Docetax
Generic Name
Docetaxel 80 mg Injection
Manufacturer
Multiple Manufacturers (e.g., Sanofi, Incepta)
Country
Global
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
docetax 80 mg injection | ৳ 11,500.00 | N/A |
Description
Overview of the medicine
Docetaxel is a taxoid anticancer agent used for the treatment of various cancers, including breast, non-small cell lung, prostate, gastric, and head and neck cancers. It works by interfering with cell division.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on cancer type, stage, and combination therapy. Typical regimens range from 75 mg/m² to 100 mg/m² administered as a 1-hour intravenous infusion every 3 weeks. Specific dose adjustments may be required based on patient tolerability and blood counts.
Elderly
No specific dose adjustments are routinely required for elderly patients, but careful monitoring for toxicity is recommended due to potential age-related physiological changes.
Renal_impairment
No specific dose adjustments are typically required for mild to moderate renal impairment, but caution is advised. Data for severe renal impairment is limited.
How to Take
Docetaxel is administered as a 1-hour intravenous infusion. Patients should be pre-medicated with an oral corticosteroid (e.g., Dexamethasone) starting 1 day before Docetaxel administration to reduce the incidence and severity of hypersensitivity reactions and fluid retention.
Mechanism of Action
Docetaxel promotes the assembly of microtubules from tubulin dimers and stabilizes them by preventing depolymerization. This leads to the accumulation of stable, nonfunctional microtubules, inhibiting cellular mitotic and interphase functions, ultimately leading to cell cycle arrest and apoptosis.
Pharmacokinetics
Onset
Effect onset is related to the cell cycle inhibition, typically within hours of administration.
Excretion
Mainly excreted via feces (approximately 75%) primarily as metabolites, with a minor amount (around 6%) excreted renally, both unchanged and as metabolites.
Half life
The terminal elimination half-life is approximately 11 to 18 hours, with a rapid initial distribution phase.
Absorption
Administered intravenously, resulting in 100% bioavailability. Peak plasma concentrations are reached rapidly after a 1-hour infusion.
Metabolism
Extensively metabolized in the liver by the cytochrome P450 3A4 (CYP3A4) isoenzyme system to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to docetaxel or to any other component of the formulation (e.g., polysorbate 80).
- Neutrophil count <1500 cells/mm³ prior to treatment.
- Severe liver impairment.
Drug Interactions
Other Myelosuppressive Agents
Increased risk of myelosuppression when given with other bone marrow suppressants. Close monitoring of blood counts is required.
CYP3A4 Inducers (e.g., Phenytoin, Carbamazepine, Rifampicin)
Concomitant use may decrease docetaxel plasma concentrations, potentially reducing efficacy. Avoid co-administration if possible.
CYP3A4 Inhibitors (e.g., Ketoconazole, Erythromycin, Ritonavir)
Concomitant use may increase docetaxel plasma concentrations, potentially increasing toxicity. Avoid co-administration or reduce docetaxel dose with close monitoring.
Storage
Store unopened vials at 2°C to 25°C (36°F to 77°F). Protect from light. Do not refrigerate the diluent. The diluted solution should be used immediately or stored for a limited time as per manufacturer's instructions.
Overdose
There is no known antidote for docetaxel overdose. Expected complications of overdose include increased myelosuppression, peripheral neurotoxicity, and mucositis. Management should include supportive care, including administration of granulocyte-colony stimulating factor (G-CSF) for myelosuppression, and symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category D. Docetaxel can cause fetal harm when administered to a pregnant woman. It is not recommended during pregnancy. Women of childbearing potential should use effective contraception. It is not known whether docetaxel is excreted in human milk, but due to potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment.
Side Effects
Contraindications
- Hypersensitivity to docetaxel or to any other component of the formulation (e.g., polysorbate 80).
- Neutrophil count <1500 cells/mm³ prior to treatment.
- Severe liver impairment.
Drug Interactions
Other Myelosuppressive Agents
Increased risk of myelosuppression when given with other bone marrow suppressants. Close monitoring of blood counts is required.
CYP3A4 Inducers (e.g., Phenytoin, Carbamazepine, Rifampicin)
Concomitant use may decrease docetaxel plasma concentrations, potentially reducing efficacy. Avoid co-administration if possible.
CYP3A4 Inhibitors (e.g., Ketoconazole, Erythromycin, Ritonavir)
Concomitant use may increase docetaxel plasma concentrations, potentially increasing toxicity. Avoid co-administration or reduce docetaxel dose with close monitoring.
Storage
Store unopened vials at 2°C to 25°C (36°F to 77°F). Protect from light. Do not refrigerate the diluent. The diluted solution should be used immediately or stored for a limited time as per manufacturer's instructions.
Overdose
There is no known antidote for docetaxel overdose. Expected complications of overdose include increased myelosuppression, peripheral neurotoxicity, and mucositis. Management should include supportive care, including administration of granulocyte-colony stimulating factor (G-CSF) for myelosuppression, and symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category D. Docetaxel can cause fetal harm when administered to a pregnant woman. It is not recommended during pregnancy. Women of childbearing potential should use effective contraception. It is not known whether docetaxel is excreted in human milk, but due to potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years for unopened vials when stored as recommended. Once diluted, solutions have a limited stability (e.g., 6 hours at room temperature).
Availability
Hospitals, Specialized Oncology Pharmacies
Approval Status
Approved
Patent Status
Patent expired for generic formulations
Clinical Trials
Docetaxel has been extensively studied in numerous randomized controlled clinical trials demonstrating its efficacy and safety across various cancer types, often in combination with other chemotherapeutic agents or targeted therapies. Ongoing trials continue to explore new indications and regimens.
Lab Monitoring
- Complete Blood Count (CBC) with differential before each cycle and periodically thereafter.
- Liver Function Tests (LFTs) (AST, ALT, bilirubin, alkaline phosphatase) before each cycle.
- Renal Function Tests (RFTs) (serum creatinine, BUN) periodically.
- Neurological examination for signs of peripheral neuropathy.
Doctor Notes
- Ensure adequate corticosteroid pre-medication is administered to mitigate hypersensitivity and fluid retention.
- Strictly monitor absolute neutrophil count (ANC) before each cycle; hold or reduce dose for neutropenia.
- Carefully assess liver function; dose reduction or discontinuation may be necessary in patients with hepatic impairment.
- Educate patients on potential peripheral neuropathy and advise prompt reporting of symptoms.
Patient Guidelines
- Report any new or worsening side effects to your doctor immediately.
- Follow the prescribed pre-medication schedule diligently to minimize adverse reactions.
- Maintain good hydration by drinking plenty of fluids unless otherwise advised.
- Avoid close contact with people who are sick or have infections.
- Do not consume grapefruit or grapefruit juice while on docetaxel therapy.
Missed Dose Advice
If a dose of Docetaxel is missed, contact your oncologist or healthcare provider immediately to reschedule. Do not attempt to self-administer or adjust the dose.
Driving Precautions
Docetaxel may cause fatigue, dizziness, or visual disturbances. Patients should be advised not to drive or operate machinery if they experience these symptoms.
Lifestyle Advice
- Practice good oral hygiene to prevent mucositis.
- Avoid activities that may cause cuts or bruises due to increased risk of bleeding.
- Get adequate rest and manage fatigue through light activity if possible.
- Use sun protection as skin may become more sensitive to sunlight.
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