Lutamid

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Lutamid

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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

Overview of Lutamid

Property Description
Active Ingredient Bicalutamide
Form Oral Tablet (Film-Coated)
Pharmacological Class Androgen Receptor Antagonist
Common Use Hormonal Modulation / Anti-Androgen Therapy
Origin Synthetic Compound

What Type of Medicine is Lutamid (Bicalutamide)?

Lutamid is a prescription-only medicine whose active component is the synthetic compound Bicalutamide. It is formally classified as an Androgen Receptor Antagonist, belonging to the functional class of Non-steroidal Anti-androgens (NSAA). The primary role of this classification is to selectively block certain hormone actions. This approach is clinically recognized for its systemic effect in mitigating androgen activity. The formulation is a single-entity medicine, which ensures that the drug's activity is entirely based on the known, measurable properties of Bicalutamide.

Lutamid's Composition and General Form

The physical form of Lutamid is an oral tablet intended for oral administration, utilizing the single active ingredient, Bicalutamide. This solid preparation is typically a film-coated tablet, a form commonly used in medicine to ensure stability and accurate delivery of the drug for systemic distribution. The primary function of this agent is to modulate the hormonal environment. The drug is typically positioned for use by adult males requiring specific hormonal modulation.

What is the Overall Purpose of an Androgen Receptor Antagonist?

The general purpose of this type of medication is to achieve hormone-related control by interrupting signals that promote the growth of certain cells sensitive to androgens. Bicalutamide achieves this utility through competitive inhibition, where it effectively occupies the receptor sites that would normally be stimulated by natural hormones like Testosterone. This peripheral blocking action provides the essential function of the drug: to modulate and counteract the biological effects of male hormones in the patient's system. For instance, in the context of advanced therapy, the drug provides a tool for long-term hormonal management.

Regulatory References

  1. NIH: MedlinePlus
  2. Testosterone

What side effects are possible with Lutamid?

Possible Side Effects and Safety Information

The safety profile of Lutamid (Bicalutamide) is defined by official regulatory documents, classifying adverse reactions according to the frequency with which they are reported.


Frequency-Classified Adverse Reactions

Adverse effects are grouped by their rate of occurrence in clinical use:

  • Very Common (Affects 1 in 10 patients or more): Effects frequently documented include hot flashes, breast tenderness (mastalgia), breast enlargement (gynecomastia), anemia, and dizziness.
  • Common (Affects 1 in 100 to less than 1 in 10 patients): These include asthenia (fatigue/weakness), peripheral edema, various types of pain, gastrointestinal issues such as nausea and constipation, and decreased libido.

Serious Adverse Reactions and Safety Constraints

Official labeling identifies specific, less common adverse reactions considered clinically significant:

  • Uncommon to Rare Reactions: These include serious conditions such as interstitial lung disease and hepatic failure, both of which have been documented with potentially fatal outcomes. Hypersensitivity reactions, including angioedema and urticaria (hives), are also listed as uncommon events.
  • System-Organ Classes: Adverse effects are grouped by the systems they affect, including Hepatobiliary (liver), Respiratory, Gastrointestinal, and Blood and lymphatic system disorders.

Special Population and Time-Related Safety

The medicine is contraindicated for use in women and children. Caution is advised for individuals with moderate to severe hepatic impairment due to the potential for drug accumulation. Certain liver enzyme elevations and hepatotoxicity are generally observed within the first three to four months of beginning treatment. The drug may also cause temporary impairment of male fertility.

Overdose and Emergency Response

Lutamid Overdose and when to seek help

Official regulatory information regarding Lutamid (Bicalutamide) overdose focuses primarily on mandated emergency actions and required supportive measures. Regulatory documentation indicates that a single dose resulting in life-threatening symptoms has not been established. Furthermore, high daily dosages (up to 200 mg daily) used in long-term clinical trials were found to be generally well tolerated.

Immediate medical assistance is required if an overdose is suspected. The official guidance mandates that you contact the poison control helpline immediately. Urgent medical help, including calling emergency services, must be sought if the individual exhibits severe manifestations such as collapse, a seizure, trouble breathing, or inability to be awakened.

Management of overdose is limited, as no specific antidote is known for Bicalutamide. Treatment is therefore symptomatic and supportive. Officially described procedures include inducing vomiting only if the patient is alert. General supportive care is indicated, which involves frequent monitoring of vital signs and close observation of the patient. Dialysis is not expected to be useful in treatment because Bicalutamide is highly protein-bound. This approach underscores the need for proactive medical intervention based on the presentation of severe clinical signs.

Therapeutic Uses of Lutamid

What Lutamid Treats: Main Uses and Benefits

Lutamid (Bicalutamide) is commonly used to help manage prostate cancer in adult males. The medicine supports the management of the disease by addressing activity influenced by male hormones, providing supportive control across relevant therapeutic domains. This anti-androgen is primarily used for the management of advanced or metastatic prostate cancer, often used in combination with other hormonal therapies.

The primary therapeutic use focuses on conditions where cancer is locally advanced or has spread. This medication is applied in addressing the acute, temporary worsening of symptoms, such as tumor flare, that may occur when patients begin therapy with other hormonal agents.

“This approach may provide supportive benefit, assisting patients in coping more steadily with the difficult initial phase of long-term management.”

By supporting the management of the disease process, this approach may assist with the easing of associated physical discomfort that arises from the underlying tumor activity, supporting improved patient comfort during chronic management.


Quick Fact: Supports Management of Disease Progression & Discomfort

Eligibility and Restrictions for Use

Lutamid (Bicalutamide) is a prescription medicine with strict population eligibility requirements defined in regulatory labeling.

Eligibility Scope

Allowed and Established Populations:

Population Group Eligibility Status
Adult Males Use is established and indicated
Older Adults (Geriatric) No specific age-related restrictions; no dose adjustment necessary

Absolute Contraindications

Lutamid must not be used by the following populations:

  • Females: Use is contraindicated in women for all indications.
  • Pregnancy and Lactation: Use is contraindicated during pregnancy and while breastfeeding due to the potential for fetal harm.
  • Pediatric Population: Use in children and adolescents is contraindicated as safety and effectiveness have not been established.
  • Hypersensitivity: Patients with a known allergic reaction to bicalutamide or any component of the tablet formulation are prohibited from use.
  • Hereditary Metabolic Disorders: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Restricted or Conditional Use

Caution is advised for specific pre-existing conditions:

  • Hepatic Impairment: Use with caution in patients with moderate to severe hepatic impairment due to the potential for increased drug accumulation. No adjustment is necessary for mild impairment.
  • Severe Renal Impairment: Caution is required as there is insufficient experience with the medicine in patients with creatinine clearance below 30 mL/min.

What should I know about interactions with other medicines?

Lutamid Interactions with other medicines and products

When starting treatment with Lutamid (generic name: flutamide), it is crucial to inform your healthcare provider about all prescription and non-prescription medicines, vitamins, and herbal products you are currently taking. This is because Lutamid, an antiandrogen, has the potential to interact with many other drugs, which may alter their effects or increase the risk of side effects.

Lutamid is primarily metabolized in the liver, and its active metabolite can affect the action of other drugs processed by similar enzyme pathways. Of particular concern are certain drug categories, where close monitoring or dosage adjustment may be required:


  • Blood Thinners (Anticoagulants): Co-administration with oral anticoagulants, such as warfarin, may increase the risk of bleeding. Close monitoring of prothrombin time is recommended, and the anticoagulant dosage may need adjustment.
  • Hepatotoxic Agents: Because Lutamid itself carries a risk of severe liver injury, combining it with other medicines known to be toxic to the liver should be done with extreme caution. This includes consulting your doctor about all drugs that may affect your liver.
  • Theophylline: Increased blood concentrations of theophylline (a medicine for breathing problems) have been reported, which may require a dosage change to prevent toxicity.

Alcohol and Tobacco

It is generally recommended to avoid consuming alcohol while taking Lutamid, as some patients have reported experiencing excessive facial flushing. Tobacco smoke contains substances that may affect the drug's metabolism; patients who smoke may require closer monitoring.

Mechanism of Action

Competitive Blockade of the Androgen Receptor

Lutamid's core mechanism is competitive antagonism at the Androgen Receptor (AR), where the active component, (R)-Bicalutamide, prevents the binding of potent natural androgens like DHT. This essential molecular step suppresses the formation of the activated hormone-receptor complex, thereby initiating the inhibition of the androgen signaling cascade.

Suppression of Androgen-Responsive Gene Transcription

The resulting blockade at the AR prevents the receptor from entering the cell nucleus and binding to DNA. This action modifies the early molecular steps that shape systemic physiological outcomes by suppressing the transcription of androgen-responsive genes. This results in the physiological consequence of modulation of androgen-dependent cellular activity.

Mechanism-Driven Disinhibition of the HPT Axis

The drug's action creates a distinct systemic effect by disrupting the body’s natural hormonal feedback loop known as the Hypothalamic-Pituitary-Testicular (HPT) Axis. By blocking peripheral ARs, the drug removes the normal negative feedback, which mechanically results in a compensatory elevation of circulating androgens, an intrinsic component of its overall pharmacodynamic profile.

Dosage and Administration Information

How to Use Lutamid (Enzalutamide) — Official Administration Guidelines

Lutamid (enzalutamide) is an oral medication. The official instructions for its use mandate a specific daily dosing regimen and administration method to ensure correct and consistent treatment.

Administration Details

Administration Scope Official Requirement
Recommended Dose 160 mg once daily.
Administration Method Swallow the capsules or tablets whole with water. Do not chew, cut, crush, dissolve, or open them.
Timing (Meals) May be taken with or without food.
Frequency Administered once a day at approximately the same time each day.
Concomitant Therapy Must be used concurrently with a GnRH analog (e.g., LHRH analog) or following a bilateral orchiectomy (surgical castration) for most approved uses.
Age Group For use in adult men. Safety and efficacy in those under 18 years old have not been established.

Instructions for Missed and Adjusted Doses

  • Missed Dose: If you miss a dose, take it as soon as you remember. If the missed dose is not noticed until the next day, skip the forgotten dose and resume treatment at the usual time. Do not take two doses at the same time to make up for a missed dose.
  • Dosage Modification: The dosage may need to be reduced to 80 mg once daily when co-administered with a strong CYP2C8 inhibitor drug. Conversely, the dosage may need to be increased to 240 mg once daily if co-administered with a strong CYP3A4 inducer drug. Any dose adjustment must be determined and managed by your supervising physician.

These instructions constitute the required procedural steps for administering the medication, establishing the standard dose, frequency, and conditions for use as defined in established regulatory documentation.

Recent Clinical Evidence

Recent Clinical Evidence for Lutamid

Clinical research into the radioligand therapy containing Lu-177 has primarily focused on men with metastatic castration-resistant prostate cancer (mCRPC). Studies have explored the effects of this treatment in populations who have previously received chemotherapy or other standard hormone therapies.

Primary Research Findings

Randomized controlled trials have evaluated the drug's effect on overall survival (OS) and radiographic progression-free survival (rPFS). Findings indicate that, when compared to standard care, treatment with the radioligand was associated with a prolonged median time to rPFS and an improvement in OS in the studied population.

Researchers also monitored prostate-specific antigen (PSA) response rates. In pivotal studies, a significantly higher percentage of participants receiving the Lu-177 therapy experienced a decline in PSA levels of 50% or more compared to the control group.

Combination Therapy Investigation

Research has investigated the use of this radioligand in combination with other treatments, such as androgen receptor pathway inhibitors (ARPIs). One Phase 2 trial assessed the combination of the radioligand therapy plus enzalutamide compared to enzalutamide alone in participants with mCRPC.

In this trial, the median PSA progression-free survival was longer in the combination therapy group compared to the group receiving enzalutamide alone. This suggests that the combination may contribute to enhanced anticancer activity in this specific patient group.

Safety in Trials

Across multiple studies, the safety profile of Lu-177 therapy was monitored closely. In trials comparing the radioligand plus an ARPI to the ARPI alone, the frequency of Grade 3-5 adverse events was observed to be similar between the two treatment groups. Fatigue, dry mouth, and nausea were among the most commonly reported adverse events.

Frequently Asked Questions (FAQ)

Common questions about Lutamid (FAQ)


Q: What should I expect in the first few days of using Lutamid?

According to official product information, common effects often reported at the start of use include hot flashes, nausea, and diarrhea. The official product information notes the importance of monitoring for potential signs of liver issues, as the rare risk of severe liver injury is typically observed within the first few months of beginning treatment.


Q: How long does the effect of Lutamid last after taking a dose?

Official information regarding the drug's properties shows that the active component is processed and eliminated by the body over time. The active compound has an estimated half-life (the time it takes for half the drug to leave the body) of approximately 6 to 8 hours.


Q: Is Lutamid a controlled substance?

Regulatory information from the U.S. health authorities classifies medications based on their potential for abuse. According to the U.S. Controlled Substances Act (CSA), this medicine is not classified as a controlled drug.


Q: Can Lutamid cause drowsiness or make me sleepy?

Yes, official regulatory documents list drowsiness as a reported side effect of the medicine. If changes in alertness are experienced, a healthcare provider should be consulted regarding how this may affect daily activities.


Q: What common over-the-counter pain relievers interact with Lutamid?

Regulatory documents caution that the medicine may interact with certain commonly available products. Official interaction lists include non-prescription pain relievers such as acetaminophen (Tylenol), and official information describes the need for caution when combining this medicine with any over-the-counter product.


Q: Does Lutamid interact with any common vitamins or supplements?

Official regulatory information specifies that healthcare professionals should be informed about all prescription medicines, vitamins, minerals, and natural supplements being taken. This is because these products may potentially interact with the way the medicine works in the body.


Q: What foods or drinks are commonly restricted while on Lutamid?

Official patient guidance states that alcohol is generally recommended for avoidance because some people may experience excessive facial flushing when combining the two. Additionally, some guidance describes reducing the intake of dairy products and avoiding laxatives to manage the common side effect of diarrhea.


Q: What is Lutamid used for besides the main condition?

The medicine is officially indicated for the management of prostate cancer in combination with another type of hormonal agent. Due to the rare, but serious, risk of severe liver injury associated with this medication, health authorities advise that its use for non-malignant (non-cancer) conditions is no longer recommended.


Q: What information is available about long-term use of Lutamid?

In the context of treating advanced disease, the medicine is typically continued until the disease shows signs of progression. Safety information for ongoing use is reflected in the requirement for regular liver monitoring, as the risk of rare, serious liver injury is most commonly observed within the first few months of treatment.


Q: What kind of studies support the use of Lutamid?

Studies and official information indicate that the use of this medicine is supported by randomized clinical trials. These studies evaluated its efficacy and safety in men with prostate cancer, often when the medicine was used alongside another specific type of hormonal agent.


Q: Is there ongoing research into new uses for Lutamid?

Yes, research continues to explore the properties of this type of drug compound. For example, studies indexed by the National Institutes of Health (NIH) are investigating novel derivatives of the active ingredient for potential use against various forms of prostate cancer cells.


Q: Does Lutamid impact fertility or reproductive health?

Official safety information for this medicine, which is indicated for use in adult men, indicates that it may cause temporary impairment of male fertility. Questions regarding this possibility should be directed to a healthcare provider.


Q: How does the time of day I use Lutamid relate to my meals?

Regulatory instructions for the medicine specify that it may be taken with or without food. Taking it with a meal or on an empty stomach does not significantly change how the active ingredient is absorbed by the body.


Q: What are the signs that Lutamid is starting to work for the intended purpose?

To determine if the medicine is having its intended effect, healthcare professionals typically monitor Prostate-Specific Antigen (PSA) levels in the blood. PSA levels are generally expected to decrease when the body is responding appropriately to this therapy.


Q: Is it possible to be allergic to the inactive ingredients in Lutamid?

Official regulatory documents state that the medicine is contraindicated (must not be used) if a patient has a known allergic reaction not only to the active ingredient but also to any component of the tablet formulation. Official product documents list all inactive ingredients.


Q: Can travel affect the way I need to use or store Lutamid?

While there are no specific regulatory guidelines for travel, the medicine must be stored in its closed container at room temperature. You should ensure the medication is protected from factors like excess heat, moisture, and direct light during travel to maintain its stability.


Q: What are the common reasons a doctor might switch someone from Lutamid to another drug?

Official guidance indicates that discontinuing the medicine may be considered if there are signs of disease progression, such as a confirmed increase in PSA levels. Switching may also be considered if serious signs of liver injury are observed through blood tests or physical symptoms.


Q: Is Lutamid suitable for patients with diabetes?

The medicine is not listed as being contraindicated for use in patients with diabetes. However, official regulatory documents require that healthcare professionals check blood sugar levels as part of the regular monitoring conducted during treatment.


Q: Why are people often confused about the difference between Lutamid and its active ingredient?

This confusion is common because medical and pharmaceutical documents often use both the specific brand name (Lutamid) and the generic name (Bicalutamide or Flutamide) when referring to the medicine. Both names refer to the same active ingredient.


Q: Is it normal to feel a mild headache when starting Lutamid?

Official patient information lists headache as a potential symptom that should be monitored. It is important to pay attention to a headache, especially if it is experienced alongside other more serious signs like unusual weakness or shortness of breath.


Q: Why is Lutamid often mentioned with [specific similar drug name]?

This medicine is officially indicated for use in combination with a specific class of hormonal treatment known as an LHRH agonist. This mandatory combined approach to treatment is the primary reason why this medicine is typically discussed alongside its companion drugs.


Q: Does Lutamid affect mood or cause anxiety?

Yes, official side effect lists include reports of mood changes among patients. These effects are typically reported to a healthcare professional if they occur.


Q: Is Lutamid known to cause weight gain or weight loss?

Official regulatory reports indicate that the medicine may be associated with changes in weight. This includes reports of both increased appetite and weight gain in some patients, though loss of appetite is also noted.

How should Lutamid be stored and disposed of?

Official Storage and Disposal Guidelines

Lutamid, typically referring to Flutamide, must be stored and disposed of according to strict regulatory requirements to ensure its stability and prevent misuse.

Storage and Handling

Condition Requirement (Flutamide)
Temperature Store at room temperature.
Protection Keep in a closed container, away from heat, moisture, direct light, and freezing.
Safety Keep the medication out of the reach of children.

Disposal Instructions

Official guidelines state that unused or expired medicine should be returned via a drug take-back program. If a program is not available, the medication should be removed from its container, mixed with an undesirable substance (such as dirt or used coffee grounds), placed in a sealed bag or can, and disposed of in the household trash. All personal information must be obscured on the original packaging before disposal.

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

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