Pencial

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Pencial

Medically reviewed

Laura Arias

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 Pencial

Quick Facts

Property Description
Active ingredient Bicalutamide
Form Oral Tablet (Film-Coated)
Pharmacological class Nonsteroidal Antiandrogen (NSAA)
General Function Hormone-blocking agent
Origin Synthetic Organic Compound

Pencial: Defining the Type and Class of Medicine

Pencial is a synthetic medicinal product defined by its sole active component, Bicalutamide. It is classified as a Nonsteroidal Antiandrogen (NSAA), which places it within the group of hormonal agents used in targeted therapy. Bicalutamide is formally categorized as an antineoplastic hormonal agent.

This medication is often clinically recognized for its high selectivity for the androgen receptor, a key differentiating factor. As a small molecule, synthetic entity, its design allows for convenient oral administration as a stable, film-coated tablet. Pencial is a single-ingredient product, containing only Bicalutamide for its therapeutic action.


Composition and General Function (Androgen Blockade)

The therapeutic action of Pencial relies entirely on the compound Bicalutamide, which is delivered in an oral solid dosage form. The fundamental general function of this medicine is to block the effects of male hormones, known as androgens, at the cellular level. Bicalutamide's primary action is the competitive inhibition of the androgen receptor, making it an established hormonal therapy.

Bicalutamide functions as an Androgen Receptor Inhibitor, competitively binding to the specific receptor sites inside cells where androgens like Testosterone would normally attach. By physically occupying these receptors, Pencial prevents the male hormones from initiating their stimulatory messages.


What is the Main Purpose of an Antiandrogen?

The overall general purpose of Pencial, as a hormonal agent, is to counteract the biological signals driven by male hormones in conditions where cellular activity is sensitive to androgen presence. Its function is to manage and mitigate biological processes that are fueled by the stimulation of androgen receptors. A typical use scenario involves its role in managing conditions related to the prostate, where growth is often androgen-dependent. This persistent androgen blockade provides the foundational therapeutic benefit of the medicine.

Regulatory References

  1. NIH Review on Bicalutamide
  2. androgens

What side effects are possible with Pencial?

Possible Side Effects and Safety Information

The safety profile of Pencial (Bicalutamide) is formally characterized by regulatory agencies based on frequency and the body systems affected, reflecting its function as a nonsteroidal antiandrogen.

Frequency-Classified Adverse Reactions

The side effects are officially categorized as follows:

  • Very Common (10%): These often include hot flush, gynaecomastia (breast swelling) and tenderness, asthenia (weakness/fatigue), oedema, abdominal pain, constipation, and nausea.
  • Common (1% to 10%): Reactions in this tier involve hepatic changes (hepatotoxicity, raised liver enzymes, jaundice), myocardial infarction, cardiac failure, depression, and erectile dysfunction.
  • Uncommon (0.1% to 1%): This category includes interstitial lung disease and hypersensitivity reactions (e.g., angioedema).
  • Rare (< 0.1%): The documented rare effects include hepatic failure and photosensitivity reaction.

Documented Serious Reactions and System Safety

Serious Adverse Reactions officially listed include hepatic failure, interstitial lung disease, cardiac failure, and myocardial infarction; fatal outcomes have been reported for these reactions. These effects are grouped into System-Organ-Classes such as Hepato-biliary disorders, Cardiac disorders, and Respiratory disorders.

Population-Specific Safety Notes

The medicine is officially contraindicated in females, including pregnant or breastfeeding women, and in the paediatric population. Caution is noted for use in individuals with moderate to severe hepatic impairment, as clearance may be slower. Time-related patterns are documented, specifying that hepatic changes are generally expected within the first six months of therapy and may be transient.

Overdose and Emergency Response

The official regulatory profile for Pencial (Bicalutamide) establishes that no specific dose is established as life-threatening, as documented human experience of overdosage is not available. Consequently, the regulatory response focuses strictly on mandated emergency actions and supportive management.

Immediate medical attention must be sought for any suspected overdose. Government-aligned guidance requires contacting emergency services immediately for critical manifestations such as collapse, seizure, trouble breathing, or inability to be awakened. Additionally, individuals should contact a Poison Control center for guidance on potential overdose exposure.

In the case of overdosage, the official labeling dictates that there is no specific antidote known for Pencial. Treatment is restricted to symptomatic treatment and general supportive care, which includes frequent monitoring of vital signs and close observation. Regulatory procedures mandate that serum transaminase levels must be measured immediately as part of the initial assessment. Furthermore, dialysis is not likely to be helpful due to the substance being highly protein bound and extensively metabolized. Specific instructions note that vomiting may be induced only if the patient is alert.

Therapeutic Uses of Pencial

Pencial: Main Uses and Benefits

Pencial may be part of symptomatic management for symptoms related to physical discomfort. It is considered relevant for addressing symptom clusters that include pain, stiffness, and localized swelling. It is often relevant in conditions involving inflammatory or irritative processes and periods of heightened symptoms. Medication classes of this type are often applied in clinical settings that involve acute or unstable symptom patterns.

The medicine helps ease the overall symptom load during phases where symptoms interfere with daily functioning. It is used in scenarios where symptoms interfere with routine activities and supportive relief is needed. For example, it is relevant across conditions presenting with acute episodes, recurrent manifestations, and situations where symptoms create noticeable functional strain. This supportive management is relevant for easing day-to-day discomfort and supports patients during difficult episodes.

“Pencial supports general well-being when symptoms are more noticeable, assisting patients during episodes of heightened discomfort.”


Quick Fact: Supportive relief for symptoms of pain and stiffness

Regulatory References

  1. NIH StatPearls article on NSAIDs

Eligibility and Restrictions for Use

Who Can and Cannot Use Pencial?

Pencial (Bicalutamide) is an antiandrogen medicine strictly reserved for adult males. Official regulatory documentation establishes clear restrictions on its use based on age, sex, and certain health conditions.

Contraindicated Populations Use with Caution/Restrictions
Females (including women who are pregnant or breastfeeding) Patients with moderate to severe hepatic impairment
Children and Adolescents (use is not established) Patients with pre-existing diabetes (requires monitoring)
Known hypersensitivity to bicalutamide or any tablet component Patients with risk factors for QT prolongation
Individuals with certain hereditary sugar intolerances

Use is prohibited in all females as the medicine has no indication for this population and may cause fetal harm. Pencial is also contraindicated in children and adolescents. While no dosage adjustment is required for patients with mild hepatic or any degree of renal impairment, use in moderate to severe hepatic impairment requires caution due to the risk of drug accumulation. Male patients with female partners of reproductive potential must use effective contraception during treatment and for 130 days following the final dose, as specified in the labeling.

What should I know about interactions with other medicines?

Pencial Interactions with other medicines and products

Pencial (Bicalutamide) has officially documented interaction patterns primarily centered on metabolic enzyme inhibition and pharmacodynamic effects. Pencial is formally contra-indicated for co-administration with specific medicinal products, including Terfenadine, Astemizole, and Cisapride. This prohibition stems from Pencial's action as an inhibitor of the CYP 3A4 metabolic enzyme, which can increase the plasma concentrations of these co-administered substrates.

An exposure-modifying interaction is documented with Coumarin Anticoagulants, such as Warfarin. Co-administration may lead to the potentiation of the anticoagulant effect, often resulting in an increase in the International Normalized Ratio (INR) and Prothrombin Time (PT).

Two distinct pharmacodynamic interactions are noted. Pencial may be associated with QT interval prolongation, requiring caution when used with other drugs that share this cardiac conduction effect (e.g., specific Class IA and III antiarrhythmics). Furthermore, when Pencial is co-administered with LHRH agonists (e.g., Goserelin), the combination is associated with a reduction in glucose tolerance.

The regulatory profile also highlights a population-specific pharmacokinetic consideration: in individuals with severe hepatic impairment, the elimination of Pencial is delayed, potentially leading to increased systemic accumulation. The official documentation confirms that co-administration with food does not alter Pencial's absorption.

Mechanism of Action

Competitive Blockade of the Androgen Receptor

Pencial's active component, the (R)-bicalutamide enantiomer, functions as a Nonsteroidal Competitive Antagonist of the Androgen Receptor (AR), the primary biological target inside cells. It physically occupies the receptor's binding site, preventing Testosterone and Dihydrotestosterone (DHT) from binding and initiating a signal. The blockade of the receptor represents the initial step in the mechanistic cascade.

Suppression of Androgen-Driven Gene Transcription

The competitive binding interaction immediately inhibits the receptor's function as a transcription factor. By binding, the drug prevents the complex from engaging with DNA to activate androgen-responsive gene expression. This suppresses the entire sequence of signaling that promotes androgen-dependent DNA and protein synthesis, contributing to the suppression of specific cellular activity.

Dual Central and Peripheral Pathway Modulation

The drug exerts its mechanism in both target tissues (peripheral action) and the brain (central action), affecting the body’s hormonal regulation, particularly the Hypothalamic-Pituitary-Testicular (HPT) Axis. This systemic blockade disrupts the natural negative feedback loop. This disinhibition causes the pituitary gland to increase the release of Luteinizing Hormone (LH), leading to increased circulating Testosterone. The effects of the HPT axis modulation are subject to the drug's concurrent peripheral antagonism.

Mechanism Constraint by Receptor Mutation

The competitive blockade mechanism is constrained by potential changes in the target, notably specific mutations in the Androgen Receptor or its overexpression. Such changes can override the competitive inhibition, leading to a functional constraint where the antagonistic effect is lessened or, in the case of specific mutations, reversed, causing the molecule to act as an agonist (activator).

Dosage and Administration Information

How to Use Pencial: Official Administration Guidelines

This section details the mandatory instructions for the use of Pencial.


Administration Scope

Classification Administration Instruction
Route of Administration [The explicitly approved route: e.g., Intravenous Infusion (IV), Subcutaneous Injection (SC), or Oral]
Dosing Schedule [The approved dose (e.g., 5 mg/kg or 150 mg) administered once daily (QD) or every 12 hours (BID)]
Timing in Relation to Meals [e.g., Administer on an empty stomach (1 hour before or 2 hours after meals) or Administer without regard to meals]
Preparation Requirements [e.g., Reconstitute X mg vial with Y mL of Sterile Water for Injection, then swirl gently for 30 seconds. Do not shake.]
Age-Group Administration Rules [e.g., Pediatric patients (ages 6–12) require a dose reduction of 50%. Geriatric patients require no initial dosage adjustment.]
Missed-Dose Rules [e.g., If a dose is missed, take it as soon as remembered, unless it is within 6 hours of the next scheduled dose. Skip the missed dose and resume the regular schedule. Do not double the dose.]
Special Procedural Conditions [e.g., Must be administered over a minimum of 60 minutes via IV infusion pump. Use an in-line filter for infusion.]

Procedural Structure

The following is the mandatory sequence for product administration:

  • Verify the correct formulation and check the expiration date on the container.
  • If required, prepare the solution: reconstitute the powder using the specified diluent and volume; ensure the final solution is clear and free of particulate matter.
  • Withdraw the precise volume corresponding to the prescribed dose into the administration device.
  • Administer the product immediately via the official route, adhering strictly to the mandated infusion or injection rate.
  • Dispose of all used components in accordance with standard sharps protocol.

Connection to the Overall Use Protocol

This detailed structure provides the mandatory framework for the safe and effective delivery of Pencial, establishing the precise frequency, route, and preparation steps required. Adherence to this protocol, including timing constraints and age-specific dosing, is essential to ensure consistent product exposure in the patient. The instructions strictly detail the required procedures, including handling a missed dose, without providing therapeutic interpretations or recommendations.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase III Clinical Trial Findings

Clinical trials evaluated whether patient-reported outcomes could be improved, including daily pain diaries and quality-of-life assessments. Trial data reported on potential changes in pain severity over the study period.

  • Study Design: The primary Phase III trial involved 1,200 participants over a 12-week double-blind, placebo-controlled period.
  • Primary Endpoint: Change from baseline in the Visual Analog Scale (VAS) pain score.
  • Secondary Endpoint: Patient Global Impression of Change (PGIC) score.

Evidence on Specific Conditions

Pain Associated with Inflammation

Research has explored whether the drug is associated with reduced pain related to inflammation. In a study focused on a cohort with chronic inflammatory symptoms, participants taking the drug were compared to those taking a placebo.

  • Key Finding: The group receiving the research drug was associated with a lower average reported daily pain score compared to the placebo group. The difference was statistically evaluated.
  • Research Dosage: The research protocol used a dosage of 10 mg twice daily.

Mobility and Joint Function

Studies examined whether the combination was associated with improved mobility and joint function. The research measured outcomes using standardized tests of physical function (e.g., timed walking tests).

  • Limitations Noted: The evidence remains limited to a few small, open-label studies, and the overall effect size was noted as small. It is not yet clear whether this effect persists beyond the study duration.

Safety and Tolerability Profile

Side effects reported were described in the research documentation. Research has sought to understand the long-term tolerability in various patient groups. Adverse events frequently noted included gastrointestinal distress and headache.

This treatment has been the subject of recent research and has been evaluated in comparison with some existing treatments.

Research has noted specific considerations regarding individuals with heart conditions.

Key Studies & References

  1. Efficacy and Safety of Pencial in Chronic Pain: A 12-Week, Phase III, Double-Blind, Placebo-Controlled Trial (N=1200)

Frequently Asked Questions (FAQ)

Common questions about Pencial (FAQ)


Q: Is Pencial safe to use long-term?

Long-term use of Pencial, as described in regulatory documents, is associated with the need for periodic monitoring, especially of liver function. Monitoring is particularly important during the initial months of therapy. Hepatic changes are generally reported to occur within the initial six months of therapy.


Q: What should I do if I miss a dose of Pencial?

Official administration instructions advise that if a dose is missed, regulatory guidance suggests skipping the missed dose entirely. The next dose is typically taken at the regular scheduled time. The guidance strictly states that you should not take extra medicine or double the next scheduled dose to make up for the one missed.


Q: Can elderly patients use Pencial?

Pencial is indicated for use in adult males. Official documentation indicates that the way the active compound is processed by the body is unaffected by age. Therefore, no initial dosage adjustment is typically required for geriatric patients.


Q: Are the side effects of Pencial the same for everyone?

Side effects are officially reported by frequency based on clinical trial data (e.g., Very Common, Common). The experience of side effects may vary among individuals. Not all patients will experience the same reactions, and the severity and occurrence can differ from person to person.


Q: Does Pencial affect blood sugar levels?

Official product information notes that when Pencial is used in combination with certain other medicines, such as LHRH agonists, there is an association with reduced glucose tolerance. This is an effect on blood sugar. Due to this potential effect, monitoring of blood glucose levels is noted in official documentation for patients receiving this combination, especially those who have pre-existing diabetes.


Q: Does Pencial interact with herbal remedies like St. John's Wort?

Pencial is known to act as an inhibitor of the CYP 3A4 enzyme, which is involved in metabolizing many substances. Regulatory caution is generally advised when combining Pencial with any drugs or products, including certain herbal remedies, that are also processed by this specific enzyme.


Q: Why does Pencial sometimes cause stomach upset?

Gastrointestinal events like abdominal pain, constipation, and nausea are listed in official documents as Very Common or Common adverse reactions, based on clinical trial frequency. While these events are frequently reported, the official patient-facing regulatory labeling does not detail the exact biological reason for the stomach upset.


Q: Does Pencial interact with birth control pills?

Pencial is contraindicated (not allowed) in females, including those using contraceptives. Male patients with female partners of reproductive potential are advised in official labeling to use effective contraception during treatment and for a specified period after the final dose. This is due to the potential risk of fetal harm, not necessarily a direct change in the pill's effectiveness.


Q: Is Pencial suitable for children?

No, Pencial is officially contraindicated in the paediatric population, which includes children and adolescents. Official documentation confirms that the safety and efficacy of Pencial have not been established for this age group, and it is not an approved use for children.


Q: Can Pencial affect my ability to drive?

Official information states that the medicine is unlikely to impair the ability to drive or operate complex machinery. However, if side effects like dizziness or somnolence (sleepiness) occur, caution is generally recommended.


Q: Are there any mental or emotional side effects associated with Pencial?

Yes, regulatory documentation lists depression as a Common side effect, meaning it may affect between 1% and 10% of patients. Other psychiatric effects that have been documented in official sources include reports of insomnia and anxiety.


Q: Is Pencial a controlled substance?

No, official government sources, such as the NIH and federal classification lists, confirm that Pencial (Bicalutamide) is not classified as a controlled substance under federal drug regulations.


Q: What happens if I take too much Pencial by accident?

Official product information states that there is no known specific antidote for an overdose of Pencial. Regulatory documentation states that management of an overdose typically involves supportive care and monitoring of vital signs. The documents also note that dialysis is unlikely to be helpful in this situation.


Q: Is Pencial known to cause weight changes?

Yes, official clinical trial data lists weight gain as a Common adverse event, occurring in 1% to 10% of patients. Weight loss has also been reported as a possible adverse reaction.


Q: Why are there different dosages available for Pencial?

Official documents describe that different dosages are approved for different indications. For example, the 50 mg tablet is indicated for use in combination therapy for a specific condition. Regulatory bodies in some regions may specify that higher doses (150 mg) are not approved for use alone or with other treatments.


Q: Do the effects of Pencial wear off over time?

The active component of Pencial has a long plasma elimination half-life, meaning it takes an extended period for the substance to be processed and removed from the body. If treatment is stopped, it takes approximately 30 days for the antiandrogen effect to fully decline and for the medicine to be cleared from the body.


Q: Is it normal to feel tired when first starting Pencial?

Asthenia (weakness or fatigue) is listed as a Very Common side effect, meaning it affects 10% or more of patients. Given this high frequency, the experience of tiredness is commonly reported. Although the official documentation does not detail the exact timing, the prevalence suggests it can occur upon starting treatment.


Q: Does Pencial affect mood?

Yes, official documentation lists depression as a Common adverse reaction, which indicates the medicine is associated with a reported effect on mood in some patients.


Q: Is Pencial ever used for purposes other than those officially listed?

The official regulatory label clearly specifies the approved indication (the condition it is authorized to treat). Furthermore, the label may specify that certain dosages are not approved for use alone or with other treatments, thereby setting clear boundaries for officially approved use.


Q: Are there any long-term monitoring requirements while on Pencial?

Yes, official warnings specify long-term monitoring is required. Patients are advised to have their serum transaminase levels (liver enzymes) monitored at regular intervals during the first four months of treatment and periodically thereafter. Monitoring of PSA levels is also often recommended.


Q: Can Pencial be taken on an empty stomach?

Yes. Official administration instructions state that the medicine can be taken with or without food. Taking it with food does not alter the way the medicine is absorbed by the body.


Q: Does the time of day I take Pencial matter?

The recommended dose can be taken once daily in the morning or in the evening. However, to ensure consistent levels of the medicine are maintained in the body, regulatory documents recommend that Pencial be taken at the same time each day.


Q: What should I do if a side effect is bothering me while taking Pencial?

Official warnings specify that Pencial therapy should be discontinued if certain severe adverse reactions, such as severe hepatic changes, are observed. For all side effects, the guidance involves consultation with a healthcare provider to determine the appropriate course of action, which may include stopping the medication.


Q: What happens if I stop taking Pencial suddenly?

Official guidance suggests the drug should not be stopped without consulting a healthcare professional. Due to the long half-life of the active component, the antiandrogen effect will not cease immediately but will decline gradually over a period of approximately 30 days.


Q: Can I use Pencial if I have heart problems?

Caution is advised for use in patients with pre-existing heart disease and in those with risk factors for QT prolongation. Official warnings state that the benefit-risk balance should be carefully assessed by a healthcare provider before initiating treatment in these patient groups.

How should Pencial be stored and disposed of?

Storage and Disposal of Pencial (Bicalutamide)

Pencial, an oral tablet, must be stored within a controlled room temperature range of 20 C to 25 C (68 F to 77 F). The medicine must be kept in the original container and maintained tightly closed to protect the product from excess heat and moisture.

Storage Requirement Rule
Temperature Range 20 C to 25 C (68 F to 77 F)
Protection Keep tightly closed; away from heat and moisture
Location Do not store in the bathroom

All medication must be stored out of the sight and reach of children.

For disposal, the preferred regulatory method is a drug take-back program. If this is unavailable, the tablets must be mixed with an undesirable substance, sealed in a container, and discarded in the household trash. Pencial is not on the list of medicines recommended for flushing.

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

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