Флутафарм

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Флутафарм

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Method of action: Antiandrogenic

Treatment option: Carcinoma

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 Флутафарм

What is Флутафарм?

Property Description
Active Ingredient Flutamide (INN)
Form Oral Tablet/Capsule
Pharmacological Class Non-Steroidal Antiandrogen
General Purpose Hormone Receptor Blocker
Origin Synthetic (Chemical)

What Type of Medicine is Флутафарм?

Флутафарм is classified as a non-steroidal antiandrogen, a synthetic medicine used to counteract the effects of male sex hormones (androgens) in the body.

It belongs to a unique pharmacological class of agents designed for hormonal modulation. Unlike some older hormonal treatments, the active substance Flutamide is recognized for its ability to selectively block androgen receptors, which is the core foundation of its therapeutic strategy. Флутафарм is a synthetic product, manufactured by Farmak, and is typically only available with a prescription, emphasizing its use in targeted, physician-guided therapy.

What is the Main Ingredient and Form of Флутафарм?

The single active ingredient in Флутафарм is Flutamide, which is delivered to the body as an oral tablet or capsule.

Flutamide is the International Non-proprietary Name (INN) for the substance, and its chemical properties are documented in official drug databases. It is designed for oral administration, allowing the tablets to be swallowed for absorption through the digestive system. This form offers convenience for long-term supportive care, ensuring a consistent delivery of the antiandrogen compound as prescribed.

What is the General Therapeutic Purpose of Флутафарм?

The general purpose of Флутафарм is to provide supportive care by helping to reduce the growth-promoting effects of androgens on hormone-sensitive tissue.

Its core function is to block the ability of male hormones, such as testosterone, from attaching to cell receptor sites, thereby neutralizing the hormone's stimulating signal. This mechanism has been a standard and established approach in medical management for decades. The drug's role is centered on controlling androgen influence.

What side effects are possible with Флутафарм?

Possible side effects and safety information

The safety profile of Flutamide, the active ingredient in Флутафарм, is characterized by potential adverse reactions classified by frequency and effect on specific organ systems, as documented by regulatory authorities like the FDA and EMA.

Frequency-Classified Adverse Reactions

Adverse effects are categorized to reflect their expected occurrence. Very common (ge 1/10) effects often include gynecomastia (breast enlargement/tenderness), diarrhea, nausea, and hot flushes (especially when used with LHRH agonists). Common (ge 1/100 to <1/10) reactions may involve fatigue, edema, and temporary changes in liver function tests. Rare effects include conditions like jaundice, rash, and confusion.

Serious Adverse Reactions and Safety Constraints

The most critical safety consideration is the risk of severe hepatotoxicity, which includes rare but potentially fatal hepatic necrosis and hepatic failure. Because of this risk, the medicine is contraindicated in patients with severe pre-existing hepatic impairment. Hematological effects, such as very rare cases of hemolytic anemia or methemoglobinemia, and rare reports of interstitial pneumonitis (lung disease) are also noted in official regulatory documents.

Population and Duration Safety Notes

Regulatory documents explicitly state that the medicine is contraindicated in women (particularly during pregnancy or lactation). The official profile also specifies that regular monitoring of liver function tests is necessary before and during treatment, particularly in the initial months, due to the time-related pattern of severe hepatic injury reports.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory documents outline the official approach to managing an overdose of Флутафарм (Flutamide), noting that no specific antidote is available. Treatment focuses on immediate medical intervention and supportive care.


Documented Overdose Manifestations

Symptoms reported in studies or included in labeling as potential effects include hypoactivity, ataxia (lack of coordination), slow respiration, piloerection (goosebumps), anorexia, and vomiting (emesis).

Required Emergency Actions

Urgent medical attention is mandated if any signs of serious toxicity occur, particularly those related to the liver. Users must seek medical advice immediately or contact a poison control centre if they suspect an overdose or observe signs of liver dysfunction, which may include jaundice (yellowing of skin/eyes), brown urine, severe abdominal pain, or unexplained fatigue.


Management and Severe Outcomes

The most serious risk is the potential for exacerbating the drug's inherent hepatotoxicity, which can lead to hepatic necrosis and hepatic encephalopathy, outcomes that have resulted in death. Because Flutamide is highly protein-bound, dialysis may not be useful in overdose management.

Supportive measures are used, and procedures like gastric lavage or inducing vomiting may be considered. Close observation and frequent monitoring of vital signs are required during recovery. Specific populations, including smokers and those with G6PD deficiency, are noted to have a higher theoretical risk for toxicity such as methemoglobinemia.

Therapeutic Uses of Флутафарм

Флутафарм is generally used to provide supportive therapeutic benefit in treating prostatic carcinoma, a condition where the malignant cells are often dependent on male hormones (androgens) for growth. It is considered relevant in managing locally advanced disease, metastatic cancer, and in situations involving markers of disease activity, such as PSA fluctuations. The goal is to assist in managing symptoms related to systemic imbalance and easing symptoms associated with hormone-sensitive conditions, such as discomfort and urinary difficulties.

The medication is commonly applied during the initiation of combination hormonal therapy to manage symptoms associated with hormonal surges. In situations where LHRH agonists are first introduced, symptoms that become more disruptive during flare-ups can occur, potentially causing acute bone pain or increased urinary strain. Флутафарм supports the handling of distressing manifestations related to this temporary spike in symptoms, providing supportive relief that assists with maintaining functional stability during the initiation phase of therapy.

“The medication is commonly used when conditions produce significant symptomatic burden and additional symptomatic support is appropriate.”


Quick Fact: Relief for Hormonal Symptom Flares

Флутафарм is commonly used in clinical settings that involve acute symptom patterns, helping to ease the temporary burden of symptoms related to physical discomfort.

Regulatory References

  1. National Cancer Institute overview

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Флутафарм — Official Regulatory Information

Populations for whom use is allowed (as stated in label):

  • Adult Male Patients (Age 18 and older) for the treatment of prostatic carcinoma.

Absolute Contraindications (Must Not Use)

The medicine is prohibited for use in several populations based on official regulatory labeling:

  • Women, including those who are or may become pregnant, as the product is indicated only for males.
  • Pediatric Patients (children and adolescents), as the safety and efficacy of the drug have not been established in this age group.
  • Patients with Severe Hepatic Impairment (pre-existing liver disease), as this is an explicit contraindication.
  • Patients with Known Hypersensitivity to flutamide or any component of the preparation.

Conditional Eligibility and Restrictions

Some patient groups require caution or monitoring as specified in official documents:

  • Pre-existing Hepatic Dysfunction (Non-Severe): Use requires caution and rigorous, regular liver function testing.
  • Hematologic Conditions: Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency or Hemoglobin M disease require caution due to the risk of certain toxicities.
  • Geriatric Patients: Use is established in older adults, who represent the primary eligible population.

Connection to the overall eligibility profile:

Official regulatory documents define eligibility for Флутафарм by establishing strict absolute contraindications based on sex, age, and organ function (severe liver disease). For the eligible adult male population, use is further defined by conditional rules that mandate caution and monitoring in the presence of specific pre-existing health conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define specific interaction constraints for co-administration of Флутафарм (Flutamide) with other substances, primarily concerning changes in drug exposure and pharmacodynamic potentiation.

Flutamide is involved in metabolic pathways that affect the clearance of other drugs. Co-administration with Theophylline may lead to increased Theophylline plasma concentrations because Flutamide or its active metabolite can inhibit Theophylline's metabolism, mainly via the CYP1A2 enzyme. Conversely, substances that modulate CYP1A2 or CYP3A4 may alter Flutamide exposure as it is a substrate for these enzymes.

Documented Pharmacodynamic Interactions

Interacting Substance Category Documented Official Outcome
Oral Anticoagulants (e.g., Warfarin) Reported increase in prothrombin time, necessitating close monitoring.
Methemoglobin-Inducing Agents Additive toxic effect that may increase the risk of methemoglobinemia in susceptible patients.

Contraindications and Substance Restrictions

Use of Flutamide is contraindicated in patients with known hypersensitivity to the product or those with severe hepatic impairment. Consumption of alcohol is documented to potentially exacerbate facial flushing, and official advice recommends avoidance if this occurs. No specific mandatory timing-separation rules for co-administered medicines are specified in the reviewed primary regulatory labels.

An increased risk of specific interaction-related toxicities, such as methemoglobinemia, is noted in specific patient populations, including individuals with G6PD deficiency, Hemoglobin M disease, and Smokers.

Mechanism of Action

Флутафарм (Flutafarm) is based on the active substance Flutamide, a nonsteroidal antiandrogen. The mechanism of action focuses on two primary domains, regulating androgen-mediated signaling pathways.


Androgen Receptor Blockade

This domain involves the primary mechanism where Флутафарм, primarily its active metabolite 2-hydroxyflutamide, acts as a competitive antagonist at the androgen receptor (AR) in target tissues. By binding to the AR, it prevents the uptake of androgens, such as testosterone and dihydrotestosterone (DHT), and inhibits their binding to the nuclear receptor. This modifies early molecular steps by suppressing the activation of AR-mediated gene transcription, modulating downstream effects of excessive androgen signaling.


Inhibition of Androgen-Stimulated Synthesis

This mechanistic domain addresses the downstream consequences of AR activation on cellular processes. Flutamide and its metabolite engage mechanisms that specifically suppress the signaling cascade responsible for androgen-stimulated cellular synthesis. This includes the inhibition of DNA synthesis in responsive cells, resulting in the modulation of signaling cascades influenced by excessive mediator activity, thereby affecting processes that drive cell growth and proliferation.

Dosage and Administration Information

How to Use Флутафарм

Флутафарм (Flutamide) is administered according to a specific, fixed schedule that ensures consistent levels of the antiandrogen compound. The instructions for use are highly dependent on the overall treatment plan, as the medicine is typically employed as part of a combination regimen.


Official Administration Guidelines

Instruction Detail
Route of Administration: The medicine is taken orally as a capsule or tablet.
Standard Dosing: The usual daily dose is 750 mg, administered as 250 mg units three times per day.
Dosing Schedule: Doses must be taken at approximately eight-hour intervals to maintain consistent action.
With or Without Food: Instructions vary: The medicine can be taken without regard to meals or is sometimes specified as preferably after food.

Procedural Structure and Contextual Use

Флутафарм is administered in combination with a primary hormonal treatment, such as an LHRH agonist or surgical castration. The medication is commonly initiated simultaneously with the LHRH agonist or, in some protocols, at least 24 hours prior to mitigate potential hormonal flares.

For localized advanced disease treated with radiation, administration typically begins eight weeks prior to the start of radiation therapy and continues throughout the entire course of radiation. If a scheduled dose is missed, the standard procedure is to skip the missed dose and resume the regular schedule; doubling the next dose is not instructed.

Special Conditions: No specific dose adjustment is officially required for older adults or in cases of chronic renal impairment, though the drug is administered with caution. Furthermore, the score line on the 250 mg tablet is only to facilitate swallowing and not intended to divide the dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Флутафарм (Flutamide)


Evidence for use in Advanced Metastatic Prostate Carcinoma

Research for Флутафарм in advanced, metastatic prostate cancer was explored primarily through Randomized Controlled Trials (RCTs) and comprehensive data summaries called meta-analyses. These studies often examined Флутафарм in combination with other hormonal treatments, including LHRH-agonists. The main outcomes that researchers monitored were measures of Overall Survival (OS) time, Time to Disease Progression (TTP), and Prostate-Specific Antigen (PSA) level changes. The studies focused on adult male patients whose cancer had spread to distant parts of the body.

Some studies monitored by researchers showed mixed results when evaluating Флутафарм's association with differences in Overall Survival compared to the use of LHRH-agonists alone. Studies report measurements of PSA level changes, with data showing patterns related to measured PSA change depending on the comparison group.


Evidence for use in Locally Advanced Prostate Carcinoma with Radiotherapy

The evidence landscape for this indication primarily involves Randomized Controlled Trials that studied the use of Флутафарм alongside external beam radiation therapy. The research examined how the combination therapy was evaluated in adult male patients with localized but advanced prostate cancer. The main outcomes measured in these studies included disease progression rates and the time until the PSA level began to rise again.

Studies observed how these outcomes were measured in the populations receiving the combined approach. Research describes the patterns of biochemical recurrence-free survival over defined time intervals in these patient cohorts.


What is Still Uncertain About Флутафарм

Research highlights that certainty remains low in a few key areas of Флутафарм's use. Firstly, findings were mixed in some of the largest studies examining the potential association of adding Флутафарм to another hormonal therapy when focused on Overall Survival. This variation means the data are still emerging and are not entirely consistent across the full body of evidence.

Secondly, data are still emerging for the sequencing of older and newer hormonal agents, meaning comparative evidence is lacking for certain switch strategies. Finally, there is limited information for long-term outcomes and durability of response beyond the immediate years following treatment in many clinical settings. The research provides context but not individual predictions, and findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Флутафарм (FAQ)


Q: Is Флутафарм the same as Flutamide?

Флутафарм is the product name for a medicine that contains the active substance Flutamide. Flutamide is the international non-proprietary name (INN) for the drug, meaning it is the official, generic name for the chemical compound.


Q: Why is Флутафарм used in combination with other treatments?

The combination approach is described in regulatory documents because Флутафарм acts by blocking the effects of male hormones (androgens) at the cellular level. This is combined with a primary treatment that works to suppress the production of these hormones.


Q: What kind of side effects are most commonly reported with Флутафарм?

Official safety documents categorize several effects as 'very common' when used alongside LHRH agonists. These include hot flashes, decreased sexual function (libido and impotence), and gastrointestinal issues such as diarrhea and nausea or vomiting.


Q: Is it normal to feel tired when taking Флутафарм?

Fatigue, which is a feeling of being extremely tired, is listed in regulatory documents as a potential symptom. Additionally, drowsiness has been reported as a less common side effect. Any persistent fatigue or extreme tiredness should be discussed with a healthcare provider.


Q: Do the side effects of Флутафарм go away over time?

Official patient information notes that some effects may not require immediate medical attention and are noted to potentially subside. However, if any side effect is severe or persistent, it should be promptly discussed with a healthcare provider.


Q: Does Флутафарм cause any changes to skin or hair?

Official safety data reports potential side effects such as rash and photosensitivity (increased sensitivity to sunlight). Changes to hair are not consistently detailed in the regulatory safety profile.


Q: Can Флутафарм be taken with common pain relievers like paracetamol?

Official advice emphasizes informing a healthcare provider about all prescription, non-prescription, and herbal products being taken. This is because Flutamide can be affected by other medications that are metabolized through similar enzyme pathways.


Q: Are there any foods or drinks that should be avoided while using Флутафарм?

Official patient advice notes that if facial flushing occurs while taking Флутафарм, avoidance of alcohol is generally suggested. This is because alcohol is documented to potentially increase this specific effect.


Q: Does Флутафарм interact with supplements or herbal remedies?

Official regulatory advice emphasizes informing a doctor or pharmacist about all vitamins, nutritional supplements, and herbal products being taken. This check is necessary due to the possibility of unknown or undocumented interactions affecting the drug's activity.


Q: Is it possible for Флутафарм to interact with heart medications?

Official regulatory documents specifically mention that Flutamide can increase the effect of oral anticoagulants, such as Warfarin, which are used to thin the blood. This requires close monitoring. All current medications should be reviewed with a healthcare provider.


Q: Can older adults use Флутафарм?

Official regulatory data confirms that the use of Флутафарм is established in older adults, who represent the primary eligible patient population for the main therapeutic use of the medicine.


Q: Is Флутафарм appropriate for people with kidney problems?

Regulatory data indicates that for people with chronic renal impairment, no dose adjustment is generally warranted. This is because official studies suggest that kidney impairment does not significantly affect the drug's key concentrations in the body.


Q: How quickly does Флутафарм typically start working?

The drug is generally absorbed after being swallowed. The active metabolite is understood to reach its consistent concentration level in the body after a few doses, based on pharmacokinetic studies.


Q: Is Флутафарм a treatment that is taken long-term?

The required duration of treatment with Флутафарм is dependent on the overall therapeutic plan determined by a healthcare professional. It may be used long-term until disease progression, or for a defined, shorter period in specific protocols, such as alongside radiation therapy.


Q: What happens if a person forgets to take Флутафарм?

Official regulatory instructions state that if a dose is missed, the patient should skip that specific dose and resume the regular schedule at the time of the next dose. The instructions advise against doubling the next dose.


Q: What is the duration of action for one dose of Флутафарм?

Pharmacokinetic data indicates the half-life of the active metabolite is approximately six hours. This measurement relates to the time it takes for half the substance to be processed by the body.


Q: How long after stopping treatment do the effects of Флутафарм wear off?

Clinical guidance notes that for certain situations involving discontinuation, a period of six to eight weeks should pass before making further treatment decisions. This provides a general timeframe for the drug's clearance to be considered.


Q: What is the difference between Флутафарм and other anti-androgen medicines?

Флутафарм (Flutamide) is classified as a non-steroidal antiandrogen (NSAA). Other medicines in this category, such as bicalutamide or enzalutamide, are also available and are referenced in official clinical guidelines, meaning Flutamide is one option in this class.


Q: How does Флутафарм help in managing its main therapeutic use?

Official documents describe that the medicine helps by competitively binding to androgen receptors. This action prevents male hormones from attaching to the receptors and stimulating the growth of hormone-sensitive cells.


Q: Is Флутафарм a chemotherapy drug?

Flutamide is classified as an antiandrogen and is used as a component of antineoplastic (anti-cancer) therapy. It is not generally considered a traditional cytotoxic chemotherapy agent, which works by directly killing rapidly dividing cells.


Q: Does Флутафарм have any effects on mood or mental clarity?

Official safety data reports less common central nervous system reactions as potential side effects. These can include nervousness, anxiety, depression, confusion, and drowsiness.


Q: Can Флутафарм affect a person's ability to drive?

Official patient information indicates that, due to potential side effects like drowsiness or confusion, caution is suggested when driving or operating machinery until the effects are known.


Q: What is the standard regulatory classification of Флутафарм?

Flutamide is officially classified as a non-steroidal antiandrogen (NSAA). Its therapeutic purpose means it is categorized within the broader group of antineoplastic agents.


Q: Can Флутафарм be split or crushed?

Official regulatory advice generally states that capsules and tablets should not be split, crushed, or opened unless otherwise directed. While some tablets may have a score line, the regulatory label notes this is only to facilitate swallowing.


Q: Does Флутафарм cause any visual changes or eye problems?

Official safety data has reported red, irritated eyes as a rare side effect. Any persistent or concerning visual changes should be reviewed by a healthcare provider.


Q: Is Флутафарм available as a generic medicine?

Yes, the active substance Flutamide is widely available as a generic medicine. Generic versions must meet official bioequivalence standards to ensure they contain the equivalent active ingredient and deliver the same therapeutic effect.


Q: Why is it important to read the patient information leaflet for Флутафарм?

Official patient advice emphasizes the importance of reading and carefully following the instructions in the patient information leaflet. This document contains crucial precautionary information regarding the safe use of the medicine, required monitoring, and potential side effects.

How should Флутафарм be stored and disposed of?

Storage and Disposal of Флутафарм (Flutamide Capsules)


Flutamide capsules must be stored at Controlled Room Temperature, which is officially maintained between 20 C and 25 C (68 F and 77 F). The product must be kept in its original container with the lid tightly closed and stored in a dry place, away from excessive heat and direct light. It is essential to keep the medicine from freezing.

For safety, Флутафарм must be stored out of the sight and reach of children and pets, as required by regulatory labeling.

Disposal of unused or expired capsules should follow official guidelines. The preferred method is to utilize a drug take-back program. If this is not available, the medication must be disposed of following specific U.S. FDA instructions for household trash, ensuring compliance with all local regulations for pharmaceutical waste.

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

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