Docefrez

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Docefrez

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Docefrez

What is Docefrez?

Docefrez is a specialized, prescription-only antineoplastic agent used for systemic cancer treatment. Its core function is to inhibit the growth and spread of malignant cells throughout the body by interfering with the cellular structures responsible for division. It is clinically recognized for its role as part of multi-drug regimens.

Property Description
Active ingredient Docetaxel (INN)
Form Concentrate for solution for infusion (IV)
Pharmacological class Taxanes (Microtubule inhibitor)
General purpose Systemic treatment of malignant growth
Origin Semisynthetic

What Type of Medicine is Docefrez?

The medication's active compound is Docetaxel, which belongs to the pharmacological class of Taxanes. This classification is characterized by specific cytotoxic activity. Docefrez, as a brand containing Docetaxel, maintains the established quality and efficacy standards associated with this compound, serving as an option in pharmacotherapy.

Docetaxel is a semisynthetic taxoid, meaning the core structure is manufactured from a precursor initially found in certain yew plant species, such as Taxus baccata, and then optimized in a laboratory for therapeutic use.

Composition and Pharmaceutical Form

Docefrez is supplied as a concentrate for solution for infusion, a specialized liquid preparation that requires mandatory dilution by a healthcare professional before administration. The formulation manages the active ingredient, Docetaxel, which is highly water-insoluble; the concentrate therefore uses non-aqueous excipients, such as Polysorbate 80 and Ethanol (alcohol), to achieve proper solubilization. The final solution is delivered via Intravenous (IV) infusion, ensuring direct entry into the systemic circulation.

Docefrez: General Purpose and Cellular Action

The drug's primary purpose is to achieve systemic control over cellular malignancy. Docetaxel works as a microtubule inhibitor by binding to and stabilizing the cell’s internal structures (microtubules) that are essential for cell division. This mechanism prevents the cancer cell from completing the necessary division process, ultimately leading to the destruction of the malignant cell. Its use is typical in situations where targeted reduction of cancer cell burden throughout the body is required.

Regulatory References

  1. Docetaxel - NCI Drug Dictionary - National Cancer Institute

What side effects are possible with Docefrez?

Possible Side Effects and Safety Information: Docefrez

Docefrez (docetaxel) is associated with several serious and common adverse reactions, as documented in governmental regulatory labeling. It is classified to require mandatory pre-treatment safety checks and dose adjustments based on individual patient parameters.


Serious and Clinically Significant Adverse Reactions

The most serious documented risks include Toxic Deaths, severe Neutropenia (low white blood cell count), which can lead to life-threatening infection (febrile neutropenia), and Severe Hypersensitivity Reactions (allergic reactions), including rare fatal anaphylaxis. Other serious concerns are Hepatotoxicity (liver damage), Severe Fluid Retention, and significant Peripheral Neuropathy (nerve damage).

Common Adverse Reactions

Adverse reactions reported with a high frequency often involve the Blood and Lymphatic System (e.g., anemia, thrombocytopenia), Gastrointestinal Disorders (e.g., nausea, vomiting, diarrhea, stomatitis), Skin and Subcutaneous Tissue Disorders (e.g., skin reactions, alopecia), and General Disorders (e.g., asthenia, pain).

Safety Considerations and Restrictions

Contraindications include prior severe hypersensitivity to docetaxel or polysorbate 80, and pre-treatment neutrophil counts below 1,500 cells/mm^3. The drug is also contraindicated in patients with significant baseline hepatic impairment. Due to the risk of fetal harm, use during pregnancy is contraindicated, and effective contraception is required for both male and female patients during and shortly after treatment. Monitoring of blood cell counts and liver function tests is mandatory before each cycle. The formulation contains ethanol, requiring caution regarding potential central nervous system effects post-infusion.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation defines the overdose profile of Docefrez (Docetaxel) by several severe, potentially life-threatening manifestations, and explicitly details when urgent medical intervention is required. There is no specific antidote known for an overdose; therefore, management is limited to symptomatic and supportive treatment and close observation.


Officially Documented Overdose Manifestations

Excessive exposure is associated with a heightened risk of severe neutropenia (low white blood cell count), which may lead to serious infections (indicated by fever, chills, or sore throat). Other documented clinical presentations include severe thrombocytopenia, severe stomatitis, and aggravated peripheral neuropathy (numbness, tingling, or weakness).

Life-threatening outcomes such as toxic death and severe fluid retention (potentially leading to cardiac tamponade) are associated with doses exceeding prescribed limits. Additionally, the Ethanol content in the concentrate may induce symptoms of acute alcohol intoxication.


When Urgent Medical Help is Mandated

Regulatory guidance mandates that a person seek immediate medical attention for symptoms suggesting a severe infection (e.g., unmanaged fever or chills), severe fluid retention, or signs of a severe allergic reaction (e.g., difficulty breathing). Emergency services (911/equivalent) must be called if the individual has collapsed, experienced a seizure, or cannot be awakened. Patients with hepatic impairment are at increased risk for severe toxicity and mortality following high exposure.

Therapeutic Uses of Docefrez

Quick Facts

  • May be used for the management of: Breast cancer, including locally advanced or metastatic disease.
  • May be used for the management of: Non-small cell lung cancer (NSCLC) after prior chemotherapy failure or in combination with cisplatin for previously untreated cases.
  • May be used for the management of: Metastatic prostate cancer (hormone refractory/androgen independent) in combination with prednisone.
  • May be used for the management of: Squamous cell carcinoma of the head and neck.

Docefrez is a prescription medication utilized in oncology settings to help address the progression of certain types of cancer. It is indicated as a therapeutic option for patients diagnosed with breast cancer, including cases that are locally advanced or metastatic, often following the failure of prior chemotherapy regimens.

The medication also serves a role in the treatment of non-small cell lung cancer (NSCLC), where it may be administered as a single agent after treatment failure with platinum-based therapy, or in combination with cisplatin for previously untreated, locally advanced, or metastatic unresectable NSCLC.

Furthermore, Docefrez, when administered with prednisone, is a part of a regimen for managing metastatic prostate cancer that is hormone refractory or androgen independent. It may also be used in the management of advanced gastric adenocarcinoma and squamous cell carcinoma of the head and neck.

Eligibility and Restrictions for Use

Who Can and Cannot Use Docefrez?

The population eligibility for Docefrez (Docetaxel) is strictly defined by government regulatory agencies based on established contraindications and population restrictions. This information details which groups are permitted, restricted, or prohibited from using the medicine, without reference to therapeutic benefits or dosing instructions.


Contraindications (Must Not Use)

Category Exclusion Condition
Hypersensitivity History of severe hypersensitivity reactions to docetaxel or drugs containing Polysorbate 80 (an excipient).
Hematologic Status Baseline absolute neutrophil count less than 1,500 cells/mm^3.
Hepatic Function Specific markers of severe hepatic impairment (elevated bilirubin, AST/ALT, and alkaline phosphatase).

Age and Reproductive Status

Category Regulatory Status
Adults Use is indicated for approved cancer treatments.
Pediatric Population Safety and effectiveness are not established; use is not recommended (under 18 years).
Pregnancy Contraindicated due to the potential for fetal harm.
Lactation Contraindicated; breastfeeding must be discontinued during treatment.

Conditional Restrictions: Use requires caution and monitoring in specific adult populations, including those with moderate hepatic impairment (often requiring dose adjustment) and patients over 75 years of age due to increased risk of toxicity. Treatment is also conditional on the recovery of blood counts between cycles.

What should I know about interactions with other medicines?

The official regulatory profile for Docefrez (docetaxel) describes interactions primarily based on its metabolic clearance pathway. Docetaxel is metabolized by the Cytochrome P450 3A4 (CYP3A4) enzyme and is a substrate for the P-glycoprotein (P-gp) efflux transporter.

Category Regulatory Statement
Metabolic Interactions Co-administration with potent CYP3A4 inhibitors is expected to significantly increase docetaxel systemic exposure, leading to a higher risk of toxicity.
Formal Restriction Use is formally contraindicated in patients with a history of severe hypersensitivity to docetaxel or to medicinal products formulated with Polysorbate 80.
Food/Substance Interaction Consumption of Grapefruit Juice should be avoided due to its potent CYP3A4 inhibitory effects, which can increase drug concentrations. The concentrate's Ethanol content may affect the central nervous system immediately following infusion.
Management Condition If co-administration with a potent CYP3A4 inhibitor cannot be avoided, the regulatory documents specify that a 50% reduction in the docetaxel dose must be considered.
Population Note Toxicity risk from interactions is magnified in patients with pre-existing Hepatic Impairment, a condition that requires careful pre-treatment monitoring.

The overall interaction profile is structured around the need to manage pharmacokinetic exposure. Strong inhibitors of the CYP3A4 enzyme and P-gp are classified as clinically significant interactions that necessitate either avoidance or dose adjustment to mitigate the risk of elevated docetaxel levels. The profile also addresses pharmacodynamic interactions through required dosage modifications when used in approved combination chemotherapy regimens.

Mechanism of Action

Molecular Targeting and Microtubule Hyper-Stabilization

The action of Docetaxel, the active compound in Docefrez, begins with its high-affinity binding to the beta-tubulin subunit of the cell's microtubules

. This interaction promotes the assembly of tubulin but crucially prevents its disassembly, resulting in a state of hyper-stabilization. This locks the cellular framework into a rigid, non-functional state, which constitutes the foundational molecular step in the resulting cascade.


Mitotic Arrest and Irreversible Cell Cycle Blockade

The consequence of microtubule hyper-stabilization is the immediate failure of the mitotic spindle to function correctly, leading to the blockage of the cellular division process. The cell enters a sustained G2/M phase arrest, recognizing the irreparable error in its division machinery. This pathway effect results in the halt of proliferation and precedes the induction of cell death in the target population.


Induction of Programmed Cell Death (Apoptosis)

The prolonged and failed attempt at cell division triggers an internal signaling cascade that activates the intrinsic apoptosis pathway. By modulating proteins such as Bcl-2, the mechanism overrides the cell's anti-survival signals, leading to programmed cell death. This physiological effect leads to the selective destruction of the target cell, which results in the selective elimination of the target cell population.

Dosage and Administration Information

Official Administration Guidelines

Docefrez (Docetaxel) is a specialized concentrate that must be prepared and administered exclusively in a healthcare setting. The instructions for its use are established based on clinical standards for this therapeutic class.

Feature Official Instruction Summary
Route of Administration Intravenous (IV) Infusion only.
Frequency and Timing Administered as a one-hour infusion typically every three weeks (q3Weeks).
Dosing Range Monotherapy doses range from 60 mg/m^2 to 100 mg/m^2, calculated based on the patient's body surface area (BSA). Combination regimens typically use a dose of 75 mg/m^2.
Premedication All patients must be premedicated with an oral corticosteroid (such as dexamethasone) starting one day prior to each infusion.

Administration Protocol and Adjustments

Docefrez is supplied as a concentrate that requires mandatory dilution by a professional before use and should be administered through non-PVC equipment. Treatment is delivered in cycles (e.g., six cycles for adjuvant breast cancer) or continues until a pre-defined endpoint is reached.

Established clinical instructions require the administration of a dose to be withheld if the patient’s neutrophil count is below 1,500 cells/mm^3. Furthermore, specific dose reductions (e.g., 25% reduction) are prescribed in subsequent cycles if the patient experiences certain toxicities after a preceding dose. No specific initial dose adjustment is mandated solely for age or renal impairment, but modifications are required for certain degrees of abnormal liver function.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Summary of Clinical Findings

Clinical trials have evaluated the active ingredient in Docefrez, docetaxel, in several cancer types, including breast, non-small cell lung, and prostate cancer. These studies focused on measuring clinical endpoints, such as disease activity scores and patient-reported symptoms, and typically compared treatment outcomes against a placebo or an active comparator drug.

Research explored the relationship between this approach and predefined clinical measures in adults. Studies assessed patient-reported pain scales and indices used to measure symptoms, reporting on the mean changes in these scores over the study duration. Trials also included reporting of adverse events across various patient groups.


Outcomes in Clinical Trials

Randomized controlled trials (RCTs) reported on the differences in measured clinical outcomes between the treatment groups. The primary endpoints often included metrics like overall survival (OS) and progression-free survival (PFS).

  • Combination Use: Research also examined the compound when used alongside other established therapies. The findings from these combination studies were reported in research publications, measuring outcomes such as health-related quality of life as a secondary endpoint.

Tolerability Data

The reporting of adverse events was included in all clinical trials. The reported adverse events included instances of neutropenia (low white blood cell count), fatigue, headache, and gastrointestinal discomfort. Fluid retention and hypersensitivity reactions were also reported and often managed with specific premedications in the study protocols.

Serious adverse events were reported at a lower frequency, consistent with the profile observed in the comparator groups in the RCTs. Full details regarding the frequency and type of adverse events are available in the trial publications.

Frequently Asked Questions (FAQ)

Common questions about Docefrez (FAQ)

Q: What types of tumors is Docefrez typically used for?

A: The active compound in Docefrez is officially indicated for the treatment of certain types of cancer. According to regulatory documents, this includes specific stages of breast cancer, non-small cell lung cancer, and prostate cancer.

Official documents also state it may be approved for conditions such as gastric adenocarcinoma and head and neck cancer, often when used as part of a combination regimen with other medicines.


Q: How long does Docefrez stay in the body after treatment?

A: Studies on the drug’s breakdown (pharmacokinetics) indicate that it is rapidly distributed throughout the body following administration. However, official information describes a prolonged terminal elimination half-life that averages over 100 hours in a late phase.

This reflects the time it takes for the drug to clear from peripheral compartments in the body.


Q: What happens if I miss a scheduled dose of Docefrez?

A: Docefrez administration is a procedure managed entirely by a specialized healthcare team in a clinical setting. Regulatory guidelines state that dosing schedules are highly individualized and are adjusted based on a patient's response and the recovery of their blood counts.

If a scheduled infusion cannot be attended, official guidance indicates that the patient's healthcare provider should be contacted to determine the appropriate timing for the next administration.


Q: Can Docefrez be used with blood thinners?

A: Regulatory documents define potential interactions based on the drug's metabolic pathway, primarily focusing on the CYP3A4 enzyme.

For safety, it is described in official documentation that patients should ensure their prescribing healthcare provider is aware of all current medications so that potential interactions not specifically listed can be reviewed.


Q: Does Docefrez interact with common pain medications like ibuprofen?

A: Docefrez is broken down by an enzyme called CYP3A4. While the label specifies inhibitors of this enzyme (like Grapefruit Juice), common non-prescription pain relievers like ibuprofen are not explicitly named.

Because this specific interaction is not explicitly detailed in the regulatory labeling, official guidance indicates that all prescription and non-prescription pain medications should be reviewed with the patient’s healthcare provider.


Q: Where can I find research papers about the effectiveness of Docefrez?

A: Official regulatory labels (such as those from the FDA or EMA) include a 'Clinical Studies' section. This section summarizes the key randomized controlled trials (RCTs) that were used to establish the drug’s effectiveness.

The full, detailed results of these research papers are available for review through public medical literature databases.


Q: What is the difference between Docefrez and Paclitaxel?

A: Both Docefrez and Paclitaxel are medications belonging to the same pharmacological class, known as Taxanes. While their mechanism of action is similar, differences exist in their chemical structure and clinical profile.

Studies suggest they may be associated with different common toxicities, such as variations in the incidence of fluid retention or peripheral neuropathy.


Q: Is there a patient brochure or informational leaflet available for Docefrez?

A: As a tightly regulated prescription medicine, the product packaging includes a detailed Patient Information Leaflet or Patient Package Insert (PPI).

This material summarizes key safety, usage, and administration details in clear, accessible language. The official Patient Information Leaflet can be obtained from the healthcare provider or administering facility.


Q: Do patients experience pain during the administration of Docefrez?

A: Pain is listed as a general adverse reaction in the clinical trial data reported in official documents. Although the drug is delivered via intravenous infusion, the regulatory label does not specify the exact frequency of localized discomfort or pain at the infusion site during the one-hour treatment.

Official information indicates that any discomfort or pain experienced during the infusion is a factor that should be reported to the healthcare team managing the treatment.


Q: Is Docefrez a chemotherapy drug?

A: Yes, Docefrez is officially classified as an antineoplastic agent within the Taxane class. Because its mechanism involves inhibiting cell division to destroy malignant cells, it falls into the general category of traditional cytotoxic chemotherapy.


Q: How is Docefrez different from other cancer treatments?

A: Docefrez belongs to the Taxane class, which has a distinct mechanism of action. It works by binding to and hyper-stabilizing microtubules—the internal structures essential for cell division.

This unique action prevents cancer cells from completing the division process (mitosis), ultimately triggering cell death.


Q: Is hair loss a guaranteed side effect of Docefrez?

A: Hair loss, or alopecia, is listed in official documentation as a very common adverse reaction, meaning it occurs in a high percentage of patients treated with the drug.

However, the regulatory label does not state that hair loss is a guaranteed or 100% certain outcome for every single patient.


Q: Are there any specific foods or drinks to avoid while taking Docefrez?

A: Official documents formally advise patients to avoid consuming Grapefruit Juice. This is because it can interfere with the breakdown of the drug, which may increase the concentration of the drug in the body and potentially raise the risk of toxicity.

The formulation of the concentrate also contains alcohol (ethanol), which requires caution.


Q: Does Docefrez affect fertility?

A: Based on the drug's mechanism of action and non-clinical data, official information indicates a potential for permanent impairment of fertility in both male and female patients.

Due to this risk, effective contraception is required for patients of reproductive potential during and for a specified time shortly after treatment.


Q: Is Docefrez a targeted therapy?

A: Docefrez is categorized as a microtubule inhibitor or a Taxane. Its action is highly specific at a molecular level (binding to beta-tubulin) to interfere with cell division.

However, in the clinical context, it is typically categorized as a cytotoxic chemotherapy rather than a gene- or receptor-specific targeted therapy.


Q: Do I need to change my daily routine significantly while on Docefrez?

A: The drug's profile includes common adverse reactions such as fatigue and general malaise, which could potentially impact daily activities.

Official warnings also advise caution regarding activities requiring full concentration (such as driving) immediately following the infusion due to the formulation’s alcohol content. Guidance on any necessary adjustments to a patient's routine should be obtained directly from the healthcare team.


Q: Is it common to feel sick right after a Docefrez infusion?

A: Adverse reactions such as nausea and vomiting are listed in official documents as very common side effects associated with the drug.

Additionally, the ethanol content in the formulation is noted in regulatory warnings as potentially causing temporary central nervous system effects immediately following the infusion.


Q: Can Docefrez interact with herbal supplements?

A: Official regulatory warnings advise that any herbal or dietary supplement that is a strong inhibitor of the CYP3A4 enzyme may increase the drug's concentration and risk of toxicity. St. John's Wort, for example, may reduce the drug's effectiveness.

Official information states that a complete list of all supplements being used should be provided to the doctor for review.


Q: What kind of long-term side effects are associated with Docefrez?

A: Official warnings and precautions sections note that certain side effects can be persistent or long-term. These can include severe peripheral neuropathy (nerve damage) and fluid retention.

Official guidance indicates that these potential issues are factors that must be monitored and reported to the prescribing doctor if they continue or emerge after treatment has concluded.


Q: How does Docefrez compare to other treatments mentioned in official guidelines?

A: Clinical trial data published in the regulatory documents compare Docefrez against either a placebo or an active comparator drug. These comparisons are the basis for its approved uses.

The results measure specific clinical endpoints like overall survival and progression-free survival, which are used by regulatory agencies to define its specific role in treatment guidelines.


Q: What are the general guidelines for managing side effects from Docefrez?

A: Official management guidelines include mandatory premedication with oral corticosteroids to help reduce the risk of hypersensitivity and fluid retention. The administration protocol also requires the dose to be adjusted or withheld based on specific patient parameters.

For example, treatment may be modified based on severely low blood cell counts (neutropenia) or persistent toxicity as defined in the official documentation.

How should Docefrez be stored and disposed of?

How to Store and Dispose of Docefrez

Official regulatory guidelines establish specific requirements for the storage, handling, and disposal of Docefrez (docetaxel).

Storage and Handling Requirements

  • Unopened Vials: Store the vials between 20 C and 25 C (USP Controlled Room Temperature), or as cool as 2 C. The vial must be kept in its original package to protect it from light.
  • Final Solution: The diluted solution is stable for a limited time (e.g., 6 hours at 2 C to 25 C) and should be prepared and administered using non-PVC equipment.
  • Inspection: The solution must be visually inspected for particulate matter or discoloration prior to administration.

Disposal Instructions

Docefrez is classified as a hazardous drug and requires special disposal procedures. Any unused portion of the vial and all materials used during preparation must be discarded according to established local, state, and federal regulations for cytotoxic/hazardous waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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