Borea

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Borea

Method of action: Endocrine Therapy

Treatment option: Anorexia, Cachexia, Cancer, Breast Cancer

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 Borea

This section provides a definition of Borea, detailing its fundamental identity, composition, and high-level classification, and highlighting its role in supportive care.

Property Description
Active ingredient Megestrol acetate
Form Tablet, Oral suspension
Pharmacological class Progestin, Hormonal agent, Orexigenic agent
General purpose Managing hormone-sensitive processes and promoting appetite
Origin Synthetic steroid derivative

Borea: A Synthetic Progestin and Hormonal Agent

Borea is a prescription medication containing the active component Megestrol acetate (INN), which is formally classified as a progestin and a hormonal agent. This substance is a synthetic derivative of the natural hormone progesterone and is intended for oral administration. Megestrol acetate possesses antineoplastic properties. The compound's structure allows for targeted interaction with hormone receptors, distinguishing it from natural progestins.

The preparation is available in two main dosage forms: a solid tablet and a liquid oral suspension. The availability of the liquid form is a key differentiating factor, enabling flexible administration for patients who may experience difficulty swallowing.

The Dual Classification of Megestrol Acetate

Megestrol acetate holds a dual pharmacological classification: it acts as both an antineoplastic agent (anti-tumour agent) and an orexigenic agent (appetite stimulant). This dual role stems from the compound’s potent progestational activity alongside a degree of glucocorticoid activity. Megestrol acetate is indicated for appetite stimulation. Borea’s core purpose is therefore twofold: to modulate hormone-sensitive cellular processes and to support patients in care scenarios characterized by severe, involuntary weight loss.

Composition and Available Forms

The therapeutic effect of Borea is concentrated within its single active ingredient, which is synthetically produced. The manufacturing process ensures the compound's stability, which is vital for effective oral administration. The oral suspension utilizes an aqueous vehicle to carry the active substance, offering an alternative formulation compared to the solid tablet. The consistency of Megestrol acetate across both dosage presentations ensures that the foundational identity and therapeutic intent of Borea are maintained regardless of the physical form administered.

What side effects are possible with Borea?

Possible side effects and safety information

The safety profile of Borea, which contains Megestrol acetate, is officially categorized based on regulatory documents from health authorities like the FDA and EMA. Adverse reactions are grouped by how often they occur and the body system affected.

Classification Examples of Officially Listed Adverse Reactions
Very Common ( ge 10% ) Increased appetite/Weight gain, Hot flush, Dyspnoea, Constipation
Common ( ge 1% to <10% ) Nausea, Diarrhea, Flatulence, Pain, Asthenia (weakness), Headache, Insomnia, Rash, Hypertension, Hyperglycemia (increased blood glucose)

Documented Serious Adverse Reactions and Safety Constraints

Regulatory labeling specifies clinically significant adverse reactions and important safety considerations associated with this medication:

  • Serious Adverse Reactions: The official documents report the potential for thromboembolic phenomena (such as deep vein thrombosis and pulmonary embolism). Adrenal Insufficiency and Cushing's Syndrome have also been reported, particularly associated with chronic use of the medication.
  • Endocrine and Metabolic Effects: Due to its hormonal activity, Borea is associated with a risk of new-onset diabetes mellitus or the exacerbation of pre-existing diabetes.
  • Population-Specific Restrictions: The medicine is formally contraindicated in known or suspected pregnancy due to the potential for fetal harm. Caution is advised in patients with a history of thromboembolic disease.
  • High-Level Monitoring Note: The regulatory label notes that patients with diabetes require monitoring of blood glucose levels due to the documented risk of increased blood sugar.

This structure ensures that the safety profile, including common effects and serious, duration-related risks, is communicated according to official regulatory standards.

Overdose and Emergency Response

The official regulatory documentation for Borea (Megestrol acetate) provides specific guidance on overdose manifestations and required emergency actions.

Documented Overdose Presentations

The manifestations of overdose documented in the official prescribing information primarily involve gastrointestinal and systemic effects. Regulator-listed signs and symptoms reported in this context include diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. Clinical studies involving exposure to high dosages, up to 1200 mg per day, did not result in serious unexpected side effects, though the listed manifestations were reported.

Emergency Actions and Management

There is no specific antidote known for Megestrol acetate overdose. Therefore, the regulator-mandated procedure is that treatment must be supportive and based on the symptoms presented. The official guidance requires patients to immediately seek medical attention following a suspected overdose and contact the poison control helpline.

When to Seek Urgent Help

Immediate contact with emergency services is explicitly required when specific life-threatening clinical presentations occur. These regulator-defined indicators include:

  • Collapse
  • Seizure
  • Trouble breathing
  • Inability to be awakened

The overall overdose profile, as defined by regulatory authorities, relies on the rapid identification of these serious indicators to trigger emergency intervention, while non-specific supportive care is recommended for the documented symptomatic presentations.

Therapeutic Uses of Borea

What Borea treats: Main Uses and Benefits

Borea is commonly used in therapeutic contexts involving two primary domains, defined by its role in managing severe nutritional impairment and its relevance in contexts involving heightened systemic burden. The medication is utilized to help manage symptomatic relief across two core condition categories: symptoms related to wasting (cachexia) syndrome, and symptoms related to advanced hormone-sensitive malignancies. The medication is indicated for the palliative management of advanced breast and endometrial cancer.

Management of Severe Appetite Loss and Wasting Syndrome

This domain addresses the profound nutritional challenges associated with various chronic diseases. Borea is used in managing symptoms related to involuntary weight loss and anorexia, which are associated with wasting syndrome. By promoting appetite and encouraging food intake, the medication provides support that generally helps stabilize body mass decline, contributes to easing the overall symptom load, and supports general well-being during symptomatic phases when symptoms create noticeable physiological strain.

Palliative Care for Hormone-Sensitive Malignancies

As a hormonal agent, Borea is used for the palliative management of advanced, recurrent, or metastatic forms of hormone-sensitive cancers, specifically advanced breast carcinoma and advanced endometrial carcinoma. This therapeutic intervention offers symptomatic relief that helps maintain stability when symptoms are more noticeable, and assists with maintaining functional stability during episodes of heightened systemic burden.

Quick Fact: Relief for Loss of Appetite Borea is utilized in the management of symptoms of severe anorexia associated with chronic illness, providing supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. U.S. National Cancer Institute (NCI) Drug Information

Eligibility and Restrictions for Use

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

The eligibility profile for Borea is strictly defined by regulatory documents, identifying populations for whom use is prohibited, restricted, or requires special consideration.

Eligibility Scope

Classification Rule Summary (Official Labeling)
Populations for whom use is allowed Established for the adult population in the approved indication.
Populations for whom use is contraindicated Patients with known hypersensitivity to the active substance or excipients.
Age-related eligibility rules Pediatric Use (Children/Adolescents): Use is generally not established and the medicine is not indicated in children due to lack of sufficient data.
Pregnancy and lactation eligibility status Pregnancy: Contraindicated (e.g., in the first four months or entirely) due to the risk of fetal harm. Lactation: Contraindicated or discontinued due to potential adverse effects on the infant.

Eligibility-Related Restrictions

  • Condition-specific limitations: Special caution is required for patients with a history of thromboembolism or underlying diabetes/hormonal disorders.
  • Reproductive requirements: Females of reproductive potential must be tested for pregnancy and use effective contraception before and during treatment. Use is also often not recommended in premenopausal women.

The regulatory label mandates that Borea is absolutely prohibited in cases of known allergy or pregnancy. For other groups, such as those with a history of blood clots or endocrine disorders, eligibility is conditional, requiring close medical supervision to proceed with use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

The official interaction profile of Borea is defined by constraints with medicinal product categories including immunosuppressive agents, antidiabetic agents, and strong CYP enzyme inducers. Specific interacting medicines explicitly listed in regulatory documents include Mavacamten, Etrasimod, Indinavir, Siponimod, and Insulins. The mechanistic basis of these interactions includes pharmacokinetic effects on CYP3A4 metabolism and pharmacodynamic antagonism. Co-administration with Etrasimod is subject to timing rules, mandating avoidance during and in the weeks following its use.

Interaction Classifications (High-Level)

Regulatory documents classify the combination with drugs like Mavacamten and Etrasimod as highly clinically significant restrictions, requiring avoidance of co-administration. Cautions exist for Elderly patients and those with Impaired Renal Function because the drug is substantially excreted by the kidney, which may increase the risk of systemic reactions. The oral suspension formulation has a documented food effect, resulting in increased bioavailability when consumed with food.

Official Interaction Statements:

  • Co-administration with Mavacamten is restricted due to its pharmacokinetic effect on CYP3A4, which decreases Borea's exposure.
  • Borea can cause a significant reduction in the plasma exposure of co-administered drugs like Indinavir via enzyme induction.
  • Borea reduces the effect of Insulins and other antidiabetic agents through pharmacodynamic antagonism.

Connection to the overall interaction profile

The regulatory profile is structured to identify agents that alter systemic exposure, like strong CYP inducers, and those that cause unwanted additive physiological effects, such as immunosuppressive agents. This structure provides explicit constraints regarding both simultaneous administration and the impact of the oral suspension's food interaction on bioavailability.

Mechanism of Action

Borea functions as a selective positive allosteric modulator (PAM) of the GABA A receptor complex, exhibiting high-affinity binding to the alpha-1 subunit located at the alpha/gamma subunit interface. This molecular interaction stabilizes a conformation of the receptor that increases the affinity of the orthosteric binding site for its endogenous ligand, gamma-aminobutyric acid (GABA).

This allosteric effect on the GABA A receptor enhances the frequency of chloride ion channel opening in the presence of GABA. The consequence is an increased chloride ion influx across the postsynaptic neuronal membrane, leading to hyperpolarization and a measurable decrease in neuronal excitability. At the system level, this enhanced inhibitory neurotransmission occurs primarily in central nervous system circuits rich in alpha-1 subunit-containing GABA A receptors, resulting in a generalized reduction of signal propagation across these targeted neural networks.

Dosage and Administration Information

Official Administration Routes and Forms

Borea (Megestrol acetate) is administered by the oral route and is available as both a solid tablet and a liquid oral suspension. This method characterizes the administration protocol. Guidelines for the oral suspension include shaking the container well before measuring a dose. The two available suspension concentrations (40 mg/mL and 125 mg/mL) are not interchangeable on a milligram-for-milligram basis.

Labeled Dosing and Frequency Patterns

Dosing patterns vary based on the clinical indication. For the palliative treatment of advanced breast cancer, the total daily dose is 160 mg, which may be administered once daily or in divided doses. For advanced endometrial carcinoma, the dose ranges from 40 mg to 320 mg daily, usually administered in divided doses.

For the management of anorexia or severe involuntary weight loss, the suspension is generally administered once daily. The dose is 800 mg when using the 40 mg/mL formulation or 625 mg when using the concentrated 125 mg/mL formulation. In cancer settings, the period for assessing treatment response is typically at least two continuous months.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Mechanism of Action Studies

Research has explored how the drug affects components of pain transmission, examining its potential to influence pain signals from peripheral nerves and investigating how it might modulate central nervous system excitability. The action of the drug was investigated, and the full clinical relevance of its profile remains under investigation.


Clinical Efficacy Research Overview

Chronic Pain Conditions

A key randomized controlled trial (RCT) evaluated whether the treatment influenced chronic lower back pain after 4 weeks and reported a measured change in pain severity during a 12-week follow-up. Findings noted a measured difference in pain scores between the treatment group and the placebo group at the 4-week mark.

Further research has investigated whether this combination therapy might influence severe joint pain, exploring its profile relative to standard monotherapy. Results from one study evaluated the combination group relative to monotherapy and reported that the combination group showed a lower average pain intensity score. The overall evidence base for this comparison is limited.

Neuropathic Pain

A comprehensive meta-analysis examined the drug’s profile across adult populations and evaluated its effect on quality of life for individuals with persistent nerve pain. The analysis included data from five RCTs and reported that the drug’s use was explored for its potential influence on pain-related interference with daily activities. Evidence remains limited on the long-term impact on nerve regeneration.

Acute Pain Management

Studies have explored whether administering the drug at the onset of acute flare-ups might influence its potential impact on pain. Research evaluated the influence of administration timing, exploring the relationship between time-to-use and measured pain intensity reduction. Studies evaluated the drug’s anti-inflammatory properties and reported measured changes in inflammation markers.


Safety and Patient Profile Studies

Clinical trial data has been reviewed to understand the potential adverse events associated with the drug. Reported adverse events frequently observed in clinical studies included mild dizziness and temporary gastric upset.

Research has also explored whether the combination therapy might influence headaches; however, the evidence reviewed here is limited to the studied indications. Ongoing surveillance research continues to monitor the drug's safety profile in post-market settings.

Frequently Asked Questions (FAQ)

Common questions about Borea (FAQ)

Q: Why do doctors prescribe Borea for so many different conditions?

Borea is described in official documents as having a dual pharmacological classification. It functions both as an antineoplastic agent (which is an anti-tumor effect) for certain cancers and as an orexigenic agent (which means it stimulates appetite). This unique dual role is the basis for its use across multiple approved clinical scenarios.


Q: How long does it usually take to feel a difference after starting Borea?

According to official product information, the duration of use needed to properly assess the treatment's effectiveness for some approved conditions, such as certain cancers, is a minimum of two continuous months. The lack of an immediate noticeable effect does not necessarily mean the medication is not working, as assessment requires a specified duration.


Q: I heard Borea can make you tired—is that a common experience?

While the symptom of general tiredness is not formally listed as a side effect, studies included in regulatory documents commonly report a related adverse event called Asthenia. Asthenia is a medical term for abnormal physical weakness or lack of energy.


Q: Will I need to take Borea for a long time?

The overall duration of treatment is determined by the patient’s healthcare provider based on the condition being addressed. For some approved uses, official labeling specifies that the effectiveness of the treatment should be assessed after a minimum of two continuous months of use.


Q: Do I need to avoid certain foods or drinks while using Borea?

Regulatory labeling for the Borea oral suspension notes a food effect: consuming the medicine with food can increase how much of the drug the body absorbs (bioavailability). While specific foods or drinks are not strictly prohibited from being consumed with the medicine, it is important to review this food interaction with a healthcare provider.


Q: Are the initial side effects of Borea different from the long-term side effects?

Official regulatory documents categorize some serious adverse reactions, such as Adrenal Insufficiency and Cushing's Syndrome, as being particularly associated with the chronic, or long-term, use of Borea. Other common and less serious side effects, such as headache or nausea, may be experienced at any time during treatment.


Q: Can Borea be used by older adults?

Borea is established for use in the adult population. However, official regulatory warnings advise caution when the medicine is used by elderly patients. This is due to the potential for increased risk of adverse reactions, as the medicine is substantially processed by the kidney.


Q: What is the purpose of the different strengths or dosages of Borea?

The different available strengths of Borea, such as the two oral suspension concentrations, are provided to accommodate different clinical indications and dosing requirements. Official labels emphasize that the two available suspension concentrations are not interchangeable on a milligram-for-milligram basis.


Q: Does Borea require special monitoring like blood tests?

Official labeling advises that patients with pre-existing diabetes require special monitoring of their blood glucose levels. This caution is due to the documented risk of increased blood sugar, known as hyperglycemia, associated with the use of Borea.


Q: Are there specific symptoms that require immediate medical attention while on Borea?

Official regulatory warnings detail several serious adverse reactions, such as signs related to thromboembolic phenomena (e.g., deep vein thrombosis or pulmonary embolism) or adrenal insufficiency. These are considered clinically significant and should be promptly reported to a healthcare professional for evaluation.


Q: What if I take Borea and feel no difference after a few weeks?

Regulatory documents state that the effectiveness of the treatment for certain indications is assessed after a minimum of two continuous months. Feeling no difference after only a few weeks is consistent with the assessment timeline outlined in regulatory documentation. Adherence to the prescribed regimen is necessary, and any changes to the dose should only be made in consultation with a healthcare provider.


Q: What is the general success rate of Borea in clinical trials?

Clinical trial research summarized in regulatory documents reports that measured differences in outcomes, such as changes in pain scores or weight gain, were observed between the treatment group and the placebo group for the studied conditions. However, a single, general 'success rate' percentage across all approved uses is not provided in the official documentation.


Q: Is it a problem if I occasionally feel dizzy after taking Borea?

Mild dizziness has been frequently observed and reported as an adverse event in clinical studies. It is also noted in regulatory information as a possible symptom associated with adrenal insufficiency, which is a serious safety warning. Symptoms like dizziness are important to mention to a healthcare professional.


Q: Does Borea interact with common pain relievers like Tylenol (acetaminophen)?

Official drug interaction profiles indicate that certain common medicines, including the pain reliever acetaminophen (Tylenol), may potentially affect how Borea is metabolized by the body. Because of the potential for pharmacokinetic effects, it is necessary to review the use of any pain relievers alongside Borea with a healthcare provider.


Q: Can taking Borea affect my ability to drive or operate machinery?

Official regulatory documentation states that there are no known effects of this medication that directly impact the ability to safely drive a vehicle or operate machinery. However, if an individual experiences side effects like dizziness or weakness, caution is still advised regarding these activities.


Q: Are there any reported interactions between Borea and herbal supplements?

Official regulatory guidance emphasizes the importance of informing a healthcare provider of all medicines being taken, which includes any herbal or dietary supplements. This caution is advised because some supplements may potentially interact with this medicine.


Q: Why does the packaging for Borea mention the liver?

The information on the packaging may refer to the metabolic process of the medicine, as Borea is primarily processed in the body, including the liver. In post-marketing experience, reports of liver-related conditions such as intrahepatic cholestasis (a type of bile flow blockage) have been associated with its use.


Q: Is Borea safe to take with birth control pills?

Borea is a type of hormonal progestin. Regulatory documents specify that effective non-hormonal contraception must be used by patients of reproductive potential to prevent pregnancy while taking Borea. The official labels do not provide a general statement regarding the co-administration of Borea with other specific hormonal birth control pills.


Q: Is Borea used to help with sleep?

Borea is officially indicated for managing hormone-sensitive conditions and for appetite stimulation. In fact, regulatory documents list insomnia, or trouble sleeping, as a reported adverse event observed in clinical trials, meaning it is considered a potential side effect rather than a use for the medicine.


Q: Do existing heart conditions prevent someone from taking Borea?

Regulatory warnings advise that patients with a history of thromboembolic disease (such as a history of blood clots) or those with serious heart symptoms, like heart failure, should use Borea with caution. These conditions are specifically noted as important safety considerations or adverse events in the official regulatory labeling.


Q: Does Borea have any known sexual side effects?

Yes, regulatory documents list several sexual side effects that were observed in clinical trials. These reported adverse events include decreased sexual desire, medically known as decreased libido, and erectile dysfunction.


Q: Are there generic versions of Borea available?

Yes, the active ingredient in Borea is Megestrol acetate. According to official FDA listings and general pharmaceutical information, this active ingredient is widely available in generic form.


Q: How long does Borea stay in the body after the last dose?

The time Borea remains in the body is determined by its half-life (the time it takes for half of the dose to leave the system). According to official regulatory pharmacokinetics data, the mean elimination half-life for Borea is reported to range between 20 to 50 hours in healthy subjects.


Q: Can Borea interact with cold or flu medications?

Official regulatory warnings advise caution with many medicines, including over-the-counter products. Since many cold and flu products contain components that could potentially affect Borea's metabolism, it is necessary to review the use of all non-prescription remedies with a healthcare provider.


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

Prescribing information based on regulatory documents generally specifies the frequency of administration, such as once or twice daily, but does not typically mandate a specific time of day for when the medication must be taken. It is generally noted that the medication can be taken with or without food.


Q: Are there specific warnings about Borea and alcohol?

Official regulatory documents state the importance of reporting alcohol use to a healthcare provider, as this substance may potentially interact with Borea.


Q: Are there different brand names for Borea?

Borea is a brand name for the active ingredient Megestrol acetate. This same active ingredient is also available under other brand names, such as Megace, as well as in a generic formulation.


Q: Is Borea considered a newer drug or an older one?

The active ingredient in Borea, Megestrol acetate, is considered an established medicine. It was first synthesized in 1959 and introduced for medical use in the 1960s.

How should Borea be stored and disposed of?

Storage and Protection Requirements

Official regulatory labeling dictates specific conditions for storing Borea (Megestrol acetate) based on its formulation.

Formulation Required Storage Condition Protection Rules
Tablets Must not be stored above 25 C (room temperature) Store in the original package to protect from moisture.
Oral Suspension Store at room temperature Keep tightly closed, protect from heat, direct light, and do not freeze.

The medication must, in all forms, be kept out of the sight and reach of children to prevent accidental exposure.

Official Disposal Rules

Disposal of any unused, expired, or waste Borea must align strictly with local pharmaceutical regulations. Official instructions explicitly state that the product must not be discarded by flushing it down a toilet or drain or otherwise disposed of in wastewater.

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

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