Pataxel

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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 Pataxel

Property Description
Active ingredient Paclitaxel
Form Concentrate for solution for infusion
Pharmacological class Antineoplastic agent, Mitotic Inhibitor
Common use Systemic treatment for malignant neoplasms
Origin Semi-synthetic compound (Taxane family)

Pataxel is a potent, prescription-only medication whose identity is centered on the active component, Paclitaxel, which is clinically recognized for its essential role as a cytotoxic agent in systemic therapy. The drug is classified as a taxane, a key class of medicine used for the general management of conditions involving uncontrolled cell proliferation.


Pataxel: An Overview of its Pharmacological Class

Pataxel is fundamentally an antineoplastic agent classified within the mitotic inhibitor drug class. Its active ingredient, Paclitaxel, is a highly successful compound belonging to the taxane family. Paclitaxel is internationally recognized as an effective cytostatic compound. This underscores the drug’s positioning as a standard component of systemic cancer treatment. Pataxel is utilized as a potent cytotoxic agent designed to interfere with the sustained growth of abnormal cells, serving the core purpose of targeted therapy for malignant neoplasms.


Composition, Origin, and Preparation Form

The composition of Pataxel focuses on its single active ingredient, Paclitaxel, which is a semi-synthetic compound derived from precursors found in the Taxus genus. This semi-synthetic status is a key differentiating factor from purely natural or fully synthetic agents. Pataxel is supplied as a sterile concentrate for solution for infusion, necessitating its intravenous route delivery under clinical supervision. The specialized non-aqueous vehicle used for the Paclitaxel formulation, containing components such as macrogolglycerol ricinoleate and ethanol, is necessary to ensure the highly lipophilic active ingredient is adequately stabilized and dispersed for systemic administration.


The General Therapeutic Principle of Paclitaxel

The core therapeutic principle of Pataxel is its function as a microtubule-stabilizing agent. The drug operates as a mitotic inhibitor by binding to the cell's internal structural components, known as microtubules, and preventing their normal disassembly (depolymerization). By arresting the cell in the middle of the division process (mitosis), Pataxel induces programmed cell death (apoptosis), resulting in the desired cytotoxic effect against rapidly proliferating cells.

Regulatory References

  1. Paclitaxel (with albumin) Injection: MedlinePlus Drug Information
  2. Definition of paclitaxel - NCI Drug Dictionary - National Cancer Institute
  3. EPAR: Abraxane, paclitaxel - European Public Assessment Report

What side effects are possible with Pataxel?

Possible Side Effects and Safety Information

The safety profile of Pataxel, whose active ingredient is Paclitaxel, is comprehensively documented in regulatory labeling and classified into specific frequency tiers and System-Organ Classes (SOC). This structured approach communicates the officially documented risks without providing clinical advice.

Frequency and System Classification

Adverse reactions are formally categorized based on incidence observed in clinical trials. Very Common (ge 1/10 patients) reactions include Myelosuppression (primarily neutropenia), Peripheral Neuropathy (sensory), Alopecia, and common Gastrointestinal effects (nausea, vomiting, diarrhea, mucositis). Common (ge 1/100 to < 1/10) effects include Bradycardia and transient elevation of liver enzymes.

Serious Adverse Reactions and Safety Patterns

The official label highlights specific, critical events. Severe Hypersensitivity Reactions and Profound Myelosuppression (Grade 3/4) are documented as serious adverse reactions that require clinical monitoring. Safety labeling notes that Peripheral Neuropathy is a cumulative effect, increasing with the total lifetime dose, while Hypersensitivity Reactions may occur shortly after the initial infusion.

Safety Restrictions and Special Populations

Regulatory documents outline specific limitations for use. Pataxel is generally contraindicated in individuals with a baseline neutrophil count below 1.5 imes 10^9 / L before treatment initiation, or in those with a known severe hypersensitivity to the drug or its excipient, macrogolglycerol ricinoleate. For Hepatic Impairment, use is generally contraindicated in patients with severe hepatic impairment. The labeling also includes specific risk statements regarding potential toxicity to the fetus.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define Pataxel (Paclitaxel) overdosage primarily by the manifestation of its known dose-limiting toxicities and acute life-threatening reactions.

Documented Overdose Manifestations

Element Regulatory Statement
Anticipated Manifestations Bone marrow suppression (chiefly severe neutropenia), severe peripheral neurotoxicity, and mucosiitis are the primary anticipated complications.
Systems Affected Hematologic system (myelosuppression), Nervous system (neurotoxicity), and Cardiovascular system (hypotension, bradycardia).
Urgent Help Required Urgent medical attention is required for any sign of a severe hypersensitivity reaction (e.g., dyspnea or hypotension) or manifestations of profound bone marrow suppression (e.g., severe neutropenia).

Regulatory Actions and Management

Element Regulatory Statement
Antidote Information No known specific antidote exists for Pataxel overdosage.
Mandatory Immediate Action The infusion must be discontinued immediately if a severe hypersensitivity reaction occurs. Symptomatic therapy should be initiated right away.
Monitoring Frequent monitoring of blood counts is required due to the risk of myelosuppression, and frequent vital signs monitoring is recommended.
Population Note Patients with hepatic impairment are at increased risk of toxicity and must be closely monitored.

The overall regulatory profile is defined by the risk of major dose-limiting toxicities and acute, potentially fatal hypersensitivity. Since no specific antidote is known, official documentation mandates the immediate cessation of administration upon severe reaction and focused symptomatic and supportive treatment directed at mitigating the primary anticipated toxicities.

Therapeutic Uses of Pataxel

What Pataxel Treats: Main Uses and Benefits

Pataxel is commonly applied in the therapeutic domain of systemic oncology for the management of malignant neoplasms. This medication is considered relevant for a range of conditions, including advanced ovarian cancer, metastatic breast cancer, non-small cell lung cancer, and AIDS-related Kaposi sarcoma. This treatment is relevant for addressing symptoms related to systemic imbalance that arise from cell proliferation. The key therapeutic benefit is used for managing disease progression and managing the symptom clusters associated with cancer growth, which is generally relevant for supporting functional stability.

The medication is generally applied in clinical settings involving high-stakes contexts, often used as adjuvant (post-surgery) or neoadjuvant (pre-surgery) chemotherapy, and in the management of locally advanced or metastatic disease. It is considered relevant in situations where patients face a high risk of recurrence or when the cancer has spread beyond the primary site. The main benefit plays a role in offering vital systemic support and additional symptomatic support that may assist with easing the overall symptom load associated with the condition, helping to maintain a sense of stability when symptoms are more noticeable.

“This systemic approach supports the patient during difficult episodes by easing distress and contributing to improved comfort during symptomatic periods.”

Quick Fact: Relief for Symptom Burden
Pataxel is applied in contexts marked by increased discomfort or tension, helping to manage symptom clusters that interfere with daily comfort.

Eligibility and Restrictions for Use

The eligibility for Pataxel is strictly defined by government regulatory documents and clinical status. Use is primarily established for adult patients receiving treatment for labeled malignant neoplasms.

Populations Who Cannot Use Pataxel (Contraindications)

The medicine is contraindicated in specific populations. Patients must not use Pataxel if they have a history of severe hypersensitivity reactions to paclitaxel or its excipient, Cremophor® EL (Polyoxyl 35 Castor Oil). An absolute hematological threshold applies: treatment is prohibited if the baseline Absolute Neutrophil Count (ANC) is below 1,500 cells/mm^3 (or <1,000 cells/mm^3 for AIDS-related Kaposi's sarcoma). Furthermore, Pataxel is contraindicated during pregnancy and breastfeeding due to documented fetal and infant risk.

Restricted or Limited Use

Use is not recommended in patients with severe hepatic impairment, as the data for safe dosing are insufficient. Eligibility for pediatric patients is not established, as the safety and effectiveness for those under 18 years have not been demonstrated. Older adults may require special caution due to a potential increase in certain toxicities. Patients with severe renal impairment also fall into a use-not-established category.

What should I know about interactions with other medicines?

Pataxel (Paclitaxel) is metabolized in the liver primarily by two specific cytochrome P450 (CYP) enzymes: CYP2C8 and CYP3A4. Interactions with other medicinal products largely depend on how those products affect the activity of these enzymes.


Enzyme-Mediated Interactions

  • CYP2C8 and CYP3A4 Inhibitors: Co-administering Pataxel with drugs known to inhibit these enzymes (making them less active) can slow down the breakdown of Pataxel. This may lead to increased levels of Pataxel in the bloodstream, potentially raising the risk of side effects, such as bone marrow suppression. Caution is required with such combinations.
  • CYP2C8 and CYP3A4 Inducers: Conversely, drugs that induce (increase the activity of) these enzymes may speed up the breakdown of Pataxel, which could lead to decreased effectiveness.
  • Caution is required when Pataxel is administered alongside any drug identified as a substrate, inducer, or inhibitor of CYP2C8 or CYP3A4.

Population-Specific Interaction Notes

Patients with impaired liver function may have altered clearance of Pataxel, resulting in increased systemic exposure. For these patients, careful monitoring and possible dose adjustment are typically necessary to manage the risk of severe toxicity, particularly myelosuppression (decreased blood cell production).

Mechanism of Action

Targeting and Stabilizing Microtubules

The molecule’s action begins at the molecular level with its binding to the beta-tubulin subunit within the cell's microtubules. This interaction functions as a microtubule-stabilizing agent, promoting tubulin assembly and inhibiting the necessary process of depolymerization. This intervention causes the formation of abnormally stable, non-functional microtubule bundles, which effectively freezes the dynamic structural mobility essential for cellular replication.

Inducing Mitotic Arrest and Apoptosis

The structural failure caused by microtubule stabilization disrupts the formation of the mitotic spindle, which is required to separate chromosomes. This failure activates the highly sensitive Spindle Assembly Checkpoint (SAC), leading to an irreversible G2/M phase mitotic arrest. This prolonged arrest triggers the cell's intrinsic apoptosis pathway, culminating in the induction of apoptosis.

Mechanism Limitations via Cellular Efflux

The mechanism of action is constrained by biological limitations, notably the overexpression of P-glycoprotein (P-gp/MDR1) and other ABC transporters. These membrane-based efflux pumps actively transport Paclitaxel out of the cell. This physical removal of the molecule from the intracellular space prevents it from achieving the critical concentration necessary to bind to beta-tubulin and initiate the stabilizing cascade, thereby diminishing the final induction of apoptosis.

Dosage and Administration Information

How Pataxel is Used: Official Administration Guidelines

Paclitaxel (Pataxel) is administered strictly via Intravenous Infusion (IV) in a controlled clinical environment, reflecting its nature as a systemic cytotoxic agent. The usage protocol is highly standardized.

Official Administration and Dosing

The dosage is typically calculated based on the patient's Body Surface Area (BSA) and varies significantly depending on the specific regimen and indication, generally falling within the range of 135 mg/m^2 to 220 mg/m^2. This calculated dose is given on an Intermittent Cyclic Use schedule, most commonly administered every three weeks (Q3W), or sometimes weekly, over a defined infusion duration of either 3 hours or 24 hours.

Administration requires mandatory procedural steps. The concentrate must be diluted prior to infusion, and the process strictly mandates the use of an in-line filter with a microporous membrane 0.22 mu m to ensure proper delivery of the solution. Furthermore, the standard formulation requires mandatory premedication (including corticosteroids and antihistamines) to be administered before the infusion begins.

Procedural Constraints and Adjustments

The integrity of the medicine during administration is protected by the special handling requirement that the solution must be stored and administered using non-PVC equipment to prevent potential leaching of plasticizers from standard sets. The duration of therapy is typically defined by a set number of treatment cycles or continued until disease progression or other limiting factors are observed. Specific adjustments to the administered dose are outlined for patients with hepatic impairment, with reductions based on specific elevations in bilirubin and transaminase levels. A subsequent dose may not be administered until the patient demonstrates adequate recovery in specific hematologic parameters (e.g., neutrophil and platelet counts).

Recent Clinical Evidence

Research Evidence for Pataxel in Advanced Ovarian Cancer

The use of Pataxel's active ingredient in advanced ovarian cancer has been the subject of multiple large-scale Randomized Controlled Trials (RCTs). These studies monitored adults with newly diagnosed or recurrent advanced disease. Researchers examined outcomes related to disease control, such as Progression-Free Survival and Overall Survival. What remains uncertain is the optimal way to use the medicine in conjunction with newer targeted treatments, such as certain biologic agents.

Research Evidence for Pataxel in Metastatic Breast Cancer

Pataxel was evaluated in a significant number of Phase III clinical trials and subsequent meta-analyses for metastatic breast cancer. The research explored its use both as a single agent and in combination regimens. Evidence is limited for long-term outcomes in very specific subgroups of patients, and research is ongoing to clarify the optimal way to incorporate Pataxel into the rapidly evolving landscape of personalized medicine.

Research Evidence for Pataxel in Advanced Non-Small Cell Lung Cancer

The evidence base for Pataxel's use in advanced Non-Small Cell Lung Cancer (NSCLC) primarily involves Randomized Controlled Trials where the drug was evaluated in combination with platinum-based chemotherapy agents. A principal area of uncertainty involves the drug's use in combination therapies, as it can be challenging to isolate the specific contribution of Pataxel from the other agents.

Research Evidence for Pataxel in AIDS-related Kaposi Sarcoma

Pataxel was evaluated in specific Phase II and III trials for patients with advanced AIDS-related Kaposi Sarcoma. Research examined the Objective Response Rate, which is a measurement of tumor regression, and the duration of that response. Data for certain groups remain insufficient, particularly for long-term outcomes tracking the durability of the observed responses over many years.

Long-Term Studies and Follow-Up

The regulatory understanding of Pataxel is supported by long-term follow-up data from the pivotal clinical trials, especially in ovarian cancer and breast cancer. Research has explored outcomes tracking patient groups for periods extending up to five years or more after the initial treatment period. These studies focus on the durability of the observations over an extended time interval.

Research in Special Populations

Pataxel was observed in trials that enrolled a mix of adults, including older adults. Studies explored in older adults appear to indicate that research does not point to specific age-related concerns that affect how the drug was observed in trials. Specific studies to confirm the applicability in the pediatric population have not been fully established.

Evidence Gaps and Areas of Ongoing Research

While Pataxel has an established base of research, official scientific literature documents several areas where research is ongoing or where certainty remains low. The research landscape is still emerging, and the data for certain groups remain insufficient, highlighting the need for continued investigation.

Key Studies & References

  1. Paclitaxel-based versus docetaxel-based regimens in metastatic breast cancer: a systematic review and meta-analysis of randomized controlled trials
  2. Definition of paclitaxel (NCI Drug Dictionary)

Frequently Asked Questions (FAQ)

Common questions about Pataxel (FAQ)

Q: How quickly does Pataxel typically start to work?

A: Pataxel’s active ingredient works at a molecular level by promoting the failure of cell division, a process known as mitotic arrest. The time required to observe a clinical response is dependent on the specific condition being treated, and monitoring is managed by the healthcare team over the course of therapy. Official documents do not provide a fixed timeline for therapeutic onset.

Q: Does Pataxel require special testing before starting it?

A: Official prescribing guidelines state that monitoring of certain blood counts is necessary prior to starting therapy. Treatment is officially restricted (contraindicated) if the baseline Absolute Neutrophil Count (a component of the white blood cell count) is below a specified threshold.

Q: How long can a person typically expect to be taking Pataxel?

A: The duration of Pataxel use is not a fixed time period but is based on a planned number of treatment cycles. Official administration guidelines state that therapy is continued until these cycles are completed or until the healthcare team observes limiting factors, such as progression of the condition or unmanageable side effects.

Q: Are there any long-term effects associated with Pataxel use?

A: Official regulatory documents identify that Peripheral Neuropathy (changes in nerve sensation) is a documented side effect that may increase with the total lifetime dose of Pataxel. Long-term follow-up data from clinical trials, tracking patients for up to five years or more, support the regulatory understanding of the medicine.

Q: Can people with kidney issues use Pataxel?

A: According to official documents, the use of Pataxel is not recommended for patients with severe renal impairment because the safety and effectiveness have not been established in this group. Official documents do not contain specific recommendations for dose modifications in cases of less severe kidney issues.

Q: Can Pataxel be taken with common over-the-counter pain relievers?

A: Official information indicates that Pataxel is broken down in the body by specific liver enzymes called CYP2C8 and CYP3A4. Any other product, including over-the-counter (OTC) pain relievers, that affects these enzymes could potentially alter the level of Pataxel in the bloodstream. Regulatory guidelines emphasize the importance of discussing all products with a healthcare professional.

Q: How is Pataxel eliminated from the body?

A: Pataxel is primarily metabolized (broken down) by the liver using specific CYP450 enzymes. Official pharmacokinetic data shows that the majority of the drug and its resulting breakdown products are typically excreted from the body through the feces, with a smaller amount passing through the urine.

Q: Can Pataxel affect my ability to drive or operate machinery?

A: Official documents note two factors that may affect alertness. First, the specific formulation of Pataxel concentrate for infusion contains ethanol (alcohol). Second, certain adverse reactions like fatigue or peripheral neuropathy may impair a person's ability to safely perform tasks requiring high mental or motor alertness.

Q: Is it normal to feel a specific sensation when first starting Pataxel?

A: The official safety label notes that Hypersensitivity Reactions (a type of allergic response) may occur shortly after the initial infusion, even when premedication is given. These reactions can include immediate sensations such as flushing or chest discomfort. These documented events are monitored clinically.

Q: Does Pataxel affect blood pressure?

A: Official safety documents list observations of both high blood pressure (hypertension) and low blood pressure (hypotension) during the period of administration. Changes in heart rhythm, such as bradycardia (slowed heart rate), have also been documented in clinical trials.

Q: Can Pataxel be safely used alongside herbal remedies?

A: The official warnings regarding medicinal products that affect the CYP2C8 and CYP3A4 liver enzymes extend to many supplements. Official documents indicate that caution is necessary when Pataxel is administered alongside herbal products that may affect these enzymes, as this can alter the concentration of the medicine.

Q: Are the side effects of Pataxel usually temporary?

A: The duration of side effects varies based on the specific effect. For example, some documented changes, such as transient liver enzyme elevation, may be temporary. Conversely, other effects, such as peripheral neuropathy, are noted as a cumulative effect and may persist or increase over the total course of therapy.

Q: Are there specific symptoms that require urgent medical attention while on Pataxel?

A: Regulatory documents highlight the potential for serious adverse events, including profound low blood counts (Profound Myelosuppression) and Severe Hypersensitivity Reactions. Associated symptoms, such as high fever or severe breathing difficulties, are noted as important signs that should be brought to the immediate attention of the healthcare team.

Q: What is the purpose of the black box warning (if any) on Pataxel?

A: In the United States, official FDA labeling includes a Boxed Warning to draw attention to the most serious safety risks. This warning serves to call attention to the risks of severe myelosuppression (profound low blood cell counts) and severe hypersensitivity reactions, which are critical safety concerns observed in clinical trials.

Q: Does Pataxel interact with alcohol?

A: The specific formulation of Pataxel concentrate for infusion contains ethanol (alcohol) as an excipient (inactive ingredient). Official warnings advise patients to consider the total alcohol content, particularly for those in populations who may be sensitive to alcohol.

How should Pataxel be stored and disposed of?

How to Store and Dispose of Pataxel (Paclitaxel)

Storage Requirements

The unopened Pataxel (Paclitaxel) concentrate must be stored at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F), and must be kept in the original carton to protect from light. Although freezing does not affect chemical stability, if the concentrate precipitates, it must be discarded if it remains cloudy after warming to room temperature. The medication must be kept out of the reach of children.

Handling and Disposal

When preparing the infusion solution, contact with PVC plastic equipment is not recommended; use non-PVC containers to prevent plasticizer leaching. Due to microbial risk, the prepared solution should be used promptly and generally administered within 24 hours. Pataxel is a cytotoxic agent, and unused product or contaminated materials must be handled and disposed of as hazardous waste according to official guidelines for cytotoxic drugs.

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

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