Pactal

Quick links to important sections

Medically reviewed

Rosario Oropesa

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 Pactal

Quick Facts

Property Description
Active ingredient Paclitaxel
Form Concentrate for solution for infusion
Pharmacological class Antineoplastic agent, Taxane
General purpose Disrupts abnormal cell multiplication
Origin Semi-synthetic compound (originally derived from Taxus species)

What Type of Medicine is Pactal? (Identity and Classification)

Pactal is a trade name for the medicine whose active ingredient is paclitaxel, a potent compound formally classified as an antineoplastic agent and a cytotoxic agent. This designation means the medicine is specifically designed to inhibit the growth and proliferation of abnormal cells. The specific pharmacological class of paclitaxel is the taxane family, a group of powerful compounds known as mitotic inhibitors that halt the cell cycle. This mechanism is clinically recognized for its broad efficacy in managing conditions characterized by high cellular replication rates.


Composition and Origin: Natural Derivative and Delivery Form

The active ingredient, paclitaxel, is a semi-synthetic compound originally derived from a natural precursor found in the bark of the Taxus (yew) species. While it has a natural origin, the pharmaceutical product is manufactured through a semi-synthetic process to ensure purity and sustainable supply.

Due to the compound's inherent poor solubility in water, the medicine is formulated as a concentrate for solution for infusion, rather than an oral form. This single-agent product requires a highly specialized, non-aqueous vehicle—which includes components like polyoxyl castor oil and dehydrated alcohol—to keep the paclitaxel dissolved for intravenous (IV) delivery. A key differentiator for all paclitaxel products is their designation as high-alert medications due to their potency, necessitating strict administration and preparation protocols.


General Purpose: Disrupting Cell Proliferation

The overarching purpose of this medicine is to control and halt the rapid, uncontrolled multiplication of abnormal cells within the body. Paclitaxel achieves this by acting as a powerful microtubule stabilizer. By stabilizing the cell's internal scaffolding, the drug effectively freezes the cell's structure, making it physically unable to complete its division (mitosis). This targeted disruption of the cellular replication cycle is the basis of its therapeutic value, leading to the self-destruction of the abnormal cells, a process called apoptosis. Paclitaxel is typically used in scenarios where systemic management of highly proliferative conditions is required.

Regulatory References

  1. Paclitaxel (Taxol) - NCI

What side effects are possible with Pactal?

Possible side effects and safety information

The safety profile of Pactal, whose active ingredient is paclitaxel, is documented by government regulatory bodies (e.g., FDA, EMA) and is primarily characterized by effects on the blood system and the nervous system.


Adverse Reaction Classification

Side effects are categorized by the frequency with which they are reported in clinical use. The major dose-limiting adverse reaction, severe myelosuppression (specifically neutropenia—low white blood cell count), is documented as a Very Common event (ge 1/10), along with peripheral neuropathy, nausea, vomiting, diarrhoea, and complete alopecia (hair loss).

Other frequently reported events (Common or Very Common) affect the Nervous System (sensory neuropathy, arthralgia, myalgia) and Gastrointestinal Disorders (mucositis).


Serious Adverse Reactions and Safety Constraints

Specific serious adverse reactions (SARs) are highlighted in official labeling. These include potentially life-threatening severe hypersensitivity reactions (anaphylaxis) that can occur shortly after the start of the infusion, and the increased risk of severe infection, such as sepsis, stemming from severe neutropenia.

Safety documents list formal restrictions (Contraindications) on the use of the medicine, including a history of severe hypersensitivity to paclitaxel or to the excipient polyoxyl castor oil, and a baseline neutrophil count below 1,500 cells/ mm^3.


Population-Specific and Exposure-Related Notes

The official safety information notes specific considerations for certain patient groups. Individuals with hepatic impairment may face an increased risk of toxicity, notably severe myelosuppression and neuropathy, due to altered clearance of the medicine. Paclitaxel may cause foetal harm and is formally contraindicated during lactation.

Additionally, the risk and severity of peripheral neuropathy are explicitly described in regulatory texts as dose-dependent and cumulative, meaning risk may increase with higher doses or longer total exposure.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information for Pactal

This section describes only the official overdose information and mandated emergency actions as documented in governmental regulatory sources.

Property Official Regulatory Statement
Documented overdose presentations The primary anticipated complications of overdosage include severe bone marrow suppression (myelosuppression), peripheral neurotoxicity, and mucositis.
Physiological systems affected Hematologic system (Myelosuppression), Nervous system (Neurotoxicity), and the Cardiovascular system (Cardiac conduction abnormalities) are listed as systems affected by the drug's primary toxicities.
Dose-related or exposure-related factors Toxicity is considered dose-limiting, with neutropenia being the major dose-limiting toxicity.
Population-specific overdose notes Overdoses in pediatric patients may be associated with acute ethanol toxicity due to the formulation vehicle. Increased toxicity risk exists for patients with hepatic impairment.

Emergency Response and Management

Classification Official Regulatory Statement
Severity classification Severity is defined by anticipated complications and the potential for fatal reactions related to hypersensitivity.
Overdose-context constraints There is no known antidote for paclitaxel overdosage. Management is restricted to symptomatic and supportive treatment.

Official overdose statements:

  • Urgent medical care is required for symptoms indicative of life-threatening events, such as severe hypersensitivity reactions (e.g., dyspnea or hypotension).
  • If signs of a severe hypersensitivity reaction occur, the infusion must be discontinued immediately, and the patient should not be re-challenged with the drug.
  • Frequent monitoring of blood counts is required due to the risk of dose-limiting toxicity, and continuous cardiac monitoring should be instituted if a patient develops significant conduction abnormalities.

Regulatory documents define the overdose profile primarily by the absence of a specific reversal agent, directing all management toward symptomatic support for the anticipated severe toxicities. This mandates immediate help-seeking for life-threatening events, such as anaphylaxis, which requires immediate and permanent cessation of drug exposure, alongside specific monitoring protocols for expected complications.

Therapeutic Uses of Pactal

Pactal is generally used in the systemic management of several advanced solid tumors. The medicine is applied to help manage the disease process and provides supportive therapeutic benefit. The medicine is commonly used for several major therapeutic areas, which are supported by official prescribing documents. These areas include advanced ovarian carcinoma, node-positive or metastatic breast cancer, non-small cell lung cancer (NSCLC), and AIDS-related Kaposi's sarcoma.

This medication is applied in conditions characterized by periods of heightened symptoms that are often advanced, metastatic, or recurrent. It helps address symptom clusters that arise from the disease, which create noticeable interference with daily functioning. This provides support that helps ease the overall symptom burden and is relevant for easing the overall systemic burden of the illness.

Pactal is relevant across diverse clinical scenarios, commonly used as first-line therapy, as adjuvant treatment (used after primary surgery), or as subsequent therapy when initial regimens have failed. This strategic application contributes to easing the overall symptom load by assisting with maintaining functional stability and may assist in managing the potential for symptoms associated with recurrence.

Quick Fact: Relief for Proliferative Disease Symptoms
Used for: Advanced and recurrent malignancies like breast, ovarian, and non-small cell lung cancer.
Main Benefit: Contributes to easing the overall symptom load by assisting with functional stability.
Clinical Context: Relevant in first-line, adjuvant, and subsequent therapy sequencing for sustained, system-wide management.

Eligibility and Restrictions for Use

This section explains who is eligible or excluded from using Pactal, based strictly on official requirements documented by regulatory authorities like the FDA and EMA.

Contraindicated Populations (Must Not Use)

Contraindication Basis for Exclusion (Official Labeling)
Severe Hypersensitivity History of severe allergic reactions (e.g., anaphylaxis) to paclitaxel or any excipient (e.g., Polyoxyl 35 Castor Oil or human albumin) in the specific formulation [DailyMed].
Severe Neutropenia Baseline Absolute Neutrophil Count (ANC) is below a specific threshold, typically less than 1,500 cells/mm³ for solid tumors [FDA Prescribing Information].
Lactating Individuals Use is contraindicated while breastfeeding is occurring [EMA SmPC].

Age and Physiological Eligibility Status

  • Adults: Constitute the primary eligible population with established safety and efficacy profiles for approved indications.
  • Pediatric Patients: Use in children and adolescents is not recommended as the safety and effectiveness have not been formally established [EMA SmPC].
  • Geriatric Patients: No additional dose reductions are mandated by age alone, though patients 75 years and older may require careful assessment in combination regimens.
  • Pregnancy: Use is generally not recommended due to the potential for fetal harm; individuals must use effective contraception during therapy.

Condition-Based Eligibility Limitations

  • Severe Hepatic Impairment: Use is prohibited when liver function markers exceed defined thresholds (e.g., total bilirubin > 5 imes ULN), while moderate impairment mandates restricted or conditional use [Medscape].
  • Severe Renal Impairment: This population is categorized as a use-not-established group; regulatory documents state that inadequate data are available to recommend specific dosage alterations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of Pactal primarily around pharmacokinetic effects and the risk of additive toxicity. Pharmacokinetic interactions are formally documented to involve the hepatic metabolic enzymes Cytochrome P450 2C8 (CYP2C8) and CYP3A4, which are the main pathways responsible for drug disposition. Co-administration with inhibitors of these enzymes may result in an officially documented increase in paclitaxel plasma concentrations, while inducers may lead to reduced concentrations.


Documented Pharmacokinetic and Pharmacodynamic Patterns

The interaction profile also includes substances that modulate drug transporters. Inhibitors of the P-glycoprotein (P-gp) efflux transporter and OATP1B1/1B3 uptake transporters are documented to increase paclitaxel exposure, leading to required restrictions. Specific administration timing rules are mandated for combination regimens: Pactal must be given before Cisplatin and 24 hours after Doxorubicin to manage known pharmacokinetic and toxicologic interactions. For P-gp modulators with a narrow therapeutic index, the label requires a minimum 6-hour separation of administration. In terms of pharmacodynamics, co-administration with agents like Deferiprone is formally associated with an additive risk of neutropenia. The interaction profile notes that Grapefruit Juice may increase exposure, and the product's excipient, Alcohol, is a documented substance that requires caution.

Mechanism of Action

Paclitaxel exerts its effects by intervening directly in the microtubule dynamics necessary for cell division. Its action is defined by a precise, multi-step cytotoxic cascade that exclusively targets actively proliferating cells.

Microtubule Hyper-Stabilization and Mitotic Blockade

Paclitaxel acts as a microtubule stabilizer, binding specifically to beta-tubulin subunits to lock the cell's microtubules into a rigid, non-functional state. This hyper-stabilization prevents the dynamic movement necessary for chromosome separation, thereby initiating a mitotic blockade by trapping the cell at the G2/M phase of the division cycle.


Induction of Programmed Cell Death (Apoptosis)

The prolonged failure to pass the G2/M checkpoint activates the Spindle Assembly Checkpoint (SAC), which initiates the cell's internal self-destruction mechanism known as apoptosis. This controlled form of cell death systematically reduces the viability of highly proliferative cells, which is the core physiological change produced by the drug's mechanism of action.


Mechanisms of Mechanistic Constraint

The drug's action on its target can be reduced by factors such as the overexpression of the efflux pump P-glycoprotein (P-gp), which actively removes the drug from the cell before it can bind its target. Additionally, mutations in the beta-tubulin target itself can diminish the drug's binding affinity, thereby constraining the initial stabilizing effect.

Dosage and Administration Information

Pactal is officially administered only as an intravenous (IV) infusion, requiring the use of a specialized concentrate that must be diluted to a specific concentration before use. Due to its potency and formulation, the medicine is administered only in a supervised clinical setting.

The official administration pattern is cyclic, typically occurring every three weeks, although a two-week schedule is established for certain indications. Dosing is standardized according to the patient’s Body Surface Area (mg/m^2), with common labeled doses being 135 mg/m^2 or 175 mg/m^2. The total infusion duration is a critical part of the labeled regimen, often requiring a fixed 3-hour or 24-hour administration period.

Administration involves several mandatory procedural steps. Premedication with specified agents (including corticosteroids and antihistamines) is required before every infusion. The prepared solution must be passed through a specialized in-line filter (le 0.22 mum) during delivery. In combination regimens, the official protocol mandates that Pactal be given prior to the administration of any platinum-based drug.

The continuity of treatment is governed by laboratory criteria. Subsequent cycles must be withheld until the patient's blood counts—specifically the absolute neutrophil and platelet counts—have recovered to official minimum levels. Dose adjustments are also explicitly detailed for patients presenting with hepatic impairment, guided by specific bilirubin and transaminase levels. The medicine is not recommended for use in pediatric patients.

Recent Clinical Evidence

Pactal: Recent Clinical Evidence

This section summarizes the official research conducted on paclitaxel, including the study types, the outcomes tracked, and limitations in the evidence base. This information is for general knowledge and does not offer treatment recommendations or clinical advice.


Evidence for Use in Advanced Ovarian Carcinoma

The research base includes major Phase 3 Randomized Controlled Trials (RCTs) involving patients with advanced ovarian, primary peritoneal, or fallopian tube cancer. Researchers extensively measured Overall Survival (OS), Progression-Free Survival (PFS), and the Overall Response Rate (ORR) (measured tumor size reduction). Median survival times were reported over several years in the observed groups. However, some earlier pivotal trials used an open-label (unblinded) design, which may introduce variability into subjective measurements.


Evidence for Use in Metastatic Breast Cancer

The evidence base for breast cancer is supported by extensive studies, including Phase 3 RCTs across both metastatic and adjuvant settings. Outcomes monitored were OS, PFS, ORR, and the duration of observed responses. Findings that varied across different study designs were observed when examining paclitaxel against other medicines.


Evidence for Use in Non-Small Cell Lung Cancer (NSCLC) and Kaposi's Sarcoma

Research for advanced NSCLC is primarily based on Phase 3 RCTs monitoring OS, PFS, and ORR. Studies also examined older adults. The evidence for Advanced Kaposi's Sarcoma relies on smaller-scale Phase 2 and Phase 3 clinical trials, assessing the ORR and response duration. Data for both indications indicate limited inclusion of very elderly patients (age 75 and older) in all combination regimens evaluated.


Long-Term Evidence and Research Gaps

Pivotal trials described long follow-up durations for Overall Survival. However, evidence is limited regarding patient outcomes reflecting daily functioning or quality of life over extended periods outside the trial setting. Subgroup findings are uncertain for those with multiple co-existing medical conditions. The main evidence gaps relate to the long-term effects that are not fully established and where comparative evidence is lacking against the newest therapeutic agents.

Key Studies & References

  1. paclitaxel injection, USP Dosage and Administration (US Package Insert)
  2. Phase II Trial of Paclitaxel in Patients With Progressive Ovarian Carcinoma After Platinum-Based Chemotherapy: A Gynecologic Oncology Group Study

Frequently Asked Questions (FAQ)

Common questions about Pactal (FAQ)

Q: Is Pactal the same type of medication as other drugs for this condition?

A: Pactal is a trade name for the active ingredient, paclitaxel. Regulatory authorities classify paclitaxel as a taxane, which is a specific class of antineoplastic or cytotoxic agents. This classification describes the particular way the medicine acts to disrupt the growth of cells with high replication rates.

Q: How quickly can someone expect to notice the effects of Pactal?

A: Official documentation indicates that the clinical effect is assessed over several treatment cycles, and measurable responses are typically evaluated by researchers following a series of infusions, rather than immediately after one dose. The timing of effects is part of the long-term treatment plan.

Q: Can Pactal cause weight gain or weight loss?

A: Official clinical trial summaries note that changes in body weight have been observed in patients receiving paclitaxel-based regimens. Both weight gain and weight loss have been reported as potential effects during treatment.

Q: What happens if I stop taking Pactal suddenly?

A: Official documents focus on the criteria for delaying or withholding subsequent cycles, which is typically based on monitoring laboratory results such as blood cell counts. The overall treatment plan, including the decision to discontinue the medicine, is managed by the patient's healthcare provider.

Q: Are there any specific supplements or vitamins that should be avoided with Pactal?

A: Official labels stress the importance of reviewing the use of all other medications, including vitamins, herbal products, and supplements, with the healthcare provider. This is because Pactal's processing in the body involves specific liver enzymes (CYP2C8 and CYP3A4) that can be affected by other substances.

Q: Can Pactal interfere with driving or operating machinery?

A: Regulatory documents state that Pactal may have an influence on the ability to drive or operate complex machinery. This is because potential side effects, such as tiredness/fatigue and dizziness, are reported as common or very common adverse reactions.

Q: Is it okay to take Pactal every day for a long time?

A: Official administration protocols describe Pactal as a cyclic therapy, meaning it is administered at set intervals, typically every one, two, or three weeks, depending on the specific regimen. It is not administered as a continuous daily medication. Furthermore, the risk of certain side effects, like peripheral neuropathy, can be cumulative with prolonged exposure.

Q: Is Pactal generally safe for people with liver or kidney issues?

A: The official label requires dose adjustments for patients with mild to moderate hepatic impairment (liver issues). For severe renal impairment (kidney issues), regulatory documents state that insufficient data are available to recommend specific dose modifications. Use in these patient groups may be conditional or restricted as indicated in the official labeling.

Q: Is it true that Pactal can affect your sleep?

A: Clinical trial summaries for paclitaxel-based therapies often report difficulty sleeping (insomnia) as an observed adverse reaction. If this occurs, it is generally listed among the less common or common side effects, which relates to potential effects on the central nervous system.

Q: What if I miss a dose of Pactal, what does the official information say?

A: Since Pactal is administered only in a supervised clinical setting as part of a fixed schedule, official protocols address the criteria for delaying the next scheduled cycle based on safety requirements, such as blood cell counts. The treatment regimen is managed entirely by the healthcare team.

Q: Can women who are planning pregnancy use Pactal?

A: Women of childbearing potential are officially advised to avoid becoming pregnant while receiving Pactal treatment. Official documents recommend using effective contraception during therapy and for a period (e.g., six months) following the completion of treatment due to the potential for fetal harm.

Q: Do people typically take Pactal in the morning or at night?

A: Official instructions specify the required infusion duration (e.g., 3 hours or 24 hours) and the necessary premedication, but they do not mandate a specific time of day for administration. The timing is typically determined by the scheduling of the healthcare facility where the infusion takes place.

Q: Can I take pain relievers while using Pactal?

A: Official regulatory documents note that consultation with a healthcare provider is generally recommended due to the potential for interactions or additive toxicities, even with common over-the-counter pain relievers. This is due to the risk of affecting the medicine's metabolism or increasing side effects like low blood cell counts.

Q: Are there different brand names for the drug Pactal?

A: Yes, Pactal is a trade name for the active ingredient, paclitaxel. Paclitaxel is also marketed under various other trade names worldwide, as well as being available in a generic form.

Q: Can Pactal interact with birth control pills?

A: Pactal is processed by liver enzymes, including CYP3A4 and CYP2C8. Official documentation advises the use of effective contraception due to the risk of fetal harm. It is appropriate to discuss the effect of this metabolism on hormonal contraceptives with a healthcare provider.

Q: Is Pactal considered safe for long-term management of the condition?

A: The official labeling notes that the risk and severity of certain side effects, particularly peripheral neuropathy (nerve damage), are explicitly described as dose-dependent and cumulative. This means the risk may increase with higher total doses or longer total exposure, which is a factor in determining the overall treatment duration.

Q: Why do some people report feeling nervous or anxious when taking Pactal?

A: Official adverse event lists for paclitaxel-based therapies often include psychological and emotional effects, such as anxiety or nervousness, as observed side effects. These events are reported in clinical use, though they are typically classified as less common.

Q: Does Pactal have a risk of dependence or addiction?

A: Pactal is classified as an antineoplastic agent (chemotherapy). Official regulatory documents regarding this medicine do not describe any potential for abuse, dependence, or addiction.

Q: What information is available about the use of Pactal during breastfeeding?

A: The use of Pactal is formally contraindicated while breastfeeding is occurring. Regulatory documents note that it is unknown whether the medicine is excreted into human milk, but based on the compound's nature, a risk to the nursing infant cannot be excluded.

Q: What is the experience of people who have used Pactal for a long time?

A: Official research summaries note that evidence is limited regarding long-term patient outcomes that reflect aspects of daily functioning or quality of life outside of controlled clinical trial settings. Pivotal trials generally focused on survival and measurable tumor response over defined periods.

Q: What are the typical benefits of using Pactal as described by official bodies?

A: Official regulatory summaries describe clinical efficacy based on evidence of improved patient outcomes. These typically include measures of survival, such as Overall Survival (OS), prolonged disease control, known as Progression-Free Survival (PFS), and the rate of measured tumor size reduction (Overall Response Rate (ORR)).

Q: What are the signs that Pactal might not be working for someone?

A: Official regulatory monitoring is primarily focused on safety, specifically checking blood cell counts to manage the risk of myelosuppression. The signs of the drug's effectiveness are carefully assessed by a healthcare provider using objective clinical measures and scans over multiple cycles. The assessment is based on objective clinical data and scans, and not solely on a patient's self-perceived symptoms.

Q: Is Pactal a widely used medication?

A: Pactal, which contains the active ingredient paclitaxel, is an established antineoplastic agent. It has been approved by major regulatory bodies (e.g., FDA, EMA) for various conditions for many years, indicating its position as a recognized therapy in oncology.

Q: Is the side effect profile of Pactal different for younger people?

A: Official labeling states that the safety and effectiveness of Pactal have not been formally established in pediatric patients (children and adolescents). For this reason, its use is not recommended in this age group, and no specific side effect profile differences are defined.

Q: What is the earliest age someone is generally considered eligible for Pactal?

A: The primary eligible population for Pactal with established safety and effectiveness is adults. Use in children and adolescents is not recommended because official regulatory data on safety and efficacy in that age group have not been formally established.

Q: Does Pactal affect mood or emotional balance?

A: Official adverse event lists for paclitaxel-based therapies often include reports of changes in emotional balance, such as anxiety or depression. These are listed as observed side effects in regulatory documents.

How should Pactal be stored and disposed of?

Pactal (paclitaxel concentrate) must be stored and disposed of according to strict official guidelines for cytotoxic agents.

Storage Conditions

Condition Requirement (Unopened Vial)
Temperature Store at controlled room temperature (20 C to 25 C).
Light Protection Keep in the original carton to protect from light.
Freezing/Refrigeration Neither freezing nor refrigeration adversely affects stability; precipitation will redissolve at room temperature.
Child Safety Keep out of the reach and sight of children.

Handling and Disposal

Contact with plasticized PVC equipment is not recommended. Diluted solutions must be stored in non-PVC containers (e.g., glass, polypropylene) and are chemically stable for up to 27 hours at ambient temperature. Due to its classification, all handling must follow proper procedures for anticancer drugs, including wearing impervious gloves. Any unused or expired product must be discarded according to cytotoxic drug disposal guidelines and must not be placed in household trash or wastewater.

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

Available in countries:

Equivalent of Pactal found in:

A-Z Index: