enterocolitis may develop at any time and could lead to death as early as the first day of symptom onset
• A 25% reduction in dose of recommended during subsequent cycles following severe neutropenia (over 500 cells/mm3) lasting 7 days or more, febrile neutropenia, or a grade 4 infection in a treatment cycle
• Observed closely for hypersensitivity reactions, especially during the first and second infusions; severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients premedicated with 3 days of corticosteroids; severe hypersensitivity reactions require immediate discontinuation of the infusion and aggressive therapy; patients with a history of severe hypersensitivity reactions should not be rechallenged; patients with a history of paclitaxel hypersensitivity may develop a reaction to docetaxel
• Severe fluid retention reported; premedicate with oral corticosteroids before each administration to reduce incidence and severity
• Second primary malignancies reported, notably acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL), and renal cancer; may occur several months or years after docetaxel therapy
• Localized erythema of the extremities with edema followed by desquamation has been observed; adjust dose for severe skin toxicity
• Severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) were observed; adjust the dose or discontinue if symptoms persist
• Cystoid macular edema (CME) reported; if impaired vision occurs, promptly schedule a comprehensive ophthalmologic examination; if CME is diagnosed, discontinue docetaxel
• Severe asthenia was reported; symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease
• Based on findings from animal reproduction studies and its mechanism of action, it can cause fetal harm when administered to pregnant women
• Monitor patients closely from the onset of any symptoms of gastrointestinal toxicity. Inform patients to contact their healthcare provider with new, or worsening symptoms of gastrointestinal toxicity
• In gastric cancer patients treated with docetaxel in combination with cisplatin and fluorouracil (TCF), febrile neutropenia and/or neutropenic infection were reported; monitor patients receiving TCF during first and subsequent cycles for febrile neutropenia and neutropenic infection
• Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) are reported in association with docetaxel treatment; patients should be informed about signs and symptoms of serious skin manifestations and monitored closely; permanent treatment discontinuation should be considered in patients who experience SCARs
• If minor reactions such as flushing or localized skin reactions occur, interruption of therapy is not required; all patients should be premedicated with an oral corticosteroid before initiation of infusion of the drug
• Tumor lysis syndrome was reported; patients at risk of tumor lysis syndrome (e.g., with renal impairment, hyperuricemia, bulky tumor) should be closely monitored before initiating therapy and periodically during treatment; correction of dehydration and treatment of high uric acid levels are recommended before initiation of treatment
• Cases of alcohol intoxication were reported with some formulations of docetaxel owing to the alcohol content (100 mg/m2 dose delivers 2 g/m2 of ethanol)

Drug interaction overview

• Docetaxel is a CYP3A4 substrate
• Metabolism of docetaxel may be modified if coadministered with CYP3A4 inducers or inhibitors
• Avoid use with strong CYP3A4 inhibitors; if unable to avoid, consider reducing docetaxel dose by 50%

Pregnancy and Lactation

• Based on findings in animal reproduction studies and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited available human data are not sufficient to inform drug-associated risk during pregnancy
• Verify the pregnancy status of females of reproductive potential before initiating therapy

Contraception

• Females of reproductive potential: Use effective contraception during treatment and for 6 months following the last dose
• Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months following the last dose

Infertility

• Based on findings in animal studies, therapy may impair fertility in males of reproductive potential

• There is no information regarding the presence of docetaxel in human milk or its effects on milk production or the breastfed child; no lactation studies in animals have been conducted; because of the potential for serious adverse reactions in a breastfed child from docetaxel exposure, including toxic death, hepatotoxicity, neutropenia, and acute myeloid leukemia, advise women not to breastfeed during treatment and for 2 weeks after the last dose