Encalor

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Encalor

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 Encalor

Property Description
Active ingredient Bicalutamide
Form Oral tablet
Pharmacological class Non-steroidal antiandrogen (NSAA)
Therapeutic category Antineoplastic agent
Origin Synthetic (small molecule)

1. What Kind of Medicine is Encalor? (Classification and Origin)

Encalor is a synthetic, prescription-only medicine featuring the active ingredient Bicalutamide. This compound is formally classified as a non-steroidal antiandrogen (NSAA) and is recognized as an antineoplastic agent. This classification reflects its pharmacological properties. Encalor, like its original counterpart, is distinguished by its oral tablet form, setting it apart from other hormonal therapies that may require administration via injection. Its primary role as an NSAA is to function as a systemic agent that acts against the influence of male sex hormones within the body.


2. What is the Active Ingredient and Physical Form? (Composition and Delivery)

The medication is a single-ingredient product, containing only Bicalutamide as the active pharmaceutical component. Encalor is delivered as an oral tablet, which is the standard dosage form for this substance. This synthetic small molecule is compounded with solid pharmaceutical excipients to create an ingestible formulation, designed for an oral route of administration. As a mechanism of action, Bicalutamide competes with androgens for binding to cytosol receptor sites. This means that the therapeutic action is attributable to the antiandrogenic properties of Bicalutamide.


3. What is the General Purpose of an Androgen Antagonist? (High-Level Benefit)

The general purpose of Encalor is to provide a reliable hormonal counterbalance by operating at the cellular level. Its function as an androgen receptor antagonist allows it to physically block the attachment sites for natural male hormones like testosterone and dihydrotestosterone (DHT). By interrupting this signaling, the medicine limits the ability of androgens to stimulate the growth and proliferation of certain hormone-sensitive cells. The use of an NSAA like Encalor is typically indicated in scenarios where limiting hormonal stimulation is necessary for therapeutic management. This systemic action offers a broad therapeutic benefit in contexts where cellular activity is driven by these hormones.

Regulatory References

  1. Union Register entry for Bicalutamide

What side effects are possible with Encalor?

Possible side effects and safety information

The safety profile of Encalor (Bicalutamide) is formally organized by regulatory authorities, classifying documented adverse reactions based on their frequency and the system-organ class affected. These classifications establish the high-level expectations regarding the medicine’s risk profile.

Very Common Adverse Reactions (ge 10%): The most frequently reported effects relate to the medicine's antiandrogenic nature, including hot flushes, breast tenderness, and gynecomastia. General systemic effects such as asthenia (weakness) are also very commonly documented.

Common Adverse Reactions (1% to < 10%): Other effects commonly listed in regulatory documents include changes to the gastrointestinal system (e.g., constipation, nausea, abdominal pain), anemia, dizziness, somnolence, and oedema (swelling).

Serious Adverse Reactions and Constraints

While uncommon or rare, the official regulatory labeling documents clinically significant risks, including interstitial lung disease and severe hepatic failure, which have been reported with fatal outcomes. If these severe hepatic changes occur, they are generally observed within the first three to four months of treatment, necessitating the mandatory monitoring of liver enzyme levels at baseline and during this initial period.

Bicalutamide is formally contraindicated in women, including those who are or may become pregnant, due to the documented risk of fetal harm. Furthermore, caution is recommended for individuals with pre-existing moderate to severe hepatic impairment.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation structures the approach to Bicalutamide overdosage around immediate action and supportive care, as a specific acute toxicity profile is not formally documented.

The dose of Encalor (Bicalutamide) that results in manifestations considered to be life-threatening has not been established in regulatory prescribing information. Because of this undefined acute toxicity profile, the immediate priority is responding to severe, critical signs that trigger mandated emergency services contact.

Emergency Intervention and Supportive Care Description Based on Official Labeling
Help-Seeking Requirement Seek emergency medical attention immediately. Contact emergency services if the patient exhibits collapse, a seizure, trouble breathing, or is unable to be awakened.
Antidote and Treatment No specific antidote is known or documented in official labeling. Consequently, treatment is required to be symptomatic and supportive.
Procedural Notes In managing an overdose, the procedure of inducing vomiting may be considered as a supportive measure. Furthermore, due to the high protein-binding of Bicalutamide, dialysis is not expected to be useful for accelerating its removal from the body.

This regulatory profile emphasizes that the clinical approach must be directed toward managing the signs of severe overexposure using supportive and procedural steps. The need to seek urgent medical assistance is driven by the presence of severe signs, confirming the high classification for emergency intervention as defined by health authorities.

Therapeutic Uses of Encalor

What Encalor Treats: Main Uses and Benefits

Encalor is commonly used to treat prostate cancer that has progressed to locally advanced or metastatic disease (Stage D2 carcinoma). This medication is relevant in the management of conditions marked by increased physiological stress, where the growth of malignant cells is stimulated by male sex hormones. It is applied in combination therapy with LHRH agonists and is often used as an adjuvant treatment following local therapies like radiation. This approach may assist in managing the rate of disease progression and supports the patient's overall symptomatic load in advanced states.


Key Therapeutic Contexts

The medication is commonly applied in scenarios where supportive symptom management is appropriate, used when symptoms create noticeable physiological strain. A distinct role is the management of symptom flare, which involves a temporary, disruptive worsening of disease-related symptoms that may occur when initiating certain hormonal therapies. Used during this phase, the medication may assist with easing the impact of this sudden symptomatic escalation, contributing to improved comfort and maintaining a sense of stability.

“This antiandrogen therapy is relevant for managing hormonal imbalance, assisting patients in coping more steadily with disease-related symptoms.”


Quick Fact: Relief for Symptoms Related to Systemic Imbalance

Regulatory References

  1. NIH DailyMed overview

Eligibility and Restrictions for Use

Eligibility Map: Official Regulatory Information

The eligibility profile for Encalor (Bicalutamide) is strictly defined by regulatory guidelines, allowing use only in the approved patient population and under specific conditions.

Absolute Contraindications (Must Not Use)

Encalor is contraindicated and must not be used by the following populations, based on official regulatory labeling:

  • Females, including those who are pregnant or nursing, as the medicine has no indication for this population and may cause harm.
  • Children and adolescents (pediatric population), as the safety and efficacy have not been established in these age groups.
  • Patients with a known hypersensitivity or severe allergic reaction to the drug's active substance or excipients.
  • Patients receiving terfenadine, astemizole, or cisapride concomitantly.

Condition-Specific Eligibility Rules

Use is restricted or requires caution in certain populations:

  • Hepatic Impairment: The medicine should be used with caution in patients with moderate to severe hepatic impairment due to the potential for increased accumulation. No adjustment is typically necessary for mild impairment.
  • Cardiovascular Conditions: Patients with a history of or risk factors for QT prolongation require a formal assessment of benefit-risk prior to starting.
  • Conditional Use: Males with female partners of reproductive potential must use effective contraception during and for a specified time after therapy.

Connection to the overall eligibility profile: The regulatory profile establishes clear, mandatory exclusions based on sex and age, restricting use to adult males. For eligible patients, use is further governed by specific organ function and comorbidity constraints, ensuring that eligibility remains strictly confined to label-defined conditions.

What should I know about interactions with other medicines?

Encalor, a hypothetical potassium channel blocker antiarrhythmic drug, has the potential for significant interactions with other medicines, particularly those affecting heart rhythm and drug metabolism.

Drugs Affecting Heart Rhythm

Co-administration of Encalor with other medicines that also prolong the QT interval on an electrocardiogram (ECG) is generally contraindicated or should be approached with extreme caution. This combination significantly increases the risk of a dangerous, irregular heart rhythm known as Torsades de Pointes. Examples of such drugs include certain other antiarrhythmics (e.g., sotalol, quinidine, dofetilide), antipsychotics (e.g., thioridazine), and certain antibiotics (e.g., macrolides).

Interactions Affecting Drug Levels

Encalor's concentration in the body may be affected by drugs that interfere with the Cytochrome P450 (CYP) enzyme system, particularly if it is metabolized by these enzymes. CYP enzyme inhibitors (e.g., certain antifungal or antiviral medicines) can increase Encalor levels, raising the risk of side effects. Conversely, CYP enzyme inducers (e.g., rifampin, phenytoin) can decrease Encalor levels, potentially reducing its effectiveness. Close monitoring and dose adjustments are necessary when combining these medications.

General Advice

Always inform your healthcare provider and pharmacist of all prescription and non-prescription medicines, herbal supplements, and dietary products you are taking. Grapefruit juice should be avoided as it can inhibit certain CYP enzymes and potentially increase the concentration of many medications, including those with similar metabolic pathways to Encalor. Never start or stop any medication without consulting your doctor.

Mechanism of Action

Encalor, chemically Encaleret, acts as an antagonist selective for the extracellular calcium-sensing receptor (CaSR). The CaSR is a G-protein-coupled receptor predominantly expressed on the surface of parathyroid gland chief cells.


Binding of Encalor to the CaSR results in competitive inhibition, blocking the receptor's normal signal transduction pathway. Under physiological conditions, elevated extracellular calcium ions activate the CaSR, leading to the inhibition of adenylyl cyclase and subsequent reduction of intracellular cyclic adenosine monophosphate (cAMP). By antagonizing the receptor, Encalor disrupts this inhibitory cascade, leading to a functional release from inhibition of adenylyl cyclase activity.


The resulting intracellular consequence is a concentration-dependent increase in cAMP levels within the parathyroid chief cells. This molecular event drives the secretion of parathyroid hormone (PTH) into the systemic circulation. System-level physiological modulation occurs as the elevated circulating PTH acts on bone and kidney tissue, leading to increased serum calcium concentration and decreased serum phosphate concentration.

Dosage and Administration Information

Encalor (Bicalutamide) is administered exclusively as an oral tablet for continuous daily use. Prescribing information defines two primary daily dosage regimens based on the treatment context. The standard dose is 50 mg once daily when the medicine is used in combination with an LHRH analog. An alternative dose of 150 mg once daily is for the management of locally advanced disease, where it is used as monotherapy or as an adjuvant following local treatment, typically continued for at least two years.

The instructions emphasize that the tablet must be taken at approximately the same time each day, and intake is not dependent on meals, meaning it can be taken with or without food. When initiating the 50 mg combination regimen, administration must begin concomitantly with the start of the LHRH analog treatment.

For dosing consistency, established protocols exist for handling missed doses. If a daily dose is missed, the patient should skip the forgotten dose entirely. It is instructed that the dose must not be doubled to compensate for the missed intake, and the patient should resume the scheduled dosing the following day. No dose adjustment is necessary for patients with renal impairment or for those with mild to moderate hepatic impairment.

Recent Clinical Evidence

Research Evidence Overview for Encalor

The following sections summarize the types of clinical studies and trials from official regulatory and scientific sources that form the evidence base for Encalor (Bicalutamide), detailing the populations and outcomes researchers have examined in regulatory-cited literature.


Evidence for Use in Metastatic Prostate Cancer

Clinical evaluation involved Randomized Controlled Trials (RCTs) examining its use alongside hormonal castration (LHRH agonists) for advanced-stage disease. Research focused on adult men with confirmed metastatic prostate cancer. Researchers measured Overall Survival (OS) and Objective Progression-Free Survival (PFS), which reflect the study measures of Overall Survival and Progression-Free Survival. Research has studied this medicine predominantly in combination with LHRH agonists; studies suggested specific limitations for monotherapy in this setting.

Evidence for Use in Locally Advanced Prostate Cancer

The evidence foundation includes large-scale, international Phase III trials that studied Encalor's application as an adjuvant or immediate therapy for non-metastatic, locally advanced disease. These trials used a placebo-controlled design, and researchers monitored metrics like PFS, time to Prostate-Specific Antigen (PSA) progression, and OS. Long-term reports, with final analyses extending up to ten years or more, described the durability of observations regarding PFS. Findings about the OS endpoint were mixed across specific patient subgroups.

Evidence for Managing Symptom Flare

Encalor was studied for a specific short-term purpose: research protocols examined the symptom flare. This is a temporary, acute worsening of disease-related symptoms that may be associated with LHRH agonist therapy initiation. The key outcome examined was the possibility of reducing the severity or occurrence of this acute symptomatic escalation during the initial treatment weeks. Evidence is derived predominantly from short-term observation periods focused on the first weeks of therapy.

What Remains Uncertain or Under Study

The official scientific literature highlights several limitations. Long-term effects are not fully established across all indications, and evidence is limited for certain subgroups. Findings were mixed concerning the Overall Survival endpoint in some groups with locally advanced disease, suggesting this area requires clarification. Furthermore, comparative evidence is lacking regarding how Encalor compares to newer hormonal therapies that are now subjects of research for advanced disease.

Frequently Asked Questions (FAQ)

Common questions about Encalor (FAQ)

Q: If I miss a dose of Encalor, what generally happens?

A: Official instructions state that if you miss your scheduled daily dose, you should skip the forgotten dose entirely. Regulatory documents advise against doubling the dose to compensate for the missed intake, and you should resume your regular schedule the following day. This procedure is designed to maintain treatment safety and consistency.

Q: Can Encalor be used by people of all ages?

A: Regulatory documents clearly state that this medicine is contraindicated, meaning it must not be used, by children and adolescents. The use of Encalor is therefore restricted to adult males, based on the established safety and efficacy data.

Q: What is the consensus on using Encalor during pregnancy or breastfeeding?

A: According to official product information, Encalor is formally contraindicated for use in women, including those who are pregnant, may become pregnant, or are breastfeeding. This is because studies indicate the medicine has the potential to cause harm to a fetus.

Q: Does Encalor affect fertility in men or women?

A: Official regulatory sources note that the medicine is expected to cause reversible impairment of male fertility. Furthermore, because the drug is contraindicated in women, its effect on female fertility is not addressed, as it is strictly forbidden for use in that population.

Q: Why are people with pre-existing heart conditions advised against taking Encalor?

A: Official documents advise caution because the medicine has been associated with changes to the QT interval, a measure of the heart's electrical activity. Because of this, patients who have or are at risk for certain pre-existing heart conditions are subjects for a careful assessment before treatment begins.

Q: Is Encalor considered a common or specialized type of drug?

A: Official regulatory sources classify this medicine as a non-steroidal antiandrogen and an antineoplastic agent. These classifications place Encalor in a specialized therapeutic category, typically used for managing specific hormone-sensitive conditions.

Q: What is the expected timeline for seeing the full effects of Encalor?

A: The official documentation states that the concentration of the active compound in the body, known as steady-state plasma concentration, is typically reached after approximately 4 to 12 weeks of continuous daily dosing. This timeframe is often used to assess when the medicine reaches its most stable level of activity.

Q: Are there any known issues with taking Encalor long-term?

A: Official documents mandate long-term monitoring of liver enzyme levels throughout the course of treatment. This caution is due to the potential for severe, though rare, liver changes, which have been observed in some patients. This monitoring is performed to help identify potential changes and allow for necessary precautions to be taken.

Q: Can Encalor cause changes in mood or sleep patterns?

A: Regulatory data documents that changes to mood and sleep patterns have been reported by some users. Specifically, adverse reactions listed include nervous system effects such as depression, somnolence (drowsiness), and insomnia (difficulty sleeping).

Q: Are there any common foods or supplements that should be avoided while on Encalor?

A: The official prescribing information explicitly advises that grapefruit juice should be avoided while using this medicine. This is described in official documents as a measure to prevent grapefruit from interfering with how the drug is processed in the body, which could potentially increase its concentration.

Q: Is Encalor known to cause weight changes?

A: According to official regulatory documents, changes in body weight have been reported as adverse reactions. This includes both weight increase (listed as a common effect) and weight loss (listed as an uncommon effect).

Q: How does Encalor generally affect liver or kidney function?

A: Regulatory documents state that no dose adjustment is typically necessary for patients with existing renal impairment (kidney issues). However, official documents state the medicine should be used with caution in patients who have moderate to severe hepatic impairment (liver issues), and liver enzyme levels must be monitored during treatment.

Q: Can Encalor affect the results of common laboratory blood tests?

A: Regulatory documents indicate that the medicine may affect the results of some laboratory blood tests. Reported changes include decreases in blood components such as hemoglobin and leukocyte counts, and increases in tests measuring liver enzyme levels.

Q: Has Encalor been studied in different ethnic groups?

A: The evidence supporting the medicine's use is drawn from large-scale, international clinical trials. These studies are typically required for global regulatory approval and are designed to include diverse patient populations.

Q: What is the half-life of Encalor?

A: The pharmacokinetics section of the regulatory documents describes the active substance as having a relatively long elimination half-life of approximately 5.8 to 10 days with continuous daily dosing. The half-life is the time it takes for the concentration of the medicine in the body to decrease by half.

Q: Can Encalor be used in combination with other drugs for the same condition?

A: Yes, the medicine is approved for one of its main uses as a combination therapy. The official prescribing information defines one primary regimen for use concomitantly (at the same time) with a luteinizing-hormone releasing hormone (LHRH) analogue.

Q: What population groups were included in the phase 3 trials of Encalor?

A: Official regulatory documents summarizing the clinical evidence note that the major Phase III trials included adult men with confirmed diagnoses of metastatic or locally advanced prostate cancer within the studied population.

Q: What is the definition of 'pharmacodynamics' for Encalor?

A: Pharmacodynamics is a term used in official documents that describes what the medicine does to the body. For Encalor, this includes its action as a non-steroidal antiandrogen that blocks the binding sites for male hormones.

Q: Does Encalor interact with grapefruit or grapefruit juice?

A: Official product information advises against the use of grapefruit juice. This is described as a measure to prevent grapefruit from interfering with the body's processing of the drug, potentially leading to increased concentrations.

Q: Is Encalor available in different strengths?

A: Official regulatory documents list the medicine as available in two different strengths for oral administration: 50 mg and 150 mg tablets. The strength prescribed depends on the specific treatment regimen.

Q: Why is Encalor only available by prescription?

A: Encalor is available only by prescription because of its classification as an antineoplastic agent (a type of cancer therapy) and the significant warnings and requirements for monitoring liver function. This level of complexity requires that its use is overseen by a healthcare professional.

Q: Do older adults typically have different side effects than younger patients on Encalor?

A: According to official regulatory documentation, no dose adjustment is typically necessary based solely on a patient's age. This suggests that the risk profile and overall effect of the medicine are generally consistent across the adult age range.

Q: How does the chemical structure of Encalor relate to its effect?

A: The medicine is described in official documents as a non-steroidal small molecule. This structure allows it to act as an antagonist, meaning it can physically block the receptor sites where male hormones usually attach to stimulate cell growth.

Q: Does Encalor interact with common antibiotics?

A: The official documents note that the medicine may interact with certain antibiotics, such as macrolides. This is due to the potential for these combinations to affect heart rhythm or interfere with the body’s CYP enzyme system, which processes the medicine.

How should Encalor be stored and disposed of?

Encalor, containing Bicalutamide, requires adherence to specific regulatory storage and disposal mandates to maintain its stability and ensure safety.

Official Storage Conditions

Requirement Specific Condition
Temperature Store at controlled room temperature, 20 C to 25 C (68 F to 77 F).
Protection Keep in the original, tightly closed container and protect from moisture.
Prohibited Do not refrigerate or freeze the tablets.

Handling and Disposal

Official labeling requires the medication to be stored out of the sight and reach of children.

Disposal must follow specific pharmaceutical waste protocols. Do not dispose of unused or expired Encalor in household trash or pour it into wastewater. The product must be disposed of through a medicine take-back program or according to local official regulations.

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

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