Docetaxel 80mg/4ml Inj, 4ml
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 and slow the spread of the disease. It is given as an injection into a vein.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the instructions closely. 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 administering this drug. However, it's essential to note that this precaution may not completely eliminate the risk of these side effects in all individuals. Discuss any concerns with your doctor. If the steroid medication is not taken as directed, inform your doctor promptly.
Before receiving this medication, ensure you are not dehydrated. Consult your doctor to determine if you need to drink additional fluids before the infusion.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult your doctor, nurse, or pharmacist for guidance on proper storage procedures.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the instructions closely. 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 administering this drug. However, it's essential to note that this precaution may not completely eliminate the risk of these side effects in all individuals. Discuss any concerns with your doctor. If the steroid medication is not taken as directed, inform your doctor promptly.
Before receiving this medication, ensure you are not dehydrated. Consult your doctor to determine if you need to drink additional fluids before the infusion.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult your doctor, nurse, or pharmacist for guidance on proper storage procedures.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain good hygiene to prevent infections, especially hand washing.
- Avoid contact with people who are sick or have infections.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Stay well-hydrated unless advised otherwise by your doctor.
- Manage fatigue by balancing rest and light activity.
- Use a soft toothbrush and rinse mouth frequently to prevent mouth sores.
- Avoid alcohol and tobacco.
- Discuss any over-the-counter medications, supplements, or herbal products with your doctor before taking them, especially grapefruit products.
- Use effective contraception during treatment and for a period after, as advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and regimen. Examples: 75 mg/m² IV every 3 weeks (breast cancer, NSCLC, prostate cancer); 60-75 mg/m² IV every 3 weeks (gastric adenocarcinoma); 75 mg/m² IV every 3 weeks (head and neck cancer). Premedication with corticosteroids is required.
Dose Range:
60 - 100 mg
Condition-Specific Dosing:
Breast Cancer (adjuvant):
75 mg/m² IV every 3 weeks for 4 cycles (after doxorubicin/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 5-FU)
Head and Neck Cancer:
75 mg/m² IV every 3 weeks (with cisplatin and 5-FU)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution is advised due to limited data.
Dialysis:
Not available; caution advised due to limited data.
Hepatic Impairment:
Mild:
Bilirubin > ULN to ≤ 1.5 x ULN or AST/ALT > ULN to ≤ 2.5 x ULN: No dose adjustment needed. Bilirubin ≤ ULN and AST/ALT > 2.5 x ULN: No dose adjustment needed.
Moderate:
Bilirubin > 1.5 x ULN to ≤ 3.5 x ULN or AST/ALT > 2.5 x ULN to ≤ 5 x ULN: Reduce dose by 25%.
Severe:
Bilirubin > 3.5 x ULN or AST/ALT > 5 x ULN: Contraindicated or not recommended due to increased risk of severe adverse reactions and mortality.
Pharmacology
Mechanism of Action
Docetaxel is an antineoplastic agent that acts by promoting the assembly of microtubules from tubulin dimers and simultaneously inhibiting their depolymerization. This leads to the accumulation of stable, non-functional microtubule bundles and the inhibition of normal mitotic spindle function, which is essential for cell division. The resulting mitotic arrest and subsequent apoptosis lead to the death of rapidly dividing cancer cells.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (IV administration)
Tmax:
Not applicable (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
113 L (steady-state)
ProteinBinding:
Approximately 94% (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:
Fecal (approximately 75% as metabolites and unchanged drug), Renal (approximately 6% as metabolites and unchanged drug)
Unchanged:
Less than 5% excreted unchanged in urine and feces
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of infusion)
PeakEffect:
Not directly applicable for cytotoxic effect; cellular effects are continuous during and after exposure.
DurationOfAction:
Cellular effects persist for several cell cycles due to irreversible microtubule stabilization.
Safety & Warnings
BLACK BOX WARNING
WARNING: NEUTROPENIA, HYPERSENSITIVITY REACTIONS, FLUID RETENTION, AND LIVER IMPAIRMENT
* **Neutropenia:** The most frequent and severe adverse reaction is neutropenia, which may result in infections, including sepsis and septic shock, which can be fatal. Frequent monitoring of complete blood counts is necessary.
* **Hypersensitivity Reactions:** Severe hypersensitivity reactions characterized by hypotension, bronchospasm, or generalized rash/erythema have occurred. Premedication with corticosteroids is required.
* **Fluid Retention:** Severe fluid retention has occurred. Premedication with corticosteroids is required.
* **Liver Impairment:** Patients with impaired hepatic function are at increased risk for severe adverse reactions, including fatal outcomes, due to increased docetaxel plasma concentrations. Docetaxel should not be given to patients with severe hepatic impairment.
* **Neutropenia:** The most frequent and severe adverse reaction is neutropenia, which may result in infections, including sepsis and septic shock, which can be fatal. Frequent monitoring of complete blood counts is necessary.
* **Hypersensitivity Reactions:** Severe hypersensitivity reactions characterized by hypotension, bronchospasm, or generalized rash/erythema have occurred. Premedication with corticosteroids is required.
* **Fluid Retention:** Severe fluid retention has occurred. Premedication with corticosteroids is required.
* **Liver Impairment:** Patients with impaired hepatic function are at increased risk for severe adverse reactions, including fatal outcomes, due to increased docetaxel plasma concentrations. Docetaxel should not be given to patients with severe hepatic impairment.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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, 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, bleeding gums, 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 Important 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, sometimes as early as the first day of symptoms, and can be life-threatening. Seek medical help immediately if you experience stomach pain (with or without fever), tender stomach, or diarrhea.
Liver problems, although rare, can occur and may be fatal. Contact your doctor immediately if you experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Tumor lysis syndrome (TLS) is a potentially life-threatening condition that can occur with this medication. Seek medical help immediately if you experience rapid or abnormal heartbeat, fainting, difficulty urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, or loss of appetite. Discuss ways to prevent TLS with your doctor.
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur. Seek medical help immediately 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.
Other Possible Side Effects
Not everyone will experience side effects, and many people may only have mild or minor side effects. However, if you experience any of the following, contact your doctor or seek medical help:
Mouth irritation or mouth sores.
Changes in nail appearance.
Changes in taste.
Muscle or joint pain.
Flushing.
Eye redness.
Excessive tearing.
Weight loss.
Changes in menstrual periods.
Constipation, diarrhea, nausea, vomiting, or decreased appetite (common side effects; discuss ways to manage them with your doctor).
Hair loss (usually temporary, but in some cases, hair growth may not return to normal).
Fatigue or weakness (may last from a few days to several weeks; contact your doctor if severe or persistent).
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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, 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, bleeding gums, 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 Important 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, sometimes as early as the first day of symptoms, and can be life-threatening. Seek medical help immediately if you experience stomach pain (with or without fever), tender stomach, or diarrhea.
Liver problems, although rare, can occur and may be fatal. Contact your doctor immediately if you experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Tumor lysis syndrome (TLS) is a potentially life-threatening condition that can occur with this medication. Seek medical help immediately if you experience rapid or abnormal heartbeat, fainting, difficulty urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, or loss of appetite. Discuss ways to prevent TLS with your doctor.
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur. Seek medical help immediately 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.
Other Possible Side Effects
Not everyone will experience side effects, and many people may only have mild or minor side effects. However, if you experience any of the following, contact your doctor or seek medical help:
Mouth irritation or mouth sores.
Changes in nail appearance.
Changes in taste.
Muscle or joint pain.
Flushing.
Eye redness.
Excessive tearing.
Weight loss.
Changes in menstrual periods.
Constipation, diarrhea, nausea, vomiting, or decreased appetite (common side effects; discuss ways to manage them with your doctor).
Hair loss (usually temporary, but in some cases, hair growth may not return to normal).
Fatigue or weakness (may last from a few days to several weeks; contact your doctor if severe or persistent).
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 (temperature 100.4°F or higher) or chills
- Unusual bleeding or bruising
- Severe fatigue or weakness
- Numbness, tingling, or pain in hands or feet
- Significant swelling in hands, feet, or ankles
- Shortness of breath or difficulty breathing
- Severe skin rash, redness, or peeling
- Severe nausea, vomiting, or diarrhea
- Severe mouth sores
- Signs of an allergic reaction during or after infusion (e.g., hives, itching, flushing, dizziness, chest tightness, difficulty breathing)
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, inform 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 reactions.
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 avoid injury, use a soft toothbrush, and consider using an electric razor.
Before receiving any vaccinations, discuss the potential risks and benefits with 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 types of cancer, 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 it is crucial to discuss any concerns with your doctor.
Some formulations of this medication may contain albumin, a component of blood, which can potentially transmit viruses. However, the medication is thoroughly screened, tested, and treated to minimize the risk of infection. If you have concerns, consult your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication may also affect fertility, so discuss any concerns with your doctor. Furthermore, this medication can harm an unborn baby, and 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 essential to use birth control during treatment and for a specified period after the last dose. Your doctor will advise you on the recommended duration of birth control. 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, inform 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 reactions.
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 avoid injury, use a soft toothbrush, and consider using an electric razor.
Before receiving any vaccinations, discuss the potential risks and benefits with 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 types of cancer, 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 it is crucial to discuss any concerns with your doctor.
Some formulations of this medication may contain albumin, a component of blood, which can potentially transmit viruses. However, the medication is thoroughly screened, tested, and treated to minimize the risk of infection. If you have concerns, consult your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication may also affect fertility, so discuss any concerns with your doctor. Furthermore, this medication can harm an unborn baby, and 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 essential to use birth control during treatment and for a specified period after the last dose. Your doctor will advise you on the recommended duration of birth control. 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 neutropenia, platelet transfusions for thrombocytopenia, and symptomatic treatment for other toxicities. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir, saquinavir, telithromycin, voriconazole, grapefruit juice) - may significantly increase docetaxel exposure and toxicity.
- Live vaccines - increased risk of infection.
Moderate Interactions
- Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, phenobarbital, St. John's Wort) - may decrease docetaxel exposure and efficacy.
- Other myelosuppressive agents - increased risk of severe myelosuppression.
- Drugs metabolized by CYP3A4 (e.g., cyclosporine, paclitaxel, vinca alkaloids) - potential for altered metabolism of co-administered drugs.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematopoietic function, especially neutrophil count, as myelosuppression is a dose-limiting toxicity.
Timing: Prior to first dose
Liver Function Tests (LFTs) - AST, ALT, alkaline phosphatase, bilirubin
Rationale: To assess hepatic function, as docetaxel is extensively metabolized by the liver and hepatic impairment increases toxicity risk.
Timing: Prior to first dose
Renal Function Tests (RFTs) - Creatinine, BUN
Rationale: To assess baseline renal function, although docetaxel is minimally renally excreted, overall patient health is important.
Timing: Prior to first dose
Fluid status and body weight
Rationale: To assess baseline fluid balance and monitor for fluid retention.
Timing: Prior to first dose
Neurological examination
Rationale: To assess baseline peripheral neuropathy.
Timing: Prior to first dose
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Prior to each cycle and weekly during the first cycle (or as clinically indicated)
Target: Absolute Neutrophil Count (ANC) ≥ 1500 cells/mm³; Platelets ≥ 100,000 cells/mm³
Action Threshold: ANC < 1500 cells/mm³ or platelets < 100,000 cells/mm³: Delay dose or reduce dose.
Liver Function Tests (LFTs)
Frequency: Prior to each cycle
Target: Bilirubin ≤ ULN; AST/ALT ≤ 1.5 x ULN (or as per specific guidelines for hepatic impairment)
Action Threshold: Elevated LFTs beyond acceptable limits: Dose reduction or discontinuation.
Fluid status, body weight, and peripheral edema
Frequency: Prior to each cycle and regularly during treatment
Target: Stable weight, absence of significant edema
Action Threshold: Significant fluid retention: Consider diuretic therapy, adjust corticosteroid premedication, or dose modification.
Neurological assessment (for peripheral neuropathy)
Frequency: Prior to each cycle and as clinically indicated
Target: Absence of new or worsening neuropathy
Action Threshold: Grade 2 or higher peripheral neuropathy: Dose reduction or discontinuation.
Hypersensitivity reaction monitoring
Frequency: During and immediately after infusion
Target: Absence of signs/symptoms of hypersensitivity
Action Threshold: Signs of hypersensitivity (e.g., rash, dyspnea, hypotension): Stop infusion, administer appropriate treatment.
Symptom Monitoring
- Fever or chills (signs of infection/neutropenic fever)
- Unusual bleeding or bruising
- Fatigue or weakness
- Numbness, tingling, or burning sensation in hands or feet (peripheral neuropathy)
- Swelling in hands, feet, or ankles (fluid retention)
- Shortness of breath, cough
- Skin rash, redness, peeling, or blistering
- Nausea, vomiting, diarrhea, constipation
- Mouth sores (mucositis)
- Hair loss (alopecia)
- Changes in vision or eye pain
- Signs of allergic reaction during infusion (e.g., flushing, hives, difficulty breathing, chest tightness)
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 a 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 and organogenesis.
Second Trimester:
Risk of fetal growth restriction, myelosuppression, and other developmental abnormalities.
Third Trimester:
Risk of fetal myelosuppression, premature birth, and other complications.
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, women should not breastfeed during docetaxel treatment and for 1 week after the last dose.
Infant Risk:
L5 (Contraindicated - significant risk to infant)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Docetaxel is not indicated for use in pediatric patients.
Geriatric Use
No overall differences in effectiveness were observed between elderly (≥65 years) and younger patients. However, elderly patients may be more prone to certain adverse reactions, such as fluid retention, neutropenia, and fatigue. Close monitoring is recommended.
Clinical Information
Clinical Pearls
- Premedication 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 CBC frequently, especially during the first cycle, as neutropenia is the most common and dose-limiting toxicity. G-CSF may be used for prophylaxis or treatment of neutropenia.
- Fluid retention can be cumulative and may manifest as peripheral edema, pleural effusion, or ascites. Monitor weight and fluid status closely.
- Peripheral neuropathy is a common 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, or ensure proper peripheral IV access and monitor for extravasation.
- Patients should be advised to avoid grapefruit and grapefruit juice due to potential CYP3A4 interaction.
- Nail changes (onycholysis, discoloration) and skin reactions (rash, desquamation) are common and can be distressing; provide supportive care and patient education.
Alternative Therapies
- Paclitaxel (another taxane)
- Other cytotoxic agents depending on cancer type (e.g., anthracyclines, platinum compounds, antimetabolites)
- Targeted therapies (e.g., trastuzumab, pertuzumab for HER2+ breast cancer)
- Immunotherapy (e.g., pembrolizumab, nivolumab)
- Hormonal therapies (e.g., tamoxifen, aromatase inhibitors for breast cancer; abiraterone, enzalutamide for prostate cancer)
Cost & Coverage
Average Cost:
$500 - $1500 per 80mg/4ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 4 (Specialty Drug) or Tier 5 (Specialty Drug) for brand; Tier 2 or 3 for generic. Coverage varies widely by insurance plan and indication.
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 for 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. Unless instructed to do so by a healthcare professional or pharmacist, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, as some communities may have drug take-back programs. Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist for more information. 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 medical attention. Be prepared to provide details about the medication taken, the amount, and the time it occurred.