Tabi

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Tabi

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Tabi

Quick Facts

Property Description
Active Ingredient Bicalutamide (INN)
Form Film-coated oral tablet
Pharmacological Class Anti-androgen, Hormone Antagonist
General Purpose Managing hormonal influence on cells
Origin Synthetic Compound

What Type of Medicine is Tabi (Bicalutamide)?

Tabi is a specialized, prescription-only drug defined as a non-steroidal anti-androgen (NSAA) used in endocrine therapy. The medicine belongs to the pharmacological class of hormone antagonists, agents designed to oppose the effects of specific hormones within the body. Tabi's core identity stems from its single active ingredient, the synthetic compound Bicalutamide (INN). This substance acts as an anti-androgen and is provided as a film-coated tablet for oral use, distinguishing its delivery system.

Composition and General Purpose

Tabi is a single-ingredient pharmaceutical preparation presented as a film-coated oral tablet, with the general purpose of managing hormonal influence on sensitive cells. The tablet form is engineered for reliable oral administration, ensuring the systemic delivery of the Bicalutamide compound, which is combined with necessary solid excipients and binders. The therapeutic benefit is achieved through the fundamental principle of androgen receptor antagonism. This is a precise mechanism where the active substance blocks the stimulating signals of male hormones (androgens) by competitively binding to their cellular receptors. This action interrupts the critical hormonal signaling pathway, serving as a cornerstone strategy for endocrine therapy by counteracting the proliferation-promoting effects of these natural hormones in adult males.

What side effects are possible with Tabi?

Possible Side Effects and Safety Information

Tabi’s officially documented safety profile is structured by regulatory bodies to communicate both expected and rare, serious adverse reactions.

Adverse Reaction Scope

Classification Examples of Reactions (System-Organ Class)
Very Common (≥10%) Hot flushes, gynecomastia (breast swelling/tenderness), asthenia (weakness), abdominal pain, nausea, and haematuria (blood in urine).
Common (1-10%) Anemia, dizziness, edema (swelling), liver enzyme elevations, alopecia (hair loss), pruritus, and dry skin.
Uncommon (<1%) Interstitial lung disease (including pneumonitis) and hypersensitivity reactions (including angioedema and urticaria).

Serious Adverse Reactions and Safety Restrictions

Official regulatory sources highlight Hepatic Failure (liver failure) and Interstitial Lung Disease as rare, potentially fatal serious adverse reactions. Hepatotoxicity, including enzyme elevations, has been generally reported within the first few months of treatment, with labeling requiring serum transaminase monitoring prior to starting treatment, at regular intervals for the first four months, and periodically thereafter.

The medicine is contraindicated in women, including those who are or may become pregnant, due to the documented potential for fetal harm. Caution is advised in patients with hepatic impairment, as the drug’s clearance may be reduced. When used in combination with LHRH agonists, blood glucose monitoring may be considered due to observed reductions in glucose tolerance.

Connection to the Overall Safety Profile

The safety profile is structured to identify frequent, expected hormonal effects while strictly outlining the necessity for careful monitoring of liver and lung health due to the low, but serious, documented risks. This regulatory framework defines specific prohibitions, most notably against use in women and in patients with a known hypersensitivity to the drug.

Overdose and Emergency Response

Overdose and When to Seek Help

The information below is strictly based on official regulatory documentation and outlines the documented overdose profile and required emergency actions for Tabi (Bicalutamide).

Feature
Documented Overdose Profile
The dose resulting in symptoms considered to be life threatening has not been established in humans, and there is no specific antidote known for Bicalutamide overdose.
Due to the drug's chemical classification, a theoretical risk of methaemoglobinaemia is documented.
Management and Constraints
Treatment is mandated to be symptomatic and consists of general supportive care, including close observation and frequent monitoring of vital signs.
Dialysis is not likely to be helpful in overdose management because the drug is highly protein bound and is not recovered unchanged in the urine.

Required Emergency Actions

Official regulatory sources mandate that medical help must be sought immediately following a suspected overdose, even if symptoms are not yet apparent.

Immediately call emergency services (e.g., 911) if the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened.

Official Overdose Summary

The regulatory overdose profile is defined by the absence of human overdose experience and the official constraint that a life-threatening dose has not been established. This lack of specific data mandates that management focuses strictly on symptomatic and general supportive care, coupled with the official guidance that no specific antidote is known. This structure requires regulators to explicitly instruct users to immediately contact emergency services if severe clinical manifestations occur.

Therapeutic Uses of Tabi

What Tabi Treats: Main Uses and Benefits

Tabi is commonly used as a core component of endocrine therapy for adult males diagnosed with advanced or metastatic carcinoma of the prostate. The medicine is primarily indicated for these hormone-sensitive disease states, including conditions that are locally advanced, have recurred, or are progressing after initial treatments.

A primary benefit is its role in supporting systemic disease management, which generally assists with managing the processes related to cell growth and spread. This support is often provided in a combination treatment plan alongside LHRH agonists. In this specific context, the medicine helps to prevent the tumor flare—a temporary worsening of symptoms that may occur when LHRH agonist therapy is first initiated.

The intent of this therapy is to provide comprehensive hormonal disease management, which indirectly helps to ease the patient’s symptomatic burden. This may assist in managing localized discomfort, such as urinary difficulties or pain caused by the proliferating tumor mass. By acting on the hormonal influence, the treatment supports the patient’s overall day-to-day comfort and stability during the course of the disease.


Quick Fact: Support for Symptoms Related to Disease Management

Symptom Category Therapeutic Benefit
Hormone-Sensitive Cancer Supports systemic disease management and helps manage cell growth.
Temporary Worsening of Symptoms Assists in preventing temporary worsening of symptoms upon treatment start.
Localized Discomfort Helps ease symptomatic burden related to local discomfort or functional strain (e.g., urinary issues).

Regulatory References

  1. NIH DailyMed information on Bicalutamide

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Tabi — Official Regulatory Information

This map outlines the official population eligibility and non-eligibility rules for Tabi (Bicalutamide), based exclusively on governmental regulatory documents.


Eligibility Scope

Classification Rule (Official Regulatory Statement)
Populations for whom use is allowed Adult males, including the geriatric population, with the approved indication.
Populations for whom use is contraindicated Females (no approved indication), children and adolescents, and patients with documented hypersensitivity to the drug or excipients.
Age-related eligibility rules Safety and efficacy have not been established in the pediatric population, leading to contraindication.
Condition-specific eligibility rules Use with caution is advised in patients with moderate to severe hepatic impairment and in those with severe renal impairment due to limited clinical experience.
Pregnancy and lactation eligibility status Use is formally contraindicated during both pregnancy and lactation.
Eligibility-related restrictions Males with female partners of reproductive potential must use effective contraception during treatment and for 130 days after the final dose. Contraindicated for patients with hereditary metabolic disorders, such as Lapp lactase deficiency.

Connection to the Overall Eligibility Profile

The regulatory profile strictly limits the use of Tabi to the adult male population. Official labeling establishes absolute prohibitions for females, children, and those with hypersensitivity, while also imposing conditional eligibility for patients with moderate-to-severe organ impairment and specific requirements for male patients with reproductive potential.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information highlights several classes of medicines that may interact with products containing Buprenorphine (the active ingredient associated with the Tabi method). These interactions are categorized based on their mechanism and resulting clinical constraint.

Interaction Domain Mechanism & Constraint Classification
CNS Depressants (e.g., Benzodiazepines, Alcohol, Sedatives) Additive depressant effects that increase the risk of severe respiratory depression, profound sedation, coma, and death. Concomitant use is generally restricted and requires close medical monitoring. High Risk / Contraindicated
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir) These agents inhibit the enzyme that metabolizes Buprenorphine, potentially increasing its concentration in the bloodstream. Requires patient monitoring and possible dose adjustments. Use with Caution
CYP3A4 Inducers (e.g., Carbamazepine, Rifampin) These agents speed up Buprenorphine's metabolism, potentially decreasing its concentration in the bloodstream. Requires patient monitoring and possible dose adjustments for under-treatment. Use with Caution
Serotonergic Drugs (e.g., SSRIs, MAOIs) Concomitant use with other agents that increase serotonin activity may result in Serotonin Syndrome. Close monitoring is required; some combinations (like MAOIs) may be contraindicated due to theoretical or reported risks. Monitoring Required / Avoid

These official interaction domains underscore that the most significant constraints involve additive depression of the central nervous system, which is explicitly noted in official labeling as a life-threatening risk. Pharmacokinetic interactions through the CYP3A4 enzyme system also necessitate management, requiring adjustments and monitoring to maintain appropriate product concentrations and avoid either toxicity or reduced effectiveness.

Mechanism of Action

Tabi (Bicalutamide) is a non-steroidal compound that primarily works by modulating the signaling pathway mediated by male hormones. Its mechanism involves specific interaction with hormone receptors, leading to downstream effects that influence cell proliferation rates.


Androgen Receptor Antagonism

This domain covers the drug's core action as a competitive receptor-mediated antagonist. Tabi binds with high affinity to the Androgen Receptor (AR), limiting the natural male hormones, such as testosterone and dihydrotestosterone (DHT), from binding to and activating the receptor. This action limits the androgen-AR complex from translocating to the cell nucleus and initiating gene transcription.


Modulation of Cell Proliferation Cascade

By inhibiting AR-mediated gene expression, Tabi modifies the signaling sequences that influence cell growth and survival in androgen-dependent tissues. This modification of early molecular steps influences processes that involve altered cell proliferation. The resulting physiological effect is the maintenance of altered cellular signaling, which impacts the rate of cell multiplication.

Dosage and Administration Information

Tabi (Bicalutamide) is administered exclusively by the oral route using the film-coated tablet formulation. The medicine is taken once daily at a consistent time each day, a principle that helps maintain steady systemic levels of the active ingredient. This administration timing is flexible regarding food and can be taken with or without a meal. The tablet must be swallowed whole and should not be crushed, split, or chewed.

The standard dosing regimens depend on the overall treatment approach. For advanced disease when used in combination with a companion therapy, the dose is 50 mg once daily. For locally advanced disease, a regimen of 150 mg once daily may be used. Treatment initiation for either strength is required to occur under the supervision of a specialist and must be timed to begin simultaneously with (or, in some protocols, shortly before) the companion LHRH analogue therapy.

The use of Tabi is generally continuous and long-term, often until evidence of disease progression is observed. If a daily dose is missed, the standard procedure is to skip the missed dose entirely and take the next dose at the regularly scheduled time; the dose must never be doubled. Furthermore, dosage adjustment is not necessary for older adults or for patients with renal impairment or mild hepatic impairment.

Recent Clinical Evidence

Research evidence / Overview of studies for Tabi

This section provides a descriptive overview of the research evidence and regulatory trials for Tabi (Bicalutamide), focusing on the types of studies conducted, the outcomes they measured, and the limitations noted in the scientific literature. This information is non-advisory and does not offer clinical guidance or recommendations.


Evidence for Advanced or Metastatic Prostate Carcinoma

Research into Tabi's use for advanced or metastatic disease primarily involved large-scale, international Randomized Controlled Trials (RCTs). These studies were generally designed to examine Tabi when used in combination with other hormone-suppressing therapies. Researchers studied primary long-term outcomes such as the length of time participants lived (Overall Survival) and the time before the cancer worsened (Progression-Free Survival).

Studies reported patterns observed in the time to progression and measurements of survival data in patient groups that received Tabi alongside a luteinizing hormone-releasing hormone (LHRH) agonist. Some trials exploring Tabi as a single agent in the metastatic setting indicated patterns, and the research explored how survival duration patterns differed between these treatment groups.


Evidence for Locally Advanced Non-Metastatic Prostate Cancer

Studies exploring Tabi's application in locally advanced, non-metastatic disease come largely from large, controlled programs that used placebo-controlled, double-blind study designs. These trials was studied for long-term outcomes, often tracking participants for well over seven years. Researchers examined whether Tabi, used as an adjuvant (in addition to standard care such as radiotherapy), had an association with outcomes related to survival and the long-term risk of the disease spreading to distant parts of the body.

Studies reported how survival data evolved across the different treatment groups. For example, some large studies suggested that research findings may only apply to the sub-population of patients with locally advanced disease and higher baseline PSA levels, and that survival outcomes for patients with truly localized, low-risk disease did not show patterns of change associated with the addition of Tabi to standard care.


Research Gaps and Areas of Uncertainty for Tabi

A key research limitation is the lack of direct comparison of Tabi with newer-generation anti-androgen drugs. Comparative evidence is lacking for these newer treatments, which limits the scope of research comparison. Furthermore, studies are ongoing to understand the patterns related to resistance that have been observed during extended Tabi use and to explore other research scenarios.

Key Studies & References

  1. Systematic Review and Meta-analysis of Nonsteroidal Antiandrogens for Nonmetastatic Prostate Cancer

Frequently Asked Questions (FAQ)

Common questions about Tabi (FAQ)

Q: What are the most common side effects people report when starting Tabi?

A: Official safety information indicates that side effects, especially concerning the liver, are often reported within the first few months of starting treatment. Very common side effects (those affecting more than 1 in 10 people) include hot flashes, physical weakness (asthenia), and breast tenderness or swelling (gynecomastia). Regulatory documents state that monitoring is required, especially during the initial months of therapy.

Q: Can Tabi treatment be stopped abruptly, or does it need to be tapered?

A: Patients are generally advised by regulatory authorities not to interrupt or suddenly stop taking Tabi without first consulting their healthcare provider. Official product information does not provide instructions for abruptly discontinuing the drug for general use. Official guidance stresses that any change to the treatment schedule requires consultation with a healthcare professional.

Q: Is Tabi typically taken alone or with other medications for prostate cancer?

A: The use of Tabi is generally approved as a combination therapy alongside another hormone-suppressing medication called an LHRH analog. While the higher strength may be approved as a single agent (monotherapy) for locally advanced disease in some regions, the dose used for metastatic disease is typically in combination. The standard approach for advanced disease is often combination use.

Q: What is an LHRH analog, and why is it often taken with Tabi?

A: An LHRH analog is a different class of hormone treatment that works to reduce the body's production of male hormones. Tabi (an anti-androgen) and LHRH analogs are often used together to achieve a strategy known as Combined Androgen Blockade (CAB). This combination aims to both block the effects of male hormones on cancer cells and reduce the overall circulating amount of these hormones.

Q: Can Tabi impact a patient's fertility or ability to father a child?

A: Based on animal studies, antiandrogen therapy like Tabi may potentially impair fertility in males. The regulatory profile includes a restriction stating that effective contraception must be used by male patients with female partners of reproductive potential due to the risk of fetal harm. The long-term effects of Tabi on male fertility have not been fully studied.

Q: Does Tabi interact with common blood thinners like Warfarin?

A: Yes, Tabi has the potential to enhance the effects of certain coumarin-type anticoagulants, such as Warfarin. Regulatory guidance states that close monitoring of Prothrombin Time (PT) and International Normalized Ratio (INR) is needed when Tabi is started, to check the blood's clotting ability.

Q: What is the relationship between Tabi and prostate-specific antigen (PSA) levels?

A: Prostate Specific Antigen (PSA) is a key blood marker used to monitor prostate cancer. Official safety information recommends that PSA levels be monitored during Tabi therapy. If PSA levels increase while on Tabi, regulatory information indicates that this should lead to an evaluation for potential disease progression.

Q: Does taking Tabi increase blood sugar levels for people with diabetes?

A: Official warnings note that LHRH agonists, which Tabi is often combined with, have been observed to cause a reduction in glucose tolerance. For this reason, official safety information suggests that blood glucose levels should be monitored in patients who are receiving Tabi in combination with an LHRH agonist.

Q: How is Tabi different from Lupron or other LHRH agonists in terms of how it works?

A: Tabi is classified as a non-steroidal anti-androgen that acts by directly blocking the effects of male hormones at the cellular receptor level. LHRH agonists (like Lupron) are a separate class of drugs that work by signaling the body to reduce the production of these hormones. Both are used in endocrine therapy, but they achieve their effect through distinct mechanisms.

Q: Is Tabi a treatment for all stages of prostate cancer?

A: Regulatory indications state that Tabi is specifically approved for the treatment of advanced metastatic carcinoma of the prostate when used in combination. It is not generally indicated for treating localized, early-stage disease. Treatment decisions depend on the specific stage and characteristics of the cancer.

Q: What are the less common, but more serious, side effects of Tabi?

A: The safety profile outlines rare but potentially serious adverse reactions. These include severe hepatic injury (liver failure) and interstitial lung disease, a serious condition affecting the lungs. Hypersensitivity reactions (such as angioedema) have also been reported.

Q: What are the signs of a possible liver problem that I should watch out for while on Tabi?

A: Official information outlines specific symptoms of potential liver issues, such as yellowing of the skin or eyes (jaundice), dark urine, pale stools, loss of appetite, persistent nausea, vomiting, or pain in the upper stomach area, which regulatory bodies state should be reported to a healthcare provider.

Q: Are there any specific concerns about sun exposure while taking Tabi?

A: Due to reported cases of photosensitivity (increased sun sensitivity), official patient information suggests avoiding excessive exposure to sunlight or UV light and using protective measures like sunscreen when outdoors.

Q: Is it normal for my urine to change color while I'm on Tabi?

A: Regulatory information lists hematuria, or blood in the urine, as a very common side effect, which can make the urine red or brown. It is also important to monitor for dark-colored urine, as this can be a sign of a serious liver problem that official labeling states needs attention.

Q: Do different brands of Tabi (bicalutamide) work exactly the same way?

A: Different manufacturers produce generic versions of the active ingredient, bicalutamide. These generic products are required to meet the same strict regulatory standards as the original drug, including demonstrating bioequivalence. This means they are expected to work in the body in the same way as the original Tabi.

Q: Can Tabi affect a patient's energy levels or cause noticeable fatigue?

A: Yes, regulatory safety documents list asthenia, which means physical weakness or lack of energy, as a very common side effect. Fatigue is also commonly reported in official patient information.

Q: Can taking Tabi lead to mood changes or depression?

A: Yes, official safety information lists depression as a common psychiatric disorder reported by patients. Mood changes may also occur. Official documentation implies that symptoms should be reported to a healthcare team for proper management.

Q: How does Tabi affect a patient's sex drive or sexual function?

A: Both a decreased libido (sex drive) and erectile dysfunction are commonly reported side effects according to the drug's safety profile. These effects are generally associated with the hormone-blocking action of the medicine.

Q: What is the typical timeframe for a treatment course of Tabi?

A: Treatment with Tabi is generally intended to be continuous and long-term. It is typically continued until there is evidence that the prostate cancer is progressing. The specific duration of the treatment course is determined by the treating physician based on the individual patient and their disease status.

Q: Is Tabi effective in reducing difficulty with urination caused by prostate cancer?

A: Tabi is approved for prostate cancer, and its goal is to limit cancer growth. However, the official safety profile lists urinary frequency and nocturia (waking up to urinate) as common adverse reactions. This indicates that while the drug fights the cancer, urinary symptoms may still be a feature of the condition or the treatment.

Q: What is the purpose of using contraception during and after Tabi treatment, even for the male patient?

A: Contraception is necessary because Tabi may cause fetal harm if a male patient's sperm fertilizes an egg of a pregnant woman. Animal studies have shown the drug can cause abnormal development of reproductive organs in male fetuses. This regulatory restriction is in place to prevent potential fetal exposure.

Q: Does Tabi cause weight gain, and if so, how is it managed?

A: Yes, weight increase is listed as a common side effect in the official safety profile. This is often an expected finding with hormone-altering therapies. Management of weight gain is not specifically addressed in the regulatory labeling.

Q: Is it normal to feel dizzy or sleepy after taking Tabi?

A: Dizziness is listed as a common side effect of Tabi. Somnolence (sleepiness or unusual drowsiness) has also been reported. Official patient information includes a warning about operating machinery or driving if these effects occur.

Q: How is Tabi stored, and what happens if it gets too hot or cold?

A: Official regulatory documents state that no special storage conditions are typically required for Tabi. While specific consequences of temperature extremes are not usually detailed, official guidance is to keep the product in the packaging and dispose of any unused or waste material according to local requirements.

Q: Can Tabi affect the results of other medical tests not related to the prostate?

A: The drug is known to cause elevations in liver enzymes (hepatic transaminases), which are measured by routine blood tests. These increases require monitoring as they may indicate a liver issue. Your doctor will likely conduct regular blood tests to check these enzyme levels.

How should Tabi be stored and disposed of?

How to Store and Dispose of Tabi (Bicalutamide) — Official Regulatory Information

Official regulatory documentation establishes the required conditions for storing and disposing of Tabi (Bicalutamide 50 mg tablets).

Storage Requirements

Condition Official Requirement
Temperature No special storage conditions are required for the medicinal product.
Stability The documented shelf-life is 2 years.
Handling No special handling requirements are documented.

Disposal Instructions

Any unused medicinal product or waste material must be disposed of in accordance with local requirements. This guidance ensures proper handling and minimization of environmental impact. The tablets are typically supplied in PVC/Aluminum foil blisters.

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

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