Docetaxel 80mg/8ml Inj, 8ml
WARNING: Severe and sometimes deadly allergic reactions have happened with this drug. Do not take this drug if you have ever had an allergic reaction to it.Some of these products have polysorbate 80. If you are allergic to polysorbate 80, talk with your doctor about whether your product has polysorbate 80 in it.The risk of death that may rarely happen with this drug is raised in people with liver problems and in people who get high doses of this drug. The risk is also raised in people with a certain type of lung cancer who have been treated with a platinum-based chemo drug in the past. This drug must not be given to some people with high bilirubin levels, liver problems, or raised liver enzymes. If you have any of these health problems or any questions, talk with your doctor.This drug may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.Low blood cell counts have happened with this drug. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Sometimes, these have been deadly. If you have questions, talk with the doctor.Have your blood work and other lab tests checked as you have been told by your doctor. If you have a low white blood cell count, talk with your doctor. This drug must not be used in certain people with low white blood cell counts. @ COMMON USES: It is used to treat cancer.
Drug Class
Antineoplastic agent
Pharmacologic Class
Taxane; Microtubule inhibitor
Pregnancy Category
Category D
FDA Approved
May 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Docetaxel is a chemotherapy medicine used to treat various types of cancer, including breast, lung, prostate, stomach, and head and neck cancers. It works by stopping cancer cells from growing and dividing, which helps to shrink tumors.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use, follow your doctor's instructions for taking this medication. Carefully read all the information provided to you and adhere to the instructions.
This medication is administered as an intravenous infusion over a specified period. To minimize the risk of severe side effects, a steroid medication like dexamethasone will be given before receiving this drug. However, please note that this precaution may not completely eliminate the risk of these side effects in all individuals. It is essential to discuss this with your doctor.
Before receiving this medication, it is crucial to be properly hydrated. Your doctor will advise you on whether you need to drink additional fluids before the infusion. If you have any concerns about the steroid medication or its administration, inform your doctor.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage procedures.
Missing a Dose
If you miss a dose, contact your doctor immediately to determine the best course of action.
To ensure safe and effective use, follow your doctor's instructions for taking this medication. Carefully read all the information provided to you and adhere to the instructions.
This medication is administered as an intravenous infusion over a specified period. To minimize the risk of severe side effects, a steroid medication like dexamethasone will be given before receiving this drug. However, please note that this precaution may not completely eliminate the risk of these side effects in all individuals. It is essential to discuss this with your doctor.
Before receiving this medication, it is crucial to be properly hydrated. Your doctor will advise you on whether you need to drink additional fluids before the infusion. If you have any concerns about the steroid medication or its administration, inform your doctor.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage procedures.
Missing a Dose
If you miss a dose, contact your doctor immediately to determine the best course of action.
Lifestyle & Tips
- Take all prescribed pre-medications (like dexamethasone) exactly as directed to reduce side effects like allergic reactions and fluid retention.
- Stay well-hydrated unless otherwise instructed by your doctor.
- Avoid grapefruit and grapefruit juice during treatment, as they can increase the amount of docetaxel in your body.
- Practice good hygiene (frequent hand washing) to reduce the risk of infection, especially when your white blood cell counts are low.
- Avoid contact with people who are sick or have infections.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Use effective birth control during treatment and for a period after, as docetaxel can harm a developing baby.
- Avoid live vaccines during treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on indication, typically 60-100 mg/m² IV over 1 hour every 3 weeks.
Dose Range:
60 - 100 mg
Condition-Specific Dosing:
Breast Cancer (adjuvant):
75 mg/m² IV every 3 weeks for 6 cycles (with doxorubicin and cyclophosphamide)
Breast Cancer (metastatic):
60-100 mg/m² IV every 3 weeks
Non-Small Cell Lung Cancer:
75 mg/m² IV every 3 weeks
Prostate Cancer:
75 mg/m² IV every 3 weeks (with prednisone)
Gastric Adenocarcinoma:
75 mg/m² IV every 3 weeks (with cisplatin and fluorouracil)
Head and Neck Cancer:
75 mg/m² IV every 3 weeks (with cisplatin and fluorouracil)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Use with caution; monitor closely. No specific dose recommendations available.
Dialysis:
Not available; docetaxel is highly protein bound and not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment for mild impairment (bilirubin ≤ ULN, AST/ALT ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN).
Moderate:
Reduce dose by 25% if bilirubin > ULN to 1.5 x ULN or AST/ALT > 1.5 x ULN to 2.5 x ULN. Contraindicated if bilirubin > 1.5 x ULN or AST/ALT > 2.5 x ULN.
Severe:
Contraindicated (bilirubin > 1.5 x ULN or AST/ALT > 2.5 x ULN).
Note:
Pre-medication with corticosteroids is essential to reduce fluid retention and hypersensitivity reactions.
Pharmacology
Mechanism of Action
Docetaxel is an antineoplastic agent that acts by promoting the assembly of microtubules from tubulin dimers and by stabilizing microtubules by preventing depolymerization. This leads to a significant decrease in free tubulin, and the stabilization of microtubules inhibits the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. This results in cell cycle arrest at the G2/M phase and subsequent apoptosis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
113 L (at steady state)
ProteinBinding:
>90% (primarily to alpha-1-acid glycoprotein, albumin, and lipoproteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life: 11.1 hours (range 4-18 hours)
Clearance:
21 L/hr/m²
ExcretionRoute:
Primarily fecal (75%) as metabolites, minor renal (6%)
Unchanged:
<5% (in urine and feces)
Pharmacodynamics
OnsetOfAction:
Rapid (cellular level)
PeakEffect:
Not directly applicable for antineoplastic effect; cellular effects are continuous during exposure.
DurationOfAction:
Cellular effects persist beyond drug clearance due to irreversible microtubule stabilization.
Note:
Pharmacodynamics are primarily related to its cytotoxic effects on rapidly dividing cells, leading to tumor regression over time.
Safety & Warnings
BLACK BOX WARNING
Docetaxel injection is a potent antineoplastic agent. It should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
1. Myelosuppression: The most frequent and serious adverse reaction is myelosuppression, primarily neutropenia, which can be severe and lead to infection, including sepsis and septic shock, which can be fatal. Frequent monitoring of complete blood counts is necessary.
2. Hypersensitivity Reactions: Severe hypersensitivity reactions characterized by hypotension, bronchospasm, or generalized rash/erythema have occurred, including fatal cases. Patients should be pre-medicated with corticosteroids.
3. Fluid Retention: Severe fluid retention has been reported, including pleural effusion, pericardial effusion, ascites, and edema. Pre-medication with corticosteroids is required.
4. Liver Toxicity: Elevated liver enzymes and bilirubin have been reported. Patients with impaired liver function are at increased risk of severe adverse reactions, including fatal outcomes. Docetaxel is contraindicated in patients with severe hepatic impairment.
5. Increased Treatment-Related Mortality: Increased treatment-related mortality has been observed in patients with impaired liver function, in patients receiving higher doses, and in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy who received docetaxel at 100 mg/m².
1. Myelosuppression: The most frequent and serious adverse reaction is myelosuppression, primarily neutropenia, which can be severe and lead to infection, including sepsis and septic shock, which can be fatal. Frequent monitoring of complete blood counts is necessary.
2. Hypersensitivity Reactions: Severe hypersensitivity reactions characterized by hypotension, bronchospasm, or generalized rash/erythema have occurred, including fatal cases. Patients should be pre-medicated with corticosteroids.
3. Fluid Retention: Severe fluid retention has been reported, including pleural effusion, pericardial effusion, ascites, and edema. Pre-medication with corticosteroids is required.
4. Liver Toxicity: Elevated liver enzymes and bilirubin have been reported. Patients with impaired liver function are at increased risk of severe adverse reactions, including fatal outcomes. Docetaxel is contraindicated in patients with severe hepatic impairment.
5. Increased Treatment-Related Mortality: Increased treatment-related mortality has been observed in patients with impaired liver function, in patients receiving higher doses, and in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy who received docetaxel at 100 mg/m².
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruising that worsens, or uncontrollable bleeding.
Signs of lung or breathing problems: shortness of breath, breathing difficulties, cough, or fever.
Dizziness or fainting.
Abnormal or rapid heartbeat.
Unusual burning, numbness, or tingling sensations.
Muscle weakness.
Additional Warnings
If the medication leaks from the vein during administration, it can cause tissue damage. Inform your nurse immediately if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
This medication may cause a condition called cystoid macular edema (CME), which can affect your vision. You may need regular eye exams while taking this medication. If you notice any changes in your vision, such as blurred vision or loss of vision, contact your doctor right away.
Severe bowel problems can occur, which may be life-threatening. If you experience stomach pain with or without fever, tender stomach, or diarrhea, contact your doctor immediately.
Liver problems, although rare, can occur and may be fatal. If you experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor right away.
Tumor lysis syndrome (TLS) is a potentially life-threatening condition that can occur with this medication. If you experience a rapid or abnormal heartbeat, fainting, difficulty urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, or loss of appetite, contact your doctor immediately. Your doctor can discuss ways to help prevent TLS.
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur. If you experience red, swollen, blistered, or peeling skin, skin irritation with or without fever, red or irritated eyes, or sores in your mouth, throat, nose, or eyes, seek medical attention immediately.
Common Side Effects
Not all medications cause side effects, and many people experience only minor or no side effects. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Mouth irritation or sores.
Nail changes.
Changes in taste.
Muscle or joint pain.
Flushing.
Eye redness.
Excessive tearing.
Weight loss.
Menstrual changes.
Constipation, diarrhea, nausea, vomiting, or decreased appetite are common side effects. If these occur, discuss ways to manage them with your doctor.
Hair loss is common, but normal hair growth usually resumes after treatment. In some cases, hair growth may not return to normal. Consult your doctor if you have concerns.
Fatigue or weakness can occur and may last from a few days to several weeks. If these symptoms are severe, interfere with daily activities, or persist, contact your doctor.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruising that worsens, or uncontrollable bleeding.
Signs of lung or breathing problems: shortness of breath, breathing difficulties, cough, or fever.
Dizziness or fainting.
Abnormal or rapid heartbeat.
Unusual burning, numbness, or tingling sensations.
Muscle weakness.
Additional Warnings
If the medication leaks from the vein during administration, it can cause tissue damage. Inform your nurse immediately if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
This medication may cause a condition called cystoid macular edema (CME), which can affect your vision. You may need regular eye exams while taking this medication. If you notice any changes in your vision, such as blurred vision or loss of vision, contact your doctor right away.
Severe bowel problems can occur, which may be life-threatening. If you experience stomach pain with or without fever, tender stomach, or diarrhea, contact your doctor immediately.
Liver problems, although rare, can occur and may be fatal. If you experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor right away.
Tumor lysis syndrome (TLS) is a potentially life-threatening condition that can occur with this medication. If you experience a rapid or abnormal heartbeat, fainting, difficulty urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, or loss of appetite, contact your doctor immediately. Your doctor can discuss ways to help prevent TLS.
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur. If you experience red, swollen, blistered, or peeling skin, skin irritation with or without fever, red or irritated eyes, or sores in your mouth, throat, nose, or eyes, seek medical attention immediately.
Common Side Effects
Not all medications cause side effects, and many people experience only minor or no side effects. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Mouth irritation or sores.
Nail changes.
Changes in taste.
Muscle or joint pain.
Flushing.
Eye redness.
Excessive tearing.
Weight loss.
Menstrual changes.
Constipation, diarrhea, nausea, vomiting, or decreased appetite are common side effects. If these occur, discuss ways to manage them with your doctor.
Hair loss is common, but normal hair growth usually resumes after treatment. In some cases, hair growth may not return to normal. Consult your doctor if you have concerns.
Fatigue or weakness can occur and may last from a few days to several weeks. If these symptoms are severe, interfere with daily activities, or persist, contact your doctor.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Fever (100.4°F or higher) or chills
- Signs of infection (e.g., sore throat, cough, painful urination)
- Unusual bleeding or bruising
- Severe allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Significant swelling in hands, feet, ankles, or face
- Sudden weight gain
- Shortness of breath or chest pain
- Numbness, tingling, or burning pain in hands or feet (peripheral neuropathy)
- Severe nausea, vomiting, or diarrhea
- Severe fatigue or weakness
- Yellowing of skin or eyes (jaundice)
- Dark urine or pale stools
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking any of the following medications: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole.
* If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication and for 1 week after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any health problems you have. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking any of the following medications: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole.
* If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication and for 1 week after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any health problems you have. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking other medications, be aware of their warnings, benefits, and risks, and discuss any questions or concerns with your doctor.
To ensure your safety, avoid driving and other activities that require alertness and clear vision until you understand how this medication affects you. Note that this medication contains alcohol, which may cause feelings of intoxication during and after treatment. If you experience confusion, dizziness, stumbling, or excessive sleepiness during or within 1 to 2 hours after treatment, notify your doctor. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your actions.
As this medication may increase your risk of infection, practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu. You may also be more prone to bleeding, so exercise caution to prevent injury, use a soft toothbrush, and consider using an electric razor.
Before receiving any vaccinations, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication. Although rare, there is a possibility of developing other cancers, including certain blood cancers and kidney cancer, when using this medication in combination with other cancer treatments. This risk may occur months to years after treatment, so discuss any concerns with your doctor.
Some formulations of this medication contain albumin, a component of blood, which may carry a risk of viral transmission. However, the medication is thoroughly screened, tested, and treated to minimize this risk. If you have questions, discuss them with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication may also affect fertility, so discuss this with your doctor if you are trying to conceive. Furthermore, this medication may harm an unborn baby, so a pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant.
If you or your partner may become pregnant, it is crucial to use birth control during treatment and for a specified period after the final dose. Your doctor will advise you on the duration of birth control use. If you or your partner becomes pregnant, notify your doctor immediately.
To ensure your safety, avoid driving and other activities that require alertness and clear vision until you understand how this medication affects you. Note that this medication contains alcohol, which may cause feelings of intoxication during and after treatment. If you experience confusion, dizziness, stumbling, or excessive sleepiness during or within 1 to 2 hours after treatment, notify your doctor. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your actions.
As this medication may increase your risk of infection, practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu. You may also be more prone to bleeding, so exercise caution to prevent injury, use a soft toothbrush, and consider using an electric razor.
Before receiving any vaccinations, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication. Although rare, there is a possibility of developing other cancers, including certain blood cancers and kidney cancer, when using this medication in combination with other cancer treatments. This risk may occur months to years after treatment, so discuss any concerns with your doctor.
Some formulations of this medication contain albumin, a component of blood, which may carry a risk of viral transmission. However, the medication is thoroughly screened, tested, and treated to minimize this risk. If you have questions, discuss them with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication may also affect fertility, so discuss this with your doctor if you are trying to conceive. Furthermore, this medication may harm an unborn baby, so a pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant.
If you or your partner may become pregnant, it is crucial to use birth control during treatment and for a specified period after the final dose. Your doctor will advise you on the duration of birth control use. If you or your partner becomes pregnant, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- Bone marrow suppression (severe neutropenia, thrombocytopenia)
- Peripheral neurotoxicity
- Mucositis
What to Do:
There is no known antidote for docetaxel overdose. Management involves supportive care, including administration of G-CSF for myelosuppression. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nefazodone, grapefruit juice): May significantly increase docetaxel plasma concentrations, increasing toxicity. Co-administration should be avoided.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort): May decrease docetaxel plasma concentrations, reducing efficacy. Co-administration should be avoided.
Moderate Interactions
- Moderate CYP3A4 inhibitors/inducers: Monitor for altered efficacy or toxicity.
- Other myelosuppressive agents: Increased risk of myelosuppression.
- Live vaccines: Avoid due to immunosuppression.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematopoietic function and assess for pre-existing myelosuppression.
Timing: Prior to first dose
Liver Function Tests (LFTs: AST, ALT, bilirubin, alkaline phosphatase)
Rationale: To assess hepatic function, as docetaxel is primarily metabolized by the liver and dose adjustments are required for hepatic impairment.
Timing: Prior to first dose
Renal Function Tests (Creatinine, BUN)
Rationale: To assess baseline renal function.
Timing: Prior to first dose
Fluid status assessment
Rationale: To assess for pre-existing fluid retention, as docetaxel can cause significant fluid retention.
Timing: Prior to first dose
History of hypersensitivity reactions
Rationale: To identify patients at higher risk for severe reactions.
Timing: Prior to first dose
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Prior to each cycle
Target: Absolute Neutrophil Count (ANC) ≥ 1,500 cells/mm³ and platelets ≥ 100,000 cells/mm³
Action Threshold: Hold dose if ANC < 1,500 cells/mm³ or platelets < 100,000 cells/mm³; consider dose reduction upon recovery.
Liver Function Tests (LFTs)
Frequency: Periodically, or as clinically indicated
Target: Within acceptable limits for dosing (see hepatic impairment section)
Action Threshold: Adjust dose or discontinue based on degree of impairment.
Fluid retention assessment (weight, edema, ascites, pleural effusion)
Frequency: Prior to each cycle and throughout treatment
Target: Minimal to no signs of fluid retention
Action Threshold: Manage with diuretics, consider dose reduction or discontinuation for severe cases.
Neurological examination (for peripheral neuropathy)
Frequency: Prior to each cycle and throughout treatment
Target: No or mild neuropathy
Action Threshold: Consider dose reduction or discontinuation for moderate to severe neuropathy.
Signs and symptoms of hypersensitivity reactions
Frequency: During and immediately after infusion
Target: No reaction
Action Threshold: Stop infusion immediately, administer appropriate treatment.
Symptom Monitoring
- Fever or signs of infection (e.g., chills, sore throat)
- Unusual bleeding or bruising
- Swelling in hands, feet, ankles, or face
- Shortness of breath or difficulty breathing
- Chest pain
- Skin rash or itching
- Numbness, tingling, or pain in hands or feet
- Severe fatigue or weakness
- Severe nausea, vomiting, or diarrhea
- Changes in vision or hearing
- Muscle or joint pain
Special Patient Groups
Pregnancy
Docetaxel can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and miscarriage due to rapid cell division during organogenesis.
Second Trimester:
Risk of fetal growth restriction, myelosuppression, and other adverse effects.
Third Trimester:
Risk of fetal growth restriction, myelosuppression, and other adverse effects; potential for premature labor.
Lactation
It is not known whether docetaxel is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during docetaxel therapy and for 1 week after the last dose.
Infant Risk:
High risk of serious adverse effects, including myelosuppression and other toxicities.
Pediatric Use
Safety and effectiveness of docetaxel in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
Patients ≥65 years of age may have an increased risk of certain adverse reactions, including fluid retention, myelosuppression, and nail changes. Close monitoring is recommended, and dose adjustments may be necessary based on tolerability and comorbidities.
Clinical Information
Clinical Pearls
- Pre-medication with oral corticosteroids (e.g., dexamethasone 8 mg twice daily for 3 days starting 1 day prior to docetaxel infusion) is crucial to reduce the incidence and severity of fluid retention and hypersensitivity reactions.
- Monitor ANC closely before each cycle; dose delays or reductions are common due to neutropenia.
- Cumulative fluid retention can occur over multiple cycles; monitor weight and signs of edema, ascites, or pleural/pericardial effusions.
- Peripheral neuropathy is a common and potentially dose-limiting side effect; monitor for symptoms and consider dose reduction or discontinuation if severe.
- Docetaxel is a vesicant/irritant; administer via a central venous catheter if possible, and monitor for extravasation.
- Patients should be advised about potential hair loss (alopecia), which is common and often complete.
Alternative Therapies
- For breast cancer: Anthracyclines (e.g., Doxorubicin), Cyclophosphamide, Fluorouracil, Capecitabine, Gemcitabine, Trastuzumab, Pertuzumab, Lapatinib, Palbociclib, Ribociclib, Abemaciclib, Endocrine therapies (e.g., Tamoxifen, Aromatase Inhibitors)
- For NSCLC: Platinum-based chemotherapy (e.g., Cisplatin, Carboplatin), Pemetrexed, Gemcitabine, Immunotherapy (e.g., Pembrolizumab, Nivolumab), Targeted therapies (e.g., Osimertinib, Afatinib, Crizotinib)
- For prostate cancer: Abiraterone, Enzalutamide, Cabazitaxel, Sipuleucel-T, Radium-223
- For gastric cancer: Cisplatin, Fluorouracil, Capecitabine, Oxaliplatin, Irinotecan, Ramucirumab
- For head and neck cancer: Cisplatin, Fluorouracil, Cetuximab, Nivolumab, Pembrolizumab
Cost & Coverage
Average Cost:
Varies widely per 80mg/8ml vial
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (often covered under medical benefit for oncology)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion to ensure prompt and effective treatment.