Pacline

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Pacline

Understanding Pacline

Pacline is a pharmaceutical medication containing the active substance paclitaxel. It belongs to a group of medicines known as antineoplastic agents, specifically within the taxane family. These medications are designed to interfere with the growth and spread of certain types of cells in the body.

Mechanism of Action

Paclitaxel works by targeting the internal structure of cells. It binds to microtubules—small, tube-like structures that are essential for cell division and movement. By stabilizing these microtubules, the medication prevents them from breaking down and reforming, which is a necessary step for cells to divide. This process effectively inhibits the ability of rapidly growing cells to replicate.

Clinical Applications

Pacline is utilized in the management of various malignant conditions. Its primary use is in the treatment of several specific types of cancer, where it may be administered as a primary therapy or in combination with other therapeutic agents. It is commonly associated with the treatment of:

  • Ovarian Cancer: Often used as a first-line treatment or when initial therapies have not been successful.
  • Breast Cancer: Employed in various stages of the disease, including advanced cases or as part of a follow-up treatment plan after surgery.
  • Non-Small Cell Lung Cancer (NSCLC): Typically used in combination with other medications for patients who are not candidates for curative surgery or radiation.
  • Kaposi's Sarcoma: Specifically used in certain advanced cases related to immune system deficiencies.

Administration Context

This medication is typically provided in a clinical setting under the supervision of healthcare professionals experienced in the administration of specialized therapies. The determination of its use depends on the specific diagnosis, the stage of the condition, and the overall health profile of the individual.

Regulatory References

  1. MedlinePlus, Paclitaxel
  2. European Medicines Agency

What side effects are possible with Pacline?

Possible Side Effects and Safety Information

The official safety profile for Pacline (Paclitaxel) is structured by regulatory authorities to classify potential adverse reactions based on frequency and affected body system. This profile emphasizes that certain reactions are an expected consequence of treatment.

Regulatory Classification of Adverse Reactions

Adverse effects are formally grouped by System-Organ Class and severity. The most frequently reported events are classified as Very Common (occurring in 10% or more of patients) and Common (occurring in 1% to less than 10% of patients).

Classification System-Organ Class Examples Frequency Tier
Haematological Neutropenia, Anemia, Thrombocytopenia Very Common
Nervous System Peripheral Sensory Neuropathy, Arthralgia, Myalgia Very Common
Gastrointestinal Nausea, Vomiting, Diarrhoea, Mucositis Very Common
Integumentary Alopecia (Hair Loss) Very Common
Cardiovascular Bradycardia, Hypotension Very Common

Serious Adverse Reactions and Safety Constraints

Regulatory documentation highlights the risk of Serious Adverse Reactions, including severe Myelosuppression (a profound reduction in blood cell counts that can lead to infection and sepsis) and severe, sometimes fatal, Hypersensitivity Reactions. These reactions often occur within the first hour of infusion.

Safety is formally constrained by specific conditions of use. The medicine is contraindicated in patients with a severely low baseline neutrophil count and in those with documented severe hepatic (liver) impairment. Furthermore, the severity and frequency of Peripheral Neuropathy are officially noted to increase with cumulative dosage and duration of exposure.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Pacline (Paclitaxel) overdose is defined by the exaggeration of the drug's primary dose-limiting toxicities. Individuals exposed to an overdose are anticipated to present with severe bone marrow suppression, which is the most significant anticipated complication. Additional documented manifestations include severe peripheral neurotoxicity and mucositis.

Emergency Actions and Antidote Status

Official labeling explicitly states that there is no known antidote for Paclitaxel overdosage. Consequently, clinical management must be supportive and specifically directed at addressing the anticipated toxicities. Patients require close monitoring to manage the progression of these severe complications.

Urgent medical attention is required for any suspected overexposure or if severe side effects are experienced after administration. Because severe bone marrow suppression carries a risk of life-threatening infection, the patient must inform a doctor or nurse immediately.

Population Note: A specific risk of acute ethanol toxicity exists for pediatric patients due to the alcohol content of the injectable formulation’s vehicle, which must be considered in case of accidental overdosage.

Therapeutic Uses of Pacline

Pacline is an established antineoplastic agent relevant for easing conditions presenting with systemic or localized discomfort linked to malignant cell activity. The drug is a core treatment for ovarian cancer, breast cancer, non-small cell lung cancer (NSCLC), and specific forms of cancer such as AIDS-related Kaposi's sarcoma. This application may provide supportive relief that helps ease the overall symptom burden and may assist with the potential for a positive clinical response.


What Pacline Treats: Main Uses and Benefits

Pacline is commonly used in clinical scenarios involving advanced or metastatic disease, where the primary objective is to manage the malignancy's progression. It is applied as first-line therapy, as adjuvant treatment after surgery to manage the risk of recurrence, and in the neoadjuvant setting to shrink tumors before surgical removal. By addressing malignant cell activity, Pacline helps significantly reduce the overall symptom load related to tumor burden and actively supports the slowing of the rate of disease spread.

“Pacline is used within protocols to support the goals of therapeutic success against a range of solid tumors, including those that are aggressive or locally advanced.”

This strategic placement may provide support that helps maintain a sense of stability and assists with maintaining functional stability during symptomatic phases.

Quick Fact: Relief for Tumor Burden and Recurrence Risk

Pacline is used for managing conditions characterized by increased physiological stress linked to growing tumor masses and is relevant in contexts involving high systemic burden. It is applied across therapeutic domains where additional symptomatic support is needed to reduce the overall symptom load and manage the risk of recurrence after initial local treatments.

Regulatory References

  1. NCI Fact Sheet on Paclitaxel

Eligibility and Restrictions for Use

Who Can and Cannot Use Pacline?

Pacline (Paclitaxel) eligibility is strictly defined by regulatory authorities and is based on a patient's physiological status and history.

Contraindicated Populations

Use of Pacline is absolutely contraindicated (must not be used) in patients with specific conditions:

  • A history of severe hypersensitivity to Paclitaxel or related Taxane medicines.
  • A history of severe allergy to the excipient Polyoxyl 35 Castor Oil (found in standard formulations).
  • Severe neutropenia, defined as a baseline Absolute Neutrophil Count (ANC) less than 1,500 cells/mm^3 (or less than 1,000 cells/mm^3 for AIDS-related Kaposi's sarcoma).
  • Severe hepatic impairment (severe liver dysfunction).

Eligibility by Age and Reproductive Status

Population Regulatory Status
Pediatric Population (under 18) Not recommended due to insufficient data on safety and effectiveness.
Pregnancy Not recommended; classified to cause fetal harm. Effective contraception is mandated during treatment.
Lactation (Breastfeeding) Contraindicated; breastfeeding must be discontinued during therapy.

Pacline is established for use in adults for its approved indications. Treatment must be withheld if ANC and platelet counts fall below required threshold levels until they recover.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Pacline (Paclitaxel) establishes restrictions based on pharmacokinetic and pharmacodynamic interactions documented in government labeling.


Pharmacokinetic and Pharmacodynamic Interactions

Interaction Type Official Regulatory Description
Metabolic Pathway Co-administration with strong inhibitors of the CYP2C8 and CYP3A4 enzymes may increase the systemic exposure and plasma concentration of Paclitaxel, reducing its clearance .
Additive Toxicity The risk of severe myelosuppression (low white blood cell count) is officially documented to increase when Paclitaxel is used with other agents that also cause bone marrow suppression.

Administration Constraints and Non-Medicinal Substances

Regulatory documents specify mandatory sequencing rules for combination therapy. Paclitaxel must be administered before Cisplatin to mitigate the documented risk of profound and prolonged myelosuppression. Additionally, Paclitaxel should be administered 24 hours after Doxorubicin to manage altered drug levels.

Specific non-medicinal substances, such as Grapefruit products and the herbal product St. John’s Wort, are listed as potential interacting substances due to their documented effects on CYP enzyme activity. Furthermore, Paclitaxel formulations containing Macrogolglycerol Ricinoleate are formally contraindicated in patients with a known hypersensitivity to the excipient.

Mechanism of Action

The mechanism of Pacline (Paclitaxel) involves an interaction with the fundamental mechanics of cellular replication, specifically through the stabilization of internal structural components, which results in the activation of programmed cell death (apoptosis).


Molecular Mechanism: Microtubule Stabilization

Pacline exerts its mechanism by binding directly to the beta-tubulin subunits of the microtubules, forcing these structures into a hyper-stabilized, non-dynamic state. This molecular lock prevents the necessary depolymerization required for cells to progress through division, thereby fundamentally modifying the cellular scaffolding integrity.


Pathway Effect: G2/M Phase Arrest and Apoptosis

The mechanical failure of the mitotic machinery, a direct consequence of microtubule stabilization, triggers a prolonged stall at the G2/M phase checkpoint, enforcing an irreversible cell cycle arrest. This sustained failure activates the intrinsic apoptotic cascade, resulting in the controlled initiation of apoptosis in cells undergoing active cell cycle progression.

Dosage and Administration Information

How Pacline is Used: Official Administration Guidelines

Pacline (Paclitaxel) administration is governed by a strictly defined, multi-step protocol, ensuring its use occurs exclusively in a specialized clinical setting.


Administration Scope

Pacline is administered strictly via Intravenous (IV) Infusion. Dosage is calculated based on the patient’s body surface area (mg/m^2), with standard regimens typically utilizing doses of 175 mg/m^2 or 135 mg/m^2. For most solid tumor protocols, treatment is scheduled in cycles every three weeks (q3Weeks), though some indications, such as AIDS-related Kaposi's Sarcoma, may follow an alternate every two-week schedule.


Preparation and Procedural Conditions

Administration is conditional on several mandatory procedural steps.

Procedural Step Requirement
Pretreatment Mandatory premedication (e.g., corticosteroids, antihistamines) is required prior to every infusion.
Preparation The concentrate must be diluted in an approved IV fluid to a final concentration between 0.3 to 1.2 mg/mL.
Equipment Administration must use non-PVC administration sets and an in-line filter with a microporous membrane.
Infusion Time Infusion duration must be precisely controlled for either 3 hours or 24 hours, according to the regimen.

Continuation Criteria

Continuation to the next course of treatment is not based on a fixed calendar date. Instead, it is strictly dependent on the patient meeting specific recovery criteria. A subsequent course cannot be repeated unless the patient's neutrophil count is ge 1500 cells/mm^3 and the platelet count is ge 100,000 cells/mm^3. Furthermore, specific dose reductions must be applied for patients presenting with hepatic impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Pacline (Paclitaxel)

Evidence Base for Advanced Ovarian Carcinoma

Phase 3 Randomized Controlled Trials (RCTs) were conducted across numerous international centers. These studies researched its use, often in combination with other chemotherapy agents. Research explored the use of Pacline and monitored outcomes in patients both before and after surgical tumor removal. Studies monitored long-term, critical outcomes, including Overall Survival (OS) and Progression-Free Survival (PFS), which measures the time before the condition worsened. Systematic reviews that combine the data from these trials describe how patient populations reported their experience. Data are insufficient for specific patient subsets, such as those with significant pre-existing health issues, because they were not the primary focus of the initial trials.

Evidence Base for Metastatic Breast Carcinoma

Pacline was evaluated in extensive large-scale RCTs across several treatment contexts. Research examined its use after initial local treatments (adjuvant setting) and monitored outcomes related to the risk of the condition returning. Studies monitored patients over very long periods, often for five to ten years, and researched outcomes related to disease-free survival. Findings describe patterns observed in these studies, which varied based on the specific molecular characteristics of the tumor. The role of Pacline within the growing number of available chemotherapy regimens remains under continuous study.

Evidence Base for Non-Small Cell Lung Cancer (NSCLC)

Pacline was studied for use in advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) primarily within Phase 3 RCTs, generally in combination with other agents. Research explored short-term symptom changes and monitored intermediate outcomes such as OS and PFS. Data show patterns related to response rates, which researchers tracked to understand how the anti-tumor activity was observed across the groups. Certainty remains low regarding the direct comparison to newer treatment types. Follow-up durations were limited in some trials, meaning long-term effects are not fully established.

Evidence in Special Populations and Research Gaps

Research has explored the use of Pacline in older adults, a population where outcomes related to systemic or functional imbalance were evaluated. Data are still emerging, and there is limited information for long-term outcomes in special groups, particularly patients with severe pre-existing kidney or liver conditions. The evidence base consists primarily of large-scale Phase 3 studies for the primary indications, but comparative evidence is often lacking for patients who are too frail or have many pre-existing conditions, meaning the results apply only to the studied populations.

Key Studies & References

  1. National Cancer Institute (NCI) Fact Sheet on Paclitaxel
  2. Paclitaxel: Uses, Dosage, Side Effects

Frequently Asked Questions (FAQ)

Common questions about Pacline (FAQ)


Q: Is Pacline intended for short-term or long-term treatment?

According to official product information, Pacline treatment is given in repeated cycles, typically scheduled every two or three weeks. The overall length of time a person receives the medication is not fixed and is evaluated by their healthcare team based on factors such as the patient's response to the medicine and whether any unacceptable side effects develop.


Q: Do the side effects of Pacline usually lessen or go away over time?

Certain common side effects, such as muscle and joint pain (myalgia and arthralgia), are often temporary and may resolve shortly after the infusion. Nerve damage (Peripheral Neuropathy), however, is noted to increase with the total amount of medicine received. While this side effect can lessen over several months after treatment stops, official information notes it may be permanent in rare instances.


Q: What are the potential long-term safety concerns associated with using Pacline?

The most noted long-term concern is that nerve damage (Peripheral Neuropathy) may increase in severity with the total amount of medicine given over time. Official post-marketing surveillance reports have also noted rare occurrences of serious effects, such as secondary cancers or heart issues, particularly when Pacline is used as part of combination therapy.


Q: What are the signs of a severe or allergic reaction to Pacline?

Official regulatory documents describe severe hypersensitivity (allergic) reactions that can occur, typically within the first hour of the infusion. Signs of a severe reaction include sudden low blood pressure, swelling (angioedema), hives, chest pain, flushing, or difficulty breathing. These reactions are carefully managed in the clinical setting.


Q: Is Pacline considered a suitable treatment option for older adults?

Pacline is established for use in adults, including older adults, for its approved uses. Official prescribing information states that general dosage modifications are not usually necessary for older adults. Adjustments would only be considered if a patient has severe underlying liver or kidney problems.


Q: Is there a recommended maximum time limit for using Pacline?

There is no fixed calendar time limit for the entire duration of therapy. However, official guidelines describe situations where treatment is typically discontinued, such as when a person develops severe non-blood-related side effects, like certain types of severe nerve damage (neurotoxicity), to prevent further harm.


Q: Will taking Pacline result in a complete cure for the treated condition?

Pacline is officially classified as an antineoplastic agent, meaning it works to interfere with the growth of malignant cells. Its purpose within comprehensive treatment protocols is to limit the proliferation of tumors and manage disease progression, according to regulatory information.


Q: How should I properly manage my Pacline supply when traveling?

Official storage requirements state that the medicine must be protected from light and maintained at a controlled room temperature. Since Pacline is classified as a cytotoxic (hazardous) medicine, special handling and disposal procedures are mandated. Transportation and handling are subject to the applicable cytotoxic waste guidelines.


Q: Is a change in weight (gain or loss) a known side effect of Pacline?

Based on post-marketing surveillance, a change in body weight (either gain or loss) has been reported as a rare side effect. Regulatory data classifies this event as occurring in less than 1 in 100 patients.


Q: Does Pacline affect a person’s ability to drive or operate heavy machinery?

Official documents note that the medicine may impair the ability to drive or operate machinery immediately following the infusion. This is because the medicine contains a significant amount of ethanol (alcohol) in its formulation, which can affect the central nervous system.


Q: What should be done if dizziness occurs after taking Pacline?

Dizziness or lightheadedness can be symptoms of low blood pressure (hypotension) or a severe allergic reaction (hypersensitivity). Since Pacline is administered in a specialized clinical setting, these events require immediate monitoring and intervention by the healthcare team during or shortly after the infusion.


Q: Does the official safety information for Pacline include a Boxed Warning?

Yes, the official U.S. label includes a Boxed Warning. This warning highlights the significant risks of severe hypersensitivity (allergic) reactions and severe myelosuppression, which is a profound reduction in blood cell counts.


Q: What is the risk of Pacline interacting with common pain relievers like Tylenol (acetaminophen) or ibuprofen?

While formal interaction data for all common pain relievers is not explicitly detailed in the interactions section, some are noted in patient care documents. For example, non-steroidal anti-inflammatory drugs (like ibuprofen) are noted for successfully relieving certain side effects, such as muscle and joint pain.


Q: Does Pacline have an interaction with alcohol consumption?

The Pacline formulation contains ethanol, which is alcohol. The official documents note that the total amount of alcohol administered with a dose should be taken into account, particularly because of its potential effects on the central nervous system.


Q: Is there a known interaction between Pacline and hormonal birth control?

Official regulatory documents state that effective contraception is required during therapy due to the risk of fetal harm. Pacline is known to be metabolized via CYP enzymes, and this metabolic pathway may interact with certain types of hormonal contraceptives.


Q: Is it safe to use cold and flu medications with Pacline?

Official safety information notes the risk associated with the combined use of Pacline with any medicine that also causes bone marrow suppression. Some cold and flu products contain ingredients that could contribute to this additive risk, which is called additive myelosuppression.


Q: What if Pacline does not appear to be providing the expected results?

Treatment continuation is dependent on the patient's response and safety criteria. Regulatory documents state that the medicine is typically discontinued if monitoring shows the patient's condition is worsening (disease progression) or if they develop significant toxicity, such as a drop in required blood cell counts.


Q: Approximately how long does Pacline remain detectable in the body after the last dose?

The time it takes for the medicine to be cleared from the body is officially reported as the elimination half-life. For Pacline, this half-life is variable, ranging from approximately 3 to 52.7 hours, depending on the infusion duration and individual patient factors.

How should Pacline be stored and disposed of?

Official Storage and Disposal Requirements

Paclitaxel concentrate (Pacline) must be stored under specific, mandated conditions to maintain product integrity and safety. The unopened vials must be stored at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F), and kept in the original carton to provide protection from light. If the vial is subjected to cold and forms a precipitate, it must be discarded if the precipitate does not re-dissolve upon warming.

After dilution, the solution must be prepared and stored in non-PVC containers (e.g., glass or non-PVC bags) because the drug vehicle can leach plasticizers from PVC materials. The stability of the diluted solution is limited and depends on the specific diluent and temperature used. Paclitaxel is officially classified as a cytotoxic drug; therefore, all unused product and contaminated materials must be handled and disposed of strictly according to local and federal cytotoxic/hazardous waste procedures. Always keep the medicine out of the sight and reach of children.

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

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